2018 Speaker Biographies

Plenary Keynotes (View)

Engineering Stream (View)

Oncology Stream (View)

Immunotherapy Stream (View)

Expression Stream (View)

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Immunogenicity & Bioassays Stream (View)

Bioconjugates Stream (View)

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Plenary Keynotes

K. Dane Wittrup, PhD, C.P. Dubbs Professor, Chemical Engineering and Biological Engineering; Associate Director, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology (MIT)

Professor K. Dane Wittrup is the Carbon P. Dubbs Professor of Chemical Engineering and Biological Engineering at the Massachusetts Institute of Technology, and the Associate Director of the Koch Institute for Integrative Cancer Research. From 1989-1999 he was Assistant Professor, Associate Professor, and then J. W. Westwater Professor of Chemical Engineering, Bioengineering, and Biophysics at the University of Illinois in Champaign/Urbana. Prof. Wittrup received a B.S. in Chemical Engineering Summa cum Laude in 1984 from the University of New Mexico, and a Ph.D. in Chemical Engineering from the California Institute of Technology in 1988 under the thesis direction of Prof. James Bailey. Following a year of postdoctoral research at Amgen (Thousand Oaks, CA), Dr. Wittrup joined the faculty at the University of Illinois. Wittrup’s research program is focused on protein engineering of biopharmaceutical proteins by directed evolution. Areas of interest include: pretargeted radioimmunotherapy; biological response modification of EGFR; and immunotherapy of cancer via engineered cytokines and vaccines.

Prof. Wittrup has received the following awards and honors recognizing his scholarship: the A. McLaren White Award, for First Prize in the National American Institute of Chemical Engineers Student Design Contest (1984); the Presidential Young Investigator Award of the National Science Foundation (1990-1995); the Allan P. Colburn Award of the American Institute of Chemical Engineers, for excellence in publications for an individual under the age of 35 (1998); the University of New Mexico College of Engineering Distinguished Young Alumnus Award (2000); the Dow Chemical Company Teaching Award(1989); the UIUC School of Chemical Sciences Award for Excellence in Teaching (1993); the UIUC College of Engineering Anderson Award for Undergraduate Advising (1991, 1994); the J.R. Mares Professorship (1999- 2007); the C.P. Dubbs Professorship (2007-); induction as a Fellow of the American Institute of Medical and Biological Engineers (1999); induction as Fellow, American Association for the Advancement of Science (2011); and Member, National Academy of Engineering (2012). Prof. Wittrup has mentored the following Ph.D. students and postdoctoral fellows who are now faculty members: Jennifer Cochran (Bioengineering, Stanford University); Ben Hackel (Chemical Engineering, University of Minnesota); Anne Robinson (Chemical Engineering, Tulane University); David Colby (Chemical Engineering, University of Delaware); Eric Boder (Chemical Engineering, University of Tennessee); Eric Shusta (Chemical Engineering, University of Wisconsin, Madison); Jennifer van Antwerp (Chemical Engineering, Calvin College); Balaji Rao (Chemical Engineering, North Carolina State University); Yong-Sung Kim (Biotechnology, Ajou University, Korea); Mark Olsen (Biochemistry, Texas A & M, Amarillo). In 2007, Prof. Wittrup co-founded Adimab, Inc. with Tillman Gerngross of Dartmouth University, and serves as CSO. In 2009, he co-founded Eleven Biotherapeutics, and serves on the Scientific Advisory Board.

Kipp Weiskopf, MD, PhD, Resident Physician, Internal Medicine, Brigham and Women’s Hospital

Kipp Weiskopf, M.D., Ph.D., is a resident physician in Internal Medicine at Brigham and Women’s Hospital in Boston, MA. He completed his training in the Medical Scientist Training Program at Stanford University. His research focuses on the development of novel cancer immunotherapies, particularly those that activate innate immune cells to attack cancer. In the laboratory of Irving Weissman, M.D., he studied the interaction between CD47 and SIRPα, which acts as a myeloid-specific immune checkpoint. He developed novel therapies that disrupt the CD47-SIRPa interaction and stimulate macrophage phagocytosis of cancer cells. He has over 10 patent applications related to this work and was a winner of the 2013 Collegiate Inventors Competition at the US Patent and Trademark Office. He is a co-Founder of Alexo Therapeutics, a biotech company formed to develop these therapeutics. He has also been the recipient of a Winston Churchill Scholarship, an NCI Ruth L. Kirschstein NRSA Fellowship, the Harold M. Weintraub Graduate Student Award from the Fred Hutchinson Cancer Research Center, and the Joanna M. Nicolay Melanoma Foundation Research Scholar Award.

Display of Antibodies

Andrew Bradbury, PhD

Andrew Bradbury is one of the founders of Specifica, a member of the Board of Directors, and serves as the Chief Scientific Officer. Andrew has almost 30 years of experience in the field of recombinant antibodies and display technologies. Throughout his career, he has developed and employed novel technologies, including the use of lox recombination to dramatically increase antibody library diversity. Andrew is a vocal proponent for the use of sequenced recombinant antibodies in research to improve reproducibility. He has frequently served as an expert witness in antibody patent cases involving some of the world’s bestselling antibody drugs. Andrew has published over 130 peer-reviewed papers and is the inventor on numerous patents and patent applications. Andrew holds a PhD from Cambridge University, where he studied under Nobel Laureate Cesar Milstein, the inventor of monoclonal antibodies, and holds an MB BS (medical degree) from the University of London as well as a BA and MA from Oxford University.

Frederic D Bushman, PhD

Frederic Bushman is the William Maul Measey Professor in Microbiology at the University of Pennsylvania, Perelman School of Medicine, and Chair of the Department of Microbiology. Dr. Bushman’s research focuses on host-microbe interactions in health and disease and include studies of the human microbiome, HIV pathogenesis, and DNA integration. Much of Dr. Bushman’s recent work is driven by deep sequencing and bioinformatic methods that allow comprehensive and model independent analysis of microbial populations and genetic modification. A particular interest is bacteriophage biology—Dr. Bushman trained in the laboratory of Dr. Mark Ptashne in the 1980s on phage lambda, and in recent years has brought metagenomic methods to studies of human phage populations. Dr. Bushman has published over 280 papers, and his ISI h factor is 82.

Bryce Chackerian, PhD

Dr. Chackerian received his BA at the University of California, Berkeley and his PhD from the University of Washington. He then trained in John Schiller's laboratory at the National Cancer Institute. In 2004, he joined the Department of Molecular Genetics and Microbiology at the University of New Mexico. The Chackerian laboratory is interested in vaccine development; particularly the use of virus particles as platforms for antigen display. It has long been recognized that highly dense repetitive antigens such as virus particles induce strong immune responses. However, more recent studies from Dr. Chackerian's laboratory has demonstrated that antigens that are normally poorly immunogenic can be made highly immunogenic by displaying them in a multivalent, repetitive format on the surface of virus particles; essentially using viruses as platforms for vaccines. Dr. Chackerian has shown that this ability to enhance immunogenicity does not only apply to epitopes derived from traditional targets, such as pathogens, but also to self-antigens which are normally subject to the mechanisms of B cell tolerance. Using virus-like particles derived from RNA bacteriophage, he has developed and implement a system that allows vaccines to be rapidly identified by affinity selection. Currently, the laboratory is working on projects to develop novel vaccines targeting Human Papillomavirus, Chlamydia, Malaria, HIV, and high cholesterol.

Jennifer Cochran, PhD

Dr. Cochran serves in the role of Chief Scientist of Lagunita Biosciences. Favoring innovation over iteration, she encourages and helps guide Lagunita portfolio companies to develop technologies that push boundaries and are disruptive. At Stanford, she is the Shriram Chair of Bioengineering, and Associate Professor of Bioengineering and (by courtesy) Chemical Engineering. She also serves as the Director of the Stanford/NIH Biotechnology predoctoral training program and co-Director of the Stanford/NIST predoctoral training program. Her expertise spans protein-based drug discovery and development for applications in oncology, regenerative medicine, and ophthalmology, and development of new technology for high-throughput protein analysis and engineering. Dr. Cochran obtained her PhD in Biological Chemistry from the Massachusetts Institute of Technology, where she also completed a postdoctoral fellowship in Biological Engineering. She has received the National Cancer Institute Howard Temin Award, the Martin D. Abeloff Scholar Award from the V Foundation for Cancer Research, an American Cancer Society Research Scholar Award, and a Sidney Kimmel Scholar Award. She was also named the 47th Mallinckrodt Faculty Scholar from the Edward Mallinckrodt Jr. Foundation. Dr. Cochran has published over 75 papers in peer-reviewed journals and is named as an inventor on over 35 patent applications.

Stefan Ewert, PhD

Stefan Ewert joined Novartis in 2004 and holds the position of a Senior Investigator within the NIBR Biologics Center. He is responsible for antibody phage display selections done in Basel. Before joining Novartis, he was instrumental in developing ESBATech’s scFv-based key technology. During his PhD thesis in the group of Andreas Plückthun at the University of Zürich, Switzerland he published several papers on antibody stability and engineering.

Jeffrey J. Gray, PhD

Jeffrey J. Gray’s research focuses on computational protein structure prediction and design, particularly protein-protein docking, therapeutic antibodies, and protein-surface interactions. Gray’s lab leads the development of RosettaDock, RosettaAntibody, the ROSIE web server, and the PyRosetta interactive platform for protein structure prediction and design; these tools are used by thousands of scientists. Gray’s lab has produced the most accurate complex structure for several targets in the CAPRI blind protein-protein docking challenge and sub-angstrom antibody binding loop structures in the Antibody Modeling Assessment. Gray’s work has been funded by NIH, NSF, DARPA, ACS, the Beckman Foundation, the Rosetta Commons, and the UCB company. Gray is also the Chair of the Homewood Council on Inclusive Excellence and the Director of the NSF-supported Rosetta Commons Summer Intern Program.

Ben Hackel, PhD

Ben Hackel is an Associate Professor of Chemical Engineering and Materials Science at the University of Minnesota. He has degrees in chemical engineering from the University of Wisconsin – Madison (B.S. 2003) and MIT (PhD 2009), where he worked with Dane Wittrup on engineering fibronectin domains as antibody mimics. Prof. Hackel was a postdoctoral fellow in Radiology at Stanford University with Sam Gambhir where he developed molecular probes for cancer detection and characterization via positron emission tomography. At the University of Minnesota, the Hackel lab develops evolutionary technologies to engineer synthetic proteins for physiological targeting and molecular imaging with applications in oncology, infectious disease, and neuroscience. In addition to his primary appointment, Prof. Hackel is a graduate faculty member of Biomedical Engineering and a member of the University of Minnesota Masonic Cancer Center, the Institute for Engineering in Medicine, and the Minnesota Supercomputing Institute.

Joseph Jardine, PhD

Joseph Jardine is the Head of Antibody Discovery at the Institute for Protein Innovation. Dr. Jardine has extensive experience in protein engineering and antibody design, particularly in the field of HIV vaccinology. In this position, Dr. Jardine will apply his expertise in leading the institute’s antibody discovery efforts, including the design and construction of a fully-synthetic human antibody library displayed on yeast. Dr. Jardine began his training at the University of Washington under William Schief, PhD and David Baker, PhD, focusing on rational protein engineering. In 2011, he moved with the Schief lab to the Department of Immunology & Microbial Science at The Scripps Research Institute (La Jolla, CA, receiving his PhD in 2014. His thesis focused on the development of germline-targeting immunogens and the design of pathway immunization strategies to elicit broadly neutralizing antibodies against HIV. After completing his PhD, Dr. Jardine elected to stay at Scripps for postdoctoral training under Dennis Burton, PhD and to continue his work on HIV vaccine development. As a postdoctoral fellow, he received a Helen Hay Whitney Postdoctoral Research Fellowship and a Young Investigator Award from the Center for HIV/AIDS Vaccine Immunology.

David R. Liu, PhD

David R. Liu is Professor of Chemistry and Chemical Biology at Harvard University, Howard Hughes Medical Institute Investigator, and Core Institute Member and Vice-Chair of the Faculty of the Broad Institute of Harvard and MIT. Liu graduated first in his class at Harvard in 1994. He performed synthetic organic and bioorganic chemistry research on sterol biosynthesis under Professor E. J. Corey’s guidance as an undergraduate. During his PhD research with Professor Peter Schultz at U. C. Berkeley, Liu initiated the first general effort to expand the genetic code in living cells. He earned his PhD in 1999 and became Assistant Professor of Chemistry and Chemical Biology at Harvard University in the same year. He was promoted to Associate Professor in 2003 and to Full Professor in 2005. Liu became a Howard Hughes Medical Institute Investigator in 2005 and joined the JASONs, academic science advisors to the U.S. government, in 2009. Liu has earned several university-wide distinctions for teaching at Harvard, including the Joseph R. Levenson Memorial Teaching Prize, the Roslyn Abramson Award, and a Harvard College Professorship. He has published approximately 150 papers and 50 issued patents. His research accomplishments have earned distinctions including the Ronald Breslow Award for Biomimetic Chemistry, the American Chemical Society Pure Chemistry Award, the Arthur C. Cope Young Scholar Award, and awards from the Sloan Foundation, Beckman Foundation, NSF CAREER Program, and Searle Scholars Program. In 2016 he was named one of the Top 20 Translational Researchers in the world by Nature Biotechnology. Professor Liu’s research integrates chemistry and evolution to illuminate biology and enable next-generation therapeutics. His major research interests include the engineering and delivery of genome-editing proteins to study and treat genetic diseases; the evolution of proteins with novel therapeutic potential using phage-assisted continuous evolution (PACE); and the discovery of bioactive synthetic small molecules and synthetic polymers through DNA-templated organic synthesis, an approach pioneered in his laboratory. He is the scientific founder or co-founder of several biotechnology and therapeutics companies including Ensemble Therapeutics, Permeon Biologics, Editas Medicine, Pairwise Plants, and Beam Therapeutics.

Chuanbin Mao, PhD

Chuanbin Mao received his PhD from Northeastern University (China) and conducted postdoctoral studies at Tsinghua University and the University of Texas at Austin. He has received many awards including Oklahoma New Scientist Award, National Science Foundation CAREER Award, Chinese American Chemistry and Chemical Biology Professors Association (CAPA) Distinguished Junior Faculty Award, University of Oklahoma Presidential Professorship and George Lynn Cross Professorhip. His research interests include phage display, drug/gene delivery, biomaterials, tissue engineering, bionanotechnology, and nanomedicine. His research has led to about 190 peer-reviewed publications.

Jennifer Maynard, PhD

Dr. Maynard received her undergraduate degree in Human Biology from Stanford University, followed by a PhD in Chemical Engineering from the University of Texas at Austin, and post-doctoral studies as an NIH NRSA fellow in Microbiology and Immunology at Stanford University. She returned to the University of Texas at Austin as a faculty member in the Department of Chemical Engineering in 2007.

James M. Olson, MD, PhD

As a physician-scientist, Dr. Olson cares for children with brain tumors and both discovers and develops new cancer therapies. His lab’s work has led to more than a dozen national clinical trials, of which he leads a Phase III trial through the Children’s Oncology Group. Dr. Olson is the founder of Presage Biosciences and Blaze Bioscience. His lab invented the chlorotoxin-based Tumor Paint, which led to the development by Blaze of the clinical candidate Tozuleristide (BLZ-100), now in human trials. He authored “Clinical Pharmacology Made Ridiculously Simple,” which has been the most used pharmacology board review book for more than 25 years. Dr. Olson earned his PhD in Pharmacology in 1989 and his MD in 1991, both from the University of Michigan. He then completed his residency in pediatrics in 1994 and his fellowship in pediatric oncology in 1997, both at the University of Washington. Dr. Olson is currently a Full Member at the Fred Hutchinson Cancer Research Center, a Professor at the University of Washington, and an Attending Physician at Seattle Children’s Hospital.

Timothy Palzkill, PhD

Dr. Palzkill holds the Cullen Trust for Higher Education Chair and is Professor and Chair of the Department of Pharmacology and Chemical Biology at Baylor College of Medicine. He received his PhD from the University of Iowa and did postdoctoral training at Genentech and Stanford University with Dr. David Botstein. His laboratory has been funded continuously by the NIH for 25 years with >130 publications. His research is focused on enzyme structure, function and evolution as well as molecular recognition in protein-protein interactions. A major research focus is on the structure, function and evolution of beta-lactamase enzymes, which hydrolyze the beta-lactam antibiotics to provide bacterial drug resistance. An additional focus is on the discovery, dissection and engineering of protein-protein interactions. This work includes the use of phage display of random sequence and genomic libraries to identify protein-protein interactions as well as directed evolution studies to enhance affinity in protein-protein interactions.

Balaji M. Rao, PhD

Bala Rao is an Associate Professor in the Department of Chemical and Biomolecular Engineering at North Carolina State University. His research group focuses on two areas: molecular mechanisms regulating early human placental development, with emphasis on use of human embryonic stem cell derived in vitro models; and, molecular recognition using non-antibody proteins and peptides, with emphasis on building novel tools for cell biology applications. Prior to joining NC State, Bala obtained his PhD in Chemical Engineering at MIT, and completed post-doctoral work at the University of Toronto.

Greg M. Thurber, PhD

Greg M. Thurber is an Assistant Professor of Chemical Engineering and Biomedical Engineering at the University of Michigan. His work focuses on applying fundamental biotransport principles to design novel therapeutics and molecular imaging agents. These widely applicable techniques have found use in the Thurber laboratory in diverse projects ranging from self-administration of near-infrared molecular imaging agents for early disease detection to the modular design of stabilized alpha helices using bioorthogonal chemistry. Some of the concepts for monoclonal antibodies have found recent applications in designing improved antibody-drug conjugates for cancer therapy. Prof. Thurber received his training in protein therapeutics at MIT under the guidance of Dr. Dane Wittrup. He completed his in vivo training in molecular imaging in the laboratory of Dr. Ralph Weissleder at Mass General Hospital and Harvard Medical School. Since joining the faculty at Michigan, he has delivered over 15 invited talks at major pharmaceutical companies, national and international conferences, and university departmental seminars. He and his students have also presented their interdisciplinary work at chemistry, chemical engineering, and pharmaceutical science conferences. Prof. Thurber has authored 30 peer-reviewed journal publications, 3 book chapters, and numerous conference proceedings. He has received several awards including an NIH K01 award and the National Science Foundation CAREER award.

Benjamin Umlauf, PhD

I performed my undergraduate research, and worked, at the Mayo Clinic with the Vaccine Research Group before attending UT Southwestern to complete my graduate studies under the mentorship of Kathlynn Brown. During this time, I studied subcellular localization of peptide targeting ligands and developed methods for identification of targeting ligands that internalize in a given cell type as well as traffic to define subcellular compartments. Finally, I translated these ligands into a novel immunotherapy platform we developed for treating Non-small cell lung cancer. I am currently a post-doc at the University of Wisconsin in the laboratory of Eric Shusta. In collaboration with John Kuo in the department of Neurosurgery, we are working to identify and develop novel targeting ligands and strategies for treating brain tumors.

Gregory A. Weiss, PhD

My lab studies the atoms, bonds, and molecules that make life possible. We invent tools to dissect how such biomolecules work, and develop technologies to control, improve, and fix them. Our team has openings for outstanding researchers at all levels in chemical biology, bioengineering, protein engineering, molecular biology, biochemistry, and biophysics.

Engineering Antibodies

Joel Cohen-Solal, PhD

Joel graduated in Paris in Pr Herve Fridman unit at INSERM on Fc gamma Receptors biology and FcɣRIIb gain of expression by metastatic melanoma. As a postdoc he joined the laboratory of Dr Betty Diamond at the Feinstein Institute in Manhasset, NY where he worked on mouse models of autoimmune diseases. He was in house scientific editor for the Journal of Experimental Medicine. In 2015 he joined Abbvie Bioresearch Center in Worcester MA as a Senior Scientist in the Global Protein Sciences group.

Caroline Colley, PhD

Caroline Colley is a team leader within the Antibody Discovery and Protein Engineering group at MedImmune (formerly Cambridge Antibody Technology, CAT) having joined CAT in 2000. She leads drug discovery teams responsible for isolation, optimization and functional characterization of candidate therapeutic biologic drugs and specializes in assay development, high-throughput screening and pharmacological characterization of biologic drugs. Caroline graduated in Microbiology (BSc Hons) from Edinburgh University (UK) in 1992 and worked as a brewing microbiologist prior to carrying out research into the mechanisms of RNA splicing for 5 years. Before joining CAT, she spent a year at GSK researching cardiovascular biology.

Bruno Emanuel Correia, PhD

Bruno Emanuel Correia (born 1980) is an assistant professor of bioengineering at the Institute of Bioengineering, École Polytechnique Fédérale de Lausanne since 2015. His research focuses on the development of computational methodologies for protein design. The Correia lab leverages these tools to design in silico novel functional proteins that ultimately aim to solve biomedical problems (e. g. vaccine design). Among his contributions, he was the first to computationally design immunogens that could act as vaccines, and he has also done important contributions in the field of chemical biology by using proteomics to map small-molecule binding sites in native proteomes. He has published approximately 20 papers (Nature 3x, Science, Cell 3x, Nature Chemistry, PNAS) and 7 patents.

Abhishek Datta, PhD

Dr. Datta currently leads the Antibody Discovery & Engineering group at Scholar Rock. Prior to joining Scholar Rock Dr. Datta was a Scientist in the Antibody display group at Biogen where he led a number of therapeutic antibody discovery and engineering campaigns using yeast display and B-cell cloning technologies. Dr. Datta has a PhD from the University of Illinois at Chicago and got his post-doctoral training at Harvard Medical School/Children’s Hospital Boston.

David S. Johnson, PhD

Dr. David S. Johnson is an inventor, entrepreneur, and expert in genomics. He filed one of the earliest patents in single cell droplet microfluidics. At GigaGen, Dr. Johnson has raised >$63 million from Grifols, Novartis, Sequoia Capital, NSF, and NIH. Dr. Johnson was formerly on the founding team and COO of Natera (NASDAQ: NTRA), which had its IPO in July 2015, and sold >$250 million worth of diagnostic tests in 2016.

JT Koerber, PhD

He received his PhD in Chemical Engineering from the University of California Berkeley where he developed a viral gene therapy platform to engineer viruses with user-defined gene delivery properties such as cell-specific tropism and antibody evasion. He then completed a post-doc with Jim Wells at the University of California San Francisco where he designed a novel structure-based design platform to generate phospho-specific antibodies. His lab at Genentech is focused on novel technologies to advance antibody discovery against challenging targets.

Greg Lazar, PhD

Greg Lazar received his BS in Molecular & Cell Biology and Chemistry from Penn State, his PhD in Molecular & Cell Biology from the University of California at Berkeley, and did postdoctoral research at the University of Cambridge, UK.  Previously he led research groups at Eli Lilly and Xencor.  Currently he is Director and Senior Scientist in Antibody Engineering at Genentech where he oversees antibody technology platforms, high-throughput protein production, and infrastructure for automation, software, and informatics.  His research group is focused on the development of novel antibody technologies to enable next generation therapeutics to treat unmet medical needs in oncology and neuroscience.

Chang-Han Lee, PhD

Chang-Han Lee got the PhD degree at Ajou University in South Korea and has studied therapeutic protein scaffold and antibody engineering. He joined George Georgiou research group in UT at Austin from 2013, and is studying Fc engineering to modulate biological function.

Jonas Schaefer, PhD

For more than six years, Dr. Schaefer has been heading the High-Throughput Binder Selection Facility of the Department of Biochemistry, using automated Ribosome Display and various High-Throughput screenings to develop specific alternative affinity reagents (called DARPins). With his team, he develops new methodologies enabling the generation, screening and validation of several thousand binders per target which are used in more than 100 international collaborations for a diversity of applications, ranging from basic research to diagnostic usage and medical applications.

Eva-Maria Strauch, PhD

Dr. Strauch is an expert in the field of computational structural design of protein-protein interactions and de novo design of small protein scaffolds. Her work has resulted the design of high affinity and highly potent proteins that target the Influenza virus and has paved new avenues for innovative therapeutics and diagnostics. Her recent work resulted in the first higher-order design for function that combined symmetry matching of oligomers with protein binding. Dr. Strauch graduated with a Ph.D. from the Chemistry/Biochemistry Department of the University of Texas at Austin, where she pioneered genetic screens for secretion, and protein interactions. For her post-doctoral training, she joined Dr. David Baker's lab at the University of Washington to develop and apply new computational methods for the design of protein-protein interfaces. She recently joined the department of Microbiology at the University of Washington as faculty in affiliation with the Institute for Protein Design.

E. Sally Ward, PhD

Dr. Sally Ward completed her Ph.D. research in the Department of Biochemistry, Cambridge University, Cambridge, U.K. in 1985. From 1985-1988 she was a Research Fellow at Gonville and Caius College whilst working at the Department of Biochemistry, Cambridge University. From 1988 to 1990, she held the Stanley Elmore Senior Research Fellowship at Sidney Sussex College and carried out research in Sir Greg Winter's laboratory at the MRC Laboratory of Molecular Biology in Cambridge.

In 1990 she joined the University of Texas Southwestern Medical Center, Dallas, as an Assistant Professor. Since 2002, she was a Professor in the Department of Immunology at the same institution and in 2004 was appointed to the Paul and Betty Meek-FINA Professorship in Molecular Immunology. In 2014 she moved as a Professor to Texas A&M Health Science Center. Her current research interests include understanding FcRn function in mouse and man, with a particular focus on using a combination of fluorescence imaging, protein engineering and in vivo studies to understand the factors that regulate the distribution and transport of antibodies. A second area of interest is to characterize the behavior, at the subcellular level, of molecular targets in cancer. Her work includes the development of antibody-based therapies in mouse models of autoimmunity and cancer. She is a member of the Board of Distinguished Advisors in the Antibody Society and serves on the editorial boards of mAbs and Protein Engineering, Design and Selection.

Danlin Yang

I have a B.AS. in Chemical Engineering from the University of Waterloo in Canada, a M.S. in Biotechnology from Lund Institute of Technology in Sweden, and I am currently a PhD candidate in Biochemistry and Biophysics at the University of New Hampshire in the U.S. I joined the Biotherapeutics Discovery CMC/Biophysics group at Boehringer Ingelheim in late 2010, and shortly after decided to pursue a PhD while maintaining my full-time position at the company. Under the guidance of my PhD advisor Dr. Tom Laue, my thesis work focuses on investigating the influence of IgG subclasses and macromolecular cooperativity in structure, stability, and assembly using a variety of biophysical methods. Simultaneously, while working at BI, my core responsibilities have revolved around antibody candidate identification, selection, and characterization from early discovery to development stage on a variety of therapeutic indications, leading to the advancement of candidates into clinical development.

Andy Yeung, PhD

Andy Yeung is an Associate Research Fellow in the Department of Protein Engineering at Rinat laboratory, Oncology R&D, Pfizer Inc. He graduated from MIT with a PhD in Chemical Engineering, followed by postdoctoral research study in the Department of Antibody Engineering at Genentech Inc. He has worked at Rinat since 2009. His research group focuses on antibody generation, design, and engineering.

Engineering Bispecific Antibodies

Mahiuddin Ahmed, PhD

He is a member of the research faculty at Memorial Sloan-Kettering Cancer Center, specializing in Antibody and Therapeutic Protein Engineering. Expertise in utilizing computational chemistry and biophysical methods to optimize antibody affinity, specificity, stability, pharmacokinetics, manufacturability and formulation

Edward A. Berger, PhD

Dr. Berger received a B.S. from CCNY, then a PhD from Cornell (Biochemistry and Molecular Biology, 1973), followed by postdocs at Stanford Univ. Sch. Med. and Scripps Clinic Research Foundation. After a 10-year faculty appointment at the Worcester Foundation for Experimental Biology, he joined the Laboratory of Viral Diseases, NIAID, NIH (1987-present). Dr. Berger’s research is focused on virus entry mechanisms (particularly HIV), and related translational approaches to treat/prevent virus infection. His basic research led to discovery of the first HIV entry co-receptor (initially called Fusin, then renamed CXCR4), followed by identification of CCR5 as the other major HIV co-receptor (CCR5, simultaneously reported by several groups). Translational approaches have focused on targeted killing of HIV-infected cells as a component of HIV cure strategies. Specifically, in the context of acute infection, a recombinant immunotoxin has potential for complementing antiretroviral therapy to fully eradicate the infection (“sterilizing cure”). For chronic infection, CAR-T cells have the potential to provide durable (life-long?) suppression of HIV in the absence of antiretroviral therapy (“functional cure).

Stanislas Blein, PhD

Stanislas joined the Biological Research Center of Glenmark Pharmaceuticals in 2007. His group focuses on the isolation and optimization of therapeutic antibodies. The group also develops new platform technologies relevant to bispecific antibodies. Stanislas accomplishments in drug development include two clinical stage bispecific antibodies and technologies for high level of bispecific heterodimerization (BEAT® platform). His range of expertise combines selection and rational design of antibodies, biophysical analysis and in-silico modelling to solve problems in antibody and protein engineering.

Prior to joining Glenmark Pharmaceuticals, Stanislas was at Domantis-GSK in Cambridge UK where he worked on the development of therapeutic domain antibodies. He performed his doctoral and post-doctoral work at the University of Edinburgh with Prof. Paul Barlow. Using high resolution NMR spectroscopy, he solved 3D structures of modular proteins from the complement system.

Ulrich Brinkmann, PhD

Dr. Ulrich Brinkmann is a member of Roche’s Large Molecule Research organization within Pharma Research & Early Development at the Roche Innovation Center Munich (Penzberg, Germany). His work focuses on protein & antibody engineering, bispecifics, and on delivery platforms for targeted payload delivery. Prior to joining Roche, he served as CSO in functional genomics and pharmacogenetics companies Xantos and Epidauros. His previous work in Ira Pastans Molecular Biology Lab at the NIH/NCI in Bethesda, USA focused on antibody stabilization and engineering technologies, and on generating recombinant immunotoxins for cancer therapy. Dr. Brinkmann is author of numerous publications (2017 H-factor=56) and inventor of many patents covering recombinant antibodies, pharmaco- & functional genomics, immunotoxins and protein engineering technologies and applications.

Yvonne Y. Chen, PhD

Dr. Yvonne Chen earned her B.S. in Chemical Engineering from Stanford University and her PhD in Chemical Engineering from the California Institute of Technology. She received postdoctoral training at the Center for Childhood Cancer Research within the Seattle Children’s Research Institute, and at the Department of Systems Biology at Harvard Medical School. Yvonne was a Junior Fellow in the Harvard Society of Fellows prior to joining the Department of Chemical and Biomolecular Engineering at the University of California, Los Angeles in 2013. The Chen Laboratory focuses on applying synthetic biology and biomolecular engineering techniques to the development of novel mammalian-cell systems, particularly cell-based immunotherapy for cancer. Dr. Chen has been a recipient of the NIH Director’s Early Independence Award, the Hellman Fellowship, the ACGT Young Investigator Award in Cell and Gene Therapy for Cancer, and the NSF CAREER Award.

Mark Cobbold, MD, PhD

Mark Cobbold, MD, PhD is an expert in translational immunology, with a particular focus on tumor immunology, immunotherapy and diagnostics. He is an Associate Geneticist, at the Massachusetts General Hospital Cancer Center and Member of the Faculty of Medicine at Harvard Medical School. Through basic research and coordinated set of clinical trials, Dr. Cobbold has made key discoveries that enhanced our understanding of the mechanisms of deregulation of signaling pathways, malignant transformation and T cell adoptive transfer immunotherapies. Dr. Cobbold received his MD in 1995 from the University of Edinburgh, Scotland and began his scientific career in Birmingham in 2000 where, under Paul Moss, he studied cellular immunotherapy for patients who received stem cell transplants. He received his PhD from University of Birmingham in 2005. During this period, he pioneered a novel T cell selection technology for manipulating and selecting antigen-specific cells for therapeutic use, and conducted a successful Phase I clinical trial using cytomegalovirus specific T-cells. Currently, Dr. Cobbold’s laboratory focuses on understanding and investigation how the healthy human immune response can recognize and target cancerous cells, and when it fails, how it could be strengthened to identify this endogenous threat.

Nicolas Fischer, PhD

Nicolas Fischer obtained a PhD in Biology from the Department of Molecular Biology University of Geneva on the structure and function of photosynthetic complexes. As a postdoctoral fellow he joined the Group of Sir Greg Winter at the MRC Department of Molecular Biology in Cambridge UK to study protein folding and Antibody engineering using phage display. In 2001 he joined NovImmune and led several therapeutic antibody discovery programs that have reached clinical development stage. He is now heading the Research Department and developing next generation bispecific therapeutic antibodies.

Yanwen Fu, PhD

I currently serve as Director of Antibody Technology and Chemical Biology in Sorrento Therapeutics. My group focus on design, generation and characterization of novel antibody-based therapeutics, including Intracellular Targeting Antibodies (iTAb), Immunomodulatory Bi-specific Antibodies and Immuno-Nanoparticle conjugates. Before joining Sorrento, I worked at Pfizer for 7 years and is a key contributor to one clinical and two preclinical drug candidates (diabetes and oncology).

Stephen Gottschalk, MD

Dr. Gottschalk is the Chair of the Department of Bone Marrow Transplant and Cellular Therapy at St Jude Children’s Research Hospital. He is a physician scientist focused on the development of T-cell therapies for cancer. He is actively conducting clinical studies with antigen-specific T cells for patients with brain and solid tumors. In the laboratory, he is focused on improving T-cell Therapy for cancer using genetic approaches.

Christian Klein, PhD

Christian Klein received a diploma in biochemistry from the University of Tübingen and the Max-Planck-Institute for Biology and received his doctorate from the Technical University Munich and the Max-Planck Institute for Biochemistry in 2002 working on structural aspects of the p53-MDM2 network. He joined Pharma Research, Roche Diagnostics GmbH in Penzberg, Germany in 2002 as a postdoctoral fellow in the Therapeutic Protein Initiative. From 2003 he worked there as laboratory head in Discovery Oncology specialized in the validation of novel targets and the pharmacology of recombinant antibodies. From 2007-2009 he headed a multidisciplinary department in Discovery Oncology responsible for the identification, validation and preclinical development of therapeutic antibodies and the establishment of a bispecific antibody platform in Discovery Oncology. During that time, he initiated and lead several projects on dual-targeting bispecific antibodies and their application including the Ang-2-VEGF CrossMAb. In 2010 he joined Roche Glycart AG, Schlieren, Switzerland as Head of Oncology Programs. In this function he acts as project leader and oversees the Roche Glycart oncology project leaders in the field of antibody-based cancer immunotherapy. Since 2006 he functions also as the preclinical pharmacology leader in the global Life Cycle Team for the novel Type II glycoengineered CD20 antibody GA101 (obinutzumab) that is currently in PhIII clinical trials in NHL and B-CLL.

John de Kruif, PhD

John de Kruif holds a PhD in Molecular Biology from the University of Utrecht, The Netherlands, and is an expert in the field of antibody engineering. After finishing his post-doctoral training, he worked for seven years at Crucell (now Janssen) as a Director Antibody Discovery. Thereafter he joined Merus NV in the role of CSO and became the CTO when Merus moved into the clinical phase.

Steven M. Larson, MD, FACNM, FACR

Steven M.Larson is the Donna and Benjamin M. Rosen Chair; Attending, Molecular Imaging and Therapy Service, Department of Radiology; Co-Leader of Imaging and Radiation Sciences Program, Comprehensive Cancer Grant, Memorial Sloan Kettering Cancer Center; Director of the Center for Radioimmunotherapy and Theranostics, Ludwig Center, Lab Head and Member, Sloan Kettering Cancer Institute. He is also a Professor of Radiology, Cornell University Medical Center, NY, NY.

Larson’s primary expertise is in molecular imaging, targeted radio diagnosis and therapy using small molecules and monoclonal antibodies. Dual boarded in nuclear medicine and internal medicine, Larson has clinical skills in oncology, cancer immunology, and clinical thyroid cancer. He has been responsible for directing and developing successful nuclear medicine and PET programs at several major institutions in the U.S., including the Veteran Administration Hospitals in Portland and Vancouver; University of Oregon, Portland; Seattle Veterans Administration Hospital; Clinical Center, National Institutes of Health; and Memorial Sloan Kettering Cancer Center (MSK). He has extensive experience as an advisor to public and private institutions, having served, among other appointments, as a member of what is now the MEDI grant review committee of NIH, the DOE Office of Science Advisory Committee, and the American Board of Nuclear Medicine, and as Chair of the Radiopharmaceutical Advisory Committee of the USFDA, Co-Chair of a National Research Council of the NAS Committee on Molybdenum-99 production with non-enriched Uranium 235, and Chair of the Molecular Imaging Committee of RSNA. He is now Chair of the Clinical Imaging Steering Committee of the National Cancer Institute; and Chair of the Clinical “Impact” Study Section of NIH, as well as a member of the National Academy of Medicine. He has received numerous awards for excellence including the Wylie prize of the USFDA, the Hevesy Award and Cassen Prize of the Society of Nuclear Medicine USA. He is inventor on 7 patents. He has published over 600 peer-reviewed publications in prestigious journals; his current H-factor is approximately 100. He has trained more than 50 residents in nuclear medicine who are now ABNM certified.

Robert Mabry, PhD

Biotechnology leader with over a decade of experience working with large pharma, biotech companies, and venture-backed startups. Extensive experience managing teams in multiple therapeutic areas and a demonstrated track record of accelerating leads into preclinical development.

Jeffrey S. Miller, MD

Jeffrey S. Miller, MD, received a Bachelor of Science degree from Northwestern University in Evanston, Illinois and received his MD from Northwestern University School of Medicine. He completed an internship and residency in Internal Medicine at the University of Iowa in Iowa City. After completing a post-doctoral fellowship in Hematology, Oncology and Transplantation at the University of Minnesota, he joined the faculty in 1991. Dr. Miller is currently a Professor of Medicine at the University of Minnesota. He is the Deputy Director of the University of Minnesota Masonic Comprehensive Cancer Center. He has more than 20 years of experience studying the biology of NK cells and other immune effector cells and their use in clinical immunotherapy with over 170 peer­ reviewed publications. He is a member of numerous societies such as the American Society of Hematology, the American Association of Immunologists, a member of the American Society of Clinical Investigation since 1999. He serves on the editorial board for Blood and is a reviewer for a number of journals and NIH grants. Dr. Miller was the recipient of the National Cancer Institute Outstanding Investigator Award for 2015.

Amarendra Pegu, PhD

I have been studying the use of monoclonal antibodies to prevent or treat HIV-1 infection by using the NHP model since the past 10 years. We have shown that these novel anti-HIV-1 antibodies can be used for prevention and treatment of viral infection using nonhuman primate models of HIV-1 infection. Based on these data, some of the best monoclonal antibodies have been down selected for testing in clinical trials to evaluate their use in both prevention and treatment of HIV-1 infection. I have also been involved in developing novel bi- and tri-specific antibody based proteins that can be used to prevent or treat HIV-1 infection. These projects have been results of extensive collaborations with partners from both academia and industry. In this regard, we have developed a novel tri-specific antibody in collaboration with Sanofi that is efficacious in animals and is now being planned to be tested in clinical trials. Overall, our goal is to develop novel antibody-based therapies that can be used in prophylactic and therapeutic strategies against HIV-1.

Mitsuo Umetsu, PhD

Dr. Mitsuo Umetsu, Professor (PhD-engineering), now is a Professor of Department of Biomolecular Engineering, Graduate School of Engineering, Tohoku University, in Japan. He received his PhD from Tohoku University in 2000. After he studied NMR application for solid biomaterials at Leiden University in the Netherlands as a JSPS Postdoctoral Fellow for Research Abroad, he was a research associate in the Graduate School of Engineering and in the institute of Multidisciplinary Research for Advanced Material, Tohoku University, in 2001-2006, and he studied the refolding of antibody fragment from in vivo aggregates. In 2006, He was an associate professor in the Graduate School of Engineering, Tohoku University, and he started to study small bispecific T-cell–recruiting antibodies. In 2014, He was a professor in the same university.

Chengbin Wu, PhD

Dr. Chengbin Wu is the Founder and Chief Executive Officer of EpimAb Biotherapeutics Inc., an innovative biologics company focusing on developing next generation antibody-based therapies. Dr. Wu has over 15 years of experience in discovery, development, and technological innovation in the antibody field, and he is a world renowned expert in bispecific antibody technologies and therapeutic development. Dr. Wu has built a distinguished career in the biopharmaceutical industry, taking on different leadership responsibilities in different parts of the world. Previously he was Chief Scientific Officer and President of R&D at Shanghai CP Guojian Pharmaceutical Co., a leading China-based biopharmaceutical company. Before that he was the Senior Vice President Biologics at Shanghai ChemPartner, where he established a comprehensive antibody R&D platform. Prior to returning to China, Dr. Wu was a Volwiler Associate Fellow at Abbott Laboratories, where he invented the DVD-Ig technology and led several antibody projects from concept to regulatory filing. Dr. Wu received his PhD degree from the University of Georgia in the US, and postdoctoral fellowship at Harvard Medical School with a grant from the Cancer Research Institute.

Antibodies for Cancer Therapies

Ezio Bonvini, MD

Ezio Bonvini is an expert in immunobiology and drug development. He joined MacroGenics in 2003 after a career at the National Cancer Institute, NIH, and the Center for Biologics Evaluation and Research, FDA, where he last served as the Chief of the Laboratory of Immunobiology and as the Acting Deputy Director of the Division of Monoclonal Antibodies. Dr. Bonvini has authored numerous publications in the field of signal transduction, immunology and immune-oncology as well as several book chapters and patents.

Paul B. Chapman, MD

Dr. Paul B. Chapman is currently Clinical Director of Melanoma and Attending Physician in the Department of Medicine at Memorial Sloan Kettering Cancer Center. He is also Professor of Medicine at Weill Cornell Medical College. He graduated from Cornell University Medical College, completed internship and residency training in Internal Medicine at the University of Chicago, and did his Medical Oncology fellowship at Memorial Sloan Kettering. He is board-certified in Internal Medicine and Medical Oncology and has spent his career working on melanoma. He was in the laboratory of Alan Houghton and focused initially on immunotherapy of melanoma. He conducted clinical and laboratory research on the question of immune recognition of melanoma. This included developing a vaccine against GD3 ganglioside and conducting pre-clinical and clinical studies that culminated in an international, randomized phase III trial. Recently his clinical research has also focused on inhibitors of kinases that are mutated or otherwise critical for melanoma growth. He was the Principal Investigator for the phase III randomized trial that led to FDA approval of vemurafenib, the first BRAF inhibitors for melanoma. He has also been a co-author on several checkpoint inhibitor trials including combination trials with ipilimumab and nivolumab. His current work has expanded to focus on targeting melanoma metabolism as a therapeutic strategy. He is a peer reviewer for major oncology journals, is an Associate editor for Clinical Cancer Research, and has been on the scientific advisory board for MRF starting in 2004. He has over 150 publications in melanoma.

Achim Doerner, PhD

A biochemist by training and having developed NK cell engaging aptamer bispecifics during his PhD, Achim works on antibody-based bispecifics, further innovative biologics, and ADCs. His main interest lies in technology development for the identification of optimal complex antibodies and engineering those for enhanced selectivity, efficacy and the fine balance of these properties.

Gianpietro Dotti, MD

Dr. Dotti studied immunotherapy strategies to treat patients with hematologic malignancies including lymphomas and leukemia and solid tumors such as neuroblastoma. In particular, he developed the program of the CD19-specific chimeric antigen receptor at Baylor College of Medicine and cloned a novel chimeric antigen receptor targeting the light chain of human immunoglobulins. This chimeric molecule engrafted in human T-lymphocytes allows a selective elimination of tumor cells expressing the kappa-light chain of human immunoglobulin while sparing the normal compartment of B-lymphocytes expressing the lambda-light chain. Dr Dotti was also involved in developing CAR-based strategies to target solid tumors such as neuroblastoma in pediatric patients and triple negative breast cancer in adult patients. In collaboration with Dr Brenner he also developed the clinical phase of a novel safety switch for T cells based on the human caspase-9. A significant focus of Dr Dotti research is the development of strategies of T cell engineering aimed at overcoming immune suppressive mechanisms of the tumor microenvironment.

Soldano Ferrone, MD, PhD

Soldano Ferrone received his MD and PhD degrees in 1964 and in 1971, respectively, from the University of Milan, Milan, Italy. He has held faculty positions at the University of Milan, Milan, Italy, Scripps Clinic and Research Foundation, La Jolla, CA, Columbia University, New York, NY, New York Medical College, Valhalla, NY, Roswell Park Cancer Institute, Buffalo, NY and at the University of Pittsburgh School of Medicine, Pittsburgh, PA. Since 2012 he is a faculty member of the Department of Surgery at Massachusetts General Hospital, Harvard Medical School, Boston, MA. Dr. Ferrone has received many awards and honors. For the last 30 years he has been the member of many review committees including NIH Study Sections, and of the editorial boards of many scientific journals. Furthermore, he is the member of several external scientific advisory boards. Dr. Ferrone’s research program focuses on the molecular characterization of escape mechanism(s) utilized by tumor cells to avoid immune recognition and destruction and on the development of combinatorial immunotherapeutic strategies to counteract the escape mechanism(s) utilized by tumor cells. These studies are greatly facilitated by the large panel of HLA antigen- and human tumor antigen-specific monoclonal antibodies he has developed and shared with the scientific community over the years. He has described the results of his studies in more than 600 papers published in peer reviewed journals. Moreover, he has been the editor of 14 books and the guest editor of 5 special issues of oncology journals.

Tim F. Greten, MD

Tim F. Greten received his medical training at Christian Albrechts University in Kiel, Germany in 1993. He did his internship in Munich followed by a 3-year postdoctoral fellowship at the Johns Hopkins University (Baltimore, Maryland), in the laboratory of Drew Pardoll and Liz Jaffee, where he initiated his work in the field of tumor immunology. In 1999 Dr. Greten returned to Hannover Medical School, where he finished his training in Internal Medicine (2003), Medical Oncology (2004) and Gastroenterology (2007). He held an Associate Professor position in the Department of Gastroenterology, Hepatology and Endocrinology. In February 2010 Dr. Greten joined CCR's Medical Oncology Branch as head of the Gastrointestinal Malignancy Section and was promoted as a tenured Senior Investigator in 2015. Dr. Greten is co-director of the NCI-Liver Cancer Program

Dr. Greten has published more than 150 peer-reviewed papers on basic tumor immunology, translational research studies in hepatocellular carcinoma (HCC) as well as on clinical trials in different gastrointestinal malignancies, including HCC. Currently, Dr. Greten serves on the Center of Excellence in Immunology Steering Committee and Center for Advanced Preclinical Research oversight committee.

Mitchell Ho, PhD

Mitchell Ho is a Senior Investigator in the National Cancer Institute (NCI) and the Chair of the Department of Biochemistry for the FAES Graduate School at the NIH. He received his PhD in the laboratory of Dr. Mariangela Segre at the University of Illinois at Urbana-Champaign, where he used anti-idiotypic antibodies as cocaine antagonists. He completed a postdoctoral fellowship with Dr. Ira Pastan at the NIH, where he engineered immunotoxins targeting CD22 and mesothelin for the treatment of B-cell leukemias and mesothelioma. The Ho laboratory at the NCI studies cancer cell surface proteins, focusing primarily on the role of glypicans including GPC2 and GPC3 as a new family of tumor antigens, and designs 'single domain antibodies' that modulate Wnt and other glypican signaling processes responsible for the development of cancer.

Zhuting Hu, PhD

Zhuting Hu is a postdoctoral fellow at Dana-Farber Cancer Institute (DFCI, Boston, Massachusetts, USA) working on tumour immunology. She completed her Ph.D. in Microbiology and Immunology from Geisel School of Medicine at Dartmouth (Hanover, New Hampshire, USA). She has designed and carried out immune analysis in a phase I clinical trial of personalized cancer vaccine in patients with melanoma.

Patrick Mehlen, PhD

Patrick Mehlen is director of the Translational Research and Innovation at the Léon Bérard Comprehensive Cancer Center in Lyon, France. He is adjunct professor at the Buck Institute for Research on Aging, California. He has published over 150 peer-reviewed scientific publications and has received several awards including the silver medal from CNRS or the Pius XI Gold Medal from Pontificia Academia Scientiarum. Dr. Mehlen has been elected EMBO member in 2006 and member of the Academy of Sciences, Institut de France, in 2013. Dr. Mehlen is co-founder and CEO of Netris Pharma, a SME developing cancer therapies based on the dependence receptor concept.

Nai-Kong V. Cheung, MD, PhD

Nai-Kong V. Cheung, Enid A. Haupt Endowed Chair in Pediatric Oncology at Memorial Sloan Kettering Cancer Center, New York, NY, received his B.Sc. degree from the University of Chicago, as well as MD and PhD in Immunology from Harvard Medical School. He studied suppressor T cells and B cell tolerance under the mentorship of Dr. Baruj Benacerraf, the 1980 Nobel laureate in Medicine. Upon completing pediatric training in Pediatrics and Pediatric Hematology/Oncology at Stanford University Medical Center, Dr. Cheung has devoted his career to translational science with a clinical focus on neuroblastoma, and a research focus on antibody-based therapies. His work has changed the outlook for children with high risk metastatic neuroblastoma, including those with central nervous system metastases. His current research is directed at target discovery, antibody humanization and engineering, as well as novel platform technologies tailored for clinical translation.

Soldano Ferrone, MD, PhD

Soldano Ferrone received his MD and PhD degrees from the University of Milano, Milan, Italy in 1964 and 1970, respectively. He has held faculty positions at the University of Milano, Milan, Italy; Scripps Clinic and Research Foundation, La Jolla, CA; Columbia University, New York, NY; New York Medical College, Valhalla, NY, Roswell Park Cancer Institute, Buffalo, NY; and University of Pittsburgh, Pittsburgh, PA. Since 2007, he works at the Hillman Cancer Center of the University of Pittsburgh. Dr. Ferrone’s research program focuses on i) the molecular characterization of escape mechanisms utilized by tumor cells to avoid immune recognition and destruction and ii) characterization of monoclonal antibodies targeting functionally relevant molecules, which meet the criteria to be utilized for the development of combinatorial immunotherapy for the treatment of malignant diseases. Dr. Ferrone has co-authored more than 900 publications. He holds several patents. He is a member of the Editorial Board of several journals. He has received many honors.

Junichi Nezu, PhD

Dr Junichi Nezu joined Chugai Pharmaceutical (Japan) in 1991, where he worked on novel gene search program and discovered disease related genes including LKB1 (responsible for Peutz–Jeghers syndrome, tumour suppressor for sporadic cancers), OCTN2 (responsible for systemic carnitine deficiency) and VEGF-D (key molecule for lymphangiogenesis). In 2001, Dr Nezu’s research focus shifted to antibody drugs. He was involved in many antibody projects as a project leader and group manager for antibody generation function. Dr Nezu worked for a year as a visiting scientist at Roche’s research institute in Germany on a bispecific antibody project. Since 2012, Dr Nezu has been the Research Head of Chugai Pharmabody Research Pte. Ltd. in Singapore. Current position since April 2017.

Patrick Ott, MD, PhD

Patrick Ott, MD, PhD, received his MD and PhD from Ludwig Maximilians University of Munich, Germany. He completed post-doctoral training in Immunology and residency training in Medicine at Case Western Reserve University. After a fellowship in Hematology-Oncology and four years on the faculty at New York University, he moved to Dana Farber Cancer Institute (DFCI)in 2012. He is currently the Clinical Director of both the Melanoma Center and the Center for Immuno-Oncology at DFCI, serves as attending physician in the Department of Medicine at Brigham and Women’s Hospital, and has an appointment as Assistant Professor at Harvard Medical School in Boston, MA. Dr Ott is a clinical investigator and an integral member of the clinical trials program at Dana Farber/Harvard Cancer Center, where he designs and conducts phase 1 immunotherapy trials for patients with melanoma and a wide range of other tumors. His primary research interests are in melanoma and immunotherapy, specifically the development of innovative tumor vaccine approaches.

Ira Pastan, MD

Ira Pastan is co-chief of the Laboratory of Molecular Biology, National Cancer Institute. He is interested in targeted cancer therapy with Recombinant Immunotoxins. These are chimeric proteins in which the Fv of a Mab reacting with a cancer cell is fused to a portion of Pseudomonas exotoxin A. His group is conducting clinical trials with SS1P and LMB-100 that target mesothelin, and have completed a phase 3 trial with Moxetumomab pasudotox that targets CD22 in Hairy Cell Leukemia. His current research is directed at improving the properties of these agents and combining them with check point inhibitors.

Kelli Ryan, PhD

Dr. Kelli Ryan holds a B.S. degree in Biology from Marquette University in Milwaukee, Wisconsin, and obtained a PhD in Immunology and Molecular Pathogenesis from Emory University in Atlanta, Georgia. She then completed postdoctoral training at Edinburgh University and at Newcastle University before joining Boehringer Ingelheim Pharmaceuticals in the department of Immunology and Inflammation. She is currently a Senior Scientist at Medimmune in the Oncology Department. During her time in industry, Kelli has been the lead biologist for several novel discovery research projects targeting oncology and autoimmune diseases.

Bradley St. Croix, PhD

Dr. Brad St. Croix received his PhD in Medical Biophysics from the University of Toronto in 1998, under Dr. Robert S. Kerbel. He trained as a postdoctoral fellow in the laboratory of Dr. Bert Vogelstein at Johns Hopkins University under a fellowship from the National Cancer Institute of Canada. In 2000, while at Johns Hopkins, Dr. St. Croix published in Science the first systematic gene expression profiling of human tumor endothelium. In 2002, he established the Tumor Angiogenesis Group at the Center for Cancer Research, NCI. In 2007, his lab described the first systematic comparison of genes that can separate physiological and pathological angiogenesis. His laboratory now focuses on understanding the role of cell surface receptors upregulated on tumor vasculature and utilizes mouse models to translate new molecular information on angiogenesis into the development of novel diagnostics and therapeutics for cancer. For example, by engineering conditional knockout mice his lab demonstrated that GPR124 is critical for angiogenesis of the developing CNS and TEM8 promotes tumor angiogenesis. Dr. St. Croix’s group has also demonstrated the therapeutic potential of targeting tumor-associated vasculature through the development of CD276 antibody-drug conjugates (ADCs). The ability of these new ADCs to selectively target pathological angiogenesis is extremely important as current anti-angiogenic drugs, such as Avastin, cannot discriminate between normal angiogenesis (e.g., during ovulation, menstruation and wound healing) and that associated with disease.

William R Strohl, PhD

Dr. William Strohl is founder and owner of BiStro Biotech Consulting LLC, a consulting company started in 2016 to help biotechnology companies grow and expand their programs and capabilities. Prior to retiring from Johnson & Johnson in August 2016, Dr. Strohl was VP and Head, Janssen BioTherapeutics, Janssen R&D, J&J, where he ran biologics discovery, early development, and technology development. Prior to that, Dr. Strohl was head of Biologics Research, the discovery arm of Janssen BioTherapeutics, in which he led the significant improvement of both quantity and quality of development candidates. Over his time at J&J, Dr. Strohl and his teams placed more than 30 highly innovative. Before joining J&J, Dr. Strohl was at Merck and Co from 1997-2008, leading Natural Products Biology, initiating a Microbial Vaccines department, and then later, leading the Biologics discovery efforts, where he was involved in two biotechnology company acquisitions and multiple licenses to improve the discovery capabilities. Prior to his work in industry, Dr. Strohl rose from Assistant to Full Professor in the Department of Microbiology and the Program of Biochemistry at The Ohio State University over the years 1980-1997. Dr. Strohl has over 140 publications and 17 issued patents, has edited two books in the area of biotechnology, and has written a book entitled "Therapeutic Antibody Engineering: Current and Future Advances Driving the Strongest Growth Area in the Pharma Industry", which was published in October, 2012.

Mark Throsby

Mark Throsby has served as our Chief Scientific Officer since January 2013 and previously served as our Chief Operating Officer from October 2008 to January 2013. His responsibilities include strategic scientific leadership, management of discovery, pre-clinical research and translational research, business development support, external collaborations and partnerships management. Before joining Merus, from October 2000 to October 2008, he served as a senior scientist and then as director of antibody discovery for Crucell N.V., a biotechnology company specializing in vaccines and biopharmaceutical technology. Dr. Throsby holds a PhD in neuro-immunology from Monash University.

Jennifer Wargo, MD, M.M.Sc.

Dr. Wargo’s career commitment is to advance the understanding and treatment of disease through science. After completing her medical degree, she entered surgical residency training at the Massachusetts General Hospital/Harvard Medical School where she became interested in the biology and treatment of cancer. During her training, she completed 2 fellowships in surgical oncology with a focus on immunotherapy for cancer. Dr. Wargo was recruited to the Division of Surgical Oncology at Massachusetts General Hospital in July 2008 and had an active research laboratory focusing on melanoma tumorigenesis and immunotherapy for cancer. One exciting finding involved data describing the effect of BRAF-targeted therapy on tumor antigen expression in melanoma as a basis for combining targeted therapy and immunotherapy in the treatment of this disease. Dr. Wargo validated those findings in patients treated with BRAF inhibitors. She has continued critical studies to better understand the effects of BRAF inhibition on immune responses in melanoma, and established a unique set of serial tumor biopsies and blood samples from patients enrolled on clinical trials on BRAF inhibitors. Through analysis of these samples, she contributed significantly to the world literature regarding resistance mechanisms and the effect of targeted therapy on anti-tumor immunity. Dr. Wargo was recruited to MD Anderson Cancer Center in September 2013 to continue this work and to build a program to collect serial biopsies in patients with melanoma and other cancers on targeted therapy and immunotherapy, and to better understand responses to therapy and to develop novel strategies to combat resistance.

Louis Weiner, MD

Dr. Louis Weiner is director of Georgetown Lombardi Comprehensive Cancer Center. He holds the Francis L. and Charlotte G. Gragnani Chair and is professor of oncology at Georgetown University Medical Center. He is responsible for the operation and development of the cancer center, including its research, clinical, and educational missions. The clinical mission includes leading the MedStar-Georgetown Cancer Institute in the metropolitan Washington area. Weiner is known for his laboratory and clinical research focusing on new therapeutic approaches that mobilize the patient’s immune system to fight cancer using monoclonal antibodies and other modalities of therapy.

Prior to joining Georgetown Lombardi as director in 2008, Weiner served as chairman of the medical oncology department and vice president for translational research at Fox Chase Cancer Center in Philadelphia, PA. He earned his bachelor degree in biology with honors from the University of Pennsylvania and his medical degree from Mount Sinai School of Medicine. After completing his internship, residency, and service as chief medical resident at the University of Vermont’s Medical Center Hospital, he held clinical and research fellowships in hematology and oncology at Tufts University School of Medicine in Boston. He serves as chair of the National Cancer Institute’s (NCI) Board of Scientific Counselors for Clinical Sciences and Epidemiology and as a member of the NCI Clinical Trials Advisory Committee (CTAC), and served on the NCI’s blue-ribbon panel working group on immunotherapy and prevention to offer expert advice on the vision, goals and implementation of the National Cancer Moonshot Initiative. He also is a member of the Advisory Panel of the National Institutes of Health (NIH) Center for Scientific Research (CSR), which administers NIH research grants.

Advancing Bispecific Antibodies and Combination Therapy to the Clinic

Julian Andreev, PhD

Julian Andreev is a PhD scientist with 16 years of experience in the Biopharmaceutical Industry. Right after his dissertation research in Dr. Joseph Schlessinger’s lab, he joined newly-formed Molecular Oncology group at EMD Serono Research Institute as Principal Investigator. At Serono, Julian played a major role into expansion of research activities into oncology drug discovery.

Following his tenure at Sanofi Cambridge Research Center, Julian joined New York-based Regeneron Pharmaceuticals, where he established a research group studying mechanisms of intracellular trafficking of therapeutic antibodies and their targets.

Julian Andreev received his BSc in Biology and MSc in Biotechnology from Hebrew University, Jerusalem. After training at Max-Planck Institute for Infection Biology in Tuebingen, Germany, he received his PhD in Pharmacology from New York University, NY in 2000.

Carl Uli Bialucha, PhD

Carl Uli Bialucha received his PhD in Molecular Cell Biology from the Laboratory of Molecular Cell Biology at University College London, UK. Following independent research as a postdoctoral fellow in Prof. Scott Lowe’s group at Cold Spring Harbor Laboratory, NY, he joined the Novartis Institutes for Biomedical Research (NIBR) in Cambridge, MA. As head of the Oncology Biotherapeutics group, he leads drug discovery efforts at the interface of cancer biology, immuno-oncology and protein engineering.

Chien-Hsing Ken Chang, PhD

Dr. Ken Chang held a PhD degree in Chemistry from the Johns Hopkins University and has been an employee of Immunomedics since 1989. He is a co-inventor and the key architect of the Dock-AND-LOCK (DNL) platform technology, which combines recombinant engineering and site-specific conjugation to generate novel therapeutics for malignant, infective and autoimmune diseases.

Raphael Clynes, MD, PhD

Dr. Clynes is a medical oncologist/hematologist and a cellular immunologist with more than 80 publications in cancer and autoimmunity including in Science, Nature Medicine, Journal of Clinical Investigation and the Journal of Experimental Medicine.

Prior to joining Xencor in May 2017, Dr. Clynes was Group Medical and Scientific Director in Early Clinical Development at Bristol Meyers Squibb, where he evaluated combination immunotherapies in cancer.

Throughout his two decades of NIH-funded research in cancer and immunity at The Rockefeller University, Memorial Sloan-Kettering Cancer Center and Columbia University, Dr. Clynes influential leadership has been widely recognized for discoveries with translational importance and relevance to human disease, including establishing the rationale for Fc engineered cancer antibody therapeutics, identifying Fc receptor antigen presentation pathways on dendritic cells, and for pioneering the use of small molecule inhibitors of JAK and Syk protein tyrosine kinases in T cell mediated autoimmunity. Dr. Clynes has participated as a Consultant and SAB Member with multiple biopharma companies and on NIH and Foundation Scientific Review. Dr. Clynes is the recipient of multiple honors including the Carrington Prize and the Kimmel, Arthritis Investigator and Cancer Research Institute Awards.

Rakesh Dixit, MD, PhD

Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology. In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) to lead Global Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings.

David D. Ho, MD, CEO

Dr. Ho is the Scientific Director, CEO and Irene Diamond Professor at the Aaron Diamond AIDS Research Center of The Rockefeller University. He received his MD from Harvard Medical University. Dr. Ho has been working on the design and delivery of HIV vaccines to heighten the body’s immune response to these vaccines. One strategy involves designing vaccines to “target” dendritic cells, a specialized immune cell in the body that coordinates many aspects of the immune response. Studies have shown that vaccines targeting dendritic cells elicit a longer and stronger immune response. This work is being sponsored by the Bill and Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery, and is being conducted with a consortium of scientists. Another strategy involves antibodies that could block HIV infection by interfering with the binding to CD4, the receptor for HIV. His group is also pursuing the use of a monoclonal antibody, known as ibalizumab, in preventing SIV infection in monkeys and HIV infection in humans. Moreover, his group is creating novel forms of HIV-inhibitory antibodies that could be used for both prophylaxis and treatment.

Dirk Hose, PhD

Dirk Hose graduated after his military service in physics and medicine at the Justus Liebig University Gießen, Germany. Since 2002, he works at the University Hospital of the Ruprecht-Karls-University Heidelberg in the Department of Hematology, Oncology and Rheumatology. He holds a doctoral degree for medicine, one for human biology, and the venia legendi for experimental hematology. He has spent several research periods at the CHU and INSERM Montpellier, France. Since 2006, he is head of the multiple myeloma research laboratory focusing on the pathogenesis of malignant plasma cell diseases including high throughput profiling, and development of novel treatment approaches, including personalized and risk adapted treatment. Examples include the collaborative development of the BCMA-TCB EM801 and EM901 (CC-93269).

Ross La Motte-Mohs, PhD

Ross La Motte-Mohs received his degrees from the University of Virginia (BS), University of Illinois (PhD), and completed postdoctoral studies at the University of Toronto, where he developed the first in vitro system to generate large numbers of engraftable human T cells from stem cells. His major research interest includes the development of antibodies and bispecifics for cancer immunotherapy with a particular focus on enhancing T-cell activity through checkpoint blockade.

Leonard Seymour, PhD

Leonard Seymour is Professor of Gene Therapies and Director of the Clinical Pharmacology section within the Department of Oncology. He was the Founding President of the British Society for Gene and Cell Therapy, is the Secretary and Trustee of the European Society of Gene and Cell Therapy and an Executive Council Member of the International Society for Cell and Gene Therapy of Cancer. He is Chair of the Scientific Advisory Board of the Chronic Granulomatous Disorder Research Trust, and also chairs the Scientific Advisory Board of the Muscular Dystrophy Consortium. Len is Course Director of the part-time MSc in Experimental Therapeutics, offered by the Department of Oncology in conjunction with the Department for Continuing Education.

Jacintha Shenton, PhD

Dr. Jacintha Shenton is currently Scientific Director Biologics Toxicology at Janssen BioTherapeutics within Janssen R&D where she is currently responsible for overseeing the development and execution of the nonclinical safety strategy for T-cell redirecting CD3 bispecific antibodies. Previously, Jacintha held Project Toxicologist roles at Novartis, where she focused on the nonclinical safety evaluation of biologics given by the intravitreal route for the treatment of ocular diseases, and at MedImmune, where she worked on biologics across several therapeutic areas including immuno-oncology. Jacintha was also a Translational Sciences Subteam Leader at MedImmune which involved strategic and scientific oversight of nonclinical safety, pharmacokinetics/pharmacodynamics, bioanalytics, and biomarkers across both nonclinical and clinical development. Jacintha began her Pharma career in the Department of Immunotoxicology at Bristol-Myers Squibb, where her project support included immunomodulatory small molecules as well as biologics. Jacintha also acted as Study Director/Study Monitor and Principal Investigator for immunotoxicology. Jacintha has published several papers and book chapters in the areas of nonclinical safety and immunotoxicology and participates in external organizations including the BioSafe gene therapy subcommittee, BioSafe immuno-oncology task force, Biotechnology Specialty Section (BTSS) of the Society of Toxicology (SOT) and the ILSI-HESI Immunotoxicology Technical Committee. Jacintha received her Ph.D. in Pharmaceutical Sciences from the University of Toronto and she completed a postdoctoral fellowship in the Toxicology Research Division of Health Canada.

Michael Tesar, PhD

Michael joined Affimed as Research Program Head in 2016. He is responsible for the development of novel antibody therapeutics based on Affimed’s proprietary NK cell-engaging antibody platform. Prior to Affimed, he held positions at MorphoSys and Pierre Fabre as group leader in antibody discovery and preclinical development. He graduated from the University of Stuttgart in 1990 and conducted his PhD research at the former Federal Research Center for Virus Diseases of Animals in Tübingen. After several years of post-doctoral training at the University of Utah and California he joined the Helmholtz Center for Infection Research in Braunschweig. Over the course of his career, Michael has developed a deep expertise in antibody discovery up to clinical development.

Bob Valamehr, PhD

Bob Valamehr is the Vice President of Cancer Immunotherapy at Fate Therapeutics, overseeing the company’s immuno-oncology and pluripotent stem cell programs, including efforts to develop novel pluripotent cell strategies to create “off-the-shelf” cell-based cancer immunotherapeutics. Previously, Dr. Valamehr has played key scientific roles at Amgen, the Center for Cell Control (a NIH Nanomedicine Development Center) and the Broad Stem Cell Research Center developing novel methods to control pluripotency, to modulate stem cell fate including hematopoiesis and to better understand cellular signaling pathways associated with cancer. He has co-authored numerous studies and patents related to stem cell biology, oncology and materials science. Dr. Valamehr received his PhD from the Department of Molecular and Medical Pharmacology at UCLA and his M.B.A. from Pepperdine University.

Improving Immunotherapy Efficacy and Safety

Andrew Allen, MD, PhD

Dr. Andrew Allen is a co-founder of Gritstone Oncology and serves as president, chief executive officer and a member of the board of directors. He was a co-founder of Clovis Oncology where he served as executive vice president of clinical and preclinical development and chief medical officer. Prior to that, he was chief medical officer at Pharmion Corporation, which was sold to Celgene Corporation for $2.9 billion following the development of Vidaza™ for the treatment of myelodysplastic syndromes and Thalomid™ for the front-line treatment of multiple myeloma. Previously, Dr. Allen served in clinical development leadership roles at Chiron Corporation and Abbott Laboratories, and worked at McKinsey & Company, where he advised life science companies on strategic issues. He currently serves on the board of directors of Epizyme and Cell Design Labs. Dr. Allen received a medical degree from Oxford University and a Ph.D. in immunology from Imperial College London.

Carlo Boutton, PhD

Carlo Boutton obtained his PhD in 1999 at the University of Leuven (Belgium) on a subject that investigated the physico-chemical behavior of proteins under high-electromagnetic (laser) fields. After his PhD he joined Algonomics (currently Lonza) where he contributed to the development of EpiBase: a platform to predict and identify T-cell epitopes in biologics. In 2003 he joined Tibotec (subsidiary of Johnson & Johnson) where he was involved in several anti-HIV and anti-HCV projects. He joined Ablynx in 2007 and currently holds the position of Director Technology. Together with his team, he focuses on improvements of the Nanobody platform and new therapeutic applications for Nanobodies, including bispecifics, immunotherapeutics and ADCs.

Daniel Christ, PhD

Associate Professor Daniel Christ is Head of Antibody Therapeutics and the Director of the Centre for Targeted Therapy at the Garvan Institute of Medical Research in Sydney. He holds degrees from the Swiss Federal Institute of Technology (ETH) and Cambridge University, where he worked with biotechnology pioneer Sir Gregory Winter on the development of the human antibody single domain format. His work focuses on stability engineering and structural studies of human antibodies, and on the engineering of cytokine therapeutics.

Naomi De Silva, PhD

Naomi De Silva obtained her PhD in Dr. John Bell’s Lab (Ottawa, Canada) and completed her post-doctoral training at the University Health Network (Toronto, Canada), where she investigated the ability of oncolytic viruses to acutely alter the tumor microenvironment. She was involved in the preclinical development of Pexa-Vec and analysis of clinical data from early stage clinical trials. She currently works at Sillajen Inc. (San Francisco, USA) supporting both translational development and clinical activities related to a Phase 3 trial evaluating Pexa-Vec in the treatment of advanced primary liver cancer.

Jessie M. English, PhD, Vice President, Head of Discovery, ImmunoOncology Translational Innovation Platform (TIP), EMD Serono

Dr. English is Vice President and Head of Discovery ImmunoOncology Translational Innovation Platform (IONC TIP) at EMD Serono, a business of Merck KGaA. In this role she is responsible for drug discovery efforts to deliver clinical candidates as well as translational science to support early stage clinical programs. Previously, Dr. English was Head of Research at the Belfer Center for Applied Cancer Science at the Dana-Farber Cancer Institute, Harvard Medical School and led multidisciplinary teams with both industry and academic collaborators in oncology drug discovery, translational programs, and development of novel translational platforms. Dr. English previously served as the VP of Kinase Biology at ArQule. In 2008 she became the oncology site lead for external discovery at Merck Research Laboratories, Boston, MA where she was responsible for driving drug discovery programs through external scientific collaborations. In 2004, she joined Pfizer and established and led Pfizer's Kinase Center of Emphasis based in Cambridge, MA. Dr. English began her career in industry at Schering-Plough Research Institute where she led a cross-functional team focusing on kinase targets for cancer therapy. Dr. English earned her B.S. with honors in biochemistry from Kansas State University and her Ph.D. in neurobiology from the University of North Carolina at Chapel Hill. She was a postdoctoral fellow at UT Southwestern Medical Center, in Dr. Melanie Cobb's laboratory where she discovered WNK1 and MEK5

Robert Hofmeister, PhD

Dr. Hofmeister joined TCR2 in 2015. He brings nearly two decades of scientific leadership and a successful track record of drug discovery and early development. Previously, Dr. Hofmeister was the Vice President of Immuno-Oncology at EMD Serono where he was involved in the development of avelumab (anti-PD-L1) and building the company’s immuno-oncology platform. He started his biotech career at Micromet AG, now Amgen Research Munich, where he helped shape the development of Blincyto®, the first FDA-approved bispecific antibody for the treatment of relapsed/refractory ALL. Dr. Hofmeister received his PhD from the University of Regensburg in Germany, where he studied the signaling of the cytokine interleukin-1. He continued to work in the cytokine field as a postdoctoral fellow at the National Cancer Institute.

Douglas Jolly, PhD

Dr. Jolly is a co-founder and Executive Vice President of R&D at Tocagen Inc., which is developing replicating retroviruses as Immuno-Oncology therapies for several cancer indications. Tocagen has Breakthrough designation for its lead product, Toca 511 & Toca FC for high grade glioma. At Tocagen, he has overall responsibility for research, process development and manufacturing. Previously he co-founded Viagene, one of the world’s first gene therapy companies. As a senior biotechnology executive for over 25 years, he has translated gene-based products from research through clinical development at several companies including Viagene (acquired by Chiron), Chiron Corporation (acquired by Novartis), Oxford BioMedica and Advantagene Inc. These products included potential therapies for cancer and infectious, metabolic and neurological diseases. He has published over 120 scientific articles and is an inventor on over 60 issued patents. Before entering the biopharmaceutical industry, Dr. Jolly pursued his academic career in biophysics and molecular virology at the Weizmann Institute, Harvard Medical School, Scripps Clinic, the University of California, San Diego and The French National Institute for Health and Medical Research (INSERM) in Paris, France. He received his education in Scotland, and holds a PhD in Biochemistry from the University of Glasgow.

Saad J. Kenderian, MD

Saad S Kenderian, MD, is a Senior Associate Consultant in the Division of Hematology and Bone Marrow Transplantation at the Mayo Clinic. He holds the academic rank of Assistant Professor of Medicine and Oncology, Mayo Clinic College of Medicine. After completing a combined Fellowship in Hematology and Medical Oncology, he joined the Division of Hematology at Mayo, received the Mayo Scholar Award and joined the Translational Research Program of the University of Pennsylvania as a Mayo Scholar, where he worked in T cell immunotherapy for over two years. He returned to the Mayo Clinic in early 2016. He has received internal and external funding for his work in immunotherapy. He has been honored with numerous awards during his training and career. He is a Member of the American Society of Hematology, American Society for Blood and Marrow Transplantation, American Association for Cancer Research. He has authored or coauthored more than 25 articles in peer-reviewed journals and holds several patents in the field of engineered T cell therapy.

Maksim Mamonkin, PhD

Dr. Mamonkin has a PhD in Immunology from Baylor College of Medicine and conducted postdoctoral training with Dr. Malcolm K. Brenner at Baylor. Dr. Mamonkin has developed and optimized CD5- and CD7-specific CARs to target T-ALL and lymphoma and investigated the role of CAR costimulation and gene editing in regulating the activity of CAR T cells specific to T-cell antigens. As a junior faculty in the Center for Cell and Gene Therapy, Dr. Mamonkin is studying the mechanisms controlling the effector function of CAR T cells and developing strategies for effective targeting of other antigens and diseases.

Kathleen McGinness, PhD

Kathleen McGinness is the Senior Director of Platform Technologies at Unum Therapeutics. Unum is discovering and developing new cellular immunotherapies for cancer using its proprietary Antibody-Coupled T-cell Receptor (ACTR) technology. Kathleen is responsible for inventing and evaluating new technologies that direct patient-derived immune cells to destroy cancer cells. Prior to Unum, Kathleen served in roles at the Broad Institute, Baxter Healthcare, and Archemix Corp. focused on target validation, drug discovery, and therapeutic platform development across a variety of therapeutic modalities and disease areas. She holds B.S. degrees in chemistry and psychology from the University of Maryland, a doctoral degree in chemistry from The Scripps Research Institute, and completed postdoctoral training in the department of biology at MIT.

Daniel J. Powell Jr., PhD

Dr. Daniel Powell Jr. is an Associate Professor in the Department of Pathology and Laboratory Medicine with a secondary appointment in the Department of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania. Dr. Powell is also a member of the Abramson Cancer Center and Penn’s Ovarian Cancer Research Center (OCRC) within the Center for Research on Reproduction & Women’s Health. Dr. Powell has served as the Deputy Director of PENN’s Cell and Vaccine Production Facility (CVPF) within the Abramson Cancer Center and the Director of the Clinical Tumor Tissue Facility (CTTF), in support of multiple Phase I and II immunotherapy trials. He is the IND sponsor for the clinical application of T cell-based cancer immunotherapy, and has aided in the clinical application of adoptive lymphocyte immunotherapy, immunomodulation and cancer vaccination in various cancer types.

Laszlo Radvanyi, PhD

Prior to joining EMD Serono, Laszlo was a Professor in the Department of Melanoma Medical Oncology at the University of Texas, MD Anderson Cancer Center in Houston for about 10 years. While at M.D. Anderson, he established a GMP-grade T-cell therapy manufacturing program for metastatic melanoma using expanded tumor-infiltrating lymphocytes (TIL) and performed basic research on TIL biology and effector function focusing on TNF-R family costimulation and CD8+ T-cell differentiation where he made new discoveries on the role of BTLA in T cells. Laszlo was co-PI or co-investigator on a number of TIL clinical trials testing new methods to augment TIL adoptive transfer therapeutic efficacy in metastatic melanoma, including development of retroviral gene T-cell transduction approaches. In addition to his work on TIL therapy and basic research, Laszlo was tasked to establish a new Immunomonitoring Core Facility as part of MD Anderson’s Cancer Center Support Grant infrastructure. He established and directed this facility for 8 years (2005-2013) hiring all the staff and running the day-to-day activities of the facility.

Robert R. Salzler, PhD

Bio not available

Steven Shamah, PhD 

Dr. Steve Shamah joined Obsidian Therapeutics in September 2016 as Senior Vice President and Head of Research where he leads a dynamic team towards the discovery and development of next generation cell and gene therapeutics. Previously, Steve served as Head of Scientific Operations for the Cell and Protein Sciences group at Juno Therapeutics and, prior to that, as VP of Cell Biology at X-Body Biosciences, an antibody discovery platform company which was acquired by Juno in June of 2015. In addition, Steve has served in various management and scientific leadership roles at SRU Biosystems, Archemix Corporation, Hydra Biosciences and Phylos Inc., with a particular focus on biologics discovery using in vitro display technologies. Steve holds a B.S. in neuroscience from the University of Rochester and earned his Ph.D. in biological chemistry and molecular pharmacology at Harvard Medical School with Chuck Stiles. He was a post-doctoral fellow in Mike Greenberg’s lab at Harvard Medical School where he studied the molecular mechanisms by which extracellular cues guide neuronal growth cones during embryonic development.

Steven J. Swanson, PhD

Dr. Swanson has over 25 years of experience in the biotechnology industry and is Senior Vice President, Research for ImmunoCellular Therapeutics in Calabasas, CA. Prior to joining ImmunoCellular, he was an independent consultant advising biopharmaceutical companies on basic immunology research, bioanalytical procedures, immunogenicity assessment, regulatory affairs and product quality. Dr. Swanson spent 15 years at Amgen as Executive Director and Department Head for Clinical Immunology, a then-new department providing immunogenicity and cytometry support for all of Amgen’s therapeutic proteins. Prior to Amgen, he led the immunoassay laboratory for 8 years in the Biotechnology department at Schering Plough Research Institute. Dr. Swanson has been actively involved in multiple industry professional associations, including the American Association of Pharmaceutical Scientists (AAPS), where he is a Fellow, and was a co-author of AAPS-sponsored Industry White Papers that were incorporated into FDA and EMA Guidance for Immunogenicity Assessment. He was also an industry representative for the EMA Committee that developed the first Immunogenicity Recommendations. Dr. Swanson has authored more than 60 publications.

Claudia Wagner, PhD

Claudia Wagner leads the TCR Discovery and Validation group in the Immunology department at Immatics in Tübingen, Germany. She is responsible for identification and characterization of TCR candidates including efficacy and safety screenings, and part of the strategic scientific leadership team at Immatics. Claudia joined the company in 2012. Before, she was trained as postdoctoral fellow in the Department of Immunobiology at Yale University, New Haven, USA. She completed her Ph.D. at the Karolinska Institute, Stockholm, Sweden in 2006.

Carston R. Wagner, PhD

Bio not available

CAR Ts, TCRs and TILs

Adrian Bot, MD

Adrian Bot, M.D., Ph.D. is the Vice President of Translational Sciences at Kite, a Gilead Company. Kite is a biotechnology company developing genetically engineered T cell therapies, based in Los Angeles, CA. He has more than 20 years of experience in biomedical research and development. Dr. Bot obtained his M.D. at the University of Medicine and Pharmacy in Timisoara – Romania and his Ph.D. in Biomedical Sciences at Mount Sinai School of Medicine in New York. Subsequently, he was a Guest Scientist at the Scripps Research Institute in La Jolla and Scientist, Principal Scientist and Director of Immunology Research at Alliance Pharmaceutical Corp. in San Diego. In Nov 2002, Dr. Bot joined Allecure Pharmaceuticals which became MannKind Corp, where he was a Director of Research and Development. He had several other appointments at MannKind: Sr. Director of Translational Medicine, Vice President of Scientific Management and Vice President of Research, prior to the appointment first as Chief Scientific Officer and then Vice President of Translational Sciences at Kite.

Mark Bonyhadi, PhD

Bio not available

J. Henri Bayle, PhD

For the past three years Dr. Bayle has been Director of Molecular Biology at Bellicum Pharmaceuticals, a firm that develops immunotherapies directed by small molecule-regulated proteins switches. He has over 17 years experience developing molecular tools based on chemically regulating protein dimerization at Bellicum and previously in his laboratory at Baylor College of Medicine and as a fellow at Stanford University School of Medicine. He received his PhD in Molecular Biology at Princeton University.

Mark Dudley, PhD

Dr. Mark Dudley is a Senior Vice President at Adaptimmune Therapeutics, a leader in genetically modified T cell therapies for solid cancers, where he is responsible for of manufacturing and development. Dr. Dudley has been a pioneer in the field of immunotherapy manufacturing, and has developed and implemented innovative early process design with accompanying analytics for multiple therapies. Previously, as Director of New Cell Products in the Cell and Gene Therapies division of Novartis Pharmaceutical Corp, Dr Dudley was responsible for establishing scalable, GMP-compliant production strategies and facilitating globalization of CAR-T products and platforms. As Director of the Cell Manufacturing Facility at the Surgery Branch of the National Cancer Institute, NIH, in Bethesda, MD, Dr Dudley investigated tumor rejection tumor rejection antigens, T cell specificity and function, and methods for the generation and administration to patients of T cell therapies. His work has resulted in more than 100 peer-reviewed publications, and he is co-author on numerous seminal papers including early tumor-infiltrating lymphocytes studies demonstrating that adoptive T-cell transfer has tumor eradicating potential. Dr. Dudley earned a Ph.D. in Biological Sciences at Stanford University, and had post-doctoral fellowships at The University of Pennsylvania in Philadelphia, PA and at the Jackson Laboratory in Bar Harbor, ME.

Maria Fardis, PhD

Dr. Fardis has extensive experience in drug development and novel cancer treatments. Prior to joining Iovance Biotherapeutics, Dr. Fardis was chief operating officer at Acerta Pharma working on the development of acalabrutinib until the company’s acquisition by AstraZeneca. Before joining Acerta, Dr. Fardis held the position of chief of oncology operations and alliances at Pharmacyclics where she oversaw development of ibrutinib (IMBRUVICA®), abexinostat (HDAC inhibitor), and FVIIa inhibitor programs. She was a key contributor in the creation of a broad clinical program for ibrutinib, as well as NDA and MAA submissions. Previously, Dr. Fardis held a number of key scientific and management roles at Gilead Sciences. At Gilead, she was involved with multiple therapeutic areas including antivirals, oncology, and cardiovascular therapeutics and worked on the development and life cycle management of ambrisentan (Letairis®). She received her PhD in organic chemistry from UC Berkeley and holds an MBA from Golden Gate University.

David Gilham, PhD

Dr. David Gilham first joined Celyad in April 2016 as member of the Scientific Advisory Board. As from September 1st, 2016, David became Vice-President R&D, heading the implementation of our Research and Development strategy for our programs in immuno-oncology. Dr. Gilham received his Ph.D in Molecular Pharmacology at the University of Dundee prior to moving to Bristol University in 1996 to work on CAR T cells with Professor Robert Hawkins. The group moved to Manchester in 1998 where his research activity has focused on engineering T-cells for cancer therapy and developing the necessary pre-clinical studies to support translation of this therapy into phase I/II clinical trials in Manchester. Prior to joining Celyad, David was a Reader in the Institute of Cancer Sciences, University of Manchester, UK and led the Clinical and Experimental Immunotherapy Group based within the Manchester Cancer Research Centre

Collin Hauskins

Collin Hauskins began his career 12 years ago at Zymogenetics working on a variety of immuno-oncology targets. His group provided support for both target protein analysis as well as potential therapeutic antibodies. After moving to Novo Nordisk, he worked in the autoimmune and inflammatory disease research group. Collaborating across the company, Collin was responsible for supporting target and antibody discovery efforts. At Novo Nordisk he also worked on a successful receptor ligand pairing team that identified PGLYRP1 as a ligand for TREM-1.

Hans Klingemann, MD, PhD

Dr. Klingemann has served as the company’s Vice President of Research & Development since joining full time in 2012. He is also the discoverer of the NK-92 cell line and co-founder of the company. Dr. Klingemann received his M.D. from the University of Würzburg Medical School, and his Ph.D. from the University of Marburg, Germany. He received specialty training in Stem Cell Transplantation under Nobel Laureate Dr. ED. Thomas at the Fred Hutchinson Cancer Research Center in Seattle. Prior to joining NantKwest, Dr. Klingemann served as the Director of the Bone Marrow and Stem Cell Transplant Program and the Director for Hematological Malignancies at Tufts Medical Center in Boston. Dr. Klingemann also served as Director of the Section of Bone Marrow Transplant & Cell Therapy at Rush University Medical Center in Chicago where he established the first clinical GMP Cell Therapy facility in the Chicago area. Over the past 25 years, Dr. Klingemann has conducted National Cancer Institute supported research on how to engineer the patient’s immune system to fight cancer, resulting in over 200 peer-reviewed publications. He is author and editor of several books on stem cell transplantation. Dr. Klingemann has been selected as Boston’s Top Doctor for the several years and was named by US News and World Report as one of the leading oncologists in the country. He maintains an academic appointment at Tufts University Medical School.

Jeffrey S. Miller, MD

Jeffrey S. Miller, MD, received a Bachelor of Science degree from Northwestern University in Evanston, Illinois and received his MD from Northwestern University School of Medicine. He completed an internship and residency in Internal Medicine at the University of Iowa in Iowa City. After completing a post-doctoral fellowship in Hematology, Oncology and Transplantation at the University of Minnesota, he joined the faculty in 1991. Dr. Miller is currently a Professor of Medicine at the University of Minnesota. He is the Deputy Director of the University of Minnesota Masonic Comprehensive Cancer Center. He has more than 20 years of experience studying the biology of NK cells and other immune effector cells and their use in clinical immunotherapy with over 170 peer­ reviewed publications. He is a member of numerous societies such as the American Society of Hematology, the American Association of Immunologists, a member of the American Society of Clinical Investigation since 1999. He serves on the editorial board for Blood and is a reviewer for a number of journals and NIH grants. Dr. Miller was the recipient of the National Cancer Institute Outstanding Investigator Award for 2015

Molly Perkins, DPhil

Molly Perkins, D.Phil., is Associate Director of Immunotherapy at bluebird bio, where she leads the CAR research team. She holds a D.Phil from the University of Oxford. Prior to joining bluebird, Dr. Perkins trained at Harvard University, Cold Spring Harbor Laboratory, the MRC Gambia Unit, the NIH Vaccine Research Center, and NIAID.

Paul Rennert, PhD

Paul is President & CSO of Aleta Biotherapeutics. His biopharma expertise covers bench to clinical trial development of diverse therapeutics for oncology, autoimmunity, inflammation and fibrosis (Repligen, Biogen, X-Rx). Since 2012 he has been involved in the genesis of novel biotechnology companies, most recently as co-founder of Aleta. Aleta Biotherapeutics develops transformative technologies to advance adoptive cellular therapies for the treatment of diverse cancers. Paul has authored numerous publications and patents, and recently served as editor for the review volume "Novel Immunotherapeutic Approaches to the Treatment of Cancer".

Michel Sadelain, PhD

Dr. Michel Sadelain, M.D, Ph.D., is Scientific Co-Founder of Juno Therapeutics Inc. Dr. Sadelain serves as Head of the Gene Transfer and Gene Expression Laboratory at Memorial Sloan-Kettering Cancer Center (MSKCC). Dr. Sadelain’s research focuses on novel approaches to enhance T cell costimulation and function. His clinical program focuses on B cell malignancies as well as solid tumors. He is the incumbent of the Stephen and Barbara Friedman Chair and the founding director of the Center for Cell Engineering at MSKCC. He served on the board of directors of the American Society of Gene Therapy from 2004 to 2007 and serves on the editorial boards of Molecular Therapy, Human Gene Therapy and Gene Therapy. Dr. Sadelain serves as Member of Scientific Advisory Board at Biocurex Inc. and TMune Therapeutics, Inc.

Andrew Sewell, PhD

Andy Sewell’s research interests have focused around how organisms deal with environmental adversity. He began his career at the University of Liverpool by applying his training in chemistry towards phytoremediation strategies. He then moved to the University of Utah in 1990 to work on gene activation by environmental stress and was promoted to the Faculty there in 1994. Tugged heartstrings saw him return to Oxford in 1995 to work on the strategies HIV and other viruses use to subvert human T-cell immunity. That same Welsh girl was influential in his relocation to Cardiff in 2006 to take up a position as Distinguished Research Professor in the School of Medicine. He continues in Cardiff and is currently a Wellcome Trust Senior Investigator. His research focuses on T-cell antigens and the receptors that recognize them. This takes the Sewell laboratory in many different directions including transplant tolerance, autoimmune disease, immunity to infection and cancer immunotherapy. Of relevance to this meeting, the Sewell laboratory uses engineered T-cell receptors and engineered T-cell ligands (peptides and synthetic compounds) to manipulate the immune system for therapeutic benefit. 

Bob Valamehr, PhD

Bob Valamehr is the Vice President of Cancer Immunotherapy at Fate Therapeutics, overseeing the company’s immuno-oncology and pluripotent stem cell programs, including efforts to develop novel pluripotent cell strategies to create “off-the-shelf” cell-based cancer immunotherapeutics. Previously, Dr. Valamehr has played key scientific roles at Amgen and at the Broad Stem Cell Research Center developing ways to modulate stem cell fate and better understand cellular signaling pathways associated with cancer. He has co-authored studies related to stem cell biology, oncology and materials science. Dr. Valamehr received his PhD from the Department of Molecular and Medical Pharmacology at UCLA and his MBA from Pepperdine University.

Agonist Immunotherapy Targets

Adam J. Adler, PhD

Bio not available

Casey Ager

Casey is currently a senior graduate research assistant in Dr. Michael Curran’s lab at the University of Texas MD Anderson Cancer Center. He received his undergraduate degree at the University of Washington in 2013, and during this time worked at the Fred Hutchinson Cancer Center in the lab of Dr. Rainer Storb investigating T cell checkpoint modulation in the context of nonmyeloablative hematopoietic stem cell transplantation. Since beginning his graduate studies in 2013, Casey has focused on developing and optimizing combinatorial therapies incorporating innate immune agonists targeting STING together with checkpoint blockade antibodies, with the goal of sensitizing prostate and pancreatic cancers to the durable effects of immunotherapy.

Adi Diab, PhD

Adi Diab, MD, is a clinical investigator whose research is focused on developing new Immunotherapeutic Strategies that will improve clinical outcomes in patients. Building on his extensive background in immunology in general and tumor immunology specifically, Dr Diab is leading multiple clinical trials involving novel immune modulator agent with Melanoma. In addition he is leading a program for Interventional Immunotherapy that was established to develop intratumoral therapeutic strategies in combination with Systemic therapy; designed to improve clinical outcome and allow better understanding of the dynamics of each patient’s immune response to the tumor. These strategies include tumor ablation such as Cryoablation, RFA or Radiation therapy as well as direct intratumoral injection of immune modulation agents such as TLR agonists, CD40 agonists and other immune-stimulating agents. He has authored or co-authored over thirty scientific publications and abstracts and serves as a reviewer for the Journal of Immunotherapy and the Journal of the American Society of Hematology. Dr Diab received his medical degree from St. George’s University. He completed a research fellowship in immunology at Memorial Sloan-Kettering Cancer Center. Following his residency at New York University Medical Center, Dr Diab completed clinical fellowships at Memorial Sloan-Kettering Cancer Center in hematology oncology and breast medical oncology.

Saso Cemerski, PhD

Saso Cemerski, Ph.D. joined MRL Boston in 2014 and has contributed to advancing Merck’s anti-LAG-3 antibody (MK-4280) into Ph1 clinical trial. He is invested in co-leading Merck’s MK-1454 program from target validation to Ph1 clinical trial entry. Saso is closely involved with other accelerated MRL preclinical programs targeting novel and emerging mol­ecules critical for mounting strong immune anti-tumor responses. Saso obtained his Ph.D. in immunology in Toulouse, France. He did his post­doctoral training at Washington University in Saint Louis and worked at Xencor (Monrovia, CA) and BMS (Lawrenceville, NJ) prior to joining MRL.

Deborah H. Charych, PhD

Bio not available

Peter Ellmark, PhD

Dr. Ellmark joined Alligator Bioscience in 2008, and as a Principal Scientist he heads the project steering group at Alligator. He also holds a position as Associate Professor in Immunotechnology at Lund University. Dr. Ellmark´s research interest is focused on developing mono and bispecific antibodies for tumor directed immunotherapy of cancer. Dr. Ellmark earned his PhD 2002 in Prof. Carl Borrebaeck´s group at the Department of Immunotechnology at Lund University working on antibody engineering and CD40 antibodies.

Claudia Ferrara, PhD

Claudia Ferrara holds a PhD in biotechnology from the Swiss Federal Institute of Technology Zürich. She worked at Glycart AG prior the acquisition by Roche in 2005. She is now a Principal Scientist, leading the Biochemistry group at Roche Innovation Center Zürich. Her area of expertise includes the biochemical and biophysical characterization of therapeutic proteins and the development of targeted agonists.

Denise L. Faustman, MD, PhD

Denise Faustman, MD, PhD, is an Associate Professor of Medicine at Harvard Medical School and Director of the Immunobiology Laboratory at the Massachusetts General Hospital (MGH). Dr. Faustman’s research accomplishments include the first scientific description of modifying donor tissue antigens to change their foreignness. This achievement formed the basis of producing genetically modified pigs for organ donation and, in 2003, earned her the prestigious National Institutes of Health and National Library of Medicine Award, “Changing the Face of Medicine,” as one of 300 American physicians (one of 35 in research) honored for seminal scientific achievements in the United States. She has also won notable awards such as the Oprah Achievement Award for “Top Health Breakthrough by a Female Scientist” and the Women in Science Award from the American Medical Women’s Association and Wyeth Pharmaceutical Company for her contributions to autoimmune disease research. Her current research focuses on discovering and developing new treatments for autoimmune diseases, particularly type 1 diabetes. She has worked 15 years on the TNFR2 receptor as a control point for Tregs and now a broadly expressed oncogene. Through the design a TNFR2 agonists and antagonists her research is aimed at novel therapeutics for autoimmunity and cancer immunotherapy.

Oliver Hill, PhD

Oliver Hill joined Apogenix in March 2006. He is an expert for protein engineering and expression. Prior to his position at Apogenix, he headed the protein expression and purification group at Graffinity Pharmaceutical Design GmbH (Heidelberg, Germany) from 1999 to 2006. At Graffinity Oliver Hill was responsible for delivering a broad spectrum of target proteins for screening on a chemical microarray platform. His work in former, academic R&D positions at the Lower Saxony Institute for Peptide Research (Hannover, Germany; 1992-1996) and the Institute for Molecular Biotechnology (Jena, Germany; 1997-1998) included gene hunting, protein engineering and the development of recombinant phage display technologies. Mr Hill studied biology at the University of Hannover where he also received his Ph.D. from the Department of Chemistry in 1997.

Debbie Law, DPhil

Debbie Law has served as CSO of Jounce Therapeutics, a Cambridge-based biotech focused on cancer immunotherapy, since January of 2015. She has helped progress JTX-2011, a novel ICOS agonist antibody from discovery to the clinic. Prior to Jounce, Debbie served as Vice President of Immunology, Oncology and Immunomodulators at Merck working on programs including pembrolizumab and MK-4166 (anti-GITR). She has over 20 years of experience in biologics in the fields of oncology and immunology has held positions including VP of Biologics Discovery (Merck); CSO for Ablynx n.v. and VP of Research at PDL Biopharma.

Debbie received her B.Sc. in Immunology from Glasgow University and her D. Phil. in Immunology from Oxford University prior to pursuing post-doctoral research at UCSF in San Francisco.

Patrick Mayes, PhD

Dr Mayes previously managed antibody discovery efforts within the Immuno-Oncology and Combinations (IOC) Unit of GlaxoSmithKline where he developed novel therapeutic antibodies against a number of receptor targets, which modulate innate and adaptive immune responses. These programs utilize a variety of different antibody platform technologies including Fc-engineered monoclonal antibodies (mAbs), bi-specific mAbs and domain antibodies (dAbs). A specific focus of the IOC unit at GSK is to identify and develop novel immune based drug combinations. Dr Mayes is involved in projects combining multiple immune targeted therapies as well as others combining immunotherapies with tumor targeted agents. He received his PhD in pharmacology from the University Of Pennsylvania School Of Medicine.

Dafne Müller, PhD

Dafne Müller received her doctoral degree from the University of Stuttgart in Germany. At the present she holds a group leader position at the department of Biomedical Engineering at the Institute of Cell Biology and Immunology of the University of Stuttgart. Working in the field of recombinant antibodies for over 10 years, her current research focuses on the development of recombinant antibody-fusion proteins with immune stimulatory or costimulatory properties for targeted cancer immunotherapy.

Harpreet Singh

Since then he has served as Managing Director and Chief Scientific Officer of Immatics Biotechnologies GmbH, helping to grow the company from a start-up to an established biotech. He is dedicated to translating pioneering scientific discoveries into highly innovative cancer immunotherapeutics with clinical utility. Dr Singh has played a leading role in raising over US$200m of venture capital funding over several financing rounds. Since 2015, Dr Singh is President & CEO of Immatics US, Inc. overseeing all operations of Immatics in Houston, Texas as to develop next-generation Adoptive Cell Therapies (ACT). He contributed significantly to raising the necessary funding including a $20m CPRIT grant by the State of Texas.

Taylor Schreiber, PhD

Taylor H. Schreiber, MD/PhD, Chief Scientific Officer. Dr. Schreiber is a physician/scientist with ten years of experience developing immuno-oncology therapeutics. Prior to Shattuck, he co-founded Pelican Therapeutics, which sprung from his work on the immunobiology of TL1A and TNFRSF25. Dr. Schreiber also served as Chief Scientific Officer of Heat Biologics, Inc., and has published over 30 articles in prestigious peer-reviewed journals.

Robert B. Stein, MD, PhD

Dr. Robert Stein has over 35 years of experience and accomplishments in the pharmaceutical and biotech industry and advises Agenus’ global research and development efforts. Bob previously served as the Company’s President of R&D. Over the course of his career, Bob has played a significant role in the discovery and development of eight marketed drugs, including Sustiva®, Fablyn®, Viviant®, PanRetin®, TargRetin®, Promacta®, & Eliquis®. Prior to working at Agenus, he held a number of progressively responsible senior management positions including Head of Pharmacology for Merck & Co., CSO & SVP of Research for Ligand Pharmaceuticals, EVP of Research & Preclinical Development for Dupont Merck, President and CSO for Incyte Pharmaceuticals, President of Roche Palo Alto, and CEO of KineMed. Bob spent the early part of his career at Merck, Sharp and Dohme Research Laboratories. He holds an MD and a PhD in Physiology & Pharmacology from Duke University.

Michael Yellin, MD

Bio not available

Difficult to Express Protein

Randal Bass, PhD

Dr. Bass serves as the Vice President of Process Development at Just and is responsible for upstream, downstream, and analytical development activities and general technical program oversight. He has over 15 years of industry experience including 12 at Amgen, where he led analytical and cross-functional process teams as well serving as head of the Analytical Sciences Department. Dr. Bass has broad experience developing large molecule therapeutics from early stage First-in- Human to commercialization through post-launch support and second generation commercial processes. He has authored numerous regulatory filings to the FDA, EMA, PMDA and many other agencies. He received his Ph.D. from the University of Colorado in Biochemistry and completed a post-doctoral fellowship in X-ray crystallography from the California Institute of Technology.

Matthew Coleman, PhD

Dr. Matthew Coleman is a senior biomedical staff scientist at Lawrence Livermore National Laboratory and is an adjunct professor of radiation oncology at University of California Davis School of Medicine. He received his Ph.D. in molecular biochemistry and cellular biology from Boston University. Dr. Coleman has authored over 80 publications in peer-reviewed journals, published proceedings and book chapters covering a diverse breadth of biophysics and molecular biology. He works on radiobiology, membrane protein biochemistry and structural determination of membrane proteins.

Hussain Dahodwalla, PhD

Hussain Dahodwala is a visiting scientist with the Vaccine production program, a part of the Vaccine Research Centre, NIH. His current role involves recombinant protein production to support HIV vaccine trial efforts. As part of the Cell line development team, Hussain works on Cell line platform studies with a specific focus on developing and implementing cell engineering strategies to improve host cell line performance.

Martin Gamer, PhD

2015 – Today: Associate Director Cell Biology (Boehringer Ingelheim Pharma GmbH & Co. KG, Germany)

Development of stable cell lines for NBE and Biosimilar projects. Leading technology developments to ensure state-of-the-art biopharmaceutical developments.

2010 – 2015: Group Leader Protein Production and Analytics (Protagen AG, Germany)

Establishment of a high-throughput protein production platform. Production of human proteins for diagnostic applications.

2008 – 2010: Scientist Industrial Biotechnology (c-LEcta GmbH/University of Leipzig, Germany)

Development of alternative bacterial hosts for the economic production of enzymes for industrial applications.

Haruki Hasegawa, PhD

Haruki is a molecular cell biologist who specializes in investigating the processes of in vivo protein folding and intracellular trafficking of therapeutically important proteins. His main research interests are to (1) elucidate cargo-specific biosynthetic mechanisms for broad classes of proteins (both drug targets and biotherapeutics) and their fate in intracellular and extracellular space after the synthesis; and (2) translate the findings into effective protein expression strategies, novel assay designs, and mechanistic understanding of disease biology.

Azad Kumar, PhD

Azad Kumar works in the Dale and Betty Bumpers Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, NIH.

Kerstin Otte, PhD

Kerstin Otte is a trained biologist and obtained her PhD at the SL-University Uppsala, Sweden. After a postdoctoral fellowhip at the Gurdon Institute in Cambridge, UK, she joined the biotech industry in Heidelberg, Germany for preclinical drug development. Kerstin Otte now holds a professorship at the Biberach University, Germany, focusing her research on biopharmaceutical cell line development.

Harun Rashid, PhD

Harun has 17 years of biotech R&D experience in cutting-edge molecular biology with expertise in recombinant protein expression and engineering, synthetic biology, genome engineering and strain development. Currently, Harun is leading the Molecular Technology team at Ambrx, Inc. to optimize their UAA incorporation technology for the production of protein therapeutics in bacterial (ReCODE) and mammalian (EuCODE) systems. Prior to that, he had engineered protein therapeutics, and optimized expression systems for development candidates at Genencor International and Catalyst Biosciences that had moved to clinical stages.

Paul D. Roepe, PhD

Dr. Roepe received his Ph.D. (chemistry) in 1987 and then performed post-doctoral research at the Roche Institute of Molecular Biology, and the Molecular Biology Institute at the U.C.L.A. School of Medicine. In 1990 he accepted joint appointments in the Program in Molecular Pharmacology and Therapeutics at Memorial Sloan-Kettering Cancer Center and the Department of Pharmacology at Cornell University Medical College, where his laboratory studied several problems related to tumor drug resistance phenomena. In the late 90's his laboratory moved to Georgetown University, where he is currently Professor of Chemistry, Professor of Biochemistry and Cellular and Molecular Biology, and co-director of the Center for Infectious Disease. His training and independent research has been highly interdisciplinary but organized around the topics of membrane transport, drug resistance, and mechanisms of drug action.

The current focus of the laboratory is to elucidate the molecular details of antimalarial drug resistance phenomena and to develop new antimalarial drug therapy guided by those details. In this work the laboratory uses a variety of novel interdisciplinary techniques along with more traditional tools of chemistry and biochemistry.

Gargi Roy, MSc

Gargi Roy is a Scientist I in the Cell Line Engineering, ADPE/Research Department at MedImmune.

Joop van den Heuvel, PhD

Joop van den Heuvel studied biochemistry at the Free University in Amsterdam and also passed his PhD there from 1985 to 1990 about the effect of mRNA structure on the translational efficiency. After that, he started as a postdoc at the former German Research Centre for Biotechnology (GBF) in Braunschweig, where he worked on the production and purification of proteins. From then on, Joop van den Heuvel has been faithful to this research field. In 1996, he became a project leader in the Department of Biochemical Engineering, and in 2002 he started to work in the Department of Structural Biology. Since 2007, he leads the “Protein Sample Production Facility“ (PSPF) of the HZI, which uses mammalian cells for a large-scale production of recombinant proteins. One year later, he additionally became the leader of the research group “Recombinant Protein Expression”, where he and his colleagues are involved in research as well as in commissioned work.

Ernst Weber, PhD

Ernst Weber, Ph.D., is Laboratory Head at Bayer Healthcare. After receiving his Ph.D. in Biochemistry from the University of Halle, he conducted his Postdoc work as an EMBO fellow at the MRC-LMB in Cambridge focusing on protein engineering. In 2008 he joined Bayer Innovation where he developed new HTS compatible molecular biology technologies with applications in the optimization of function and expression of single proteins or even complete enzymatic pathways. 2012 he moved to Bayer Pharmaceuticals and is here responsible for antibody optimization and a project leader in lung and inflammatory research. Since 2015 he coordinates the setup of the bispecific antibody technology platform.

Yi Xia, MD

Experience:

Dept. of Antibody Engineering, Genentech, S. San Francisco, California  2005-Present

Antibody engineering, antibody production, and antibody characterization

Zymed Laboratories/Invitrogen, S. San Francisco, California 2003-2005

Hybridoma antibody generation and antibody characterization

Deltagen, Inc., Redwood City, California 2001-2003

Engineered a humanized anti-CD123 therapeutic antibody for adult acute myeloid leukemia (AML)

Education:

M.S., Biochemistry & Molecular Biology

Keck School of Medicine, University of Southern California

M.D., Passed United States Medical Licensing Examination (USMLE)

Certified by the Educational Commission for Foreign Medical Graduates

(ECFMG, certification number: 0-623-114-6)

Bachelor of Medicine, Shanghai Medical College, FuDan University

US Patents for this topic:

Beaumont T., Kwakkenbos M.J., Brown E.J., Morisaki J.H., Hazenbos W.L.W., Mariathasan S., Kajihara K., Xia Y. Gram-positive Bacteria Specific Binding Compounds (Pseudomonas). US9, 458, 228, B2 Oct. 2016.

Beaumont T., Kwakkenbos M.J., Brown E.J., Morisaki J.H., Hazenbos W.L.W., Mariathasan S., Kajihara K., Xia Y. Gram-positive Bacteria Specific Binding Compounds (Staph Aureus). US9, 399, 673, Jul. 2016.

Beaumont T., Kwakkenbos M.J., Brown E.J., Morisaki J.H., Hazenbos W.L.W., Mariathasan S., Kajihara K., Xia Y. Gram-positive Bacteria Specific Binding Compounds (ThioMab, AAC). US9, 090,677, Jul. 2015.

Beaumont T., Kwakkenbos M.J., Brown E.J., Morisaki J.H., Hazenbos W.L.W., Mariathasan S., Kajihara K., Xia Y. Gram-positive Bacteria Specific Binding Compounds (Native Antibody). US8, 617,556, Dec. 2013.

Alexei Yeliseev, PhD

Alexei Yeliseev is a Staff Scientist at the National Institute on Alcoholism and Alcohol Abuse, National Institute of Health. He heads the protein biochemistry group focusing on developing technologies for expression, purification, and functional and structural characterization of G protein-coupled receptors. In addition to his research work he serves as a member of editorial board of Protein Expression and Purification and Journal of Receptor, Ligand and Channel Research.

Optimizing Protein Expression

Nicola Beaucamp, PhD

Nicola Beaucamp was appointed Head of Process Research in Pharma Research & Early Development as of September 1, 2015, based in Roche Innovation Center Munich, Germany. With this senior management position, she is responsible for pre-clinical and clinical supply up to phase I for the Roche Research unit in Europe. With more than 15 years’ experience in biotechnology and pharmaceutical industry, Nicola has huge know-how in all phases of the R&D value chain. She is biologist by training and did her academic studies at the University of Regensburg, Germany where she obtained her PhD at the Institute of Biophysics and biophysical Chemistry. After two years at the Molecular Neurobiology Group at the University of Bristol, UK, Dr. Beaucamp returned to Germany to start her career as group leader in a Biotech Company before joining Roche in the beginning of 2005.

Colin Clarke, PhD

Dr. Clarke graduated with a PhD in Bioinformatics from Cranfield University, UK, and specialises in the application of multivariate statistics and machine learning algorithms to high dimensional data. Upon completion of his doctoral training Colin took a position at Dublin Institute of Technology (DIT) applying chemometric approaches to analyse Raman and Infrared spectroscopy data from cells and tissues. He moved to the National Institute for Cellular Biotechnology at Dublin City University in 2009 to work in Martin Clynes’ group investigating the biology of CHO cells during biopharmaceutical production. A major component of his research in this time has centred on the application of statistical methods to study CHO transcriptomic and proteomic expression datasets. Examples of his work in the area include the use of partial least squares (PLS) to predict cell specific productivity from gene expression data and the elucidation of mRNA co-expression networks from a large-scale CHO mRNA dataset. An area of particular interest was the integration of miRNA, mRNA, proteomic and genomic data to understand the biological processes regulating the growth rate of CHO cells. In 2014, he moved to NIBRT following the award of SFI’s prestigious Starting Investigator Research Grant. Dr Clarke’s bioinformatics group is currently focused on further understanding the CHO cell biological system using next-generation sequencing and advanced computational techniques.

Jan-Willem de Gier, PhD

Jan-Willem de Gier is Professor of Biochemistry at Stockholm University. Main interest of his laboratory is the creation of E. coli recombinant protein production strains. To this end both evolutionary and engineering approaches are used. In addition, he is co-founder of the biotechnology companies Xbrane Biopharma AB and Abera Bioscience AB.

William Gillette, PhD

Bill Gillette works for Leidos Biomedical Research, Inc., in Frederick MD, where he focuses on fulfilling the protein needs of the RAS program. Dr. Gillette is currently focusing on high-throughput micro-scale purification as a means to identify positive constructs, optimization of chromatography and supporting analysis techniques to evaluate protein expression constructs and the success of the micro scale chromatography experiments. His work is in the context of the Protein Expression Laboratory that provides protein expression/purification core service to the laboratories of the NCI, NIH and USAMRIID. He received his PhD in Microbiology from NC State University, Raleigh, NC.

David Humphreys, PhD
David got a first degree in molecular biology and biochemistry from Durham University and a PhD in protein expression and folding from Birmingham University. He has worked at Celltech and hence UCB NewMedicines for 21 years as post-doc, group and project leader on multiple aspects of antibody engineering and protein expression and is currently head of the Protein Sciences team. David has 30 publications and is inventor on 40 patent families. 

Kinjal Mehta, PhD

I am a Protein Biochemist by background and was trained in Dr. Jin Montclare’s laboratory at NYU, where I studied various histone acetylatransferases and with collaboration with machine learning experts, was able to create a library of enzymes with altered specificity or promiscuity as desired. Currently, I am a Principal Scientist in the Protein Sciences Department at Jounce Therapeutics. Jounce is dedicated to developing cancer immunotherapies using its Translational Science Platform to prioritize targets and identify related biomarkers to match the right therapy to the right patients. My group here at Jounce is responsible for recombinant production and preliminary characterization of antibodies and target proteins. We conduct transient mammalian expressions at various scales with a considerable amount of automation from transfection through storage of purified antibodies and target proteins. With the support of automation available in our labs, my team achieves an impressive throughput to produce large number of high-quality proteins routinely.

Jesse Rinehart, PhD

Dr. Jesse Rinehart is an Associate Professor in the Department of Cellular & Molecular Physiology at the Yale University School of Medicine with a joint appointment in the Systems Biology Institute. Dr. Rinehart’s research aims to understand and “decode” the roles of protein phosphorylation in humans. His laboratory uses an innovative combination of quantitative phosphoproteomics and synthetic biology study protein phosphorylation in single proteins and protein networks. Recently, research in Dr. Rinehart’s laboratory has been accelerated by their Escherichia coli based technology that enables site-specific incorporation of phosphoserine into human proteins. Dr. Rinehart received his PhD in Molecular Biophysics and Biochemistry from Yale in 2005. He studied protein synthesis and the evolution of the genetic code during his graduate work. His did his postdoctoral research with Richard Lifton in the Department of Genetics at Yale, and focused on protein phosphorylation in physiological systems.

Robert Roth, PhD

Robert Roth is an Associate Principle Scientist at AstraZeneca based in Mölndal, Sweden. After completing a PhD in Biochemistry at Lund University, he started as a Post Doc at AstraZeneca in 2003. For the first couple of years, he worked with the expression and purification of membrane proteins as part of the initiative to establish this capability within the company. After that, he had several roles concerning different aspects of protein expression in both prokaryotic and eukaryotic systems. For the last 3 years, he is responsible for the scientific and technical development of protein expression activities supplying protein reagents to preclinical activities ranging from structural biology to testing of therapeutic proteins in animal disease models.

Jorg Thommes, PhD

Jorg Thommes is the Senior Vice President Pharmaceutical Sciences and Technology at Visterra. In this role, he is responsible for all aspects of CMC development, manufacturing, and drug supply for Visterra’s products. Visterra is a clinical-stage biopharmaceutical company focused on applying its novel Hierotope® platform to identify unique disease targets and to design and engineer precision antibody-based biological medicines against such targets that are not adequately addressed with conventional approaches. Prior to joining Visterra, Dr. Thommes was at Biogen, Inc., where he served among other positions as Senior Vice President, Engineering and Technology, and his responsibilities included process development for all therapeutic modalities, global and site engineering, and manufacturing sciences. Previously, Dr. Thommes was the Director, Protein Purification Development, at IDEC Pharmaceuticals and prior to IDEC, he held a research and teaching position at the Institute of Enzyme Technology at University of Dusseldorf, Germany. He serves on the board of the Recovery of Biological Products conference series and was chairman of that board from 2014 to 2016. Dr. Thommes received a Diplom-Chemiker degree from University of Bonn, Germany, a Doctorate of Natural Sciences from University of Bonn, Germany, and a Habilitation Degree in Biochemical Engineering from University of Dusseldorf, Germany.

Bernd Voedisch, PhD

Bernd Voedisch works as a lab head in the Biologics Center at the Novartis Institutes for Biomedical Research in Basel, Switzerland. He is responsible for the generation of protein reagents and recombinant mammalian cell lines facilitating Biologics research projects for various disease indications. He is a trained biotechnologist and received his PhD from the Technische Universitaet Braunschweig in Germany.

Jamey Young, PhD

Dr. Young has authored 50 articles and book chapters describing the application of mathematical modeling and ¹³C flux analysis to a variety of research topics, including microbial physiology, liver and islet cell physiology, cancer cell metabolism, photosynthetic metabolism, and cell culture engineering. He developed the first publicly available software package (INCA) capable of both isotopic steady-state and nonsteady-state ¹³C flux analysis. INCA has been licensed over 100 times for academic use and by 10 different companies. His lab has successfully applied INCA to achieve several breakthroughs, including the first comprehensive ¹³C flux studies of photosynthetic cyanobacteria and plant leaves. He was awarded the NSF CAREER Award in 2010 and the DOE Early Career Award in 2012, and he was named a Vanderbilt Chancellor’s Faculty Fellow in 2017. Dr. Young is also a co-founder of Metalytics, LLC, which is a provider of metabolic flux analysis software and services to the biotechnology industry.

Protein Expression System Engineering

Abhishek Chatterjee, PhD

Abhishek earned his undergraduate education in Chemistry at Calcutta University (B.Sc., 2001), and Indian Institute of Technology, Kharagpur (M.Sc., 2003). He then obtained his Ph.D. in Chemical Biology from Cornell University in 2009 working with Professor Tadhg Begley. His graduate work focused on elucidating the complex molecular mechanism of vitamin B1 biosynthesis in plants and fungi. Then, as a postdoctoral fellow with Professor Peter Schultz at The Scripps Research Institute, he worked on expanding the scope of the unnatural amino acid mutagenesis technology. Abhishek joined the faculty at Boston College in the Department of Chemistry in the summer of 2013. His research focuses on developing genetically encoded tools to probe and manipulate the biology of higher eukaryotes.

Patricia L. Clark, PhD

Patricia L. Clark is the O’Hara Professor of Chemistry & Biochemistry at the University of Notre Dame, where she is also a Concurrent Professor of Chemical and Biomolecular Engineering. Her laboratory uses a broad range of biophysical, genetic and other tools to investigate the effects of protein folding from one end to the other (such as during translation), versus all-at-once (as in the test tube). As the leader of an NIH-funded research network comprised of eight laboratories, she coordinates a multi-disciplinary investigation into the effects of translation rate on protein biogenesis. She has received multiple awards throughout her career, including an NSF CAREER Award, the Michael & Kate Bárány Award from the Biophysical Society, and the Joyce Award for Excellence in Undergraduate Teaching from Notre Dame.

Michael Dyson, PhD

Mike Dyson is Chief Technology Officer at IONTAS Ltd., a therapeutic antibody discovery company. He is a co-inventor of the IONTAS mammalian cell antibody display platform and has acted as the project leader for several successful therapeutic antibody discovery projects. Mike was previously Head of Protein Engineering at Acambis plc (acquired by Sanofi) and was the Project Leader, responsible for protein expression, within the Atlas Project at the Wellcome Trust Sanger Institute. He has over 20 years’ experience in cell and molecular biology gained during research at the Massachusetts Institute of Technology, Universities of Edinburgh and Cambridge and the biotechnology industry. He has published 31 papers and book chapters (cited over 1000 times, h-index 19) and is inventor on 7 US patent and patent applications.

Tobias Grosskopf, PhD

A special area of interest of mine has always been how we can describe biochemical reactions mathematically and forward predict microbial behavior based on the biochemical environment. Starting my career as a marine biologist, I did my PhD at the GEOMAR institute in Kiel, Germany, working on global-scale measurement and modeling of biologically mediated nitrogen cycling in the oceans. Getting more granular, I completed a Post-Doc at the University of Warwick (Coventry, UK) modelling microbial communities and their interactions in the context of biogas production. Since early 2017 I joined Roche where I work as a Scientist to build mechanistic, hybrid and statistical models of CHO and E.coli cells to help us better understand, monitor and predict the process of Antibody production. Further, I am interested in building algorithms that automate analysis workflows and guide optimization of experiment design and process layout.

Olivier Henry, PhD

Professor Olivier Henry is a member of the bioprocess group at the chemical engineering department of Ecole Polytechnique de Montreal. His main research interests are in the development of cell culture processes for the large-scale production of recombinant proteins, viral vectors and vaccines. His research group works on the optimization and control of bioreactors and the development of advanced monitoring strategies for animal cell cultures. His laboratory is also conducting comprehensive metabolic engineering studies allowing detailed and quantitative characterization of cell metabolism in culture. This research is supporting the development of enhanced expression platforms for the high-yield production of bioactive therapeutic proteins.

Eric Kelsic, PhD

Eric Kelsic’s research focuses on combining high-throughput molecular automation with machine learning to engineer new technologies for genetic medicine. He currently works with Professor George Church on a project at the Wyss Institute to discover highly efficient, anti-immunogenic, cell- and tissue-specific AAV capsid proteins for in vivo DNA delivery. By developing improved search algorithms for protein engineering, he hopes to improve and enable applications ranging from the treatment of rare genetic diseases and chronic genetic ailments to new anti-aging therapies. Eric received his PhD in Systems Biology from Harvard University in 2015, and prior to that a BS in Physics from the California Institute of Technology.

Michael Jewett, PhD

Michael Jewett is the Charles Deering McCormick Professor of Teaching Excellence, an Associate Professor of Chemical and Biological Engineering, and co-director of the Center for Synthetic Biology at Northwestern University. He is also an Institute Fellow at the Northwestern Argonne Institute for Science & Engineering.  Dr. Jewett’s lab seeks to re-conceptualize the way we engineer complex biological systems for compelling applications in medicine, materials, and energy by transforming biochemical engineering with synthetic biology. Dr. Jewett is the recipient of the NIH Pathway to Independence Award in 2009, David and Lucile Packard Fellowship in Science and Engineering in 2011, the DARPA Young Faculty Award in 2011, the Agilent Early Career Professor Award in 2011, the 3M non-tenured faculty grant in 2012, the Camille-Dreyfus Teacher-Scholar Award in 2015, and the ACS Biochemical Technologies Division Young Investigator Award in 2017. He received his PhD in 2005 at Stanford University and completed postdoctoral studies at the Center for Microbial Biotechnology in Denmark and the Harvard Medical School.

Minseung Kim, MSc

Minseung Kim is a Ph.D. candidate at the University of California, Davis, where he is working on data integration and genome-scale multi-omics predictive modeling for microbial species under the supervision of Prof. Ilias Tagkopoulos. Prior to this, he finished mandatory military service for South Korean nationals by serving as a research associate at Yonsei University, the University of California, Berkeley and Samsung Biomedical Research Institute. He earned his masters degree from Columbia University and he holds two bachelor degrees from Illinois Institute of Technology and Hongik University.

Nathan Lewis, PhD

I am an assistant professor in the Department of Pediatrics in the UC San Diego School of Medicine. My group focuses on the integration of -omic data with in silico models of metabolism for probing into drug development in Chinese hamster ovary cells (Xu, et al. Nat Biotech, 2011), (Lewis, et al. Nat Biotech, 2013), (Kildegaard, et al., Curr Opin Biotech, 2013), and human disease (Lewis, et al., Nat Biotech, 2010). We also are interested in tool development for constraint-based modeling  (Lewis, et al., Nat Rev Microb, 2012).

Colton Lloyd, PhD Candidate

A Ph.D. candidate in the Systems Biology Research Group at UC San Diego, Colton Lloyd works under the supervision of Professor Bernhard Palsson. His research regards developing and applying genome-scale models of metabolism and gene expression to examine the role of fundamental cellular constraints governing the growth properties of E. coli. He is a recipient of the National Science Foundation Graduate Research Fellowship and holds a bachelor’s degree in biomedical engineering from The Ohio State University, where he graduated summa cum laude.

Shahram Misaghi, PhD

I am a senior scientist at the Cell Line Development department in Genentech. I have been in my current role since 2010. My research involves improving/innovating processes that result in generation of cell lines expressing bio-therapeutics (proteins and antibodies used as drugs) at high titers and with specific product quality attributes. Bachelor: University of California Berkeley, Molecular and Cell Biology. PhD: Harvard University, in Biological and Biomedical Sciences. Post-doctoral fellow at Massachusetts Institute of Technology (MIT) and Genentech.

Dimitris Papamichail, PhD

Dimitris Papamichail is an Assistant Professor of Computer Science at The College of New Jersey (TCNJ). He completed his Ph.D. in Computer Science at Stony Brook University, and has held a position at the University of Miami prior to joining TCNJ in 2013. His research focuses on practical algorithmic problems, primarily drawn from the life sciences, and is largely driven by collaborations. He is interested in synthetic biology and the design of protein coding sequences with enhanced properties, genomic sequence classification, design and implementation of efficient bioinformatics tools, and computational phylogeny. His research has been funded by the National Science Foundation (NSF) and the Andrew W. Mellon Foundation. An overview of Dr. Papamichail's research and educational activities is available at http://www.tcnj.edu/~papamicd.

Lisa Alexandra Pieper, PhD

After having studied Biotechnology at the RWTH Aachen, Lisa A. Pieper performed her PhD at the Institute of Cell Biology and Immunology (University of Stuttgart) in cooperation with Boehringer Ingelheim. Lisa joined Boehringer Ingelheim in 2017 as postdoctoral researcher in the group of Early Stage Bioprocess Development. Her main focus is on the upstream development of cell culture processes within the context of an integrated state-of-the art process platform for the production of high-quality biologics.

Anokha Ratnayake, PhD

I am a Principal Scientist at Pfizer Groton CT. I received my Msc degree in Chemical Engineering from Imperial College-University of London and PhD in Natural Products and Organic Synthesis from University of Hawaii at Manoa (2003). I received academic and industrial postdoctoral training from University of Utah and Wyeth Research, respectively. I worked in Natural Products and Medicinal Chemistry based programs for about 4 years before entering the ADC field in 2010. In 2017, I moved to the DNA-Encoded Library Technology (DELT) group where I currently work on validating on-DNA chemistries and developing and optimizing analytical methods for monitoring on-DNA chemical transformations.

Lars Stöckl, PhD

Lars Stöckl is a leading scientist at Glycotope GmbH since 2005. As a cell and protein biochemist, he first was responsible for the development of novel GlycoExpress cell lines which resulted in MabExpress and other glycoengineered cell lines. Since 2007, he is project manager of one of Glycotope’s most advanced pipeline projects, FSH-GEX, and is currently responsible for the development strategy at Glycotope. Before the appointment at Glycotope, he studied Chemistry at the Technical University of Munich, and gained experience in the field of cell line engineering and protein chemistry during his PhD and Postdoctoral fellowship at the Robert Koch-Institute /Berlin, the Charite / Berlin and the Breakthrough Breast Cancer Research / London.

Characterization of Biotherapeutics

Michael Adamo, Bristol-Myers Squibb

Michael Adamo received a Bachelor’s degree from Rutgers University in Biotechnology in 1999. He has spent the majority of his career in chromatographic analytical method development for proteins and large molecules. He is currently a Senior Scientist at Bristol-Myers Squibb Company in Hopewell, NJ where he leads a small group of scientists. His current projects include analytical method development for fusion proteins, antibodies, antibody drug conjugates and I-O combination drug products.

Eric S. Alonzo, PhD, bluebird bio

Eric Alonzo PhD, currently leads the CAR T cell analytics team within the Pharmaceutical Sciences Division at bluebird bio. His research focuses on development of cell-based assays for CAR T cell products. Prior to bluebird bio, Dr. Alonzo lead efforts developing T cell-based therapies at Agenus (Lexington, MA), and previous to his work at Agenus, he a postdoctoral fellow at Massachusetts General Hospital and Harvard Medical School working on a mouse model of T cell acute lymphoblastic leukemia. Dr. Alonzo received his PhD from the Cancer Biology Program at Memorial Sloan-Kettering Cancer Center.

Nathan Brown, PhD, AbbVie

Nathan Brown received his PhD in Chemical Engineering from Northwestern University in Evanston, IL in 2008 for his work on structure-activity relationships of synthetic analogues of surfactant protein C. Following his graduate work and a brief stay at Baxter Healthcare, Nathan has been a senior scientist at AbbVie Bioresearch Center in Worcester, MA for the past seven years. He currently leads the Biologics Pharmacy and Analytics group within Global Protein Sciences, where his group is responsible for analytical and biophysical method development and characterization in support of early and late discovery initiatives.

Shan Chung, PhD, Genentech

Dr. Shan Chung is a Principal Scientist and Group Leader in the Department of BioAnalytical Sciences (BAS) at Genentech, a Member of the Roche Group. Shan received his PhD in Molecular Biology from University of Pennsylvania and completed his postdoctoral training on protein engineering of human T-cell receptors at Harvard University. He joined Genentech in 2006 and currently leads the Effector Function and Cell Biology group in BAS. Shan has extensive experience in development, validation, and implementation of bioanalytical and potency assays. He is a subject matter expert in the fields of Fc effector functions, neutralizing antibody assays, and immunogenicity prediction/assessment of biotherapeutics. Shan has supported more than 40 successful IND/BLA filings at Genentech.

Mei Han, PhD, Senior Scientist, Pharmacokinetics & Drug Metabolism, Amgen, Inc.

Mei has worked in Biotech industry for 18+years. She has worked at different functional areas at Amgen including Analytical sciences, Protein Sciences and PKDM department. She has extensive experience in analytical method development, method transfer, protein characterization, purification, protein in vitro and in vivo characterization using different technologies such as chromatography, electrophoresis and mass spectrometry. She is currently working on predose and postdose pharmacokinetic samples characterization.

Stacey Helming, PhD, Regeneron Pharmaceuticals

Stacey Helming completed her graduate work with the School of Public Health at the University at Albany, State University of New York. She has worked as a Scientist with Regeneron Pharmaceuticals, Inc. for two years, managing the leachable and extractable testing in the Chemistry Development group.

Vibha Jawa, Ph.D., Director, Biologics and Vaccine Development, Merck

Dr. Vibha Jawa is currently a Director, Biologics and Vaccine Bioanalytics at Merck where she is responsible for developing a strategy and provides oversight and management of scientific programs for discovery, development and optimization of biologics and vaccines.  In this role, she is partnering with discovery and development groups to design better molecules.  Dr Jawa received her bachelors in Biochemistry (1991) from Delhi University and her doctorate in Biochemistry/Immunology (1998) from All India Institute of Medical Sciences, New Delhi, India with a thesis work studying the immune mechanisms behind autoimmune diseases followed by a postdoctoral fellowship at University of Pennsylvania on monitoring the immune response to viral vectors.  She continued to work in the field of gene therapy evaluating viral vectors for hemophilia therapy in the Bay area followed by City of Hope Cancer Centre Stem Cell and Gene Therapy group.  At Amgen from 2003-2016, her focus was to develop methods for assessing immunogenicity to biologics and the mechanisms behind development of immunogenicity. Her current research interests include evaluating immune response biomarkers for early drug development and efficacy, immunogenicity prediction using in silico, in vitro and in vivo technologies, modeling impact of immunogenicity on PK and PD and their application to a system based approach, antigen processing and presentation and the role of T cells in immune response to drug products.  Vibha is a member of professional organizations like American Association of Pharmaceutical Scientists (AAPS) and American Association of Immunology (AAI) and Federation of Clinical Immunology Society (FOCIS).  Within AAPS, Vibha has been actively involved as a Steering Committee member of the Therapeutic Protein Immunogenicity Focus Group (TPIFG) and is currently leading the Immunogenicity Prediction Action Program Area (IPAPA).   She has been an invited speaker in multiple sessions at AAPS for past few years and has successfully moderated and organized programming at AAPS NBC (National Biotechnology Conference) and AAPS Annual Meetings.  She has also organized and participated in AAPS webinar and e forum to propagate learning and sharing information among AAPS members.  Dr Jawa also serves as a manuscript reviewer for The AAPS Journal and J. Pharm Sci Journal.

Jay Jones, Seattle Genetics

Jay received his undergraduate degrees from the University of Washington and has many years of experience characterizing proteins. He has been part of the Analytical Sciences department at Seattle Genetics for the past 12 years developing tools for the characterization of monoclonal antibodies and antibody-drug conjugates. Currently, he focuses on using mass spectrometry for the elucidation of structure of a variety of therapeutic candidates.

Lynn Kamen, PhD, Genentech

Lynn Kamen is a Scientist in the BioAnalytical Sciences department at Genentech. After receiving her PhD in Immunology at the University of Michigan, studying the role of phosphoinositide signaling during Fc receptor-mediated phagocytosis. She continued her studies in signal transduction of innate immune cells during her postdoctoral research at UCSF in Clifford Lowell’s lab where she examined the impact of focal adhesion kinase deficiency upon neutrophil and macrophage activation. Following her postdoc, Lynn worked in several smaller biotech companies in the Bay Area continuing to develop assays to measure immune cell activation. Since joining Genentech, Lynn has developed a number of novel in vitro biological characterization assays to help predict safety and efficacy of therapeutic candidates.

Alex Lazar, PhD, ImmunoGen, Inc.

Alex Lazar is the Director of the Analytical and Pharmaceutical Sciences department at ImmunoGen, Inc. Alex is responsible for the development of analytical methods for the testing of immunogonjugates and their components (antibodies, linkers, and cytotoxic agents) and development of formulations for antibodies and immunoconjugates. Alex received his PhD in Analytical Chemistry from Brigham Young University in 1998, after which he completed his post-doctoral training at Oak Ridge National Laboratory. He worked as a Senior Scientist at biopharmaceutical companies (Zycos, EMD Pharmaceuticals) until 2004, when he joined ImmunoGen. Since then, his work has been focused on the development of immunoconjugate biotherapeutic products. Alex attended national and international scientific conferences, where he gave several presentations related to his work with ADCs.

Kelvin Lee, PhD, University of Delaware

Kelvin H. Lee is Gore Professor of Chemical and Biomolecular Engineering at the University of Delaware and is Director of NIIMBL: the National Institute for Innovation in Manufacturing Biopharmaceuticals. He received a BSE in Chemical Engineering from Princeton and PhD in Chemical Engineering from Caltech. Prior to his current appointment, he was on the faculty at Cornell University.

Zhenhong Li, PhD, RegenxBio

Dr. Zhenhong Li is a highly accomplished technical and quality executive with over 28 years of intense, successful and hands on experience in Biotechnology and Pharmaceuticals Industry. She has a PhD in Chemistry from Princeton University and then went on got further trainings in cellular signal transductions by tyrosine kinases at the National Institutes of Health and Bristol Myers Squibb during her post-doctoral years. Throughout her career, she has worked at Bristol Myers Squib, Gilead Sciences, MedImmune, Baxter Biosciences, Human Genome Sciences, GSK and Regenxbio in the fields of small molecules, nucleotides, protein therapeutics, vaccines and finally in gene therapy. Her expertise are at strategically harnessing cross functional talents and technological advancement and applying the effective and objective analytical technology in product characterization, production support and quality control operations.

Anthony Mire-Sluis, PhD, AstraZeneca

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego. He is the Chairman of the IABS Biotherapeutics Committee, Vice Chairman of the USP Biologicals Characterization Expert Committee and an expert for the International Committee for Harmonization.

Da Ren, PhD, Amgen

Da Ren is a Principal Scientist in Process Development at Amgen. His specialties include molecule assessment, analytical development, and release/stability testing. Da published over 20 papers in the field of therapeutic protein characterization.

Rich Rogers, PhD, Just Biotherapeutics

Dr. Rogers got his PhD from the Johns Hopkins University in 2003. In Mike Matunis’ lab he studied the effects of Sumo modification on transcription factors. As a post doc, Dr. Rogers joined John Aitchison’s lab at the Institute for Systems Biology. At the ISB, Dr. Rogers expanded his research on post translational modification by applying mass spectrometry to detect phosphoryatlation and other ubiquitin-like modifications in macrophages. In 2012, Dr. Rogers joined the Analytical Sciences group at Amgen. At Amgen, Dr. Rogers developed a mass spectrometry based multi-attribute method (MAM) for biotherapeutic characterization and release from QC. Dr. Rogers is currently working for Just Biotherapeutics in Seattle. At Just, Dr. Rogers is continuing his work on the MAM.

Krishnan Sampath, PhD, MacroGenics

Krishnan Sampath is currently a Senior Director of Analytical and Drug Product Sciences at Macrogenics, Inc. He has more than 15 years of experience leading analytical method development and characterization, formulation, drug product process development, biophysical characterization, and combination product development for biologics. Prior to joining Macrogenics in 2015, he worked at Hospira, a Pfizer company for 4 years in the areas of drug product development and bioanalytical sciences for biosimilar programs. Before that, Krishnan was at Amgen Inc for more than 9 years where he worked on protein formulation, biophysical characterization and analytical methods. He obtained his Ph.D from the University of Colorado in the area of Pharmaceutical Sciences. He has authored over 25 journal publications and book chapters, presented at several global conferences, organized conference sessions and is serving on the editorial advisory board for Journal of Pharmaceutical Sciences.

Zhe Zhang, PhD, Novartis

Zhe Zhang works in Novartis focusing on biologics developability assessment since 2016. In Integrated Biologics Profiling (IBP) group, Zhe provides profiling analysis for protein drug candidates by mass spectrometry. Before joining Novartis, Zhe received his PhD in Chemistry from University of Massachusetts Amherst focusing on mass spectrometry application for protein aggregation characterization. Zhe also earned his B.S. in University of Science and Technology of China.

Biophysical Analysis of Biotherapeutics

George Bou-Assaf, PhD, Biogen

George has a BS in chemistry from the Lebanese University (Beirut, Lebanon) and a PhD in Biochemistry from Florida State University. His graduate studies under Prof. Alan Marshall focused on development and optimization of hydrogen/deuterium exchange mass spectrometry to study the interactions between the subunits of the troponin complex. Shortly after he graduated, he joined the technical development group at Biogen in 2011 where his job responsibilities focus on the biophysical characterization of proteins and gene therapy products.

Michael Brenowitz, PhD, Albert Einstein College of Medicine

The son of an invertebrate zoologist, Michael Brenowitz developed an interest in science in the bays of Long Island and tide pools of California. His study of biology at Wesleyan University took a molecular turn following a semester’s study at the Duke University Marine Laboratory where he was introduced to the discipline of ‘Biochemical Adaptation’. He continued on this path during his graduate training at Duke through investigations into the assembly and allostery of invertebrate respiratory proteins. His study of allostery engendered a deeper interest in thermodynamics that led to The Johns Hopkins University where he collaborated in the development of quantitative ‘footprinting’, an approach that provides local measures of global binding and folding processes. Upon joining the faculty at the Albert Einstein College of Medicine he developed research programs exploring transcriptional regulation, RNA structure and folding and most recently epigenetic regulation in concert with the development of novel ‘footprinting’ methods that have led to the new method presented at this conference.

Guodong Chen, PhD, Bristol-Myers Squibb

Dr. Guodong Chen has extensive pharmaceutical research experience in major pharmaceutical companies, including Eli Lilly, Schering-Plough and Bristol-Myers Squibb. He is a Research Fellow heading analytical group at Bristol-Myers Squibb central New Jersey site. His matrix team leadership includes Biologics Program Leader. He has over 80 research publications in peer-reviewed journals and book chapters, three edited/co-edited books on pharmaceutical and biopharmaceutical analysis, multiple patents on antibody therapeutics and has given over 100 presentations at national/international conferences and academic institutes. His scientific contributions also include short course instructor at EAS, Pittcon and ASMS conferences, journal reviewer and session chair at various forums. He serves on the Editorial Board for Journal of the American Society for Mass Spectrometry. He received his PhD in Analytical Chemistry from Purdue University under the direction of Professor R. Graham Cooks.

Dana Filoti, PhD, Senior Scientist, Biologics Preformulation DPD, AbbVie Bioresearch Center 

Dana Filoti received her Bachelor's degree in Physics from the University of Bucharest and her Ph.D. in Materials Science from University of New Hampshire.  Her graduate work focused on high-rate nanomanufacturing and nanostructure evolution of antimicrobial phase-segregated sputtered thin film structures. She then worked as a Post-Doctoral fellow at the Biomolecular Interaction Technologies Center (BITC) on the development of instrumentation and methods for examining macromolecular interactions via charge measurements to address colloidal stability issues associated with biomolecules at high concentration. She has experience in biologics developability assessment and formulation, analytical development and biophysical characterization. She is currently a member of the Drug Product Development Preformulation group at AbbVie, where her focus includes tier screening for candidate selection, drug delivery systems and subvisible particle characterization of protein therapeutics.

Mark T. Fisher, PhD, University of Kansas Medical Center

Dr. Mark Fisher received his BS degree in Chemistry from Purdue in 1982 and a PhD in Biochemistry from the University of Illinois in 1987 under Dr. Stephen Sligar where he examined how cytochrome P450s biophysically controlled drug clearance rates by modulating electron transfer rates. He subsequently became a Postdoctoral fellow at NIH under Dr. Earl Stadtman until 1992 where he was among the pioneers in research to understand how molecular chaperones control protein folding and serve as protein homeostasis buffers in the cell. He is currently a full Professor in the Biochemistry and Molecular Biology Department at the University of Kansas Medical Center. His current research is focused on capturing or reversing protein misfolding/unfolding intermediates using various chaperonin detection based biolayer interferometry (BLI) platforms. These platforms can be used to test in silico drug design and validation of protein stability enhancements. This approach is used to accelerate drug discovery pipelines for novel protein stabilizers. For general protein formulation analysis, the Fisher laboratory has developed chaperonin BLI biosensors to capture and detect transient preaggregate species that appear prior to large scale aggregation. In some instances, these initial captured species can be released into micro volume quantities that can be visualized by electron microscopy and identified by highly sensitive Mass spectroscopy methods. In some instances, the 3D reconstruction of captured protein species is accomplished through specific biosensor release of captured proteins into micro volume aliquots followed by single particle reconstruction analysis. In all cases, the overreaching goal of this biotechnology approach is to detect, identify and, in some cases, visually pinpoint defects in protein sample integrity (aggregation prone regions) using high throughput approaches.

David Hayes, PhD, Boehringer Ingelheim Pharmaceuticals, Inc.

David Hayes studied Liberal Arts in the great books seminar style at Magdalen College, Bedford, New Hampshire. He then studied Biophysics in Tom Laue’s lab at the University of New Hampshire, earning both a Masters (AUC data analysis) and a PhD (membrane confined electrophoresis). He taught at Magdalen College, Bedford and Warner, NH for 17 years, and for the last two years there was academic dean. He then worked for Walter Stafford at Boston Biomedical Institute to complete his AUC training. He then worked in the analytical biochemistry department in development at MedImmune. Currently he is in the biophysics group in the Biotherapeutics Discovery department of Research at Boehringer Ingelheim.

Igor Kaltashov, PhD, University of Massachusetts Amherst

Igor A. Kaltashov received his undergraduate degree at Moscow Institute of Physics and Technology in 1989 and a PhD degree from the University of Maryland Baltimore County in 1996, where he worked on applications of mass spectrometry to problems in biochemistry under the guidance of Prof. Catherine Fenselau. Following two years as a post-doctoral fellow at Johns Hopkins Medical School (with Prof. Robert J. Cotter), he became a Director of the newly created Mass Spectrometry Center at the University of Massachusetts-Amherst in 1997. He was appointed an Assistant Professor in Chemistry at UMass-Amherst in 2000 and promoted to Associate Professor with tenure in 2006, and to Full Professor in 2011. His research program is focused on developing mass spectrometry-based experimental techniques to study structure, conformation, dynamics and interactions of proteins, with a particular emphasis on biopharmaceutical products. In recent years, the research portfolio was expanded to include other complex macromolecular medicines, such as heparin and related products. Throughout the last decade, the group actively collaborated with several biopharmaceutical companies, including AbbVie, Alexion, Biogen, Pfizer, and Shire Human Genetic Therapies. Prof. Kaltashov co-authored over a hundred and thirty papers in peer-review journals and book chapters, and a monograph “Mass spectrometry in biophysics: Conformation and dynamics of biomolecules,” whose second edition was published in 2012.

Hubert Kettenberger, PhD, Roche Innovation Center Munich, Germany

Hubert Kettenberger holds a PhD in biochemistry from the University of Munich. After a PostDoc at the Max-Planck-Institute for Biochemistry he joined the Large Molecule Research unit of Roche in Penzberg/Germany in the year 2006 and is now a Senior Principal Scientist in the field of protein engineering. His areas of expertise include the biochemical and biophysical characterization of therapeutic proteins. Moreover, HK developed strategies, in-vitro and in-silico methods for the assessment of new drug candidates (antibodies, bispecifics, next-generation biotherapeutics).

Jennifer F. Nemeth, PhD, SCPM, Janssen Research & Development

Dr. Nemeth obtained a B.S. in Chemistry from the University of Scranton in 1995 followed by a PhD in Analytical Chemistry from Emory University in 1999, and a post-doctoral fellowship at Vanderbilt University under Dr. Richard Caprioli. Dr. Nemeth was employed as a bioanalytical mass spectrometrist at Genetics Institute (now Wyeth BioPharma) and ExSAR Corp.; and joined Janssen R&D (then Centocor) in 2004. Dr. Nemeth has held both functional and project leadership roles in both the discovery and clinical space within Janssen. Recently, Dr. Nemeth returned to the analytics arena in Janssen to build a biophysical structural characterization lab focusing on mass spectrometry and epitope mapping applications.  Her publications include detailed protein characterizations, as well as new methods for protein analysis using mass spectrometry.

Mark Pollo, Principal Scientist, Pfizer, Inc.

Mark Pollo, Principal Scientist at Pfizer, Inc. is a Master’s level Scientist with over 25 years of experience in the pharmaceutical industry performing formulation development, characterization and analytics for novel protein biotherapeutics.  Mark has several publications focusing on the capabilities of flow imaging methods, elucidation of protein structural changes associated with phase transitions and has continued to lead technological advancement of improved methods for characterization of subvisible and submicron particulates in biotherapeutic formulations.

Deniz B. Temel, PhD, Bristol-Myers Squibb

I am a biophysicist, protein chemist and structural biologist with experience in discovery and development. My scientific passion is to understand protein protein interactions which play crucial role in conformational, colloidal and formulation stability.

Kristopher Truncali, Janssen Research & Development

Kristopher Truncali is a scientist in Biophysics at Janssen Research & Development. His work is focused primarily on Hydrogen-Deuterium Exchange (HDX) mass spectrometry. Kris has a background in both Molecular Biology and Computer Science. He also programs in-house C# applications for complex solutions as well as routine automation.

William Weiss, PhD, Eli Lilly and Company

Will is a Principal Research Scientist in Bioproduct Research and Development at Eli Lilly and Company. As a part of his current role, he leads the Biophysical Characterization group in Indianapolis, which designs, executes, and interprets biophysical studies to characterize higher order structure and molecular interactions underlying the physical properties, biopharmaceutics, and stability of therapeutic bioproducts. His group supports process and product development and technical troubleshooting, provides comprehensive data packages to enable regulatory submissions, and evaluates and implements new capabilities to meet evolving portfolio needs.

Protein Aggregation and Stability in Biopharmaceuticals

Andrea Allmendinger, PhD, F.Hoffmann-La Roche, Switzerland

Andrea Allmendinger joined Hoffmann-La Roche Basel in 2010 where she currently holds the position of a Senior Scientist in the department of 'Late-stage Pharmaceutical and Processing Development' for parenteral products. Her projects include the formulation and process development of parenteral drug products for clinical PhIII and market. She started with commercial product support focusing on technical transfers of NCEs and NBEs in particular on process characterization and validation for freeze dried products. Andrea's research lately focuses on all aspects of formulation development of freeze dried formulations. Most recently, she became assistant lecturer at the University of Freiburg in the department of Pharmaceutical Technology and Biopharmacy. Andrea is a pharmacist by training and conducted her studies at the University of Heidelberg in Germany and at the University College London. She holds a PhD in Pharmaceutical technology from the University of Basel where she focused on rheological behavior of liquid high-concentration protein formulations.

Arun Alphonse Ignatius, PhD, Pfizer

Arun Alphonse Ignatius is a Principal Scientist at the Pharmaceutical R&D group at Pfizer. He currently manages project teams responsible for formulation and process development activities from early phase clinical development through licensing. His current focus is on building new technologies and platform formulation processes for gene therapy products. He has over 25 peer-reviewed publications in the area of protein formulation, biophysical characterization and structural biology.

David Brockwell, PhD, University of Leeds, United Kingdom

in 2004 after post-doctoral work at the same institution. He obtained a first degree in Pharmacy and a PhD in Medicinal Chemistry, both at the University of Manchester, UK. Dr Brockwell’s research broadly comprises three fields: (i) using AFM to characterise and rationally modulate the mechanical strength of proteins and their complexes; (ii) the folding mechanisms of outer membrane proteins and the effects of periplasmic factors and the BAM complex on their folding; and (iii) the aggregation of biopharmaceuticals.

Didier Clenet, PhD, Sanofi Pasteur, Canada

Didier has joined R&D Formulation & Stability platform of Sanofi-Pasteur in 2011. He focuses his work on high throughput screening formulations, stability prediction using advanced kinetics, vaccine activity – structure relationship, particulate matter in vaccines and adjuvants process optimization and physic-chemical characterization.

For more than 15 years in Sanofi R&D, Didier was dedicated on physical and biophysical characterization of active ingredients, freeze-dried products and monoclonal antibodies (mAbs, ADC). His research interests are structural characterization and aggregation state determination using a variety of biophysical techniques (light scattering, flow-imaging, DSC and thermokinetics, fluorescence and infra-red spectroscopy, …. ). Didier implemented Biophysical lab and a lab-automation platform for bioproduct formulations.

He is coaching young scientists and performed courses in several French Universities.

Tom Crowley, PhD, Pfizer Inc.

Tom received his bachelor’s degree in biology at Fitchburg State College in Fitchburg Massachusetts in 1985. He worked in the Biological Chemistry department at the Joslin Diabetes Center in Boston Massachusetts as a research associate from 1985 to 1989. In 1989 he joined the Biochemistry group at Seragen, a small biotechnology firm in Hopkinton Massachusetts, where he focused on peptide map development and characterization for novel protein-toxin conjugates. In 1993 he joined the Drug Product Development group at Genetics Institute in Andover Massachusetts as a protein formulation scientist. Tom has remained at the company as it has changed hands from Wyeth to Pfizer gaining valuable experience in all facets of drug product development. He received his Master’s degree in 2007 from the Bouve College of Health Sciences at Northeastern University in Boston Massachusetts in Pharmaceutical Sciences. His interests include platform approaches to drug product development and the development of tools and strategies to assess the manufacturability of assets in late discovery.

Zhimei Du, PhD, Merck & Company, Inc.

Zhimei Du is Director, Bioprocess at Merck. She earned a PhD from Cornell University Medical College, Immunology Program, studying the signaling crosstalk during inflammation. After graduation, she joined Robert G. Roeder’s laboratory at Rockefeller University, studying transcriptional regulation mechanism and epigenetic effects during B cell development. After three years, she was recruited by Regeneron’s antibody engineering group, focusing on bi-specific Ab development. Later, she joined Amgen’s Cell Sciences & Technology department, focusing on cell line development and process development and then became the Upstream process lead at Teva Pharmaceuticals.

Jason Fernandez, Biogen

Jason Fernandez is a Scientist in the Protein Pharmaceutical Development group at Biogen. He is responsible for the formulation, process development, tech transfer and container development of liquid parenteral dosage forms. Jason has over 15 years of experience focused on therapeutic protein drug product development over multiple companies.

Raja Ghosh, PhD, McMaster University, Canada

Raja Ghosh is Professor of Chemical Engineering at McMaster University, Canada. He obtained his Doctorate degree from Oxford University, United Kingdom. His research interests are primarily in the areas of purification of biopharmaceuticals using membrane technology and chromatography.

Zhi (Jay) Guo, PhD, AbbVie Bioresearch Center 

I am a senior scientist at Global Protein Science group in the division of Biologics at Abbvie Bioresearch Center. I use various biochemistry and genetic tools to study drug targets to initiate biologic generation and I am specializing at protein engineering for fusion protein design like bi-specific antibodies and immunocytokines. I received my PhD from University of Texas at Austin where I studied cellular response to DNA damage and Oxidative stress. Before I joined Abbvie, I was a postdoc fellow at Harvard Medical School, where I performed genetic and proteomic screens for new treatment against breast cancer.

Theodore W. Randolph, PhD, University of Colorado, Boulder

Ted Randolph received his PhD in Chemical Engineering at the University of California, Berkeley. He worked as a post-doctoral fellow at the Ecole Polytechnique Federale de Lausanne, and then joined the Department of Chemical Engineering at Yale University as an Assistant Professor. After promotion to Associate Professor, he was named to Yale’s first John J. Lee Junior Professorship Chair in Chemical Engineering. In 1993, Dr. Randolph accepted the Patton Associate Professorship Chair in the Department of Chemical Engineering at the University of Colorado. He currently serves as the Kenneth and Genevieve Gillespie Professor of Bioengineering and the co-Director of the University of Colorado’s Center for Pharmaceutical Biotechnology. Dr. Randolph has published more than 200 journal articles, and is an inventor on 27 US patents. His research interests include biopharmaceutical formulation, lyophilization of proteins, and vaccine formulation.

John Rech, Technology West Pharmaceutical Services

Mr. Rech has ten years of experience in the pharmaceutical industry and six years of experience in the packaging and rubber industry with West Pharmaceutical Services. Previous areas of focus were related to customer complaint an plant investigation and particle analysis as a senior scientist. After several years in this role, he was recognized as the SME on particle testing for the analytical lab. Recently he was promoted to the role of Technology Manager for Particle Testing, where his current leading method development and validation projects and is responsible for bringing new capability and technology into the West organization.

Peter Schurtenberger, PhD, Lund University, Sweden

Peter Schurtenberger is a Professor in Physical Chemistry and the director of the Lund Institute of advanced Neutron and X-ray Science at Lund University. His research interests focus on soft matter, biophysics, nanotechnology, materials sciences, on the characterization of soft and biological matter with light, X-ray and neutron scattering, and on the development of new instruments for this task. He received his PhD from the Swiss Federal Institute of Technology (ETHZ) in Zurich in 1984. After working as a postdoc at Lund University, Sweden, MIT and Harvard University Medical School, he spent 12 years as a senior researcher at the Department of Materials of ETHZ. In 1999 he was appointed as the chair in experimental soft matter physics at the University of Fribourg. In 2006 he founded the Fribourg Center for Nanomaterials, and became the first director of the newly founded Adolphe Merkle Institute for Pure and Applied Nanoscience in 2008. He moved to Lund University at the end of 2010. He has been elected as a member of the Royal Swedish Academy of Sciences, the Royal Swedish Academy of Engineering Sciences, and a honorary member of the European Colloid and Interface Society. He is co-founder and board member of the company LS Instruments. He has published more than 240 scientific articles and book chapters.

Peter M. Tessier, PhD, University of Michigan

Peter Tessier is the Albert M. Mattocks (Endowed) Professor in the Departments of Chemical Engineering, Biomedical Engineering and Pharmaceutical Sciences, and a member of the Biointerfaces Institute at the University of Michigan in Ann Arbor, MI. He received his B.S. in Chemical Engineering from the University of Maine (1998, Co-Valedictorian), and his Ph.D. in Chemical Engineering from the University of Delaware (2003, NASA Graduate Fellow). Tessier performed his postdoctoral studies at the Whitehead Institute for Biomedical Research at MIT (2003-2007, American Cancer Society Fellow). Tessier started his independent career as an assistant professor in the Department of Chemical & Biological Engineering at Rensselaer Polytechnic Institute in 2007, and he was an endowed full professor at Rensselaer (Richard Baruch M.D. Career Development Professor) prior to moving to the University of Michigan in 2017.

Tessier’s research focuses on designing, optimizing, characterizing and formulating a class of large therapeutic proteins (antibodies) that hold great potential for detecting and treating human disorders ranging from cancer to Alzheimer’s disease. He has received a number of awards in recognition of his pioneering work, including a Humboldt Fellowship for Experienced Researchers (2014-2015), a Young Scientist Award from the World Economic Forum (2014), a Biochemical Engineering Journal Young Investigator Award (2016), a Young Investigator Award from the Biochemical Technology division of the American Chemical Society (2015), a Pew Scholar Award in Biomedical Sciences (2010-2014), a National Science Foundation CAREER Award (2010-2015), a Rensselaer Early Career Award (2012), and Rensselaer School of Engineering Research (2012) and Teaching (2013) Awards.

Neal Whitaker, PhD, The University of Kansas School of Pharmacy

Dr. Neal Whitaker is an Associate Researcher at the Macromolecule and Vaccine Stabilization Center (MVSC) at the University of Kansas (KU). Dr. Whitaker received his PhD in Biochemistry from Texas A&M University in 2012, where his studies focused on protein transport kinetics in E. coli. In 2015 he became a staff member of the MVSC under the mentorship of Professors David Volkin and Russ Middaugh. At the MVSC Dr. Whitaker has worked with numerous industrial, non-profit, and academic clients and collaborators to characterize, formulate and stabilize biopharmaceutical drug candidates and vaccines.

Yingda Xu, PhD, Adimab

Yingda received his PhD degree from Michigan State University in Analytical Chemistry with focus on mass spectrometry. After a brief postdoc training in proteomics, Yingda joined the protein analytical science department of BMS for analytical assay development and validation to support BLA filing and post market commitment. Yingda then moved on to the protein analytics group in Adimab to broaden his horizon in the antibody discovery and characterization. At Adimab, Yingda is currently leading the Protein Analytical group to perform antigen characterization, in-process antibody binding screening, and full spectrum delivery antibody QC, such as thermal stability, binding affinity by Fortebio and MSD, LCMS, SEC, epitope binning and mapping, etc.

Immunogenicity Case Study and Clinical Management

Steven Arkin, MD

Steven Arkin has directed clinical research and development programs in the pharmaceutical industry setting for the past 12 years, first with Wyeth Clinical R&D and subsequently with Pfizer Worldwide R&D. He has had a leadership role in investigating treatments for multiple rare disease conditions including Hemophilia, Intracerebral Hemorrhage, Duchenne Muscular Dystrophy, Polycystic Kidney Disease and Chronic Myeloid Leukemia. Steven has served on the AAPS-TPIFG Committee on Harmonization of Clinical Immunogenicity and is currently a member of Pfizer’s Immunogenicity Expert Working Group and the DIA Small Populations Working Group. Steven did his undergraduate work in biology and natural science at the University of Pennsylvania and he obtained his Medical Doctor degree at the New York University School of Medicine. He did his residency in pediatrics at Saint Christopher’s Hospital for Children and his fellowship in Pediatric Hematology/Oncology at the Morgan Stanley Children’s Hospital. Prior to joining the pharmaceutical industry, Steven had an 18-year experience in the academic setting where his clinical and laboratory research activities focused on hemostatic abnormalities in children and on congenital bone marrow failure disorders respectively. Steven has over 40 peer reviewed publications, editorials and book chapters and he has been an ad hoc reviewer for multiple journals. He has served on the CDC Uniform Data Collection Study Committee, the Hemophilia Association of New York (HANY) Medical Advisory Committee, the HHS Region II Hemophilia Services Advisory Committee and he has performed grant review for the Fanconi Anemia Research Fund, St Baldrick’s Foundation and for HANY. He is a member of the International Society for Thrombosis and Hemostasis, the American Society of Hematology, the American Society of Pediatric Hematology/Oncology and the Society for Pediatric Research.

Adam Cheifetz, MD

Dr. Cheifetz is Director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School. He is Director of the Harvard Medical School Gastroenterology Clerkship Elective and Assistant Director of the Advanced Fellowship in Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center. Dr. Cheifetz specializes in the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory bowel diseases. In addition to his clinical work, he is involved in multiple research projects relating to IBD and has published over 125 articles and chapters on the subject. His research currently focuses on optimizing the use of biologics through the proactive use of drug concentrations and antibodies. Dr. Cheifetz lectures nationally and internationally on IBD.

Jocelyne Demengeot, PhD

Prof. Jocelyne Demengeot leads a research unit at the Instituto Gulbenkian de Ciencia for 19 years, a non-profit private institution situated in Portugal. Her team combines fundamental and clinical research to address the molecular and cellular basis of immune regulation in health, and its disorder in autoimmune diseases. In the recent years, the team developed a growing interest for the intriguing heterogeneity of patients in what concerns their immune responses to biological drugs.

Sandra Garces, MD, PhD

Sandra Garces, MD PhD, works at Eli Lilly since 2016, as Senior Medical Advisor in Global Patient Safety, focused on IMG-related aspects. Previously she worked as Rheumatologist-Scientist at Garcia de Orta’s Hospital and Gulbenkian Institute of Science, in Lisbon. Her work has been focused on revealing the clinical relevance of drug immunogenicity and developing strategies to assess and incorporate immunogenicity information in routine clinical practice towards more cost-effective therapeutic strategies.

Ann Gils, PhD

As a pharmacist, Ann Gils obtained her PhD in Pharmaceutical Sciences in 1997. She is a full professor at the Laboratory for Therapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium. The core technology of the laboratory is the development of monoclonal antibodies and antibody fragments with the aim to develop these antibodies either as therapeutics or as diagnostics. In the past few years, she has developed and validated a number of assays to measure the serum and anti-drug antibody concentrations of biologicals (infliximab; adalimumab; etanercept, golimumab, vedolizumab, secukinumab and ustekinumab) and has participated in Therapeutic Drug Monitoring studies in the field of gastroenterology, rheumatology and dermatology. Through PKPD modeling, she studies the effect of co-variates on PK and PD. She has published more than 200 papers in the field of thrombosis and therapeutic drug monitoring of biologicals.

George R. Gunn, III, PhD

George Gunn is currently the Head of Immunogenicity and Clinical Immunology and

a Senior Scientific Director at GlaxoSmithKline, leading a group of 25, multi-disciplinary scientists supporting pre-clinical and clinical immunogenicity method development, validation and bioanalysis. Prior to joining GSK, George held positions of increasing responsibility in the areas of discovery research and biologic development, encompassing immunogenicity assessment, research and regulatory roles at Centocor and Janssen R&D. George received his bachelors of science in molecular biology from Grove City College, and his Ph.D. in Immunology from the University of Pennsylvania. His areas of research interest include prediction, detection, characterization and reporting of immune responses targeting biotherapeutics. George is a co-inventor of 3 patents and has published research and review articles in the fields of immunogenicity assessment, inflammation research, infectious disease and immuno-oncology. George has been an active member of the American Association of Pharmaceutical Scientists (AAPS) and the American Association of Immunologists (AAI). Through AAPS he is on the Therapeutic Product Immunogenicity Focus Group Steering Committee and currently leads the Anti-Drug Antibody Clinical Relevance Action Program Area.

Soumi Gupta, PhD

Soumi Gupta received her Ph.D. in Microbiology from University of California, Davis in 2003, where the focus of her research was aimed at furthering our understanding of the immune correlates of protection towards a successful AIDS vaccine. She pursued post-doctoral training in Immunology at Chiron Corporation where she investigated anti-HIV T and B cell-mediated responses in mucosal and systemic compartments following mucosal immunization with alphavirus-based replicon particles encoding for HIV-Gag, Pol and Env. Following her post-doctoral training, she worked at Monogram Biosciences as a scientist in research and development, developing assays to characterize genotypic and phenotypic resistance to HIV antivirals. While at Monogram, she also worked in oncology clinical data development. After five years at Monogram, Soumi joined Janssen Pharmaceuticals working in medical affairs in Infectious Diseases. Soumi joined BioMarin in February of 2015 as a Director in Immunogenicity Assessment where she provides immunologic expertise to drug programs across developmental stages and develops immunogenicity and safety strategies for novel biologic therapeutics. Soumi has over 15 years of experience in immunology and infectious disease, vaccinology, HIV drug resistance, oncology diagnostics and drug development.

Katherine A. High, MD

Dr. Kathy High, an accomplished hematologist with a longstanding interest in gene therapy for genetic disease, began her career studying the molecular basis of blood coagulation and the development of novel therapeutics for the treatment of bleeding disorders. Her pioneering bench-to-bedside studies of gene therapy for hemophilia led to a series of studies that characterized the human immune response to AAV vectors in a variety of target tissues. Kathy’s work has evolved to encompass clinical translation of potential genetic therapies for multiple inherited disorders. As the director of the Center for Cellular and Molecular Therapeutics at the Children’s Hospital of Philadelphia, Kathy assembled a multidisciplinary team of scientists and researchers working to discover new gene and cell therapies for genetic diseases and to facilitate rapid translation of preclinical discoveries into clinical application. Kathy was a long-time member of the faculty at the University of Pennsylvania and of the medical staff at CHOP, where she was also an Investigator of the Howard Hughes Medical Institute. She served a five-year term on the FDA Advisory Committee on Cell, Tissue and Gene Therapies and is a past president of the American Society of Gene & Cell Therapy (ASGCT). She received her A.B. in chemistry from Harvard University, an M.D. from the University of North Carolina School of Medicine, a business certification from the University of North Carolina Business School Management Institute for Hospital Administrators and an M.A. from the University of Pennsylvania.

M. Benjamin Hock, PhD

Ben joined the clinical immunology group at Amgen in 2010. He began at the bench developing and validating immunoassay methods. In 2014 he transitioned to product strategy, interpretation, and reporting. Ben joined the Immunogenicity Assessment group at BioMarin in 2017. Throughout his immunogenicity career, Ben has focused on the relationship between specific bioanalytical methods, and the clinically-relevant questions/hypotheses those methods are designed to address.

Vibha Jawa, PhD

Dr. Vibha Jawa is currently a Director, Biologics and Vaccine Bioanalytics at Merck where she is responsible for developing a strategy and provides oversight and management of scientific programs for discovery, development and optimization of biologics and vaccines. In this role, she is partnering with discovery and development groups to design better molecules. Dr Jawa received her bachelors in Biochemistry (1991) from Delhi University and her doctorate in Biochemistry/Immunology (1998) from All India Institute of Medical Sciences, New Delhi, India with a thesis work studying the immune mechanisms behind autoimmune diseases followed by a postdoctoral fellowship at University of Pennsylvania on monitoring the immune response to viral vectors. She continued to work in the field of gene therapy evaluating viral vectors for hemophilia therapy in the Bay area followed by City of Hope Cancer Centre Stem Cell and Gene Therapy group. At Amgen from 2003-2016, her focus was to develop methods for assessing immunogenicity to biologics and the mechanisms behind development of immunogenicity. Her current research interests include evaluating immune response biomarkers for early drug development and efficacy, immunogenicity prediction using in silico, in vitro and in vivo technologies, modeling impact of immunogenicity on PK and PD and their application to a system based approach, antigen processing and presentation and the role of T cells in immune response to drug products. Vibha is a member of professional organizations like American Association of Pharmaceutical Scientists (AAPS) and American Association of Immunology (AAI) and Federation of Clinical Immunology Society (FOCIS). Within AAPS, Vibha has been actively involved as a Steering Committee member of the Therapeutic Protein Immunogenicity Focus Group (TPIFG) and is currently leading the Immunogenicity Prediction Action Program Area (IPAPA). She has been an invited speaker in multiple sessions at AAPS for past few years and has successfully moderated and organized programming at AAPS NBC (National Biotechnology Conference) and AAPS Annual Meetings. She has also organized and participated in AAPS webinar and e forum to propagate learning and sharing information among AAPS members. Dr Jawa also serves as a manuscript reviewer for The AAPS Journal and J. Pharm Sci Journal.

Priya Kishnani, MD

Dr. Kishnani moved to the United States in 1991 after completing a residency in pediatrics in Mumbai, India. She completed a fellowship in clinical and biochemical genetics at Duke University Medical Center (DUMC) in 1995 and shortly thereafter joined the faculty at Duke University. Dr. Kishnani is certified by the American Board of Medical Genetics and the American Board of Biochemical Genetics. Dr. Kishnani is chief of the medical genetics division and director of the Alice and YT Chen Pediatric Genetics and Genomics Center. Part of Duke University Medical Center, the center focuses on developing new therapies for rare genetic disorders. She also serves as director of the lysosomal storage disease program, biochemical genetics training program, and metabolic clinic at DUMC.

Chiyomi Kubo, PhD, DVM

I have been an expert of immunosafety and immunogenicity at Chugai Pharmaceutical since 2006. I received my PhD in Immunology from University of Tokyo in 2006.

Kun Lu, PhD

Dr. Kun Lu is a staff scientist at Regeneron Pharmaceutical company, where she manages the critical protein reagent group to support bioanalytical assay development and clinical sample testing. Dr. Kun Lu graduated from Emory University with a doctorate degree in protein biochemistry. Then she completed her postdoctoral training at Howard Hughes Medical Institute at University of Maryland- Baltimore County. Dr. Kun Lu joined Regeneron in 2012 after she worked at State University of New York at Albany for a short period of time.

Theo Rispens, PhD

Theo Rispens studied chemistry in Groningen, The Netherlands. He received his PhD in 2004 following research of chemical reactivity in biological models systems. Since 2006 he has worked at Sanquin, where is staff member at the department of Immunopathology of Sanquin Research. Current research activities focus on the structure and function of immunoglobulins and the mutual interactions between the immune system and therapeutic antibodies. One research line involves mechanisms of humoral tolerance, in particular the biology of IgG4 antibody responses in health and disease. Furthermore, he studies the immune response to biologicals in autoimmune patients, particularly in rheumatology, and is responsible for the development of novel immunoassays to support this research line, and to implement for world-wide service testing at Sanquin Diagnostics, to support the optimization of treatment strategies with biologicals.

Amy Rosenberg, MD

Amy Rosenberg received her medical degree from Albert Einstein College of Medicine and is Board Certified in Internal Medicine. She was a post-doctoral fellow in Al Singer’s Laboratory in the NCI before coming to CBER, FDA in 1988. She became Director of the Division of Therapeutic Proteins, CBER/CDER in 2000. Her division (now DBRR3 in the Office of Biotechnology Products, CDER) regulates diverse protein therapeutics, including monoclonal antibodies and fusion proteins, enzyme replacement therapies, hematologic and somatic cell growth factors, and immunomodulatory agents. She has been a driving force in risk evaluation and mitigation pertaining to the immunogenicity of therapeutic proteins (Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products) and in the elucidation and implementation of immune tolerance induction protocols in clinical settings. Most recently, she co-edited the AAPS/Springer Book “Biobetters: Protein Engineering to Approach the Curative”.

Karen Thudium, PhD

My expertise is developing mechanistic PK-PD models to characterize the pharmacokinetics of large molecules (ADCs, mAbs) in xenograft models and tox studies for FIM dose selection, Identifying appropriate pharmacodynamic markers to support rational RP2D and support dosing selection for other indications, and identifying optimal sample collection times in clinical studies through optimal sampling techniques. In addition, I also support clinical team in preparation of regulatory documents and provide expertise in clinical protocol development as well as collaborate with preclinical research team in design of animal studies for appropriate PK/PD collections.

Immunogenicity Assessment and Regulatory Approval of Biologics

Tudor Arvinte, PhD

Tudor Arvinte studied physics at University of Jassy, Romania, and received his Ph.D. in biophysics from University of Düsseldorf, Germany. He held numerous research positions in Europe and the USA at: Max-Planck Institute, Germany; C.N.R.S., France; Cornell University, New York; Texas A&M University; Ciba-Geigy U.K., Novartis, Switzerland. T. Arvinte worked with more than 200 biopharmaceuticals, three of his formulations reached the market, has over 90 publications and 15 patents. He is Titular Professor at Geneva University and CEO of Therapeomic, Inc. Basel Switzerland, a contract research biotech company focused on the characterization and formulation of biopharmaceuticals.

Bernard Maillere, PhD

B Maillere, PhD is currently director of research and head of the laboratory of immunochemistry of the cellular immune response at CEA, a French governmental research organism in France. His work focuses on immunogenicity of therapeutic proteins and vaccines, T cell response and T cell epitope mapping. He co-leads the workpackage of immunogenicity prediction of the European project ABIRISK on immunogenicity of therapeutic proteins.

Björn Boll, PhD

Dr. Boll studied in Göttingen and received his PhD from the University of Tübingen in Germany focusing on purification and characterization of proteins of antibiotic biosynthesis. He afterwards performed studies of the biological consequences of sub-visible particles at the Analytical Development Department at Roche in Basel, Switzerland. After joining Merrimack Pharmaceuticals in the Boston area and driving the physical-chemical characterization of early phase projects, Dr. Boll is now heading the particle lab and higher order structure analytics at Novartis in Basel, Switzerland.

Shan Chung, PhD

Dr. Shan Chung is currently a Principle Scientist in the Department of BioAnalytical Sciences (BAS) at Genentech. He received his Ph.D. in Molecular Biology from the University of Pennsylvania and conducted postdoctoral research on Gene Expression and Protein Engineering of human T-cell receptors in Professor Jack Strominger’s laboratory at Harvard University. Shan joined Genentech in 2006 and currently leads the Effector Function and Cell Biology group in BAS. His group’s responsibilities include assessment of Fc effector functions of antibody drug candidates as well as development and validation of neutralizing antibody assays. Shan has supported more than 30 successful IND/BLA filings at Genentech.

Julio Delgado, MD, MS

Dr. Delgado is Chief Medical Officer of ARUP Laboratories, Chief of the division of Clinical Pathology at University of Utah School of Medicine, as well as an associate professor of pathology at the University of Utah. He received his MD degree from Universidad Industrial de Santander in Colombia and MS degree in epidemiology from the Harvard School of Public Health, completing both clinical training in clinical pathology and research fellowship in immunology at the Harvard Medical School. His research interests include testing for immunogenicity to biologicals and transplantation immunology.

Jeremy Fry, DPhil

Jeremy Fry gained his DPhil. from the University of Oxford developing gene therapy strategies to induce immunological tolerance in transplant recipients. Jeremy joined ProImmune to generate a new class of MHC multimer staining reagents. For the past 17 years as ProImmune's Director of Sales, he has led the sales team in a growing business, focusing on developing and implementing innovative technologies that radically improve our understanding of immune responses.

William Hallett, PhD

Will Hallett received his PhD in Cellular and Molecular Biology from the University of Nevada, Reno in 2008. His postdoctoral studies on immunotherapy at the Medical College of Wisconsin and the University of Wisconsin-Madison led him to the FDA in 2012. He performs Product Quality and Immunogenicity reviews for the Office of Biotechnology Products in CDER. He is a member of the OBP Immunogenicity Working Group.

Marisa K. Joubert, PhD

Marisa Joubert is a Principal Scientist and Group Leader of the Attribute Impact Group in the department of Process Development at Amgen Inc (Thousand Oaks, CA). She has been at Amgen since 2008 as a pharmaceutical scientist in drug product development. Her group evaluates the impact of biotherapeutic attributes on the safety and efficacy of drug products. She is also the team lead of a multi-department cross-functional working group that assesses the risk of immunogenicity of key product quality attributes. She has received several awards for this work including the 2015 Ebert Prize from the American Pharmacists Association. Prior to joining Amgen, she was a Senior Researcher at the Council for Scientific and Industrial Research in Pretoria, South Africa, where she evaluated novel therapeutic agents for treating HIV-1. She received her PhD in 2006 from the University of California, Los Angeles, in Biochemistry and Molecular Biology.

Lynn Kamen, PhD

Lynn Kamen is a scientist in the BioAnalytical Sciences department at Genentech. After receiving her Ph.D. in Immunology at the University of Michigan, studying the role of phosphoinositide signaling during Fc receptor-mediated phagocytosis. She continued her studies in signal transduction of innate immune cells during her postdoctoral research at UCSF in Clifford Lowell’s lab where she examined the impact of focal adhesion kinase deficiency upon neutrophil and macrophage activation. Following her postdoc, Lynn worked in several smaller biotech companies in the Bay Area continuing to develop assays to measure immune cell activation. Since joining Genentech, Lynn has conducted in vitro biological characterization on several therapeutic molecules and developed a number of immunogenicity assays to support ongoing clinical trials.

Uma Kavita, PhD

Uma Kavita received a B.S in Microbiology from the Ohio State University, PhD in Microbiology and Immunology from Wake Forest University and her post-doctoral training in Cellular Immunology from Princeton University. She has worked for more than 17 years in biotech and biopharma in widely diverse research and development capacities. In her current role as a Senior Research Investigator at Bristol-Myers Squibb, Dr. Kavita represents the bioanalytical department in cross-functional collaborations with discovery, pharmacology, toxicology, clinical research and development, CMC and regulatory departments and leads the method development of PK and Immunogenicity assays for various drug modalities including domain antibodies, anti-sense oligonucleotides and gene therapeutics.

Susan Richards, PhD

Dr. Richards currently is a member of Translational Medicine Early Development (TMED) in Sanofi R&D where she contributes as global scientific expert in immunogenicity and chairs the TMED Immunogenicity Council. Previously, she was the Head of the Clinical Laboratory Sciences Department in Sanofi/Genzyme Biologics R&D, responsible for four functional areas: Clinical Assay Development, Clinical Specialty Lab, CLS Quality Systems, and Investigative Clinical Immunology. Assays were developed as “fit for purpose” including fully validated using various technology platforms (ligand binding, cell-based, flow-cytometry, molecular, LC-MS/MS) for bioanalysis of PK, biomarkers and immunogenicity of biotherapeutics in clinical development. Clinical Specialty Lab is CLIA certified in Immunology, Clinical Chemistry and Urinalysis and supports clinical trials and post-marketing requirements. Research activities included investigating the use of methotrexate for immune tolerance induction. Dr. Richards has also been an active member of the American Association of Pharmaceutical Scientists (AAPS) for over 15 years and currently is the Past Chair and a Steering Committee member of the Therapeutic Product Immunogenicity Focus Group (TPIFG).

Daniela Verthelyi, MD, PhD

Dr. Verthelyi received her MD from the University of Buenos Aires and a PhD from the Virginia Tech in USA, and then completed a fellowship training in Immunology at the Section in Retroviral Immunology of the Center for Biologics Evaluation and Research of the FDA before joining the Laboratory of Immunology of Division of Therapeutic Proteins and eventually becoming its Chief. She has authored over 60 peer reviewed articles and several patents, serves on the NIH Human Immunology advisory board, The NIH Immunology Interest Group and NIH-FDA Cytokine Interest Group, and has received of the FDA's ‘Excellence in Laboratory Sciences Award, among other honors

Zuben E. Sauna, PhD

Zuben Sauna is a Principal Investigator and a Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety. His laboratory exploits a combination of computational, in vitro and ex vivo approaches to understand why some individuals and/or sub-populations develop immune responses while others do not. His work has published extensively in high impact journals such as Nature Biotechnology, Nature Medicine, Science, Science Translational Medicine and Nature Reviews Genetics. He received his Ph.D. from Poona University, India with subsequent training at the National Cancer Institute, Bethesda, USA.

Optimizing Bioassays for Biologics

Joseph Callahan, PhD

Joe is a technical development scientist with Genentech in the Biological Technologies group. He earned his Ph.D. in cell biology at UCSF and his B.A. in molecular and cell biology at UC Berkeley. Since joining Genentech in 2013, Joe has had an impact on multiple projects from early development to commercialization. This includes:  leading robustness/validation efforts for assays for large molecules, examining the synergistic effects between therapeutics in cell-based assays, and helping craft and articulate strategies and study designs to enhance high-quality assays on aggressive timelines. Joe is passionate about developing well-controlled biological assays and leading teams to succeed in delivering top results to accelerate drug development. He enjoys teaching and mentoring, and has actively participated in multiple interview and outreach programs.

Shan Chung, PhD

Dr. Shan Chung is currently a Principal Scientist in the Department of BioAnalytical Sciences (BAS) at Genentech. He received his Ph.D. in Molecular Biology from the University of Pennsylvania and conducted postdoctoral research on Gene Expression and Protein Engineering of human T-cell receptors in Professor Jack Strominger’s laboratory at Harvard University. Shan joined Genentech in 2006 and currently leads the Effector Function and Cell Biology group in BAS. His group’s responsibilities include assessment of Fc effector functions of antibody drug candidates as well as development and validation of neutralizing antibody assays. Shan has supported more than 30 successful IND/BLA filings at Genentech.

Gaël Debauve, PhD

Gaël joined UCB in July 2011 taking up the head of the bioassay development group that aims to develop, revamp, validate and tech transfer CMC biological potency assays from preclinical phase to phase III and beyond (lifecycle management). In 2007, he completed a Ph.D. in Biomedical Sciences at the University of Mons (Belgium). Then, he joined SGS (a contract laboratory organization) for four years. During his time in SGS group, he extended his experience in Molecular and Cell Biology, as well as running a GMP laboratory. In 2010, Gaël took an associate professor position at the University of Mons (UMons, Belgium) where he lectures on quality standards in the pharmaceutical industry. In 2011, he also completed a Master degree in Management at the Louvain School of Management (UCL, Belgium). Since 2017, Gaël is providing his bioassay expertise to the EDQM MAb working party as ad-hoc specialist.

Jenny Hu

Jenny Hu is a bioanalytical scientist in PKDM department at Amgen. She has been involved in the assay development, optimization, and validation of immunogenicity, PK, and biomarker assays on different platforms for the past 16 years at Amgen. Prior to that, she worked on the drug discovery research in the field of oncology and inflammation. She obtained a Bachelor of Science degree in Biology from FuDan University in China and held a Master of Science degree in Molecular Biology from University of Southern California. She has multiple publications and has presented in various meetings on neutralizing bioassay for NAb testing.

Natalia Kozhemyakina, PhD

PhD. Head of Bioassay Laboratory at Biocad, Russian leading innovative biotechnology company. The lab is responsible for selection the bioassay strategy and development, optimization, automation and validation/qualification bioassays including potency assays for Biologics and Small molecules in support of manufacturing and product development, stability and characterization studies.

Emily Lowe, PhD

Dr. Emily Lowe is multidisciplinary scientist with 15 years of research experience in immunology and host-pathogen interactions. She is currently a Senior Scientist at Kite Pharma, a Gilead company, where she has been leading the Bioassay Team since 2015 to develop cell-based potency assays in the Analytical Development group within the Product Sciences department. Prior to joining Kite, Dr. Lowe worked in Dr. Jerome Zack’s laboratory at UCLA where she helped to develop “induction/kill” strategies to eradicate HIV reservoirs in vivo using genetically engineered immunity and the humanized mouse model. During her PhD studies into innate immunity and inflammation, Dr. Lowe split her time between the laboratories of Dr. Genhong Cheng (UCLA) and Dr. Moshe Arditi (Cedars-Sinai) where she discovered that Toll-like Receptor 2 played a protective role in both the epithelial and immune compartments during the development of colitis-associated colorectal cancer. Dr. Lowe’s passion for immunology began at the University of Washington where she completed two B.S. degrees, one in Microbiology and one in Biochemistry.

Areti Manola

Areti is an associate director in the Manufacturing, Toxicology and Applied Statistical Sciences group within Statistics and Decision Sciences, Janssen R&D. Responsibilities include cross-Pharma non-clinical statistical support to Pharmaceutical Development, Manufacturing, Biotechnology and Regulatory groups, across various therapeutic areas for both small and large molecules. Prior to J&J, Areti worked as a statistical consultant for Unilever Research U.S. Areti received her Masters of Science degree in statistics from Rutgers University.

Kenneth R. Miller, PhD

Dr. Ken Miller is a Principal Scientist in Global Technical Operations at AstraZeneca. Ken serves as an analytical lead for late-stage and commercial projects, and is responsible for providing leadership to AZ Supply Biologics’ Analytical Services and support to enterprise-wide analytical activities within Global Technical Operations. He joined AstraZeneca after being a member of Biopharmaceutical Development at MedImmune for 12 years. During his time at MedImmune, Ken led a team of analytical scientists in the development of binding assays to support product characterization and process development, including Biacore binding assays to support GMP lot release and stability testing. Ken was also a CMC analytical lead, and was responsible for the delivery of the analytical sections of IND submissions, including ones for antibody drug conjugates (ADCs) and immuno-oncology (IO) products. While at MedImmune, Ken was a champion of applying Quality by Design (QbD) approaches to bioassay method development. Since 2010, Ken has served as a volunteer member of the USP General Chapters Biological Analysis expert committee. In that role, he chaired an expert panel that implemented three general chapters related to Immunological Test Methods, and is currently chairing an expert panel tasked with preparing a general chapter on the validation of commercial test kits used to support testing of biopharmaceutical products. Ken received a Bachelor of Science degree in Biochemistry from Case Western Reserve University and a doctoral degree in Biological Sciences from Carnegie Mellon University.

Ashley Mullan

My name is Ashley Mullan, I have a Bachelor of Science in Biology and a Master of Science in Biotechnology from University of Maryland. I am a scientist currently working in Bioassay Development at MedImmune located in Gaithersburg, Maryland.

I have been developing Bioassays at MedImmune for 8 years utilizing both binding and cell based platforms. My expertise lies within bioassay development for novel molecules, specifically bi-specific fusion proteins and ADCs as well as Fc effector function studies.

Sandra Prior, PhD

Sandra Prior received her Ph.D. in Natural Sciences from the University of Navarra, Pamplona, Spain in 2000 working in collaboration with the Federal Institute for Technology (ETH) in Zurich, Switzerland. She worked initially as a scientist at the National Institute for Biological Standards and Control (NIBSC), Potters Bar, U.K. evaluating the toxicological and immunological properties of recombinant toxin constructs used as therapeutic vaccines and was also involved in a number of research programs investigating the safety and protective mechanisms of combination bacterial vaccines. In 2010, she joined Lonza Biologics Applied Protein Services in Cambridge, U.K. as a senior scientist where she worked on bioassay development as well as preclinical and clinical immunogenicity assessment of biotherapeutics. In 2015 she re-joined NIBSC and is currently working in the development of bioassay standards for therapeutic Monoclonal Antibodies (mAb). In addition to her mAb standardization activities she is involved in a number of research projects investigating structure-function relationships in the context of safety and efficacy of biotherapeutic mAbs. She is currently a member of the European Pharmacopoeia Monoclonal antibodies working party expert committee (MAB WP) as well as a member of the Immune Mitigation Action Programming Area (IMAPA) within the Therapeutic Product Immunogenicity focus Group (TPIFG), AAPS Biotechnology section.

Perceval Sondag

Perceval Sondag holds a Bachelor Degree in Physical Therapy and a Master’s Degree in Biostatistics, both obtained from the Catholic University of Louvain-la-Neuve in Belgium. After starting his career by implementing statistical thinking in the newly created Operational Excellence department of the Brussels Saint-Luc University Hospital.

He joined Arlenda in 2013 as a Statistician consultant, and moved to the US based team in 2015. He specializes in Bayesian modelling and statistics applied to bioassays and process manufacturing. In addition to his job at Arlenda, providing statistical support for small and big pharmaceutical companies across the globe, he currently works on a PhD thesis about Similarity Testing for Bioassays. He is a member of the USP Expert Panel for Bioassays and has authored or co-authored multiple publications, including a book chapter on assay validation.

Dirk Usener, PhD

Biologist/Biochemist, PhD and PostDoc at the German Cancer Research Centre (DKFZ) 5 years Senior Scientist at Ganymed-Pharmaceuticals , 2007 Sanofi in different positions and since 2012 responsible for Bioassays development in Frankfurt

Steven Walfish

Mr. Walfish is Principal Science & Standards Liaison in the Global Science and Standards Division at United States Pharmacopeia (USP). Prior to this role Mr. Walfish was Principal Statistician at BD in Franklin Lakes, NJ. He is responsible for supporting continuous improvement efforts and process development for worldwide operations. Prior to BD he was a statistician at GE Healthcare in Waukesha, WI. Previously, Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.

Adrienne Wildt, PhD

Adrienne Wildt received her PhD at Boston University School of Medicine where she went on to Wyeth for her post-doctoral work. She joined a discovery research group at a small start-up developing and implementing assays for small molecule screening. She has been at ImmunoGen for 5 years where she has worked in the CMC Bioanalytical group developing bioassays to support drug substance release and characterization as well as establishing automation capabilities within the group.

FUSION PROTEIN THERAPEUTICS

Ruben Boado, PhD

Dr. Boado co-founded ArmaGen in 2004, following more than 25 years of academic experience in fields of molecular and cell biology of the BBB, and drug delivery to the brain. His leadership and expertise have been instrumental in the development of ArmaGen’s extensive product pipeline, including potential biotherapeutic treatments for mucopolysaccharidosis, stroke, Alzheimer’s disease and Parkinson’s disease. Dr. Boado was the principal investigator in a number of Small Business Innovation Research (SBIR) programs granted by the National Institutes of Health to ArmaGen. Dr. Boado is also a co-inventor of the intellectual property that supports ArmaGen’s pipeline. He was previously professor of Medicine at UCLA, and has published over 195 scientific peer-reviewed publications and book chapters related to the BBB. Dr. Boado received his Ph.D. in Biochemistry at the University of Buenos Aires.

Mathieu Cinier, PhD

Since joining Affilogic in 2011, Dr. Mathieu Cinier successfully led 60+ Nanofitin generation programs for a wide range of applications, and Nanofitin-based biotherapeutics are currently being developed in collaboration with Sanofi, Takeda Pharmaceutical and other undisclosed international pharmaceutical companies. He also applied its extensive protein engineering knowledge to expand the potential of the Nanofitin technology, and is now assuming the position of Scientific Director.

Christina M. Coughlin, MD, PhD

Dr Christina Coughlin joined Immunocore as Chief Medical Officer in April 2015. She is experienced in oncology drug development, with expertise in both clinical development and translational medicine. Prior to joining Immunocore, Dr Coughlin led two early development programmes at Novartis, Pfizer and Morphotek Inc. Dr Coughlin holds an M.D. and Ph.D. from the University of Pennsylvania, where she studied patient responses to tumour antigens and novel cancer vaccine approaches.

Madiha Derouazi, PhD

Madiha Derouazi has been working on vector engineering and therapeutic cancer vaccines for over 9 years. She has a strong background in applied molecular and cellular biotechnology, with research interests at the interface of fundamental and translational research. After several years working on recombinant protein production (upstream), she started developing different antigen delivery vectors. In the Laboratory of Tumor Immunology of the University of Geneva, she designed and characterized the CPP-based multi-epitopic cancer vaccine that is currently being progressed by AMAL Therapeutics. Madiha Derouazi holds a PhD in Biotechnology from the Ecole Polytechnique Fédérale de Lausanne (EPFL), Switzerland and a Masters in Biotechnology Engineering from the University of Technology of Berlin, Germany.

Stephen D. Gillies, PhD

Dr. Gillies was initially trained in microbiology but since his postdoc at MIT he has focused on protein engineering and expression, primarily recombinant antibodies and antibody based fusion proteins. He began his biotech career at Damon Biotech where he developed recombinant pro-urokinase that led to the sale of the company to Abbott (now Abbvie). He developed two of the earliest recombinant antibodies that are now marketed drugs – Erbitux and Unituxin – and has pioneered the development antibody cytokine fusion proteins (immunocytokines). He served as President of Fuji Immunopharmaceuticals which later became Lexigen Pharmaceuticals. Two immunocytokines developed by Lexigen were the first in the clinic for treatment of neuroblastoma and prostate carcinoma and this led to the acquisition of Lexigen by Merck KGaA. After serving as President of the newly formed EMD-Lexigen and as Global Head of Oncology Research for Merck KGaA, he left to found Provenance Biopharmaceuticals which is focused on the clinical development of an IC for the treatment of non-Hodgkin’s Lymphoma. He continues to develop next generation immunocytokine technology both in-house and in collaboration with other biotech partners.

Ravi Kumar, PhD

Dr. Kumar joined Acceleron in March 2004 and is currently Senior Vice President and Chief Scientific Officer. Previously, Dr. Kumar worked for 12 years at Genetics Institute and Wyeth Pharmaceuticals. At Genetics Institute, Dr. Kumar was a key member of the Small Molecule Drug Discovery group and was responsible for cell biology. Following the integration of discovery functions from GI and Wyeth Pharmaceuticals, Dr. Kumar served as Senior Scientist in the Biological Chemistry group. Dr. Kumar is the author of several key scientific manuscripts in the area of protein glycosylation and TGF superfamily and is named as an inventor of several patents. Dr. Kumar received his PhD from the University of New Brunswick, Canada and completed his post-doctoral fellowship at Albert Einstein College of Medicine, Bronx, NY.

Curtis Lockshin, PhD

Curtis Lockshin holds a PhD in Biological Chemistry, and has served in management roles inside the pharma/biotech industry for over 19 years, including drug discovery, commercial biologic manufacturing, and corporate operations.

Ekkehard Moessner, PhD

Dr. Moessner graduated in chemistry, with a PhD in Molecular Biology; his Postdoc was in Antibody Engineering. He joined Glycart Biotechnology in 2003, which was acquired by Roche in 2005. Since then, he has been involved in several projects of protein design, engineering and selection.

Nicola Pozzi, PhD

Nicola Pozzi is an Assistant Professor in the Department of Biochemistry, Saint Louis University School of Medicine. His research focuses on the molecular understanding of the pathophysiological mechanisms that lead to thrombosis and immunothrombosis, an innate immune response that links coagulation to the recognition, containment and destruction of microbial pathogens. To achieve such goal, his lab applies a unique combination of protein (bio)chemistry and engineering, X-ray crystallography, single-molecule fluorescence spectroscopy, and surface plasmon resonance.

Oliver Siefert, PhD

Oliver Seifert holds a PhD in Molecular Biology from the University of Stuttgart and he is a Post-Doc at the Institute of Cell Biology and Immunology based at the University of Stuttgart, Germany. Research interests focus on the design and development of bispecific antibodies and recombinant bifunctional molecules, including half-life extension strategies, for tumor therapy.

Patrik Strömberg, PhD, MBA

Dr. Strömberg has a PhD in Biochemistry in medical biochemistry and biophysics from the Karolinska Institute in 2002. His MBA was awarded by the Stockholm Business School of Stockholm University in 2015. He has 15 years of pharma experience, including 5 years at the AstraZeneca Biotech Laboratory working with recombinant protein technology. For the last 10 years (since 2007), Dr. Strömberg has worked at Biovitrum/SOBI in various positions. Currently he is Senior Director, Head of Biomedical Science and Portfolio Innovation within the R&D organization.

Kenneth W. Walker, PhD

Dr. Kenneth Walker has more than 25 years’ experience in the field of protein science. He joined Amgen in 1999 and is currently a Director of Research in Therapeutic Discovery with the primary responsibility of leading protein drug development for a wide array of research programs. His areas of expertise are protein therapeutics including engineering, multi-specifics, chemical conjugation, half-life extension, folding, purification as well as laboratory automation, workflow and data systems.

Zhirui Wang, PhD

My main interest and expertise is using unique diphtheria toxin resistant yeast Pichia pastoris expression system as a platform to develop diphtheria toxin-based recombinant immunotoxins for specific depletion of targeted cell populations in vivo. I completed my Ph.D. training in Molecular Biology from University of Giessen in Germany. I gained my expertise in protein engineering and targeted drug delivery systems through my post-doctoral training in Dr. David Neville’s lab at NIH. Currently I hold appointments as associate immunologist at Massachusetts General Hospital and assistant professor of surgery at Harvard Medical School.

Stefan Weigand, PhD 
Since 02/2015, Global Head LMR, Roche Innovation Center (RIC) Basel
Head of Biochemical & Analytical Research, LMR, RIC Penzberg
Department Head Host Cell Biology, Oncology, RIC Penzberg
Program Manager External Innovation, Oncology RIC Penzberg
Senior Scientist, Medicinal Chemistry, Roche Innovation Center Penzberg
Scientist, Medicinal Chemistry, Bayer Pharmaceuticals
Postdoctoral Fellow, Stanford University 

Sunny Zhou, PhD

Prof. Sunny Zhou is a Professor in the department of Chemistry and Chemical biology and Faculty Fellow in the Barnett Institute of Chemical and Biological Analysis at Northeastern University. His laboratory has an abiding interest in protein chemistry and analysis such as “hybrid modality engineering”, a process to introduce bioorthogonal functional groups into traditional protein scaffolds to impart novel functions. He also actively collaborates with biopharma on the development of protein pharmaceuticals.

Engineering Antibody-Drug Conjugates

Roger Beerli, PhD

Dr. Roger R. Beerli, PhD (CSO, NBE-Therapeutics AG) has over 15 years of experience in discovery, engineering and preclinical development of therapeutic antibodies. Previously he has led R&D activities related to therapeutic antibody development at Cytos, Switzerland, and later at Intercell, Austria. Roger is a renowned expert in mammalian cell based antibody expression and display for the discovery of fully human therapeutic antibodies. He was the main architect and inventor of Cytos' eMAB® mammalian cell antibody development platform, which, under Roger's leadership, was successfully used for the development of fully human therapeutic antibody candidates against numerous targets, including Nicotine and Influenza A, both at Cytos, and also later at Intercell, after the platform had been acquired by Intercell. Roger Beerli studied molecular biology at the University of Zurich, Switzerland, and obtained his PhD for work at the Novartis-associated Friedrich Miescher Institute in Basel, Switzerland, for research on ErbB receptor tyrosine kinases. Afterwards he performed postdoctoral research at The Scripps Research Institute in La Jolla, California, USA, in the lab of Prof. Dr. Carlos F. Barbas III. Here he specialized in phage display for protein and antibody engineering and was among the first to demonstrate artificial regulation of endogenous genes using engineered transcription factors. Roger Beerli has published widely in the areas of protein discovery, protein engineering and antibody development, and he is co-inventor on numerous patents and patent applications.

Dennis Benjamin, PhD

An industry veteran, Dr Dennis Benjamin joined Seattle Genetics in December 2004 where he leads the company’s research department to conduct research directed towards discovering new IND candidates, advancing the ADC technology and enabling correlative studies in early clinical trials Prior to joining Seattle Genetics, Dr Benjamin spent 6 years at Praecis Pharmaceuticals, most recently as Director of Biochemistry. Dr Benjamin received a B.Sc. in Chemistry from MIT, a PhD in Medicinal Chemistry from UCSF and was a Hitchings-Elion Postdoctoral Fellow at the University of Oxford.

Kurt Gehlsen, Ph.D

Dr Gehlsen has more than 30 years experience in basic research, pharmaceutical and medical device development, clinical development, regulatory affairs and executive management. Dr. Gehlsen is currently Vice President and CSO at Research Corporation Technologies, Inc. Previously, he was Senior Vice President and CSO at Maxim Pharmaceuticals, Inc. and developed Ceplene^TM, the first approved remission maintenance therapy for AML. Prior to Maxim, Dr. Gehlsen was founder and CEO of Trauma Products, Inc., and developed RescueFlow^TM, the first approved small volume resuscitation solution for life-threatening trauma. He was Director of Research in the Experimental Medicine Division of Pharmacia, AB and did his post-doctoral fellowship with Erkki Ruoslahti at the Sanford Burnham Institute. Dr. Gehlsen has held various research positions at the Sidney Kimmel Cancer Center, California Institute for Biological Research, and La Jolla Institute for Experimental Medicine. Dr. Gehlsen received his doctoral degree from the University of Arizona College of Medicine.

Yelena Kovtun

Yelena Kovtun, an Associate Director at ImmunoGen, Inc., is currently leading the corporate research program focused on the discovery and development of new antibody-drug conjugate (ADC) therapies for hematological malignancies. She led research programs at ImmunoGen, Inc. (Waltham, MA, 2002-present) and Cereon Genomics, Monsanto (Cambridge, MA, 2000-2002) following completion of post-doctorate at Harvard Medical School.

Chawita Netirojjanakul, PhD

Bio not available

Kounosuke Oisaki, PhD

Kounosuke Oisaki was born in 1980 in Tokushima, japan and received his bachelor degree from the University of Tokyo (UT) in 2003 under the direction of Professor Masakatsu Shibasaki. He obtained his PhD from UT in 2008. Then he moved to the University of California-Los Angeles, USA for postdoctoral studies with Professor Omar M. Yaghi. In 2010 he returned to Japan and joined Professor Motomu Kanai's group at UT as an assistant professor. He is currently a lecturer. His research interest is development of chemoselective catalytic transformations, aiming at the application to medicinal chemistry of small organic molecules and chemically modified biologics.

Andreas Pahl, PhD

Professor Pahl has 20 years’ experience in research and teaching and excellent expertise in pharmacology, toxicology and pharmacokinetics. In 2008 he joined industry to pursue drug development for inflammatory and autoimmune diseases at Nycomed and Takeda. In 2012 he joined Heidelberg Pharma as the CSO extending his expertise to the area of oncology and antibody-drug conjugates. Since 2016 he is also CSO of Wilex, the mother company of Heidelberg Pharma meanwhile renamed to Heidelberg Pharma. Professor Pahl continues to be adjunct Professor for pharmacology and toxicology at the University of Erlangen-Nuremberg.

Obadiah J. Plante, PhD

Bio not available

Jan Schnitzer, PhD

Bio not available

Ginette Serrero, PhD

Bio not availble

Philipp Spycher, Ph.D

Undergraduate studies at the University of Basel (Switzerland) in Nanoscience, graduate studies at the ETH Zurich in Biomedical Engineering and since three years post-doctoral researcher at the Paul Scherrer Institut (PSI) in Switzerland. From December 2017 I will be a PSI Founder Fellow at the PSI Villigen.

Breanna Vollmar, PhD

Dr. Breanna Vollmar received her PhD in Biochemistry from the University of Washington studying the structure of large protein complexes and membrane proteins using cryo-electron microscopy. In 2014, Dr. Vollmar transitioned to working on next generation antibody-drug conjugates at Genentech, Inc.

Alain Wagner, PhD

Dr. Alain Wagner received a PhD in organic chemistry from Université Louis Pasteur (1991, Strasbourg, France), followed by a post-doctoral fellowship with Prof. Peter Schultz at Affymax Research Institute (1991-1993, Palo Alto, USA). He joined CNRS in 1994 to develop projects around combinatorial approaches in drug discovery. Promoted research director in 2001, Alain Wagner took a sabbatical to found and manage Novalix Pharma (2002). He latter participated actively in the creation of eNovalys (2009) a company to stake on the digital technology to become a major component of the research workflow by funneling and exploiting raw experimental data as a source of innovation. On returning to the CNRS (2008) he took the lead of the Laboratory of Functional Chemo-Systems and investigates the possibilities offered by controlling synthetic reactivity for biomolecules engineering and more recently for interfering with living organisms. Exploiting this latest results and patents Alain has recently co-founded Syndivia SAS, which provides advanced technologies for drug bio-conjugation / drug release. Dr Wagner published more than 140 articles in peer-reviewed journals and is an inventor of 19 patents.

Robert Yongxin Zhao, PhD

Robert Zhao obtained his Ph. D. at University of Illinois and Post-doc training at Cornell University Graduate School of Medicine and Memorial Sloan-Kettering Cancer Center. After worked as a scientist at Monsanto Co and Pharmacia Corp for two years, he worked as senior scientist in the ADC field at ImmunoGen, Inc  for 12 years where he developed several ADC payloads and linkers that have been advanced in the clinic study. In 2012, he co-found Hangzhou DAC Biotech Co. Ltd in China working on a new generation of ADCs

Clinical Progress of Antibody-Drug Conjugates

Adnan Abu-Yousif, PhD

Adnan Abu-Yousif leads execution of the targeted payload strategy in discovery at Takeda Oncology. Prior to that, he contributed to the discovery and translational support of Merrimack Pharmaceuticals pipeline molecules. He first explored the biological properties of a variety of targeted delivery vectors including an EGFR+ tumor-targeted, activatable photoimmunoconjugate under the supervision of his postdoctoral mentor, Dr. Tayyaba Hasan and hasn’t looked back. Adnan has a Ph.D. in Pharmacology, Toxicology and Experimental Therapeutics from the University of Kansas.

Donald A. Bergstrom, MD, PhD

Dr. Bergstrom joined Mersana as CMO in January, 2014. Since joining the company, Mersana has grown from a privately held discovery-stage company to a publicly-traded company with multiple development-stage products. He has nearly 15 years of pharmaceutical industry experience in translational medicine and drug development. Dr. Bergstrom was Associate Vice President and Global Head of Translational and Experimental Medicine (TEM) at Sanofi Oncology from 2010-2014. Prior to joining Sanofi, Dr. Bergstrom was at Merck Research Laboratories where he held roles of increasing responsibility in the Clinical Molecular Profiling and Oncology Clinical Research groups, and where he built the Experimental Medicine Oncology group. He completed his MD degree at the University of Washington and his PhD and post-doctoral training at the Fred Hutchinson Cancer Research Center, both in Seattle, WA. He was a resident in Clinical Pathology at the University of Washington.

Mahendra Deonarain, PhD

Dr Deonarain studied at Imperial College and Cambridge University where he carried out PhD research into protein engineering. From 1997-2011 Dr Deonarain was a Principle Investigator and Reader in Antibody Technology at Imperial College, which led to some novel technologies being developed commercially. Dr Deonarain now retains honorary links with Imperial College. He has published over 70 papers and patents in protein/antibody engineering/conjugates. He is now CEO/CSO of Antikor Biopharma leading a team to develop the next-generation of antibody-fragment based ADCs for solid tumours.

Renu Singh Dhanikula, PhD

Dr. Renu Singh Dhanikula, PhD is a Senior Research investigator at Bristol-Myers Squibb. Dr. Singh received her PhD from University of Montreal, Canada. She has over 6 years of experience in pharmaceutical industry in the field of drug metabolism and pharmacokinetics, with emphasis on application of PK/PD modelling to enable translation of preclinical efficacy to clinic. She is a member of American Association for Pharmaceutical Scientists and International Society of Pharmacometrics. She has several publications in the peer-reviewed journals and presentations in the scientific conferences.

David Goldenberg, ScD, MD

Dr. Goldenberg founded Immunomedics, Inc., in 1982, served as Chairman of the Board of Directors until March, 2017. He also served as Chief Scientific Officer and Chief Patent Officer until November, 2017. In addition to his position with Immunomedics, Goldenberg was founder, president and a trustee of the Center for Molecular Medicine and Immunology, an independent nonprofit research center, and its clinical unit, the Garden State Cancer Center both funded by NIH and other grants. In 1985 and again in 1992, he received an “Outstanding Investigator Grant” award from the NCI and several other awards, including the Paul C. Aebersold Award from the Society of Nuclear Medicine. He has been a professor at several medical schools, authored ca. 800 articles, numerous book chapters, edited 2 books, published over 1,100 abstracts on cancer research, detection, and treatment. Goldenberg is also an inventor of over 300 patents issued in the U.S.

Trevor Hallam, PhD

Dr. Trevor Hallam has more than 25 years of experience in pharmaceutical discovery and development. He joined Sutro Biopharma as CSO in late 2010. Since then Dr. Hallam has shaped Sutro's biochemical synthesis technology to generate a disruptive discovery and manufacturing platform for novel best-in-class bispecific and antibody-drug conjugate protein therapeutics. Prior to Sutro, Dr. Hallam has held several senior R&D positions in the US and Europe, most recently Vice President Biologics, Vice President U.S. Medical Affairs, and Vice President, Research and Pre-clinical Development at AstraZeneca. He began his pharmaceutical career in the UK working for Smith Kline & French followed by senior management positions at Glaxo and Roche. Dr. Hallam conducted his post-doctoral training in the laboratory of Timothy Rink MD DSc at the Physiological Laboratory, University of Cambridge after receiving his Ph.D. in Biochemistry from King's College, University of London.

Jay Harper, PhD

Dr. Jay Harper received his Ph.D. in Cell & Developmental Biology from Harvard University in 2000 and conducted postdoctoral research on the initiation of the angiogenic switch with Marsha Moses, Ph.D. in the Vascular Biology Department at Boston Children’s Hospital. After joining Genzyme in 2006, he worked on advancing the anti-TGFb antibody, GC1008, through the pipeline and into clinical trials for cancer. Additionally, he helped build their antibody-drug conjugate (ADC) capabilities through both core capability development as well as by leading specific ADC project teams.

He joined MedImmune in 2011 and since then has used his experience to progress MedImmune's ADC platform and advance preclinical research programs towards the clinic. He has been the project lead for a number of different ADC projects and his team is helping to evaluate novel ADC technology to incorporate into MedImmune’s next gen ADCs. In addition, he is currently working with the immunooncology group to determine if synergistic anti-tumor activity can be achieved by combining ADCs and IMTs and to determine the mechanism(s) of action of such enhanced activity.

He is the co-inventor on a number of patents, has been invited to speak at various conferences and is either a lead author or a co-author on several journal articles, reviews and book chapters.

Philip Howard, PhD

Dr Howard is a Founding Scientist and Chief Scientific Officer at Spirogen. He has been conducting research into the pyrrolobenzodiazepine (PBD) family of antitumor antibiotics for twenty years in both academia and industry. Philip has worked as a part of a multi-disciplinary team, supported by Cancer Research UK and Spirogen, on the synthesis, biological evaluation and development of the PBD dimers. Since 2008 he has been working on the development of the PBDs as payloads for antibody-drug conjugate therapy with a number of leading companies including, Seattle Genetics, Stemcentrx, ADC Therapeutics, Genentech, Regeneron and Tanabe Research Laboratories USA Inc. Dr Howard designed the tesirine payload (SG3249) and the warhead SG3132 released by the talirine payload. His work at MedImmune is focused on the further development of their PBD-ADC platform. At the time of writing, more than 23 PBD-ADCs, arising from Spirogen collaborations, have been submitted to clinicaltrials.gov for 11 targets.

Shih-Yao (David) Lin, PhD

Bio not available

Gail Lewis Phillips, MSc

My laboratory studies receptor tyrosine kinases as targets for development of anti-cancer therapeutics, with emphasis on the HER/erbB family (EGFR/HER1/erbB1, HER2/erbB2, HER3/erbB3 and HER4/erbB4). Our early research efforts focused on the role of HER2 in HER2-amplified breast cancer, and the biological effects of antibodies directed against HER2. This work led to the development and approval of both Trastuzumab and Pertuzumab.  More recently, we developed an antibody-drug conjugate (ADC) comprised of Trastuzumab covalently linked to a potent cytotoxic agent, DM1, for delivery of the cytotoxic drug specifically to HER2-overexpressing tumors. Trastuzumab emtansine (KADCYLA®, T-DM1) has undergone extensive clinical testing in multiple lines for HER2-positive breast cancer and was FDA-approved in February 2013. We are currently exploring use of T-DM1 in other cancers that overexpress HER2 as well as investigating new HER2-directed ADCs utilizing cytotoxic agents with different mechanisms than DM1.

Ed Reilly, PhD

Ed Reilly is an immunologist and cancer biologist who trained as a Postdoctoral Fellow and Visiting Scientist at the MIT Center for Cancer Research. He presently serves as Senior Research Fellow and Project Director in the Oncology Discovery Group within AbbVie where he leads several late stage discovery ADC and Immuno-Oncology programs.  

Pamela Trail, PhD

Bio not available

Alessandra Micaela Villa, PhD

After obtaining her PhD in 2008 from the Swiss Federal Institute of Technology in Zurich (ETH), under the

supervision of Prof. Dr. Dario Neri, Dr. Villa joined Philochem AG, an ETH spin-off, where she was responsible for the generation of new phage display libraries and the development of high-affinity antibodies. In 2011, Dr. Villa then moved to the European Institute of Oncology of Milan, where she worked on the identification of new ovarian cancer targets by proteomic approaches. Back to Philochem AG in 2016 as “Head of Phage Display Technology”, she is currently responsible for the discovery of new therapeutic antibodies.

Eric Westin, PhD

Dr. Westin received his training in Oncology from the National Cancer Institute, subsequently becoming a Physician Scientist in the Department of Medicine at Virginia Commonwealth University. Following his time in academic medicine, he returned to the NIH with the National Institute of Aging, then moved to oncology drug development with Eli Lilly in 2006. He has held positions at both Eli Lilly and later at Takeda leading the early oncology development group, prior to joining ImmunoGen in June 2017 as Vice President of Clinical Development. 

William C. Zamboni, PharmD, PhD

William Zamboni is an Associate Professor in the UNC Eshelman School of Pharmacy and UNC Lineberger Comprehensive Cancer Center. He is the Director of the UNC Translational Oncology and Nanoparticle Drug Development Initiative (TOND₂I) Lab at the University of North Carolina in Chapel Hill. He has been involved in translational studies of anticancer agents for >20 years. His research interests are on the application of pharmacokinetic, pharmacodynamic and phenotypic principles in the optimization of the chemotherapeutic treatment of cancer, including nanoparticles, antibodies and antibody drug conjugates. A focus of his research is on evaluating the bi-directional relationship between the disposition of these agents and the mononuclear phagocyte system.

Emerging Indications for Therapeutic Antibodies

Dan Allison, PhD, Alder Biopharmaceuticals

PhD in Genetics from the University of Washington. Twenty five years in the biopharmaceutical industry. Currently Senior Director of Antibody Technologies at Alder Biopharmaceuticals. Expertise in the discovery and development of biologics, with a particular focus on antibody discovery, engineering, expression and upstream/downstream process development.

Robin Barbour, Prothena Biosciences

Robin has been involved in the development of monoclonal antibodies for over 25 years. At Elan, she headed the group that developed both the murine version of natalizumab for Multiple Sclerosis and Bapineuzumab for Alzheimer’s Disease. In addition, she holds several patents in assay methods for Alzheimer’s Disease, Parkinson’s Disease and Immunogenicity monitoring. She is currently Senior Director of Antibody and Assay Development at Prothena Biosciences, a company spun out from Elan Pharmaceuticals in 2012. Her group responsible for both discovery and characterization of novel antibodies for the potential treatment of a broad range of diseases that involve protein mis-folding or cell adhesion, and development of assays for pK, ADA and Biomarkers to support Prothena’s preclinical and clinical development efforts.

Gabriela Dos Santos Cruz De Matos, PhD, GlaxoSmithKline

Bio not available

Joachim Feldwisch, PhD, Affibody AB, Sweden

Dr. Feldwisch, Director Preclinical Development of Affibody AB, joined the company in 2002. He has more than 25 years of experience in life science research with particular expertise in protein engineering of alternative scaffolds, protein biochemistry and development of drug candidates for clinical trials. He received his MSc in Biology with main focus on biochemistry and molecular biology from the University of Cologne and earned his PhD at the Max-Planck-Institute für Züchtungsforschung in Cologne in 1992. In the following years he worked at Pharmacia, Pharmacia&Upjohn and later Biovitrum both with biotherapeutics and small molecule pharmaceuticals. His current research interests include optimization of small scaffold proteins as well as preclinical and clinical development of Affibody molecules for therapeutic use.

Robert P. Giugliano, MD, Brigham and Women’s Hospital; Harvard Medical School

Dr. Giugliano, MD is a Senior Investigator with the TIMI Study Group, Staff Physician in the Cardiovascular Division at Brigham and Women’s Hospital, and Associate Professor of Medicine at Harvard Medical School. He is a graduate of Dartmouth College (Mathematics,1985), Harvard Medical School (Doctorate of Medicine,1989), and Harvard School of Public Health (Master of Science, Epidemiology, 1997). Dr. Giugliano completed residency and chief residency at Cedars-Sinai Medical Center (UCLA affiiliate,1989-93) and cardiology fellowship at Massachusetts General Hospital (1993-6). He joined the Brigham and Women’s Hospital as a Medicine Research Fellow in the Thrombolysis in Myocardial Infarction (TIMI) Study Group directed by Eugene Braunwald, and was appointed to the Cardiovascular Division faculty of the Brigham and Women’s Hospital in 1998. Dr. Giugliano’s areas of research interests include novel antithrombotic, fibrinolytic agents, and lipid-lowering therapies, and patient outcomes following Acute Coronary Syndromes (ACS). He has authored more than 250 articles and chapters, and delivered hundreds of lectures. Dr. Giugliano is the Principal Investigator for the ENGAGE-AF TIMI 48 trial (edoxaban in AF), and a member of the Operations Committees and Lead TIMI Investigator for the IMPROVE-IT (ezetimibe post ACS), FOURIER (evolocumab in stable cardiovascular disease), EBBINGHAUS (evolocumab and congition) and EARLY ACS trials (eptifibatide in ACS). Dr. Giugliano serves on numerous Data Safety Monitoring Boards, clinical endpoint committees, and Holter/ECG Core Laboratories. He actively participates in the clinical activities of the Cardiovascular Division, attending in the Levine Cardiac Intensive Care Unit, telemetry unit, and consult services, and sees patients in a busy growing outpatient practice.

Gregory C. Ippolito, PhD, The University of Texas at Austin

Dr. Ippolito initially studied physics at Reed College and then completed training in B-cell immunology at The University of Alabama at Birmingham, The University of Cologne (Germany), and The University of Texas at Austin. A former Director for Research and Development at a publicly traded antibody biologics company, he has had the privilege since 2011 to launch, spearhead, and supervise antibody technology development and human immunology projects in the laboratory of Professor George Georgiou at The University of Texas at Austin.

Leonard Kaczmarek, PhD, Yale University School of Medicine

Len Kaczmarek is a Professor of Pharmacology and Cellular and Molecular Physiology at Yale University School of Medicine. He carried out his undergraduate and graduate work at the University of London and carried out research at UCLA, the Free University of Brussels, Belgium and Caltech before joining the Yale faculty in 1981. He served as Chairman of the Yale Department of Pharmacology from 1989 to 1998. Professor Kaczmarek’s laboratory studies the biochemical changes that occur within neurons to produce prolonged changes in the behavior of an animal. In particular, his group discovered the genes for many of the ion channel proteins that are directly responsible for the electrical excitability of nerve cells. He is currently investigating the way mutations in these proteins in humans are responsible for several forms of intellectual disability and autism. Dr. Kaczmarek has authored or edited several books, and is co-author of the textbook “The Neuron”.

Hikaru Koga, Chugai, Japan

Master’s Degree in Agriculture, The University of Tokyo, 2015.

Chugai pharmaceutical Co., LTD. Biologics Discovery Dept. Research Division, 2015-Present

In Chugai, I experienced lead antibody acquisition by phage library and mainly centered on antibody engineering.

Andrea Marschall, PhD, Postdoctoral Researcher, Biochemistry, Brandeis University

Andrea Marschall studied Molecular Biotechnology at Heidelberg University, gained a PhD in Stefan Dübel's lab on targeting antibodies into living cells, continuing with Postdoctoral research at the Helmholtz Centre for Infection Research in Braunschweig (Germany) and at Brandeis University in Boston (USA).

Thomas Mikita, PhD, Pfizer, Inc.

I am currently a Director and Research Project Leader at Pfizer's Centers for Therapeutic Innovation. I lead or have led projects in Thrombosis, Oncology and Fibrosis. Prior to Pfizer I worked at CV Therapeutics (now Gilead) where my research focused on target discovery with a focus on atherosclerosis. My postdoc at Tularik (now Amgen) focused on IL-4/Stat6 signaling from receptor to nucleus. I have a PhD in Molecular Biophysics and Biochemistry from Yale University where I focused on the study of DNA replication inhibitors involved in cancer chemotherapy

Janice M. Reichert, PhD, The Antibody Society

Dr. Janice Reichert is an internationally-recognized expert in the development of antibody therapeutics. She is Executive Director of The Antibody Society, a non-profit association representing individuals and organizations that engage in antibody research or development. Dr. Reichert is also Founder and Editor-in-Chief of mAbs, a peer-reviewed, PubMed-indexed biomedical journal that focuses on topics relevant to antibody research and development, and Founder and Managing Director of Reichert Biotechnology Consulting LLC, a pharmaceutical business intelligence research firm. Dr. Reichert writes frequently on development trends for antibody therapeutics, including the annual ‘Antibodies to watch’ articles published in mAbs, and she has presented her research results as an invited speaker at conferences held worldwide.

Luke Robinson, PhD, Visterra, Inc.

Luke Robinson, PhD, is currently an Associate Director of Research at Visterra, Inc., a clinical-stage biopharmaceutical company. He has over 10 years of experience in biotechnology and protein engineering research. At Visterra, Dr. Robinson leads a research team developing new protein engineering tools and discovering novel therapeutic mAbs. Prior to Visterra, Dr. Robinson's PhD thesis at MIT involved developing a novel structure-based method to engineer a broad-spectrum neutralizing mAb to dengue virus, the results of which were patented, licensed by Visterra and further developed, with initiation of clinical trials anticipated soon. Dr. Robinson is an inventor on multiple patents and has authored publications in top-tiered journals, including Cell and New England Journal of Medicine.

Dan Sexton, PhD, Shire

Dan Sexton is currently a Director in Nonclinical Pharmacology at Shire supporting immunology and hereditary angioedema programs. Prior to Shire, Dan was at Dyax Corp, in roles ranging from antibody discovery and characterization to the preclinical development of biologics. Dan was trained as an enzymologist at the University of Windsor (PhD) and Penn State (post-doc). While at Dyax, Dan led the discovery and early development of lanadelumab, the antibody being presented today.

Devin Sok, PhD, Director, International AIDS Vaccine Initiative (IAVI)

Devin has been working with the International AIDS Vaccine Initiative since 2014 where he leads a group that specializes in antibody discovery for HIV and evaluating antibody responses to immunization experiments in different animal models. Although the bulk of his work is based on identifying rare broadly neutralizing antibodies to HIV, he has also collaborated on antibody discovery projects for both Ebola and Zika viruses. Dr. Sok received his PhD from The Scripps Research Institute under Dennis R. Burton and has authored over 40 peer-reviewed publications in the HIV broadly neutralizing antibody field.

Christine Tkaczyk, PhD, MedImmune

Christine Tkaczyk joined Medimmune in 2008, and is currently a senior scientist in the Infectious Diseases/Vaccine department where she leads different programs in the bacteriology group. Dr Tkaczyk hold a PhD in immunology from the Pasteur Institute and came to the US in 1999 as a visiting fellow in the Laboratory of Allergic Diseases at the National institutes of Health.

Tianlei Ying, PhD, Fudan University, China

Dr. Tianlei Ying graduated from Fudan University with a PhD in 2010. After postdoctoral training at the National Cancer Institute, NIH, he joined the School of Basic Medical Sciences, Fudan University in 2014 as Chief of the Antibody Engineering and Drug Discovery Laboratory. Dr. Ying's research interests include antibody-based therapies for cancer, HIV and other infectious diseases. In the past 5 years, he has published over 50 papers in journals such as Nat Biotech, Nat Commun, Cell Host Microbe, J Infect Dis, mAbs, and co-authored 15 patents and patent applications. Currently, he is involved in the development of novel antibody fragments of small size and long half-lives; this technology could also be used for extending serum half-lives of protein therapeutics. He also developed several exceptionally large human antibody libraries, and identified panels of highly potent fully human mAbs against cancer and infectious diseases. Some of these mAbs have been licensed to top biopharmaceutical companies and are expected to move into the clinic shortly.

Ali Zarrin, PhD, Genentech

Ali Zarrin obtained his B.Sc. from University of Minnesota and PhD from University of Toronto. He then joined Fred Alt’ laboratory at Harvard University to study molecular mechanisms of antibody diversifications. Ali Joined Genentech from 2007 where he holds his primary appointment in Immunology Discovery and joint appointment in Antibody Engineering.

CRISPR for Genome Editing

Patrick Collins, PhD

Patrick Collins, Ph.D. is a senior scientist in the Genome Analysis Unit at Amgen. He works in high throughput functional genomics utilizing CRISPR-Cas9, shRNA, cDNA and reporter screening platforms. Dr. Collins joined Amgen in 2011 from SwitchGear Genomics where he served in a number of positions, ultimately overseeing both new product development as well as managing academic collaborations and contract work as Director of Research and Development. Dr. Collins holds a B.A. in biology from Pomona College and a Ph.D. in genetics from Stanford University.

Marina Falaleeva, PhD

Marina Falaleeva Ph.D. has worked as a Scientist at Sangamo Therapeutics since July 2016, supporting next-generation sequencing based assay development. Dr. Falaleeva received her Ph.D. in molecular biology from the Lomonosov Moscow State University, where she worked on the development of ultrasensitive methods for nucleic acid detection. Prior to joining Sangamo, Dr. Falaleeva worked as a postdoctoral scientist at the University of Kentucky, where she studied the molecular mechanisms of rare genetic disorders.

Gus Frangou, PhD

Gus Frangou, Ph.D. is an Assistant Professor of Oncology in the Department of Cancer Genetics at Roswell Park Cancer Institute and a Fellow in the Harvard TH Chan School of Public Health. He received his Ph.D. from the University of Cambridge. His research interests focus on gaining a more comprehensive understanding of cancer networks and identifying therapeutic targets relevant to specific cancer genotypes. Interdisciplinary experimental loss/gain-of-function genetic approaches and computational tools are employed in his laboratory to accurately predict patterns of cancer essentiality based on the underlying molecular characteristics of cancer patients.

Tony Ho, MD

Dr. Tony Ho is a highly accomplished R&D leader with experience across all phases of R&D, including: discovery, early and late-stage clinical development, and regulatory, throughout his nearly 20 year career. He was previously Senior Vice President and Head of Oncology Integration and Innovation at AstraZeneca. During his tenure at AstraZeneca, he oversaw both development and commercialization of the two key drugs – Lynparza, a first-in-class PARP inhibitor for ovarian cancer and Imfinizi (anti-PD-L1), AstraZeneca’s first immuno-oncology drug for bladder cancer. For both drugs, he led the program through filing, regulatory defense, payer access, and commercial launch, and initiated Phase III development across multiple tumor types. Prior to joining AstraZeneca, Tony was the Neurology and Ophthalmology Clinical Section Head at Merck Research Laboratories, Merck & Co., Inc. and led multiple development programs including the approval of Maxalt for pediatric migraine and Zioptan for glaucoma. Prior to joining Merck, Tony was the Co-Founder and Chief Scientific Officer of Neuronyx, Inc., a regenerative medicine company. Tony completed his B.S. in Electrical Engineering at the University of California, Los Angeles, and received his M.D. from the Johns Hopkins University School of Medicine. After an internship in Internal Medicine at the Massachusetts General Hospital, Tony completed his residency and neurophysiology fellowship in the Department of Neurology at the Johns Hopkins Hospital. He was Assistant Professor at Johns Hopkins Hospital in the areas of neuropathy and neuromuscular diseases. He has published widely in several fields with over 80 papers and is co-inventor of seven patents. He is currently adjunct Associate Professor of Neurology at University of Pennsylvania and Assistant Professor of Neurology at Johns Hopkins University.

Fuguo Jiang, PhD

Fuguo Jiang is a postdoctoral fellow currently in the lab of Jennifer Doudna at the University of California, Berkeley. He received his BS and MSc in China, then completed his Ph.D. research at Rutgers University. In August 2013, he joined Jennifer Doudna’s laboratory for his postdoctoral training. Since then, Dr. Jiang has been making great strides towards understanding the molecular mechanism of the CRISPR/Cas9 system, working alongside his colleagues in the Doudna lab. He has combined X-ray crystallographic data and single-particle cryo-electron microscopy approaches to describe the mechanism of RNA-guided DNA target recognition and anti-CRISPR mechanism of the Type II-A CRISPR-Cas9 family. These proteins are powerful tools from genome editing in a wide variety of organisms.

Colin A. Johnson, PhD

Prof. Colin A. Johnson trained under Bryan Turner and Eamonn Maher at the University of Birmingham, before moving to the University of Leeds in 2007. He has a long track-record in human recessive disease gene identification that has been funded by a Biomedical Award from the Sir Jules Thorn Charitable Trust and the Medical Research Council, and has led to current research interests in gene discovery, understanding ciliary ultrastructure and organization, and regulation of alternative splicing in human health and disease. He has published 132 peer-reviewed publications (h-index 51, total citations of 11,492).

Julia Joung

Julia Joung is a graduate student in the lab of Feng Zhang at the Broad Institute of MIT and Harvard. She received her B.S. from Stanford University in bioengineering, where she worked with a postdoc in the neurobiology lab of Ben Barres on astrocyte-mediated synaptic pruning. At Stanford, she was selected as the departmental commencement speaker and for the Terman Engineering Scholastic Award. After graduation, as a research scientist at Counsyl, she helped develop a large-scale, cost-effective sequencing protocol for genetic diagnostics. In the lab of Feng Zhang, she develops CRISPR-Cas9 tools for screening long noncoding RNAs and better understanding neurodevelopmental diseases.

Kristian Bruun Laursen, PhD

My current research aims to bridge the understanding between nutrition/metabolites and epigenetics/transcription. In my postdoc work I focused on vitamin A (retinoic acid) and associated changes in transcription and epigenetics of embryonic stem cells. In this work, I discovered a ligand-independent function in genetic imprinting of a ligand-activated receptor, and identified an epigenetic mechanism of delayed transcriptional activation, which define a subset of retinoic acid inducible genes. In my work as faculty, I am applying mouse models to study the metabolic and epigenetic changes associated with kidney cancer (clear cell renal carcinoma). This is combined with tissue culture models, where I am currently pursuing a link between vitamin C and a known cancer metabolite by combining my dox-regulated knockdown mouse line with our kidney cancer mouse model (TRACK). The mouse work is supplemented with nanoparticle delivery of siRNA and CRISPR. This research aims to 1) identify the mechanism of the metabolic shift associated with kidney cancer, and 2) provide specific tools for therapy and further research.

Joonsun Lee, PhD

Joonsun received bachelor's and master's degrees from Korea Advanced Institute for Science and Technology (KAIST). She joined Toolgen in 2016, and is working on engineering Cas9 proteins and developing CRISPR techologies in the platform R&D center.

John McCafferty, PhD

John McCafferty was one of the founders of Cambridge Antibody Technology (CAT, now Medimmune) in 1990 and published the first paper/patent describing antibody phage display. After 12 years at CAT he returned to academia at the Sanger Institute and the University of Cambridge. In 2012 John formed IONTAS, a small innovative biotechnology company using phage display to develop novel antibody therapeutics. IONTAS have also developed a novel technology for construction of very libraries in mammalian cells by using CRISPR/Cas 9 and TALE nucleases to efficiently direct the integration of a library of antibody genes into single genomic locus within a population of cells.

Beatriz “Bettie” Osuna

Beatriz “Bettie” Osuna is a graduate student in the Bondy-Denomy lab at the University of California, San Francisco. She is from Southern California where she earned a B.S. in Microbiology, Immunology, and Molecular Genetics at the University of California, Los Angeles. Bettie is currently studying anti-CRISPR-Cas9 mechanisms in Listeria monocytogenes.

Barrett Steinberg, PhD

Barrett Steinberg received a BS from Boston University and a PhD in biomolecular engineering from Johns Hopkins University, where he studied directed evolution of beta lactamase in the Ostermeier Lab. He currently researches RNA and protein engineering at Editas Medicine to better enable gene editing technologies.

Nanotechnology in Medicine

Jose Luis Corchero Nieto, PhD

Dr. José L. Corchero (graduated in Biology, 1990), obtained a Master Degree in Biotechnology (1993) and a Ph.D. in Biological Sciences (1997), both dealing with the production of recombinant proteins in E. coli. In 1998, he moved to the field of development of diagnostic kits, first at the ”Centers for Disease Control” (Atlanta, USA) with a post-doctoral fellowship, and later on at Biokit S.A. (2000-2007), a Spanish private company. Since 2007, he is a senior scientist of CIBER-BBN (Networking on Bioengineering, Biomaterials and Nanomedicine) within the Nanobiotechnology group, led by Prof. Antonio Villaverde (Universitat Autònoma de Barcelona). Dr. Corchero current research mainly deals with the production of therapeutic proteins for rare diseases, and the development of new vehicles for the targeted delivery of such proteins.

Brian Cunningham, PhD

Brian T. Cunningham is the Willett Professor of Engineering in the Department of Electrical and Computer Engineering at the University of Illinois at Urbana-Champaign, where he also serves as the Director of the Micro and Nanotechnology Laboratory, and the leader of the Omics Nanotechnology for Cancer Precision Medicine Theme at the Carl Woese Institute for Genomic Biology. His research is in the development of biosensors and detection instruments for pharmaceutical high throughput screening, disease diagnostics, point-of-care testing, life science research, and environmental monitoring. He has published 185 peer-reviewed journal articles, and is an inventor on 83 patents. Prof. Cunningham was a co-founder of SRU Biosystems in 2000, and founded Exalt Diagnostics in 2012 to commercialize photonic crystal enhanced fluorescence technology for disease biomarker detection. Prof Cunningham’s work has been recognized with the IEEE Sensors Council Technical Achievement Award and the IEEE Engineering in Medicine and Biology Technical Achievement Award. He is a Fellow of IEEE, OSA, AAAS, NAI, and AIMBE.

Daryl Drummond, PhD

Daryl Drummond currently serves as the Head of Research and Senior Vice President of Discovery for Merrimack Pharmaceuticals, where he oversees the discovery efforts for Merrimack’s Nanotherapeutics and Biologics-based therapeutics. Dr. Drummond received a Ph.D. degree in Biochemistry from Indiana University in 1997, with an emphasis on membrane biochemistry and biophysics, and later did a postdoc under the renowned father of lipid-based drug delivery systems, Demetrios Papahadjopoulos at UCSF and California Pacific Medical Center. Dr. Drummond was one of two principle inventors for many of Merrimack's nanotechnology-based drugs and platform technologies, most notably Onivyde, a highly stabilized liposomal formulation of irinotecan. He joined Merrimack in October of 2009 following the merger of Merrimack with Hermes Biosciences. Dr. Drummond received a Ph.D. degree in Biochemistry from Indiana University in 1997, with an emphasis on membrane biochemistry and biophysics. He later joined Hermes Biosciences in 2000 as an Associate Director of Liposomal Research and Development following a post-doc in the laboratory of the renowned father of current liposome drug delivery systems, Demetrios Papahadjopoulos. Overall, Dr. Drummond has more than 20 years of experience in the research and development of advanced drug delivery systems, including four unique drugs that have been tested in various clinical trials, >40 issued patents or patent applications, and more than 65 peer reviewed publications focused on lipid-based nanotherapeutics. The focus of his research is in developing targeted nanotherapeutics for treating a wide range of solid tumors. He successfully developed novel platform technologies for targeting lipidic nanocarriers such as liposomes using a range of novel ligands, but most notably Fab’ or scFv antibody fragments. He has also developed platform technologies for dramatically improving the in vivo drug retention of difficult to stabilize small molecule drugs, and for systemic delivery of nucleic acids. Three of their nanotherapeutics are being studied in clinical trials, including an ErbB2-targeted liposomal doxorubicin which is currently being evaluated in a Phase II study in ErbB2-overexpressing breast cancers and a nanoliposomal formulation of irinotecan which recently showed promising results in a Phase III trial in gemcitabine-refractory pancreatic cancer. A fourth antibody targeted lipososomal drug (MM-310) is scheduled to enter the clinic in the second half of 2016.

Ali Fattom, PhD

Dr. Fattom has >25 years in the vaccine development. He started at the NIH developing conjugate vaccine against Stphylococcus and other bacterial pathogens. He spent 18 years in the industry developing bacterial vaccines against Staphylococcus through phase 3 clinical trials. He was the inventor and lead the development of nicotine vaccine to prevent and treat tobacco smoking addiction. For the last seven years, at NanoBio, Dr. Fattom has lead the effort in utilizing Nanostat technology for the development of intranasal vaccines to prevent colonization and infection by respiratory and sexually transmitted diseases. Active programs under development are intranasal vaccines against anthrax, pandemic flu , RSV, and Sexually transmitted diseases genital herpes and Chlamydia. Dr. Fattom is the inventor on >20 patents and had >70 publications in the field of vaccines and vaccinology.

Taeghwan Hyeon, PhD

Taeghwan Hyeon is SNU Distinguished Professor of Seoul National University (Chemical and Biological Engineering) and a Director of Center for Nanoparticle Research of Institute for Basic Science (IBS).  Since 1997, he has been working on the synthesis and applications of uniform-sized nanoparticles and related nanostructured materials, and published > 350 papers in prominent international journals (>37,000 citations and h-index of 107). He is Fellow of Royal Society of Chemistry (RSC) and Materials Research Society (MRS). He received many awards including the Korea S&T Award from Korean President (2016), Hoam Prize (2012, Samsung Hoam Foundation), POSCO-T. J. Park Award (2008), IUVSTA Prize for Technology (IUVacuumSTA, 2016). He is an Associate Editor of J. Am. Chem. Soc.

Paul Millner, PhD

Paul A. Millner: has over thirty years experience as a protein chemist/molecular biologist and within the past 13 years has focussed on bionanotechnology, in the design of electrochemical biosensors and optical nanobiosensors. Appointed Lecturer in Biochemistry in 1986 at University of Leeds, he became Reader in Biotechnology in 2006 and Professor of Bionanotechnology in 2009 and from June 2011 until April 2017 Head of the School of Biomedical Sciences. His research interests lie in interfacing biomolecules, including antibodies, binding proteins and enzymes to no-bio surfaces such as electrodes, nanoparticles and nanofibers for imaging, biosensing and drug delivery. The Millner group employs a highly multi-disciplinary approach to this end with active collaborations ranging across basic bioscience and engineering to clinical practitioners.

Christopher Hartshorn, PhD

Dr. Christopher M. Hartshorn serves as a program director at the National Cancer Institute Office of the National Institutes of Health. In this role, he manages nano- and passive continuous monitoring-centric research projects, evaluates effectiveness of the programs, and maintains proper stewardship over federally funded research. Furthermore, he serves as a technical expert to extramural programs and participates in development and direction of new research initiatives within the NCI Center for Strategic Scientific Initiatives. Prior to the OCNR, Dr. Hartshorn worked for the National Institute of Standards and Technology (NIST). Dr. Hartshorn earned his Ph.D. in Physical Chemistry and Materials Science from Washington State University.

Seungpyo Hong, PhD

Dr. Seungpyo Hong is Professor of Pharmaceutics in the Pharmaceutical Sciences Division, School of Pharmacy at the University of Wisconsin-Madison (UW-Madison). He also holds an adjunct appointment as Associate Professor in the Underwood International College at Yonsei University, Seoul, Korea, and serves as Associate Editor for Nanomedicine: Nanotechnology, Biology and Medicine of Elsevier. He graduated from Hanyang University in Seoul, Korea with B.S. and M.S. degrees in polymer engineering in 1999 and 2001, respectively. After working as a researcher at Korea Institute Science and Technology (KIST), he started his Ph.D. study at the University of Michigan working with his advisors Profs. Mark Banaszak Holl and James Baker, Jr. Dr. Hong graduated with his PhD in Macromolecular Science and Engineering in 2006 and joined MIT as a postdoctoral associate in the laboratory of Prof. Robert Langer. From 2008 to 2014, he was Assistant Professor in the College of Pharmacy at the University of Illinois at Chicago (UIC) where he was promoted to Associate Professor with tenure in 2014, and subsequently joined the UW-Madison faculty as Professor in 2016. Since 2008, he has led a research group under the major research theme of “Biomimetic Nanotechnology” for cancer treatment. To date, Prof. Hong’s research has culminated in over 65 peer-reviewed articles that have a combined total number of citations over 9,300 times with an h-index of 31, 7 book chapters, and 14 issued or pending patents, while delivering over 100 invited talks worldwide and over 130 conference proceedings. His academic/research achievements have been recognized by the related scientific communities, resulting in him receiving a number of awards including 2012 AAPS New Investigator Award in Pharmaceutics and Pharmaceutical Technologies and 2012 UIC Researcher of the Year - Rising Star Award.  His interests extend to entrepreneurship and translation of his research products, leading him to co-found a biotech startup, Capio Biosciences, Inc., where he serves as Co-founder and President.

Kei Kishimoto, PhD

Dr. Kishimoto is the Chief Scientific Officer of Selecta Biosciences, a biotechnology company developing synthetic vaccines based on a novel self-assembling nanoparticle technology. Prior to joining Selecta, Dr. Kishimoto was Vice President of Research at Momenta Pharmaceuticals where he led multidisciplinary teams in inflammation, oncology, and cardiovascular disease. Previously he was Senior Director of Inflammation Research at Millennium Pharmaceuticals, where he provided the scientific leadership for four programs in clinical development, and an Associate Director of Immunology at Boehringer Ingelheim. Dr. Kishimoto received his doctoral degree in Immunology from Harvard University and his post-doctoral training at Stanford University.

Hayat Onyuksel, PhD

Dr. Hayat Onyuksel is currently Professor of Pharmaceutics and Bioengineering at the University of Illinois at Chicago (UIC), Department of Biopharmaceutical Sciences, College of Pharmacy. She received her B.S. degree in Pharmacy from Ankara University, Turkey, and Ph.D. degree from London University, England. After a brief post-doctoral experience at the University of Michigan, Dr. Onyuksel joined academia. Since1987 she is a faculty at UIC. Dr. Onyuksel's research interest is in the area of targeted drug delivery. She uses lipid-based nano-carriers to develop nanomedicines with improved drug solubility, stability and safety. Applying her innovative targeted approach she has prepared several nanomedicines and showed on animal models successful treatments of cancer, diabetes, and inflammatory diseases. Dr. Onyuksel has published 117 scientific journal papers, 35 conference proceedings, 192 abstracts, and 9 issued patents. Dr. Onyuksel has been serving in several NIH grant/contract review panels since 1992. She was a regular member of newly formed NIH Nano study session during 2009-2011. She was an associate editor of the Journal Nanomedicine: Nanotechnology, Biology, and Medicine during 2011-2013. She is currently on the Editorial Board of nine scientific journals related to nanotechnology and pharmaceutical sciences. She has received several prestigious awards including New Investigator Award from American Association of Colleges of Pharmacy (1989), the UIC Inventor of the Year Award (2003), the UIC Woman of the Year Award (2003), American Association of Pharmaceutical Scientist Fellow (2006), UIC Graduate Mentoring Award (2008), UIC University Scholar (2008), AAPS Lipid Based Drug Delivery Outstanding Researcher Award (2008). In December 2014 she received the most prestigious scientific award of Turkish Republic (TUBITAK) directly from the Turkish president.

Jinjun Shi, PhD

Dr. Jinjun Shi is an Assistant Professor at Harvard Medical School, and a faculty member in the Center for Nanomedicine, Brigham and Women’s Hospital. His research interests include nanotechnology, bioresponsive materials, and biomolecular delivery. The development of immunonanotherapeutics by him and his colleagues has resulted in the clinical trials of synthetic nanoparticle vaccines for inflammatory diseases. He has published 46 peer-reviewed papers and holds over 40 patents/patent applications worldwide. He has also received many awards, such as the K99/R00 Career Development Award from National Institutes of Health, the Movember Challenge Award and the Young Investigator Award from Prostate Cancer Foundation, and others. He obtained his PhD degree in Chemistry from Texas A&M University, and received postdoctoral training at Harvard Medical School and Massachusetts Institute of Technology.

Matthias Stephan, MD PhD

Matthias Stephan is an Associate Member at the Fred Hutchinson Cancer Research Center, Program in Immunology. The ultimate goal of Dr. Stephan’s research is to create unconventional treatments at the interface between materials science and immunology. He began specializing in this area as a graduate student at Memorial Sloan-Kettering Cancer Center, where he pioneered auto-costimulation and trans-costimulation as molecular strategies to augment the function of lymphocytes in the microenvironment created by tumors (licensed and employed by JUNO Therapeutics). During his postdoctoral training at the Massachusetts Institute of Technology, Dr. Stephan developed a nanoparticle-based strategy to provide autocrine sources of adjuvant growth factor that support adoptively transferred, tumor antigen-specific T lymphocytes. Much of this work became the intellectual and technical foundation for a Cambridge-based startup company (Torque Therapeutics, Inc.). The long-term goal of his ongoing research at Fred Hutch is to make immunotherapy more practical and widespread by creating off-the-shelf reagents that can rapidly boost the body's natural ability to fight cancer and infectious disease.

Introduction to Protein Engineering

David Bramhill, PhD, Bramhill Biological Consulting, LLC

Dr. Bramhill has over 20 years’ experience in biologics, both in large biopharma and startup biotech companies. He has experience in isolating and improving antibodies using phage display and is an inventor on library design techniques for small scaffolds. He also has experience in diverse expression systems for producing antibodies, antibody fragments and different scaffolds. He has taught numerous technical courses for over 10 years at international conferences.

Introduction to Structure-Based Drug Design and Development

Christopher Corbeil, PhD, National Research Council Canada

Christopher received his PhD from McGill University under the supervision of Prof. Nicolas Moitessier. After his PhD, he joined the National Research Council of Canada (NRC) as a Research Associate under the supervision of Dr. Enrico Purisima investigating solvation and protein loop searching. Following his time at the NRC he joined Chemical Computing Group as a Research Scientist developing tools for biologics design. After 4 years, he decided to leave private industry and rejoin NRC as a Research Officer focusing on investigating tools for computer-aided biologics design.

Traian Sulea, PhD, National Research Council Canada

Dr. Traian Sulea has joined NRC Canada at its Biotechnology Research Institute in Montreal as a post-doctoral fellow in 1995, and as a Research Officer in 1997. He is also cross-appointed as Adjunct Professor with the Institute of Parasitology of McGill University since 2012. Dr. Sulea has broad expertise in applying computational approaches to the discovery and optimization of bioactive small-molecules and biologics. He has contributed to the development of computational methods for biomolecular applications, focusing on continuum solvation models and binding-affinity scoring functions. In recent years, he applied computational structural modeling to the design of biotherapeutics including growth-factor traps and avidity-optimized Intellimabs for tumor targeting, as well as to antibody humanization, affinity maturation and de novo design. Dr. Sulea has authored over 80 scientific articles and book chapters, and is an inventor on 10 issued and 8 pending patents.

Introduction to Bioprocessing

Sheila G. Magil, PhD, BioProcess Technology Consultants, Inc.

Sheila Magil has over 20 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a PhD in Biochemistry from the University of Minnesota.

Frank J. Riske, PhD, BioProcess Technology Consultants

Frank J Riske, PhD, Senior Consultant at BioProcess Technology Consultants has over 25 years of experience in the biopharmaceutical industry. Prior to joining BioProcess Technology Consultants, Dr. Riske was Senior Director in the Late Phase Process Development Group at Genzyme, a Sanofi company. Before Genzyme, Dr. Riske held positions at Epic Therapeutics, Repligen and Hoffmann-LaRoche. Dr. Riske has extensive experience in the development of downstream processes for cytokines, proteins and virus from plasma, E coli, Pichia and mammalian systems and in the development and manufacture of novel drug delivery systems. Dr. Riske received his B.S. in Biology from Fairfield University, PhD in Biochemistry and Microbiology from Rutgers University and completed a post-doctoral position at Hoffmann-LaRoche.

Next Generation Sequencing for Antibody Discovery and Engineering

Simon Friedensohn, MSc, ETH Zurich, Switzerland

Simon Friedensohn is a PhD candidate in Sai Reddy’s Laboratory of Systems and Synthetic Immunology at ETH Zurich (since 02.2015). His research work focuses on developing both experimental as well as computational methods for high-throughput immune repertoire sequencing in order to improve antibody discovery and engineering from NGS datasets. He holds a B.Sc. and M.Sc. in Biotechnology from ETH Zurich. Previous to joining the Reddy lab, he completed a scientific internship at Roche where he worked on high-throughput (mi)RNA profiling for comparative genomics.

Enkelejda Miho, PhD, ETH Zürich, Switzerland

Enkelejda Miho is a Professor at Institute of Medical and Analytical Technologies, School of Life Sciences FHNW, Switzerland. Her research focuses on large-scale network analysis and machine learning to uncover the architecture of complex immune repertoires and to mine their sequence space features for basic and applied systems immunology.

Prof. Enkelejda Miho holds a M.S. in Pharmaceutical Chemistry and Technology from the University of Bologna (2011) and a DAS in Pharmaceutical Medicine from the European Center of Pharmaceutical Medicine (ECPM), University of Basel (2016). Prof. Miho completed her doctorate in Biotechnology at ETH Zurich (2017). As a Pioneer Fellow at the Innovation & Entrepreneurship Lab (ETH ieLab), she founded aiNET, the immuno-informatics ETH spin-off for therapeutic antibody and T-cell discovery.

Immunology for Drug Discovery Scientists

Masha Fridkis-Hareli, MSc, PhD, ATR, LLC

Masha Fridkis-Hareli, M.Sc., PhD is an immunologist, consultant and inventor with over 20 years of experience in academia and industry. She is a Founder and President of ATR, LLC, a translational research company providing scientific consulting and laboratory services in immunoassay development to research institutions and the biotechnology industry. During her post-doctoral training at Harvard University she designed and developed a group of novel compounds for treatment of autoimmune diseases. After serving as Principal Investigator at the Dana Farber Cancer Institute, Dr. Fridkis-Hareli transitioned to industry where she held a variety of positions with increasing responsibilities at Resolvyx Pharmaceuticals, Charles River Laboratories, Taligen Therapeutics and Alexion Pharmaceuticals. Dr. Fridkis-Hareli is a co-author of over 100 publications and 17 issued patents. She is an adjunct professor at the Metropolitan College at Boston University, where she teaches biotechnology and immunology courses, and a co-chair of the Drug Discovery Working Group at the Massachusetts Biotechnology Council.

Tatiana Novobrantseva, PhD, Verseau Therapeutics

Dr. Tatiana Novobrantseva is a co-founder and the Head of Research and Development in the new immunology focused company Verseau Therapeutics. Prior to co-founding Verseau, she consulted for multiple companies on various immunological aspects of drug development across different stages and therapeutic modalities. At her prior position as Director of Tumor Immunology at Jounce Therapeutics, Tatiana defined research plans for several programs at the company’s inception, as well as led portfolio of programs on (re)activating immune system against cancer. Her previous positions include Associate Director at Alnylam Pharmaceuticals and Scientist II at Biogen. Some of Tatiana’s scientific accomplishments include discovering the critical role for B cells in liver fibrosis, pushing the envelope on siRNA delivery to immune cells and championing a siRNA-assisted dendritic cell cancer vaccine project. Tatiana is an inventor on more than 22 patents and an author on more than 36 peer-reviewed manuscripts. Tatiana completed her PhD with Dr. Klaus Rajewsky in Cologne, Germany, focusing on B cell development and function.

Translational Considerations for Development of Monoclonal Antibodies and Emerging Constructs:
Focus on Construct Design

Translational Considerations for Development of Monoclonal Antibodies and Emerging Constructs:
Focus on Preclinical Development

Glareh Azadi, PhD, Merck Research Laboratories

Glareh Azadi, Ph.D is a senior scientist in PPDM ADME Biologics group at MRL, Palo Alto. She joined MRL in 2016 and works in various projects in early discovery of therapeutic antibodies. She holds a Ph.D in Biomedical Engineering from Brown University.

Gadi Bornstein, PhD, TESARO, Inc.

Dr. Bornstein has over fifteen years of experience in Oncology R&D with an emphasis in preclinical antibody discovery and development. Dr. Bornstein currently leads biologics discovery efforts at TESARO. He received his B.S. in biochemistry at the University of California, Davis and his doctoral degree in biochemistry at the University of Southern California Keck School of Medicine. Dr. Bornstein completed his postdoctoral training at Stanford University in the Division of Immunology and Rheumatology.

Following his postdoctoral training, Dr. Bornstein joined Amgen Fremont, Inc. (formerly Abgenix, Inc.) as a Staff Scientist in the Preclinical Oncology department. Dr. Bornstein has held roles of increasing responsibility at AstraZeneca, Pfizer, and Novartis, where he was a project team leader, lead biologist, and key contributor to scientific strategies for multiple oncology programs.

Veronica Juan, PhD, Merck Research Labs

Since completing her graduate studies at the University of California, Santa Cruz, Veronica Juan has worked in computational biology and antibody engineering at several biotechnology companies in the San Francisco Bay Area for the past fifteen years. These include Eos Biotechnology, Protein Design Labs (PDL), Abbott (now Abbvie), and Full Spectrum Genetics, Inc. She is currently a Principal Research Scientist at Merck, Discovery Biologics, in the engineering group within Protein Sciences, focusing on in silico assessment and engineering of antibody candidates for developability and lead selection.

Scott L. Klakamp, PhD, Janssen

Dr. Scott Klakamp is the Sr. Director and Head of Biophysics at Janssen R&D, LLC.  Dr. Klakamp is one of the leading scientists in utilizing Biacore® and KinExA® to measure the binding kinetics and equilibrium dissociation constants of human monoclonal antibody/antigen complexes. Prior to Janssen, Dr. Klakamp was the Founder and Principal Consultant of SKD Consulting LLC. Before SKD Consulting, he was the Vice President of Chemistry and Biochemistry at BiOptix Inc. Dr. Klakamp has also held positions of increasing responsibility in the areas of analytical and biophysical characterization at Chiron, Amgen/Abgenix, AstraZeneca/MedIummune, and Takeda Pharmaceuticals.

Mohammad Tabrizi, PhD, Merck Research Laboratories Palo Alto

Mohammad Tabrizi, PhD is a leader in translational sciences as related to development of antibody-based therapeutics. His product development experience spans many therapeutic areas including oncology and inflammatory disease, and his technical expertise includes preclinical pharmacology and safety, preclinical and clinical pharmacokinetics, pharmacodynamics, GLP-compliant bioanalytics, and clinical pharmacology of therapeutic monoclonal antibodies.

Introduction to Biophysical Analysis for Biotherapeutics: Discovery & Development Applications

Christine P. Chan, PhD, Sanofi

Dr. Christine Chan is a protein biochemist with broad experience in the biopharmaceutical industry, including prior experience at Sandoz Pharmaceuticals and Merck & Co., Inc. She specializes in the analysis of recombinant products produced from mammalian cells for vaccines and biologics development. Her application experience includes expression cell line selection, drug substance & drug product process development, manufacturing tech transfers and lifecycle management of commercialized products. Dr. Chan received her PhD from the University of California-Davis and conducted post-doctoral work at the University of Washington. She has authored over 30 publications with two recent reviews on forced degradation studies on protein-based therapeutics and stability testing considerations.

SPONSORED SPEAKER BIOS

Amrik Basran, PhD, CSO, Avacta Life Sciences

Dr. Amrik Basran has over 15 years’ experience of both the biotech and pharma industries. He joined Avacta in 2013 as Chief Scientific Officer to develop the Affimer platform for therapeutic use, focusing on immuno-oncology where there is a high unmet medical need for new novel drugs to improve the long term clinical outcome for cancer patients.

John Burke, PhD, Co-Founder, President and CEO, Applied BioMath, LLC

Dr. Burke received his PhD in Applied Mathematics from Arizona State University, and his BS and MS in Applied Mathematics from University of Massachusetts, Lowell. Prior to co-founding Applied BioMath, Dr. Burke was at Boehringer Ingelheim as Associate Director, Head of Systems Biology and promoted to Senior Principal Scientist. Dr. Burke has also held positions at Merrimack Pharmaceuticals, the Systems Biology Department at Harvard Medical School, and in Douglas A. Lauffenburger’s lab at MIT.

Ross Chambers, PhD, Vice President, Antibody Discovery, Integral Molecular

Ross Chambers is the Director of Antibody Discovery at Integral Molecular. He pioneered the use of DNA immunization for antibody production and developed Integral Molecular's B-cell cloning system for isolating antibodies. Dr. Chambers earned his Ph.D. from the University of Otago, New Zealand and did post-doctoral studies at UC Davis and Berkeley. Before joining Integral Molecular, he was the Director of R&D at SDIX and directed the discovery of thousands of commercial antibodies.

John Champagne, Northeast Regional Manager, Wyatt Technology

Bio coming soon

Samuel Ellis, Vice President, Thomson Instrument Company

Sam Ellis, Vice President & Biochemist, Thomson Instrument Company

Mark Emalfarb, CEO, Dyadic International, Inc.

Mark Emalfarb has led the evolution of Dyadic from its roots of industrial biotech into biopharmaceuticals where the company is applying its C1 proprietary gene expression platform to speed up development and lower production costs of biologic vaccines and drugs for animal and human health.

Jeremy Fry, DPhil, Director, Sales, ProImmune

Jeremy Fry gained his DPhil. from the University of Oxford developing gene therapy strategies to induce immunological tolerance in transplant recipients. Jeremy joined ProImmune to generate a new class of MHC multimer staining reagents. For the past 17 years as ProImmune's Director of Sales, he has led the sales team in a growing business, focusing on developing and implementing innovative technologies that radically improve our understanding of immune responses.

John Gebler, PhD, Director, Biopharm Business Development, Pharmaceuticals, Waters Corporations

Bio coming soon

Pierre-Alain Girod, PhD, CSO, Selexis SA

Dr. Girod, CSO of Selexis since 2006, has led Selexis’ on-going scientific and technological innovations for optimizing expression and production of a wide range of protein products in the commercial setting. Prior to Selexis, Dr. Girod worked the University of Lausanne, where he discovered a family of genetic sequences involved in the epigenetic gene regulation that became the founding technology for Selexis’ SUREtechnology Platform™ and revolutionized the field of recombinant protein expression in mammalian cells.

Frank Grosveld, PhD, Professor, Cell Biology, Erasmus MC; Founder, Harbour Antibodies BV, Harbour BioMed

Dr. Frank Grosveld founded Harbour Antibodies BV in 2006 at Erasmus MC. He and his team developed two strains of fully human transgenic mice technology: H2L2 and HCAb.

Dr. Grosveld studied biochemistry at the University of Amsterdam and obtained his PhD from McGill University. He has started several companies and a Professor of Cell Biology and the Biomics Center at Erasmus MC. Dr. Grosveld is a member of the Scientific Advisory Board for Harbour BioMed.

Claes Gustafsson, Chief Commercial Officer, ATUM (formerly DNA2.0)

As ATUM’s Co-Founder and CCO, Dr. Gustafsson oversees the company’s external communications. Prior to co-founding ATUM, Gustafsson was at Maxygen Inc., where he led, managed and collaborated with key strategic teams for more than five years. He held a Scientist position at Kosan Biosciences, a number of research, teaching, and post-doctoral positions at UCs Santa Cruz, San Francisco, and at University of Umeå. He holds 43 issued U.S. patents and has published >40 scientific papers.

Robert Hart, CEO, Halo Labs

Bio coming soon

Guy Hermans, PhD, CSO, Isogenica Ltd.

Guy joined Isogenica as CSO in 2016, bringing in over a decade of experience in antibody fragment discovery and early development, as well as antibody discovery technology development. At Isogenica, he drives technology development programs and licensee interactions. Prior to joining industry, he performed research into the pathogenesis and immunotherapy of autoimmune and inflammatory disorders, ranging from immunotherapy trials to target discovery and validation work at Stanford University Medical School.

Akinori Hishiya, PhD, Principal Scientist, Biology, SOLA BioSciences

Akinori Hishiya developed the novel technology which offers a unique and promising way to control intracellular protein folding machineries specific to a target protein. The technology holds the potential to enhance productivity of therapeutic recombinant proteins, and to cure many conformational diseases such as cystic fibrosis. He has been published in many prestigious scientific journals such as Circulation Research and EMBO Journal, and holds several patents and patent applications.

Duncan Huston-Paterson, DPhil, Project Leader, Integral Molecular

Duncan Huston-Paterson is a Project Leader at Integral Molecular guiding development of the Membrane Proteome Array platform for applications in novel therapeutic target discovery, antibody deorphaning and off-target safety profiling. Dr. Huston-Paterson obtained his DPhil from Oxford University, where he published research on various topics at the intersection of biophysics, enzymology and infectious disease.

Christel Iffland, PhD, Vice President, Antibody Technologies, Ligand

Dr. Iffland received her Ph.D. in Molecular and Cell Biology from the Université de Nice Sophia-Antipolis (France) and completed her post-doctoral research training at the Albert Einstein College of Medicine and the Dana-Farber Cancer Institute. In 2000, she joined EMD Serono where she worked on antibody characterization, phage display and single B cell cloning. Dr. Iffland joined Ligand in 2017 to support current and new partnerships and collaborations for the OmniAb franchise, providing scientific guidance and input.

Colin Jaques, PhD, Senior Principal Scientist, Process Development, Research and Technology, Lonza

Colin Jaques has been at Lonza Biologics for 13 years working with the production of therapeutic proteins in mammalian cell culture. He currently serves as a Technical Director leading a team in the Mammalian Process group in the Research and Technology department. Colin has a first degree in Biotechnology from Imperial College and a Master of Science and a PhD in Biochemical Engineering from University College London.

Xin Jiang, Product Manager, iCE, Marketing, ProteinSimple, a Bio-Techne brand

Xin Jiang earned his Ph.D. in Pharmacology from Indiana University. He completed his postdoc training in neuropharmacology at University of Washington before starting his career in product marketing at Molecular Devices. Since 2016 he is the product manager of the iCE systems at ProteinSimple.

Alex Kelly, US Business Development Manager, Retrogenix

Alex is responsible for growing Retrogenix’s North American business portfolio and is based at Retrogenix's UK headquarters in the Peak District. Prior to joining the company, Alex spent two years at specialist pharmacogenomics service provider Epistem. Here he built successful relationships with major pharmaceutical and biotech companies worldwide as part of his business development and lead generation role. Alex has a first-class degree in Pharmacology with Industrial Experience from the University of Manchester, UK.

Kaman Kim, PhD, Vice President, Research, Xyphos

Kaman Kim received her PhD in Microbiology and Immunology from Stanford University with post-doctoral training at University of California San Francisco. She joined AvidBiotics in 2013 to lead an anti-bacterial project and has since worked to develop the immuno-oncology program which was recently split into Xyphos Inc.

David Laidlaw, CEO, Kuhner Shaker, Inc.

Mr. Laidlaw directs operations for Kuhner Shaker’s USA offices in San Carlos, CA and Woburn, MA. David has held various roles as a bench Scientist and Manager contributing to product, process and business development with an emphasis on small and bench-scale cultivations.

Tim Larson, PhD, Marketing Specialist I, Marketing, Takara Bio USA

Tim Larson received his B.S. and Ph.D. in Biomedical Engineering from the University of Texas at Austin, then subsequently he did postdoctoral work at the Stanford School of Medicine. His research focused on the interaction of proteins and nanomaterials for the development of therapeutic and diagnostic technologies. He joined Takara Bio USA in 2015, where he is currently the product manager for the Protein Science product portfolio.

Valerie Le Fourn, PhD, Research & Development Cell Culture Director, Selexis SA

Bio coming soon

Anders Lund, PhD, Scientific Director, Bioanalytics Characterization Group, BioPharmaceutics Development, Sanofi

Bio coming soon

Vera Molkenthin, PhD, Chief Scientist, AbCheck s.r.o.

Dr. Vera Molkenthin earned her PhD in Biology at the University of Mainz and has more than ten years of experience in antibody discovery and engineering. Dr. Molkenthin was leading the Antibody Discovery group at Affimed AG and managed the transfer of the technology to AbCheck in 2009. Since 2010 Dr. Molkenthin has been leading numerous partnered projects using AbCheck’s expanding technological capabilities.

Mark Paris, PhD, Associate Director, Translational Applications, Mitra Biotech

Mark is the technical lead for Mitra’s biopharma marketing effort and works with clients to craft custom solutions for their drug development needs. He spent 16 years in commercial antibody discovery and clinical development focusing on immuno-oncology. He has >12 years of experience running core molecular and immunohistochemistry labs. He is a graduate of Case Western Reserve University with a Ph.D. in Genetics.

Ian Parsons, Director, Analytical Laboratory, Charles River

Bio coming soon

David Rabuka, Global Head, Research & Development, Chemical Biology, Catalent Biologics, Catalent Pharma Solutions

David Rabuka is Global Head of Research and Development, Chemical Biology at Catalent Biologics with overall R&D responsibility to oversee continued research and development of SMARTag™, as well as oversee strategy, resource allocation, scientific oversight of preclinical and clinical studies. He joined Catalent Biologics following Catalent’s acquisition of Redwood Bioscience Inc., where he was founder, President and Chief Scientific Officer. David’s scientific areas of expertise include chemical synthesis, drug delivery, translational research, Chemistry Manufacturing and control (CMC), protein chemistry and bioconjugation. David received a Ph.D. in Chemistry at the University of California, Berkeley as a Chevron Fellow in the lab of Professor Carolyn Bertozzi where his research included developing and applying Redwood’s platform technology to cell surface modification. Prior to pursuing his Ph.D., David worked at the Burnham Institute synthesizing complex glycans and later at Optimer Pharmaceuticals, which he joined as an early employee, focused on the development of glycan and macrolide based antibiotics. David graduated with honors B.S. in Chemistry and Biochemistry from the University of Saskatchewan where he received the Dean’s Science Award and holds a M.S. in Chemistry from the University of Alberta. He is an author on over 40 major publications as well as numerous books chapters and patents.

Kannan Sankar, PhD, Postdoctoral Associate, Schrödinger

Kannan Sankar is a postdoctoral associate at Schrödinger, where he develops computational approaches for improving the developability of therapeutic proteins and antibodies. He graduated from Iowa State University with a PhD in Bioinformatics and Computational Biology, working on computational methods for understanding protein structure and dynamics. Previously he was also as an intern in the Antibody Engineering department at Genentech.

Aaron Sato, PhD, CSO, Antibody Center, LakePharma

Aaron brings almost 20 years of drug discovery and antibody engineering experience. Most recently, he was Vice President of Research at Sutro Biopharma, where his team discovered best-in-class ADCs and bispecific antibodies. Previously, he was Senior Director of Antibody Engineering at OncoMed Pharmaceuticals and oversaw human antibody lead discovery. Before OncoMed, he was Senior Director of Lead Discovery at Dyax Corp. Dr. Sato obtained his doctorate degree from MIT in biological chemistry.

Sirle Saul, Key Account and Technology Officer, Business Development, Icosagen Technologies, Inc.

Bio coming soon

Volker Schellenberger, CEO & President, Discovery, Amunix

Volker Schellenberger is President and CEO of Amunix Operating Inc, which he co-founded with Willem Pim Stemmer in 2006. He initially served as Amunix’ Chief Scientific Officer and is the lead inventor of the company’s XTEN technology. Volker has over 20 years of industry experience in protein engineering and drug discovery. Prior to co-founding Amunix he served as head of Genencor’s protein engineering department.

Leila Sevigny, PhD, Senior Scientist, Sanofi Genzyme

Leila Sevigny is currently a Senior Scientist in the Biologics Research department at Sanofi in Framingham, MA. She earned her Bachelor of Science at the University of Connecticut studying molecular cell biology. She then went on to receive her PhD in Genetics from Tufts University studying G-protein coupled receptors in oncology and cardiovascular disease. After her PhD, she began working on antibody discovery and research at MassBiologics with a focus on infectious disease and came to Sanofi Genzyme in March of 2013 to expand her knowledge in the field with an emphasis in bispecific antibodies.

Ekaterina Shimanovskaya, Scientist, Epitope Mapping, Pepscan

Bio coming soon

Jennifer Sims, Non-Clinical Expert, NDA Advisory Board, NDA Group

Jennifer Sims is a non-clinical expert for NDA. Jenny is a former Non-Clinical Assessor for the Medicines and Healthcare Regulatory Agency, UK, and was a Committee for Human Medicinal Products Safety Working Party delegate. She was the Head of Biologics Safety & Disposition and Translational Sciences, AstraZeneca and Novartis. Jenny is a NDA expert in non-clinical safety strategies for chemical, biological & advanced therapies, mechanistic safety, juvenile animal study design and interpretation.

Ernest Smith, Senior Vice President, Research, & CSO, Research, Vaccinex, Inc.

Dr. Smith joined Vaccinex at its inception in 1997 and was a key developer of its core cDNA library and antibody discovery technologies. In his current position, Dr. Smith is responsible for and contributes to the company's research and technology development projects, and is a member of the clinical development team. Dr. Smith has a BA in Biology from St. John Fisher College and a Ph.D. in Microbiology and Immunology from the University of Rochester.

Noel Smith, PhD, Principal Group Leader, Applied Protein Services, Lonza Biologics

As a Senior Group Leader in Lonza’s Applied Protein Services Group, Noel Smith is responsible for developing human in vitro assay platforms to optimize the potency and safety of therapeutic proteins, vaccines and immunotherapies during the early stages of development. He studied Medical Biochemistry at the University of Wales and completed a PhD and subsequent post-doctoral studies at the University of Cambridge.Noel is also a board member of the European Immunogenicity Platform (EIP).

Nels Thorsteinson, Scientific Services Manager, Biologics, Chemical Computing Group

Nels Thorsteinson is a Scientific Services Manager at Chemical Computing Group, responsible for providing scientific support, programming custom applications and guiding CCG's biologics applications development. Nels majored in biomedical computing at Queen's University, Canada, completing his graduate studies at the University of British Columbia focusing on bioinformatics and computational chemistry.

Maria Wendt, PhD, Head, Science, Biologics, Genedata

Maria Wendt, Ph.D. is Head of Science at Genedata A.G. Dr. Wendt develops data management solutions for biopharma and biotech companies to support their biologics drug discovery and development programs. This includes biologics registration and workflow support solutions covering antibody and protein screening and engineering, protein expression and purification, and assays and analytics. She earned her Ph.D. at Iowa State University in chemical engineering.

Brady Wu, Associate Director, Protein Production, GenScript USA, Inc.

Dr. Brady Wu graduated from Peking University with a B.S. degree with Honors in Biological Sciences in 2007. He graduated from Ohio State University in 2013 with a Ph.D. in Chemistry. In 2013, Dr. Wu joined GenScript USA Inc. as a senior scientist in the Protein Department. In 2015, Dr. Wu got promoted to his current position as Director of Protein Department at GenScript and currently manages over 100 employees and is the strategic head for the business development and financial planning for the department.

Mingjie Xie, CEO, Rapid Novor, Inc.

Mingjie received his M.Sc. degree in Computer Science from Western University in 2006 and received his MBA from Richard Ivey School of Business in 2016. He is currently the co-founder at Rapid Novor Inc. Prior to co-founding Rapid Novor, he was the Chief Operating Officer at a bioinformatics software company.

2025 PROGRAMS

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• Display of Biologics
• Engineering Antibodies
• Machine Learning for Protein Engineering

• Antibodies for Cancer Therapy
• Emerging Targets for Oncology & Beyond
• Driving Clinical Success in Antibody-Drug Conjugates

• TS: Intro to Multispecific Antibodies
• Advancing Multispecific Antibodies
• Engineering Bispecific and Multifunctional Antibodies

• Advances in Immunotherapy
• Engineering Cell Therapies
• Next-Generation Immunotherapies

• Difficult-to-Express Proteins
• Optimizing Protein Expression
• Maximizing Protein Production Workflows

• ML and Digital Integration in Biotherapeutic Analytics
• Biophysical Methods
• Characterization for Novel Biotherapeutics

• TS: Intro to Immunogenicity
• Predicting Immunogenicity with AI/ML Tools
• TS: Bioassay Development and Analysis

• Biologics for Immunology Indications
• Radiopharmaceutical Therapies
• Next-Generation Immunotherapies

• ML and Digital Integration in Biotherapeutic Analytics
• Predicting Immunogenicity with AI/ML Tools
• Machine Learning for Protein Engineering