Immunogenicity & Bioassays

Ensuring the Safety and Efficacy of Biologics

This year's Immunogenicity & Bioassays Stream focuses on the latest science, technologies and strategies to ensure the safety and efficacy of novel biologics, with particular focus on new drug modalities including antibody therapies, immunotherapies, and cell & gene therapies. Part One looks at new case studies and how to use immunogenicity data in clinical settings; Part Two examines immunogenicity assessment for novel biologics such as ADCs, bispecifics, CAR-T and mAbs along with an emphasis on new regulatory guideline for cell and gene therapies; and Part Three will showcase emerging technologies and strategies for day-to-day challenges when developing bioassays to evaluate potency, function and robustness of novel biologics.

Conferences Include:

August 31 - September 1

Immunogenicity Case Studies and Clinical Management

September 2-3

Immunogenicity Assessment and Regulatory Approval of Biologics

September 3-4

Optimizing Bioassays for Biologics

Keynote Speakers Include:

Marla Abodeely, PhD, Director, Bioassay, Global MSAT Analytical Science and Technology, Sanofi

Wojciech Jankowski, PhD, Commissioner’s Fellow, CBER, FDA

Sandra Garces, MD, PhD, Clinical Research Director, Global Drug Development, Amgen

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