AAPS Workshop on Enzyme- and Transporter-Based Drug Interactions: Progress and Future Challenges
Co-sponsored with ISSX
November 10, 2007
San Diego Convention Center
San Diego, CA
ACPE #073-999-07-592-L04
Background
This one-day workshop will take place on November 10, 2007 before the Annual Meeting at the San Diego Convention Center. The driving force behind this workshop is the recognition that the transporters and enzymes are dynamically interacting to affect levels of drugs and metabolites in the body. Hence, viewing each topic (enzymes or transporters and their regulation) separately is no longer tenable. There is also an impetus at the FDA to closely scrutinize transporter- and enzyme-drug interactions. An understanding of the mechanism of interaction and the regulation by nuclear receptor is a pre-requisite for the formulation of predictive solutions
Goals and Objectives
The goals are to provide the scientific bases on issues surrounding the importance of drug-enzyme and drug-transporter interactions. Although much progress has been made in predicting in vivo metabolic drug interactions based on in vitro studies, the quantitative prediction of clinically relevant transporter- and enzyme-based drug interaction remains to be a challenge. The more complex metabolic drug interaction such as inductive, mechanism-based and allosteric drug interactions render difficulty for prediction in vivo. The objectives of the workshop are to cover the current state of knowledge on transporters and enzymes: their regulation by nuclear receptors, and the importance of enzyme- and transporter-drug interactions. This workshop will further assess the progress made in quantitatively predicting metabolic and transporter-based drug interactions as well as highlight areas where such predictions are poor or not possible. Speakers from industry, academia and the FDA will address why some of these predictions are poor and what research is needed to rectify these poor predictions. The topics and views would be welcomed by scientists from both industry and academia since both elements on mechanisms-based research and FDA requirements are present.
Workshop Agenda
Saturday, November 10
8:00 am
Coffee Service
8:00 am
Introductory Remarks
K. Sandy Pang, Ph.D.
University of Toronto
Moderators
Raimund Peter, Ph.D.
AstraZeneca
K. Sandy Pang, Ph.D.
University of Toronto
8:30 am
Enzyme Based Drug Interactions: Where Have We Been and Where Are We Going?
R. Scott Obach, Ph.D. (invited)
Pfizer, Inc.
8:50 am
Transporter-based Drug Interactions: Where Have We Been and Where Are We Going?
Yuichi Sugiyama, Ph.D.
Tokyo University
9:30 am
Regulation of Enzymes and Transporters by Nuclear Receptors: CAR, SXR/DXR, FXR, AHR, GR, and VDR
Ed LeCluyse, Ph.D
Cellzdirect
10:10 am
Coffee Break
Moderators
Roman Venkataramanan, Ph.D.
University of Pittsburgh
Jashvant Unadkat, Ph.D.
University of Washington
10:40 am
Regulatory Aspects of Drug-Drug Interactions
Shiew-Mei Huang, Ph.D.
U.S. Food and Drug Administration
11:20 am
Importance of Enzyme and Transporter Based Drug-drug Interactions in Drug Development
A. David Rodriguez, Ph.D.
Bristol-Myers Squibb Company
or
David Greenblatt, M.D.
Tufts University
12:00 pm
Panel Discussion
12:30 pm – 2:00 pm
Lunch
Moderators
Marilyn Morris, Ph.D.
University at Buffalo
Keith Hoffmaster, Ph.D.
Pfizer Research Technology Center
2:00 pm
Allosteric Enzyme and Transporter-based Drug Interactions: In Vitro & In Vivo Studies
Tim Tracy, Ph.D.
University of Minnesota
2:40 pm
Mechanism-based Enzyme and Transporter-based Drug Interactions: In Vitro & In Vivo Studies and Their Correlations
St. Judes Hospital, Memphis
3:20 pm
Coffee Break
Moderators
Reina Bendayan, Ph.D.
University of Toronto
Yuichi Sugiyama, Ph.D.
Tokyo University
3:50 pm
Neglected Metabolic Pathways in DDI: Phase II Enzymes
Ramon Venkataramanan, Ph.D.
University of Pittsburgh
4:30 pm
Predicting DDI from In Vitro to In Vivo: Challenges of the Future
Jash Unadkat, Ph.D.
University of Washington
5:10 pm
Panel Discussion
5:30 pm
Concluding Remarks
Reina Bendayan, Ph.D.
University of Toronto
5:35 pm
Adjournment
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