Symposium
PBSS-SOT Joint Symposium: Combination Therapy Drug Development: Fundamentals, Advances, and Case Studies
Speakers:
Joseph Francisco (CRL), Philip Gatti (FDA), Paul Feldman (Intarcia), Jonathan Wang (Genentech), Lynn Genarro (Genentech), Rosa Chan (UCSF), Anne Chester (Gilead), Rebecca Begley (Gilead), Jessica Hawes (FDA)
Organizers:
Date:
2017-05-16
Time:
7:30-17:30 Pacific Time
Registration fee:
(USD): Regular: $50; Academic: $50; Students or Unemployed: $50
Location:
South San Francisco Conference Center (255 South Airport Boulevard, South San Francisco, CA 94080)
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2017-05-15
(it will close sooner if the seating cap is reached)
About the Topic
Morning Session
7:30 am – 8:30 am Registration & Breakfast
8:30 am – 8:45 am Opening message from The NorCal & PBSS Presidents (Toufan Parman, PhD, DABT, Director, General Toxicology, SRI; Shichang Miao, PhD, VP, Preclinical Development & Clinical DMPK, ChemoCentryx)
8:45 am – 9:20 am Introduction to the Preclinical Development of Combination Therapies (Joseph Francisco, CRL)
9:20 am – 9:55 am Safety Assessment of Combination Therapeutic Agents: Regulatory Guidance and Expectations (Philip Gatti, FDA)
9:55 am – 10:30 am Addressing The Challenges With The Discovery of Combination Peptide (Paul Feldman, Intarcia)
10:30 am – 10:45 am Coffee Break
10:45 am – 10:55 am Sponsor Platform AM: TBD
10:55 am – 11:30 am Challenges and solutions in the development of multi-analyte bioanalytical methods (Jonathan Wang, Genentech)
11:30 am – 12:05 am Presentation 4: TBD (Lynn Genarro, Genentech)
12:05 pm – 1:30 pm Lunch Break: Lunch with Experts, Posters
Afternoon Session
1:30 pm – 1:45 pm Chapter announcements and acknowledgements
1:45 am – 2:05 am NorCal Student Award presentation: Evaluation of DILI Predictive Hypotheses in Early Drug Development (Rosa Chan, UCSF)
2:05 pm – 2:40 pm Combination Toxicity Study of 2 Approved Cardiovascular Drugs (Anne Chester, Gilead)
2:40 pm – 3:00 pm Coffee Break
3:00 pm – 3:10 pm Sponsor Platform PM: TBD
3:10 pm – 3:45 pm Clinical Pharmacology considerations for development of combination products (Rebecca Begley, Gilead)
3:45 pm – 4:20 pm Combination Drug Applications: Nonclinical Reviewer Perspectives (Jessica Hawes, FDA)
4:20 pm – 4:35 pm Closing Remarks
4:35 pm – 5:50 pm Reception & Networking
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