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CHI Announces Roundtable Discussions to be Held at its Immunogenicity and Bioassay Summit 2016
Attendees have the opportunity to vet ideas with their peers, share examples of their work, and be a part of a group problem-solving endeavor
Roundtable breakout discussions include:
Meeting Regulatory Expectations Regarding Immunogenicity Assessment
Moderator: Kathleen A. Clouse, Ph.D., Director, Division of Biotechnology Review and Research 1, OBP/OPQ/CDER/
Challenges in Developing Neutralizing Antibody (NAb) Assays
Moderator: Shan Chung, Ph.D., Senior Scientist, BioAnalytical Sciences, Genentech, Inc.
Overcoming Drug Interference in ADA Assays
Moderator: Melissa R. Snyder, Ph.D., Laboratory Director, Antibody Immunology Laboratory, Pathology and Laboratory Medicine, Mayo Clinic
Critical Issues in ADA Assay Validation
Moderator: Jim McNally, Ph.D., Associate Director and Immunogenicity Expert, Global Early Development, Quantitative Pharmacology & Drug Disposition, EMD Serono
Practical Application of Immunogenicity Preclinical Risk Assessment
Moderator: Boris Gorovits, Ph.D., Senior Director, PDM, Pfizer, Inc.
Focus on Immunogenicity of Biosimilars
Moderator: Paul Chamberlain, NDA Advisory Board
Dealing with Pre-Existing Positive ADA Activity in Study Patients
Moderator: Li Xue, Ph.D., Principal Scientist, Pharmacokinetics Dynamics & Metabolism, NBE, Pfizer, Inc.
Product Quality Attributes and Immunogenicity
Moderator: Valerie Quarmby, Ph.D., Staff Scientist, BioAnalytical Sciences, Genentech, Inc
Current and Emerging Predictive Tools: Selecting Candidates and Predicting Clinical Outcome
Moderator: Vibha Jawa, Ph.D., Director, Biologics and Vaccines Analytics, Merck and Co. and Moderator: Tim Hickling, Ph.D., Immunogenicity Sciences Lead, Biomedicine Design, Pfizer, Inc.
Protein Design Tools for Biotherapeutic Deimmunization
Moderator: Zuben Sauna, Ph.D., Principal Investigator, Division of Hematology Research and Review, FDA/CBER
Progress towards Inducing Immunological Tolerance to Biotherapeutics
Moderator: Ronit Mazor, Ph.D., Post-Doctoral Fellow, Molecular Biology, National Cancer Institute, National Institutes of Health
Development of Mouse Models for Predictive Studies
Moderator: Michael Brehm, Ph.D., Associate Professor, Molecular Medicine, University of Massachusetts Medical School
Why Design of Experiments (DOE) Should be the First Statistical Tool in your Professional Toolbox!
Moderator: Martin Kane, MS, CRE, Managing Data Scientist, Statistical and Data Science Practice, Exponent
Considerations for Developing Potency Assays for Bispecific Antibodies
Moderator: Peter Day, Ph.D., Scientist, Genentech
A detailed agenda with times and registration details are posted at http://www.ImmunogenicitySummit.com.
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