National Biotechnology Conference 2009 Preliminary Program - (Page 20) INFORMATION - WORKSHOPS, SHORT COURSES and TRAINING COURSE TOPIC 3: Assessment of Fc Functionality Background and Rationale Fc regions of mAb therapeutics are often engineered to enhance efficacy, or to alter PK and/or safety profiles. However, methods for in vitro assessment of Fc effector functionality are rarely discussed. There several in vitro ways to assess Fc functionality, but best practices have not been defined. It is also not clear how data from these in vitro analyses relates to efficacy or toxicity in vivo. Regulatory Perspective on Bioassays for Biological Therapeutics Susan Kirshner, Ph.D. (Invited) U.S. Food and Drug Administration CHMP Initiative to Standardize the Interferon Neutralizing Antibody Assay Huub Schellekens, M.D. Utrecht University Discussion to Provide • Overview of current methodologies used to assess Fc effector functions • Case examples of clinical significance of Fc effector functions and its prediction/correlation with in vitro Fc effector function assays • Practical perspectives on potential CMC applictions of Fc effector function assays • Strategies and methodologies for assessing Fc functionality Moderators Eric Wakshull, Ph.D. Genentech Shalini Gupta, Ph.D. Amgen, Inc. Susan Kirshner, Ph.D. (Invited) U.S. Food and Drug Administration Friday, June 26 8:00 am – 5:45 pm 2009 LBABFG Immunogenicity TRAINING COURSE (Day 2: Course Conclusion) 2 Day Event An additional fee is required to attend this course. 7:30 am Coffee Break 8:00 am – 9:00 am Day 1 Review and Questions and Answers 9:00 am – 10:30 am Challenges in Generating High Quality Data on Drug-target Interactions in Support of Biotherapeutic Development Jihong Yang, Ph.D. Genentech MODULE 5: Method Optimization, Pre-study Validation and In-study Validation 10:30 am – 10:45 am Coffee Break Alternative Label-free Technologies for Assessing Drug-target Interactions Allen Minton, Ph.D. NIH/NCI 10:45 am – 12:30 pm Overview of PK Assay Strategies Alyssa Morimoto, Ph.D. Genentech MODULE 6: Statistical Considerations: DOE, Cut-points and Assay Performance Speaker to be Announced Characterizing the In Vivo Disposition and Clearance of Biotherapeutics: Influence of Bioanalytical Assay Format Victor Wrobelewski, Ph.D. Eli Lilly and Company 12:30 pm – 1:30 pm Lunch Complimentary to all Course Attendees 1:30 pm – 3:15 pm Development and Validation of Cell-based Assays for Assessment of Antibody-dependent Cellular Cytotoxicity (ADCC) of Therapeutics Jaya Goyal, Ph.D. Biogen Idec MODULE 6 (conclusion): Ab Characteriza-tion (Nab, Isotype and Subclass) 3:15 pm – 3:30 pm Coffee Break Introduction to Potency Assay Development and Validation Michael Mulkerin, Ph.D. Amgen, Inc. 3:30 pm – 5:30 pm MODULE 7: Breakout Sessions 5:30 pm – 6:00 pm Bioassays in Immunogenicity Testing - Their Development and Validation: Overview of NAb Assay Validation White Paper Susan Richards, Ph.D. Genzyme Wrap Up and Questions and Answers 6:00 pm Adjournment 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 20 PRELIMINARY PROGRAM
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