Speakers: Natalie Hosea, Amgen; Jan Wahlstrom, Amgen; Simon Wong, Aditum Bio; Sekhar Surapaneni, Nimbus Therapeutics; Shinji Yamazaki, Certara; Jennifer Yang, consultant; Naveed Shaik, Pfizer; Cornelius Cilliers, Bristol Myers Squibb; Xinning Yan, FDA
Organizers: Jan Wahlstrom, PhD (Amgen), Jennifer Yang, PhD (consultant), Barbara Saechao (BMS (Mirati)), Simon Wong (Aditum Bio)
Date: 2024-10-01
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Out-of-pocket: $45; Major Sponsorship: $3000; Vendor Show: $695; Lunch Sponsorship: $1,250; Happy Hour Sponsorship: $975; On-site Registration:$500
Location: Hilton Del Mar, 15575 Jimmy Durante Blvd, Del Mar, CA 92014
Major Sponsor: (2)BioAgilytix; Fortrea
Vendor show vendors registered to date: (9)abzena; Aliri Bioanalysis; Alturas Analytics; BioIVT; Curia; Discovery Life Sciences; Ellegaard BioResearch; Frontage Laboratories; Resolian
Registration: http://www.PBSS.org
Registration deadline:2024-09-30  (it will close sooner if the seating cap is reached)

About the Topic

Characterization of ADME (absorption, distribution, metabolism, and excretion) and the clinical pharmacology profiles remains a critical component for the successful development of new medicines. With complex regulatory requirements for both IND and NDA, the task can seem daunting, and unfortunately - inconsistent. Disparity across small and large pharma creates a diverse landscape of ADME data supporting first in human and registrational studies, and increased reliance on contract research organizations has shifted DMPK/ClinPharm expertise to a “one size fits all” approach. Assembling a seasoned panel of dedicated and recognized DMPK/ClinPharm scientists, this workshop explores the key components of IND and NDA filings for small molecules, leveraging decades of experience to provide perspective on data that drives decisions and works in concert with clinical pharmacology to advance molecules towards successful approval.