Speakers: Leane Scoz, BeiGene; Shinji Fujimori, Erasca Inc; Diana Sperger, Gilead; Gerard Jensen, Oliyai Consulting; Ziqi Gui, Stealth startup; Mike Brandl, Sumitomo Pharma; Paresma Patel, FDA
Organizers: Minli Xie, Erasca; Jim Zhang, Olema Oncology
Date: 2024-06-13
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $45; Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor:
Vendor show vendors registered to date: (9)Adare Pharma Solutions; Ardena; Biomere; Cambrex; digiM solution; Emery Pharma; Meadowhawk Biolabs; Quotient Sciences; Veranova
Registration: http://www.PBSS.org
Registration deadline:2024-06-12  (it will close sooner if the seating cap is reached)

About the Topic

This PBSS workshop will cover the CTD Module 3 content, development, manufacturing and testing of drug substance and drug products of small molecule therapeutics through different phases of clinical development as well as regulatory expectations and key activities required to establish the commercial process and appropriate control strategy. The topics would include approaches such as phase-appropriate CMC strategies and Quality-by-Design elements in design and develop process and products.  This workshop will cover best practices and example case studies from leaders in the field.