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: 5/16/2017
Time: 7:30-17:30
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: https://www.PBSS.org
Registration deadline:5/15/2017  (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