Translational Considerations for Development of Monoclonal Antibodies
Part 1 (Morning, 10:00 am – 1:00 pm): Focus on Early Discovery
Part 2 (Afternoon, 2:00 pm – 5:00 pm): Focus on Nonclinical Development to the Clinic
It is recommended that attendees register for both Part 1 and Part 2 to receive the full benefit of the course.
The effective information flow and translation of accumulated knowledge across various antibody development stages remain a major challenge. Successful strategies for development of monoclonal antibodies require integration of relevant knowledge with respect to target antigen properties, antibody design criteria such as affinity, isotype selection, pharmacokinetic (PK)-pharmacodynamic (PD) properties, and antibody cross-reactivity across species from the early stages of antibody development. Biophysical measurements are one of the critical components necessary for the design of effective translational strategies for lead selection and evaluation of the relevant animal species for preclinical safety and efficacy studies. Incorporation of effective translational strategies from the early stages of the antibody development process is a necessity; when considered it not only reduces development time and cost, but also fosters implementation of rational decision making throughout all phases of antibody development.
The class is designed as a full-day, intensive course with real-world examples and a case study test at the end of the day that ties in learnings from both parts 1 and 2.
Attendees will learn:
Part 1 (Morning): Focus on Early Discovery
- Critical considerations for development of biologics in contrasts with small molecule modalities
- Evaluation of factors that govern biologics exposure and biodistribution
- Application of antibody engineering in the development of next generation antibody-based therapeutics
Part 2 (Afternoon): Focus on Nonclinical Development to Clinic
- Antibody affinity and biophysical characterization: Biacore, Kinexa, and FACS
- Considerations for target selection, antibody screening and mAb preclinical development
- Critical translational considerations
- Case studies: integration of information in support of biologics preclinical development
Instructors:
Gadi Bornstein, Ph.D., Global Correlative Science Leader, Director, Novartis Pharmaceuticals.
Randall Brezski, Ph.D., Scientist, Antibody Engineering, Genentech
Enrique Escandon Ph.D., Sr. Principal Scientist, DMPK and Disposition, Merck Research Laboratories
Vaishnavi Ganti, Ph.D., Senior Scientist, Biologics Discovery-DMPK, Merck Research Laboratories
Scott L. Klakamp, Ph.D., Vice President of Chemistry and Biochemistry, Bioptix
Mohammad Tabrizi, Ph.D., Head, Director & Senior Fellow, Merck Research Laboratories Palo Alto
PART 1 (MORNING):
TRANSLATIONAL CONSIDERATIONS FOR DEVELOPMENT OF MONOCLONAL ANTIBODIES: FOCUS ON EARLY DISCOVERY
It is recommended that attendees register for both Part 1 and Part 2 to receive the full benefit of the course.
10:00 Introduction and Overview
Mohammad Tabrizi, Ph.D., Director, Biologics Discovery, Merck Research Laboratories Palo Alto
10:15 Biologics Modalities vs. Small Molecules: Considerations for Development
Vaishnavi Ganti, Ph.D., Senior Scientist, Biologics Discovery-DMPK, Merck Research Laboratories
11:00 Networking Coffee Break
11:15 Exposure and Biodistribution: Biologics Modalities
Enrique Escandon Ph.D., Sr. Principal Scientist, Merck Research Laboratories Palo Alto
12:00 Considerations for Target Selection, Antibody Screening and mAb Preclinical Development
Gadi Bornstein, Ph.D., Global Correlative Science Leader, Director, Novartis Pharmaceuticals
12:45 Interactive Q&A with Faculty
1:00 Close of Morning Session, End of Part 1
Part 2 (AFTERNOON):
TRANSLATIONAL CONSIDERATIONS FOR DEVELOPMENT OF MONOCLONAL ANTIBODIES: FOCUS ON NONCLINICAL DEVELOPMENT TO THE CLINIC
It is recommended that attendees register for both Part 1 and Part 2 to receive the full benefit of the course.
2:00 Introduction and Overview
Mohammad Tabrizi, Ph.D., Director, Biologics Discovery, Merck Research Laboratories Palo Alto
2:05 How Do We Measure the Binding Kinetics and Affinities of Antigen/MAb Complexes
Scott L. Klakamp, Ph.D., Vice President of Chemistry and Biochemistry, Bioptix
3:00 Application of Antibody Engineering in the Development of Next Generation Antibody-Based Therapeutics
Randall Brezski, Ph.D., Senior Scientist, Janssen Research & Development, LLC
3:50 Networking Coffee Break
Practice Session:
4:00 Overview and Objectives
4:05 Practice Problems and Review
5:00 Close of Session, End of Part 2
Speaker Biographies
Gadi Bornstein, Ph.D., Director, Global Correlative Science Leader, Novartis Pharmaceuticals
Dr. Bornstein has over fifteen years of experience in R&D with an emphasis in preclinical antibody discovery and translational research in oncology. 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 led numerous antibody programs with increasing responsibility at Amgen Fremont (formerly Abgenix Inc.), AstraZeneca, and Pfizer. Career highlights include numerous publications, patents, and guest speaker appearances at scientific conferences.
Randall Brezski, Ph.D., Scientist, Antibody Engineering, Genentech
Dr. Randall J. Brezski received his B.S. in biology at Bucknell University and Ph.D. in immunology at the University of Pennsylvania. Upon completion of his doctoral degree, he received a postdoctoral fellowship from the Johnson & Johnson Corporate Office of Science and Technology (COSAT) at Centocor where he studied antibody structure and function. Following postdoctoral training, Dr. Brezski worked at Janssen R&D for over 5 years focusing on antibody engineering and Fc gamma receptor biology. Dr. Brezski is currently a Scientist in the Antibody Engineering Department at Genentech leading a laboratory focused on improving antibody discovery technologies as well was optimizing antibody properties to fit particular disease microenvironments. Dr. Brezski is also an Assistant Editor for the journal mAbs and is a co-author or co-inventor on over 20 combined research papers, reviews, book chapters, and issued patents.
Enrique Escandon, Ph.D., Sr. Principal Scientist, DMPK and Disposition, Merck Research Laboratories Palo Alto
Currently, a Principal Scientist at the DMPK and Disposition Department in Merck Palo Alto, in charge of the Metabolism and Cellular Interactions group. Previously, head of the Experimental Pharmacology Oncology/Vascular Biology Group at Genentech and responsible for the strategic plan; design and implementation of all pre-clinical ADME-IND enabling studies at Danisco/Genencor Inc. and Cambridge Antibody Technology Inc. Entire postgraduate career has been in the Biotechnology industry, specifically in the area of Pharmacology and Metabolism with 19 articles published in international scientific journals in addition to regulatory documents in support of IND and BLA filings for several protein therapeutics including Nerve Growth Factor, Apo2L, Avastin, Lucentis anti-IL-23, anti-TSLP and IVIG. Bachelor’s Degree in Basic Biomedical Research from the Universidad Nacional Autonóma de Mexico (Mexico City) and his Ph.D. in Cell Biology and Genetics from Cornell University Graduate School of Medical Sciences (New York, NY). Post-Doctoral training at the Department of Neurosciences, Genentech Inc. (South San Francisco California).
Vaishnavi Ganti, Ph.D., Senior Scientist, Biologics Discovery- DMPK, Merck Research Laboratories
Dr. Ganti joined the Discovery Biologics - DMPK group at MRL, Palo Alto after completing her doctoral studies at Temple University, Philadelphia. Her doctoral thesis was focused on preclinical pharmacokinetics and its application in understanding chemotherapy related cognitive deficits. She is currently involved with various processes in discovery and development of therapeutic antibodies.
Scott L. Klakamp, Ph.D., Vice President of Chemistry and Biochemistry, Bioptix
Dr. Scott Klakamp is the Founder and Principal Consultant of SKD Consulting LLC. Prior to SKD Consulting LLC, he was a Senior Research Fellow at Takeda San Francisco, Inc. He led the Biophysical Chemistry and Research Informatics Department and has extensive experience in research and development involving the biophysical and analytical characterization of biologics and monoclonal antibodies. Dr. Klakamp is one of the leading scientists in utilizing Biacore®, KinExA®, and FACS techniques to measure the binding kinetics and equilibrium dissociation constants of human monoclonal antibody/antigen complexes. Dr. Klakamp has been an author on over 30 research and review papers, book chapters, and patents, and has been an invited speaker at numerous international and national meetings.
Mohammad Tabrizi, Ph.D., Head, PK/PD & Senior Fellow, Merck Research Laboratories Palo Alto
Mohammad Tabrizi, Ph.D. 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.