Date/Time: Tuesday, November 10, 2015; 8:45am-5:00pmLocation: San Francisco Bay Area: Foster City Crowne Plaza HotelSpeakers: Matthew Wright PhD (Genentech), Mark Ratain PhD (University of Chicago), Joseph Ware PhD (Genentech), Grazyna Fraczkiewicz PhD (Simulations Plus), Jan Wahl-strom PhD (Amgen), Atik Rahman PhD (FDA), Charles Yang PhD (Genentech)Organizers: Matthew Wright, Joseph Ware, Shichang Miao Registration fee (US$): Regular: $195; For unemployed & students: $30Registration: www.PBSS.org

About the Topic:

Food can impact the absorption and pharmacokinetics of a drug through various mecha-nisms, such as an enhancement in drug solubility, increase in GI motility, delayed gastric emptying, increase in bile flow, or direct interaction with the drug. Food effect has been rou-tinely tested for oral drugs in the clinical development process. In recent years it has also become known that alteration of the pH condition in the gastric-intestinal environment caused by factors such as concomitant medications and disease state can also significantly impact the solubility of certain drugs and hence the absorption of the drug. At this workshop, experts from industry, academia and the FDA will discuss the fundamentals of food and pH effects and the implications and remedies in the drug development process.

The following topics will be discussed:

• Review of Human GI Physiology and Responses to Food - Physicochemical and BCS Class Considerations • Effect of food on drug absorption and PK: fundamentals and a case study for reducing toxicity of oncology drugs with the positive benefits of food effect • pH-dependent drug-drug interactions • PBPK modeling to predict and learn from food effect and pH-dependent interactions (bottom-up/top down approaches) • Case study and Lessons Learned • FDA's perspective on food effect and pH-dependent Drug-Drug Interactions • To Eat or Not to Eat? Contemplating a Nobler Formulation to Address FoodEffect

San Francisco Bay Area Workshop:

WORKSHOP