Sunday, September 24


9:00 am - 12:15 pm
Concurrent Morning Short Courses

Short Course 1: Reaction Phenotyping – Methods and Regulatory Requirements for Identifying the Role of Phase 1 and Phase 2 Enzymes in Drug Disposition
Chair: Michael Sinz, Bristol-Myers Squibb

Reaction Phenotyping for CYP Enzymes
Michael Sinz, Bristol-Myers Squibb

Reaction Phenotyping for non-CYP, Phase 1 Enzymes
Tonika Bohnet, Biogen

Reaction Phenotyping for UGT Enzymes
Michael Zientek, Takeda

Unusual Pathways of Drug Metabolism – Unexpected Reaction Phenotyping Findings
Faraz Kazmi, Johnson & Johnson

Short Course 2: The Basics of Predicting Clearance Mechanisms for Human PK in Drug Discovery and Development and the Application of Extended Clearance Classification Systems
Chairs: Ayman El-Kattan, Pfizer and Yurong Lai, Gilead

Prediction of Metabolic Drug Clearance in Humans
Nina Isoherranen, University of Washington

The Role of Hepatic Transporters in Drug Disposition and Elimination
Kim Brouwer, University of North Carolina

The Application of BCS and BDDCS in Drug Discovery and
Development
Les Benet, University of California, San Francisco

The Utility of Extended Clearance Classification in Predicting Human Drug Clearance in Early Drug Discovery
Ayman El-Kattan, Pfizer


12:15 pm - 1:30 pm
Short Course Attendee Lunch


1:30 pm - 4:45 pm
Concurrent Afternoon Short Courses

Short Course 3: Metabolism-Mediated Toxicity: Importance, Prediction, and Evaluation
Chair: Amit S. Kalgutkar, Pfizer

Predicting Metabolism-Mediated Toxicities of Drug Candidates
Amit S. Kalgutkar, Pfizer

How Reactive Metabolites Induce an Immune Response that Sometimes Lead to an Idiosyncratic Drug Reaction
Jack Uetrecht, University of Toronto

Modeling Hepatic Drug Metabolism and Toxicity: Where are We Heading?
Dominic Williams, AstraZeneca

Integrating DILI Hazards in Predicting Toxicity of Drug Candidates: Assessment and Management of Human Risk in the Pharmaceutical Industry
Gerry Kenna, Drug Safety Consultant

    Short Course 4: Predicting Human Transporter-related Clearance and Drug-Drug Interactions (DDIs) as Currently Practiced in Regulatory Agencies and Industry
    Chairs: Ping Zhao, Bill and Melinda Gates Foundation and Yurong Lai, Gilead

    Review of FDA Drug-Drug Interaction Guidance
    Lei Zhang

    Considerations of Communicating DDI Findings from Various Sources in US Prescription Information
    Joseph Grillo

    Static and Dynamic Models to Predict Human Hepatic and Renal DDIs
    Manthena Varma, Pfizer

    Case Studies of Evaluating DDIs Related to Renal Drug Transporters
    Kate Hillgren, Eli Lilly and Company


    6:00 pm - 7:00 pm
    Opening Remarks and Keynote Lecture

    Opening and Welcome Remarks
    Meeting Chair, Jashvant Unadkat, University of Washington and Meeting Co-Chair, Allan Rettie, University of Washington

    Regulatory Science: Evolution of a Discipline
    Issam Zineh, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 


    7:00 pm - 9:00 pm
    Opening Welcome Reception with Exhibitors