Thursday, November 17
12:30 pm Registration for Part Two
1:30 Chairperson’s Remarks
Daniel T. Mytych, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.
CLINICAL IMMUNOGENICITY STRATEGY
1:35 Design and Implementation of Clinical Immunogenicity Program
Meena Subramanyam, Ph.D., Vice President, Translational Sciences & Technology, Biogen Idec, Inc. - Biography
Using case studies this talk will highlight critical quality attributes that can potentially impact the PK/PD properties of the therapeutic, and discuss the value of non-clinical studies and phase I human studies to understand the immunogenicity of the therapeutic. It will also provide recommendations for when and how immunogenicity assessments should be made in the pivotal clinical trials and how to develop an analysis plan to study the impact of anti-drug antibodies on clinical end points.
GLOBAL REGULATORY CONCERNS
2:05 FDA Guidance on Immunogenicity Testing
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, FDA - Biography
The US FDA published its Draft Guidance for Industry: Assay development for immunogenicity testing of therapeutic proteins in December 2009. The Draft Guidance provides FDA recommendations for the development and validation of assays to test for anti-therapeutic antibodies to protein therapeutics. The Guidance has undergone a period of public comment and the Agency is currently assessing the comments provided by the public with the aim of revising the Draft Guidance. This talk will highlight aspects of the Draft Guidance.
2:35 European Update on Unwanted Immunogenicity of Biologicals and Biosimilars
Robin Thorpe, Ph.D., FRCPath, Head, Biotherapeutics Group, National Institute for Biological Standards and Control, UK - Biography
The Biosimilars Working Party of the CHMP has drafted a guideline on unwanted Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins, and a new guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use is being drafted. This presentation will provide an update on unwanted immunogenicity and the status and interpretation of existing EU guidelines. Considerations relevant to the immunogenicity assessment of biosimilars will also be included.
3:05 Networking Refreshment Break in the Exhibit Hall with Poster Viewing
3:35 Panel Discussion with the Speakers
ROLE OF T REGULATORY CELLS
4:05 Can Enhancement of T Regulatory Cell Function Decrease Immunogenicity?
Ethan M. Shevach, M.D., Chief, Cellular Immunology Section, Laboratory of Immunology, National Institute of Allergy and Infectious Diseases, National Institutes of Health - Biography
Studies over the past 15 years have identified a new lineage of T lymphocytes, T Regulatory Cells, that express the transcription factor Foxp3. Foxp3+ Treg are a dedicated population of suppressor T cells and function on multiple different target cell types within the immune system. Foxp3+ Treg cells use a variety of suppressor mechanisms including the secretion of suppressor cytokines. Enhancement of Treg function has been proposed as a novel method for the treatment of autoimmunity and transient activation of Treg may facilitate the induction of tolerance to both allografts and immunogenic proteins.
4:35 End of Plenary Session and Part One
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