Speakers:
Organizers: Ola Saad & Sivan Cohen (Genentech, Inc.)
Date: 2022-09-15- 09/16/2022
Time: 8:30-12:30 Pacific Time
Registration fee: Free
Location: Online via zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2022-09-14  (it will close sooner if the seating cap is reached)

About the Topic

The Immunogenicity of Biologic Drugs workshop is a 2 half-day program aimed to promote the discussion and exchange of scientific ideas from the FDA and leading industry and academic experts on the application and clinical relevance of immunogenicity mitigation and assessment assays. Tentative topics covered in this workshop include, but are not limited to:

• ADA assay Development, Validation, and interpretation (drug and target interference, pre-existing antibodies)

• Advancements of predictive immunogenicity risk tools (in vitro, in silico) and lessons learned with implementation

• Bioanalytical Strategies for New Modalities 

• Highlights from and comments around 2022 FDA Immunogenicity Labeling Draft Guidance

- Steve Swanson (Senior Principal Scientist, Genentech)

- Yi Wen (Research Advisor/Leader, Eli Lilly)

- Francesca Civoli (Vice President Bioanalytical Sciences, Coherus BioSciences)

- Vibha Jawa (Executive Director, BMS)

- Wenyu Liu (Senior Scientist, Genentech)