Immunogenicity & Bioassays

- 免疫原性 -

Ensuring the Safety and Efficacy of Biologics

 

This year's Immunogenicity & Bioassay 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:

5月4 - 5日

Immunogenicity Case Studies and Clinical Management
( 免疫原性案例研究和臨床管理 )

5月6 -7日

Immunogenicity Assessment and Regulatory Approval of Biologics
( 生物製劑的免疫原性評估和監管核准 )

5月7 - 8日

Optimizing Bioassays for Biologics
( 生物製劑的生物化驗優化 )


Keynote Speakers:

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


Priya Sunil Kishnani, MBBS Chen Family Professor of Pediatrics, Chief, Medical Genetics, Molecular Genetics and Microbiology, Duke University

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