Cambridge Healthtech Institute’s Sixth Annual
Immunogenicity for Regulatory Success
Non-Clinical, Preclinical and Clinical Strategies for Risk Assessment and Smooth Interaction with the Regulatory Authorities
Part of the Tenth Annual PEGS: the essential protein engineering summit
May 7-8, 2014| Seaport World Trade Center | Boston, MA
Assessment of immunogenicity for many types of biotherapeutics continues to challenge the industry. Investigators need to know how to develop and validate assays, when to perform them, and how to interpret the results as a meaningful risk assessment before moving into the clinic. The FDA requirement for neutralizing antibody assays is a particular hurdle. In the clinic, investigators need to work out how to deal with interfering drugs and to understand the significance of pre-existing antibodies. This conference will enable the investigator to work out an immunogenicity testing strategy for regulatory success and to ensure that their drug is both safe and efficacious.
Combination Biologic Therapy Development: Impact on Immunogenicity Evaluation
Lakshmi Amaravadi, Ph.D., Director, Translational Medicine, Biogen Idec, Inc.
Drug Tolerance: Validation vs. Real Life Data and Interpretation
Holly Smith, Principal Research Scientist, Toxicology, Eli Lilly & Co.
International Bioassay Standardization for the Quantification of Neutralizing Antibodies
Michael Tovey, Ph.D., INSERM Director, Research Laboratory of Biotechnology & Applied Pharmacology, ENS Cachan
Evaluation of Immunogenicity for Enzyme Replacement Biotherapeutics
Yongchang Qiu, Ph.D., Group Director and Head, Bioanalytical and Biomarker Development, Shire, Inc.
Case Study on Identification and Potential Impact of Immune Complexes
Binodh Desilva, Ph.D., Executive Director, Bioanalytical Sciences & Biologics, Bristol Myers Squibb
Assessment of Biotherapeutic Drug Allergenicity
Robert G. Hamilton, Ph.D., D.ABMLI, F.AAAAI, Professor, Medicine and Pathology, Johns Hopkins University School of Medicine
Strategy for Immunogenicity Risk Assessment
Meena Subramanyam, Ph.D., Vice President, Translational Medicine, Biogen Idec, Inc.
Re-Assessment of Immunogenicity Risk based on Clinical Data
Eric Wakshull, Ph.D., Senior Scientist and Group Leader, Bioanalytical Sciences, Genentech, Inc.
Latest Trends in Neutralizing Antibody Detection and the Clinical Relevance of Immunogenicity Assessment
Shalini Gupta, Ph.D., Director, Clinical Immunology, Amgen, Inc.
Pre-Existing ADAs: Detection, Incidence, and Characterization of a Pre-Existing Response to a Monoclonal Antibody Therapeutic
Melissa L. Cheu, M.S., Principal Research Associate, BioAnalytical Sciences, Genentech, Inc.
Case Studies on Pre-Existing Antibodies
Thomas Lee, Ph.D., Scientific Investigator, Clinical Immunology, GlaxoSmithKline, Inc.
Regulatory Perspectives on Issues Regarding Immunogenicity for Monoclonal Antibodies
Kathleen Clouse, Ph.D., Director, Monoclonal Antibodies CDER/FDA
Non-Biologic Complex Drugs and Immunogenicity: Copaxone and Regulatory Considerations for Complex Drugs
J. Michael Nicholas, Ph.D., Vice President, Specialty Life Cycle Initiatives, Teva Pharmaceuticals
I have really enjoyed attending the PEGS. I was very impressed with the quality of the science and interactions at this event. I attended the “Immunogenicity for Regulatory Success” meeting and find myself still reviewing the slides that were presented on those topics. Thanks for making those available. I believe that the panel members, as experts in the field, were able to provide a higher level view covering the discovery, generation and clinical/therapeutic potential of non-conventional antibody formats. This was especially useful for those attendees who are either still new in the field or who only are involved with one facet of the drug discovery process.
Senior Director Biologics Generation, AbbVie Bioresearch Center