CONFERENCE SERIES: Biological Therapeutic Products

Recorded at: Immunogenicity Summit

Digital Course: Navigating the Regulatory Hierarchy of Concerns to Minimize Impact of Immunogenicity-Related Risks on Product Registration


Navigating the Regulatory Hierarchy of Concerns DVD CoverAbout this Product: 

Immunogenicity Summit 2012, led by Dr Amy Rosenberg, Director of the Division of Therapeutic Proteins at CDER and Paul Chamberlain from the NDA Advisory Board, a well recognized and experienced expert in presenting immunogenicity risk assessments to European and North American regulatory agencies.

This product covers product quality aspects and clinical consequences and the immunogenicity risk assessment process, and provides real examples demonstrating the application of principles and an interactive case study. 



About this Product:
2 Presentations
110 Slides
Over 132 Minutes
Individual: $345
Site License: $1380

Formats Available:
Digital Download
On Demand

Agenda at a Glance:  

1.    Priorities for the regulator  

  • Hierarchy of concerns
  • Data requirements
  • Common gaps

2.    Integrated Approach  

  • Risk identification
  • Aligning identified risks with CMC, bioanalytical, non-clinical and clinical strategy
  • Ongoing risk management

3.    Interactive case study  

  • Illustration of preparation of an effective response to a regulatory scenario pertaining to immunogenicity-related risks for an investigational therapeutic protein

Speaker Biographies:  

Amy RosenbergAmy S. Rosenberg, M.D., Director, Division of Therapeutic Proteins, CDER/FDA

Dr. Amy Rosenberg is a graduate of the Albert Einstein College of Medicine. Following medical residency training, she was a post-doctoral fellow in the laboratory of Dr. Alfred Singer at the NCI, where she focused on the cellular mechanisms of allograft rejection. In 1988 she moved to CBER, FDA, progressing from Staff Fellow to Director of the Division of Therapeutic Proteins in 2000.  While maintaining a research program in immunology, her main regulatory focus is on the immunogenicity of therapeutic protein products, including product and patient factors that impact immunogenicity, and immune tolerance induction to preclude immune responses that abrogate product efficacy.


Paul ChamberlainPaul Chamberlain, NDA Advisory Board

Paul Chamberlain is a biopharmaceutical product specialist who specializes in presenting immunogenicity risk assessments to European and North American regulatory agencies. He works with sponsors to develop strategies for evaluating the probability that a product might induce an undesirable immune response, as well as preparing expert reports on signal interpretation to support regulatory submissions. He is a Member of the NDA Advisory Board (


About the Conference: 

The Immunogenicity Summit 2012 presented talks addressing current concerns regarding innovator and biosimilar biotherapeutics, which are approaching the clinic in increasing numbers. Talks included hypersensitivity and immune complex formation, handling pre-existing antibody, mastering neutralizing antibody assays, the design of the preclinical and clinical program, and FDA regulatory guidance. Talks also addressed the increasing interest in factors that contribute to immunogenicity such as T cell epitopes, sub-visible particles and aggregates to support clinical risk assessment. Immunogenicity prediction and immunogenicity mitigation is gaining momentum with investigators endeavoring to identify product characteristics that contribute to immunogenicity with a view to engineering and/or selecting non-immunogenic products. This was covered in depth. A session on novel immune tolerance induction approaches was also included.



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