Speakers: Luzelena Caro (Gilead), Yuan Zhao (EMD Serono), Neha Bhis (Allucent), Joy Hsu (Genentech), Rajanikanth Madabushi (FDA)
Organizers: Jennifer Dong (EMD Serono), Lisa Benincosa (Allucent), Ashley Lennox (Allucent), Manushree Bharadwaj (Allucent), Snow Ge (BridgeBio Pharma), Shichang Miao (Consultant)
Date: 2023-11-13
Time: 8:45-17:30 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Between Jobs: $125; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $995; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (2)Fortrea; Quotient Sciences;(Lunch Sponsorship still open)
Vendor show vendors registered to date: (5)Allucent; Altasciences; Emery Pharma; Meadowhawk Biolabs; PharmaBlock
Registration: http://www.PBSS.org
Registration deadline:2023-11-12  (it will close sooner if the seating cap is reached)

About the Topic

Clinical pharmacology is an integral component of drug development that plays a vital role in establishing the right target, right dose, and right population throughout the development and the life cycle management of an investigational product. This workshop will provide an overview of how clinical pharmacology contributes to key decision‑making milestones throughout the drug development process, from establishing a first-in-human dose to crafting the package insert for filing. The fundamental principles and strategy for conducting clinical pharmacology studies as well as modeling and simulation approaches to accelerate the drug development process will be covered. Real-world applications will illustrate contemporary approaches to developing and executing a clinical pharmacology program. This workshop is suitable for novice drug developers, experts from other disciplines interested in learning more about the field, and clinical pharmacologists looking to refresh their knowledge and discuss emerging topics.