2018 Speaker Interviews

Improving Yield and Stability of Cannabinoid Receptor

Alexei Yeliseev, PhD, Staff Scientist, Group Leader, LMBB, NIH, NIAAA

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Top-Down Mass Spectrometry Strategy for Novel Drug Characterization

Zhe Zhang, PhD, Senior Scientist, Integrated Biologics Profiling, Novartis

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Multivalent Antibody-TRAIL Fusion Proteins for Cancer Therapy

Oliver Seifert, PhD, Scientist, Institute of Cell Biology and Immunology, University of Stuttgart

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Development of Uniform-Sized Inorganic Nanoparticles for Clinical Applications

Taeghwan Hyeon, PhD, SNU Distinguished Professor, School of Chemical and Biological Engineering, Seoul National University

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High Affinity Factor XIa-specific IgGs and Reversal Agent as Potential Treatment for Thrombotic Disease

Thomas Mikita, Ph.D., Director, Centers for Therapeutic Innovation, Pfizer, Inc.

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Trends and Challenges in the Development of Therapeutic Antibodies for Non-Oncology Indications

Janice M. Reichert, PhD, Executive Director, The Antibody Society

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Capturing, Identifying and Visualizing Preaggregate Transients Using Chaperonin-Based Biolayer Interferometry Platforms

Mark T. Fisher, PhD, Professor, Biochemistry and Molecular Biology, University of Kansas Medical Center

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Combining Viral Particle Counting, Biological Characterization and Advanced Kinetics to Predict Vaccine Stability

Didier Clenet, PhD, Research Scientist, Formulation & Stability, Sanofi Pasteur, France

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2018 Podcasts

Building a Single Donor Phage Antibody Library with NGS Validation

Andrew M. Bradbury, PhD, MB BS, CSO, Specifica, Inc.

Dr. Andrew Bradburytalks about his latest work using NGS to build a single donor library, and shares lessons he has learned along the way. He describes the unique approach they are using at Specifica and outlines tips for creating antibody libraries with improved diversity and developability.

Discovery of High-Affinity Human PD-1 and LAG-3 Antibodies Using Novel Microfluidic and Molecular Genomic Methods

David S. Johnson, PhD, CEO, GigaGen

Cambridge Healthtech Institute’s Kent Simmons recently spoke with Dr. David Johnson, CEO of GigaGen, about his upcoming presentation “Discovery of High-Affinity Human PD-1 and LAG-3 Antibodies Using Novel Microfluidic and Molecular Genomic Methods”, to be delivered in the Engineering Antibodies meeting at the 2018 PEGS Boston. PEGS is scheduled for April 30 - May 4, 2018 in Boston, with the antibodies program set for May 2-3.

Challenges and Opportunities in the Next Generation of Bioassays for Biologics

Steven Walfish, Principal Scientific Liaison, USP

Steven Walfish of the USP recently spoke with CHI about his role in updating the USP Bioassay Chapters. He is currently leading the General Chapters Statistical Expert Committee. Steven also remarks on current challenges and how new technologies are changing the field of bioassays. To hear more, don’t miss his presentation in Optimizing Bioassays for Biologics at the PEGS Summit this May 3-4 in Boston, MA!

How to Interpret and Implement FDA Guidelines for Biologics?

William Hallett, PhD, Product Quality & Immunogenicity Reviewer, CDER/OPQ/OBP, FDA

Dr. William Hallett outlines what he considers some of the greatest obstacles to assess immunogenicity of biologics. He also comments on the reason behind the new requirement for lower cut-point in assays, how to accelerate Biobetters to the market in the world of Biosimilars, and advice for the industry in biologic development to accelerate FDA approval.

An Interview With The 2018 Young Scientist Keynote, Dr. Kipp Weiskopf

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

Please enjoy this interview with the 2018 PEGS Young Scientist Keynote, Dr. Kipp Weiskopf. In the interview, you’ll gain Insights into new exciting developments in the growing field of cancer immunotherapy and hear Dr. Weiskop’s perspectives on where this field is heading and how this work will impact the next generation of cancer immunotherapy.

2017 Podcasts

Generation of BiKEs and TriKEs to Improve NK Cell-Mediated Targeting of Tumor Cells

Jeffrey S. Miller, M.D., Professor, Medicine, Division of Hematology, Oncology and Transplantation; Deputy Director, Masonic Cancer Center, University of Minnesota

Dr. Jeffrey Miller outlines what he considers to be some of the greatest obstacles to developing BiKEs and the new class of molecules called TriKEs, describes his method and what is unique about his approach, details unexpected discoveries, shares advice for introducing novel antibody therapeutics in the clinical setting and talks about what he considers some of the most exciting new developments emerging for bispecific antibody killer engagers.

Development on Novel Therapeutic Antibodies for Cancer Derived from Single Human B Cells

Edward F. Patz, Jr., M.D., James and Alice Chen Professor, Radiology; Professor, Pharmacology and Cancer Biology, Radiology, Duke University Medical Center

Dr. Edward Patz outlines what he considers some of the greatest obstacles to developing novel antibodies from single human B cells, how he recognized a novel and unexpected target in lung cancer, the current status of the first novel antibody he developed, advice for people introducing novel antibody therapeutics in the clinical setting and exciting new developments emerging for antibodies derived from single human B cells.

Topics Include: Antibody therapeutics, Cancer Therapy, Autoantibodies, Single Human B Cells

Future Directions for HX-MS in Formulation Development and Similarity Assessment

David D. Weis, Ph.D., Associate Professor, Pharmaceutical Chemistry, University of Kansas

A podcast interview with PEGS speaker David Weis of the University of Kansas. Dr. Weis is speaking in the Biophysical Analysis of Biotherapeutics meeting, where he will give a presentation on the topic “Hydrogen Exchange Mass Spectrometry in Formulation Development and Similarity Assessment”

Topics Include: Analytical Ultracentrifugation (AUC), Assays for developability evaluation, Biophysical analysis of high concentration proteins, Biophysical assay qualification and validation, Characterization and Analysis of Particulates, Developability, Engineering solutions to biophysical liabilities, Field-Flow Fractionation (FFF), Formulation solutions to biophysical liabilities, Light Scattering, Low-field NMR, Mass spectrometry, Miniaturization of biophysical assays, Multiplexing and parallelization of biophysical analytical methods, Orthogonal methods, Predictive modeling for biophysical characteristics, Protein Formulation, Size exclusion chromatography, Spectroscopic methods for biophysical analysis, X-ray crystallography

New Technology on Multiplex ADA Isotyping

Shuangping Shi, Ph.D., Director, Biologics and Vaccines Bioanalytics, Merck Research Laboratories

JBiotherapeutic drugs such as monoclonal antibodies (mAbs) have the potential to induce immunogenicity; therefore, it is critical to perform an immunogenicity assessment to ensure drug efficacy and patient safety. In general, an immunogenicity assessment is performed in a multi-tiered approach: screening of anti-drug antibodies (ADA), confirmatory test, titer assessment, characterization of ADA for neutralizing drug activity and isotyping. The goal of our work is to develop multiplex approaches on various platforms including Meso Scale Discovery (MSD), Luminex and Delfia for ADA characterization.

Preventing Toxicity in CAR T Cell Therapy

Peter Emtage, Senior Vice President, Research, Cell Design Labs

Peter Emtage from Cell Design Labs recently spoke with CHI. He will be speaking at PEGS in the Preventing Toxicity in Immunotherapy conference on May 2nd, 2017. Cell Design Labs is working with small molecules to modulate CAR T cells, which would allow clinicians to monitor and prevent toxicity issues in cancer treatment.

Topics Include: Immunotherapy, CAR, T cell, Toxicity, Toxicity in immunotherapy, immuno oncology, immuno-oncology, cancer, cancer treatment, oncology, adoptive cellular therapies, immune-related adverse events, immune related adverse events

The Promise of Neoantigens for Personalized Cancer Vaccines

Philip M. Arlen, M.D., President and CEO, Precision Biologics, Inc.

Philip Arlen from Precision Biologics recently spoke with CHI. He will be speaking at PEGS in the Adoptive T Cell Therapy conference on May 3rd 2017. Precision Biologics is working with cancer vaccines to develop personalized cancer treatments that target tumors without damaging healthy human tissues.

Topics Include: neoantigens, cancer vaccines, vaccines, immunotherapy, CAR, t-cell, t cell, colorectal cancer, personalized diagnostics, personalized immunotherapies, tumor, cancer, cancer treatment, chimeric antigen receptor, clinical trials

Programming Proteins by Deep Sequencing and Design

Kent Simmons of CHI speaks with Dr. Tim Whitehead, Assistant Professor of Chemical Engineering and Materials Science at Michigan State University about his upcoming keynote presentation “Programming Proteins by Deep Sequencing and Design” at PEGS Boston 2017.

Topics Include: Podcast, PEGS, Protein Engineering, Next-Generation Sequencing, Protein Affinity


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