MONDAY, OCTOBER 23
MORNING | 10:00 AM - 1:00 PM

SC 1: Mechanism of Action and Risk Based Approach for Developing Neutralizing Ab Assays

Instructors:

Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert at EMD Serono

Shan Chung, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech, Inc.

The development of neutralizing antibody assays is a daunting task that is complicated by the specific nature of each biotherapeutic. Many factors must be assessed to choose the proper assay format, to develop a robust assay and choosing when to invest in the development and implementation of these assays. This short course will focus on these topics and provide examples of current industry practices and publications. Specific focus will be given to a mechanism of action based approach to selecting the assay format and relevant case studies will be provided.

Topics:

  • Current regulatory guidance
  • NAb assay strategy – Immunogenicity Risk Assessment
  • Assay format selection – Mechanism of Action based approach
  • Validation and Implementation of NAb Assays
  • Case Studies

Jim_McNallyJim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert at EMD Serono

Jim McNally is a QPD Program Representative, Head of Clinical Bioanalytics, and Immunogenicity Expert. In this role, he responsible for the immunogenicity strategy, bioanalytical support and scientific oversight of outsourcing of large molecule programs for EMD Serono. Previously, he was the lead of the Clinical Assay Development, Validation and Testing bioanalytical group at Pfizer based in Andover, MA. The group was responsible primarily for developing assays to support pharmacokinetic and immunogenicity analysis of the Pfizer large molecule portfolio. Prior to joining Pfizer in 2010, Jim held similar roles in the Clinical Lab Sciences group at Genzyme and Immunobiology group at Repligen. A graduate of the Microbiology and Virology Ph.D. program at LSU Medical Center in 1998, Jim has a special interest in immunomodulation and immunogenicity of biotherapeutics.

Shan_ChungShan Chung, Ph.D., Senior Scientist and Group Leader, BioAnalytical Sciences, Genentech, Inc.

Dr. Shan Chung is a Principal Scientist and Group Leader in the Department of BioAnalytical Sciences (BAS) at Genentech, a Member of the Roche Group. Shan received his Ph.D. in Molecular Biology from University of Pennsylvania and conducted postdoctoral research on Protein Engineering of human T-cell receptors at Harvard University. He joined Genentech in 2006 and currently leads the Effector Function and Cell Biology group in BAS. Shan has more than 20 years industry experience on research and development of pharmaceutical products and specifically development, validation, and implementation of cell-based bioanalytical and potency assays. He is a subject matter expert in the fields of Fc effector functions, neutralizing antibody assays, and immunogenicity prediction/assessment of biotherapeutics. Shan has supported more than 40 successful IND/BLA filings at Genentech.

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