Immunogenicity: Regulatory and Clinical Case Studies

Managing and predicting immune response from biological therapies can be challenging to the drug development scientist, especially as new constructs and immunotherapy approaches continue to be discovered. The regulatory approaches to ensuring safety of new products needs to take into account what has been learned in the clinic to date. This meeting will review case studies of clinical candidates in order to learn the most clinically relevant information for immunogenicity, and also share insights from regulators on winning approaches for ensuring safety of biologic drugs.


KEYNOTE Presentation

Amy S. Rosenberg, M.D., Division Director, Biotechnology Products, FDA

Bioprocess and Immunogenicity-Global Perspective

Naren Chirmule, Ph.D., Senior Vice President, R&D, Biocon, Bangalore, India


Humanized Mice as a Tool to Measure Immunogenicity

Michael Brehm, Ph.D., Associate Professor, Molecular Medicine, University of Massachusetts Medical School

Anatomy of an Anti-Drug Antibody (ADA) Assay

Desai Dharmesh, Group Leader, Bristol-Myers Squibb

Statistical Methods for Immunogenicity Assessment

Harry Yang, Senior Director R&D, MedImmune


Measures of a Clinically Relevant Immune Response: Weighing Between the Sensitivity and Impactful Response

Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.

De-Immunizing Immunotoxins

Ira Pastan, Co-Chief, Molecular Biology, National Cancer Institute, National Institutes of Health

Panel Discussion: Clinical Relevance

Michele Fiscella, Ph.D., Director, Covance


Positive Effects in Reducing Immunogenicity Target Interference

Erik Meyer, Ph.D., Senior Scientist, GlaxoSmithKline

ERT Immunogenicity and Experimental Immune Tolerance Induction: Results of a BioMarin Sponsored Advisory

Brian Long, Ph.D., Senior Scientist, Immunology Assessment, BioMarin Pharmaceuticals Inc.

Robust Immune Response to a Product Related Impurity and Impact on Immunogenicity Rate of an Antibody Therapeutic

Sally Fischer, Ph.D., Principal Scientist, Development Sciences, Genentech, Inc.

For more details on the conference, please contact:

For partnering and sponsorship information, please contact:

Christina Lingham
Executive Director, Conferences
Phone: 781-972-5464

Jason Gerardi
(Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452

Carol Dinerstein
(Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471