Speakers: Andy Polson (Discovery Lead; Principal Scientist), Ola Saad (Bioanalytical; Principal Scientist), Dale Miles (Pharmacology Subteam Lead; Principal Scientist), Donglu Zhang (DMPK; Staff Scientist): ALL from Genentech
Organizers: Cyrus Khojasteh, PhD
Date: 2020-11-13
Time: 11:00-13:00 Pacific Time
Registration fee: (USD):
Location: Online via Zoom
Major Sponsor: (1)Catalent
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2020-11-11  (it will close sooner if the seating cap is reached)

About the Topic

This is the inaugural symposium for the "Success Stories of Recently Approved Drugs" series, a collaboration between PBSS - San Francisco Bay and California Life Science Association (CLSA).

Polatuzumab vedotin (POLIVY) is an antibody-drug conjugate (ADC) that contains a humanized immunoglobulin-G1 (IgG1) anti-human CD79b monoclonal antibody and a potent anti‑mitotic agent, monomethyl auristatin E (MMAE), linked through a protease‑cleavable linker, maleimidocaproyl‑valine‑citrulline‑p‑aminobenzyloxycarbonyl (mc‑vc‑PAB). Polatuzumab vedotin has been recently approved in US, Canada, and European Countries to treat B-cell lymphomas. This symposium covers an overview of POLIVY discovery and development which will include its early discovery and clinical readouts, novel clinic pharmacology strategies, and unique regulatory response strategies. The audience will learn about a successful ADC discovery story and embrace the differences between small molecule and ADC drug development.   

Agenda:

11:00 – 11:20 Introduction – Shichang Miao (PBSS), Andrew Satikas (CLSA) and Cyrus Khojasteh (Genentech)

11:20 – 11:40 Discovery and Pharmacology of Polivy - Andy Polson (Genentech)

11:40 – 11:55 Bioanalysis, Biotransformation, and /immunogenicity - Ola Saad (Genentech)

11:55 – 12:05 Major Sponsor Presentation – Catalent

12:05 – 12:35 Clinical Pharmacology - Dale Miles (Genentech)

12:35 – 12:50 Regulatory feedback - Donglu Zhang (Genentech)

12:50 – 1:10 Q&A - All speakers