AAPS Workshop on Enzyme- and Transporter-Based Drug Interactions: Progress and Future Challenges
Co-sponsored with ISSX
Funded by grants from:
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.
Planning Committee
K. Sandy Pang, University of Toronto, Chair
Reina Bendayan, University of Toronto, Co-Chair
Keith Hoffamaster Pfizer Research Technology Center, Co-Chair
Marilyn E. Morris, University of Buffalo, Co-Chair
Raimund M. Peter, AstraZeneca, Co-Chair
Yuichi Sugiyama, The University of Tokyo, Co-Chair
Jash Unadkat, University of Washington, Co-Chair
Raman Venkataramanan, University of Pittsburgh, Co-Chair
Joesph W. Polli, Glaxo Smith Kline, Co-Chair
Kate Hilgreen, Eli Lilly, Co-Chair
Continuing Education
The University of Wisconsin, an approved provider of continuing pharmaceutical education, offers continuing education credits. The fee must be paid at the time of registration or on-site. Continuing education credits will not be available after the meeting has occurred.
Earn: 0.7 CEUs (7 credit hours)
Program Number: 073-999-07-591-L04
Fee: $30, payable with registration
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
8:10 am
Enzyme Based Drug Interactions: Where Have We Been and Where Are We Going?
R. Scott Obach, Ph.D.
Pfizer, Inc.
8:45 am
Transporter-based Drug Interactions: Where Have We Been and Where Are We Going?
Yuichi Sugiyama, Ph.D.
Tokyo University
9:20 am
Regulation of Enzymes and Transporters by Nuclear Receptors: CAR, SXR/DXR, FXR, AHR, GR, and VDR
Ed LeCluyse, Ph.D
Cellzdirect
9:55 am
Coffee Break
Moderators
Raman Venkataramanan, Ph.D.
University of Pittsburgh
Jashvant Unadkat, Ph.D.
University of Washington
10:15 am
Regulatory Aspects of Drug-Drug Interactions
Shiew-Mei Huang, Ph.D.
U.S. Food and Drug Administration
10:50 am
Importance of Enzyme and Transporter Based Drug-drug Interactions in Drug Development
A. David Rodrigues, Ph.D.
Bristol-Myers Squibb Company
11:25 am
Concurrent Breakout Sessions
Breakout Session 1:
DDI in binding: Changes in volume and importance of other eliminating organs
Breakout Session 2:
Inhibition constants: KI vs. IC50
12:00 pm – 1:30 pm
Lunch
Moderators
Marilyn Morris, Ph.D.
University at Buffalo
Keith Hoffmaster, Ph.D.
Pfizer Research Technology Center
1:30 pm
Allosteric Enzyme and Transporter-based Drug Interactions: In Vitro & In Vivo Studies
Tim Tracy, Ph.D.
University of Minnesota
2:05 pm
Mechanism-based Enzyme and Transporter-based Drug Interactions: In Vitro & In Vivo Studies and Their Correlations
Stephan Hall
Indiana University
2:40 pm
Neglected Metabolic Pathways in DDI: Phase II Enzymes
Raman Venkataramanan, Ph.D.
University of Pittsburgh
3:15 pm
Coffee Break
Moderators
Reina Bendayan, Ph.D.
University of Toronto
Yuichi Sugiyama, Ph.D.
Tokyo University
3:35 pm
Predicting DDI from In Vitro to In Vivo: Challenges of the Future
Jash Unadkat, Ph.D.
University of Washington
4:10pm
Translation of In Vitro Data to In-vivo – IVIVE and Modeling and Simulations
Amin Rostami
Sheffield University, Surrey
4:45 pm
Concurrent Breakout Sessions
Breakout Session #3:
Importance of Given Transporter to Total Transport and Estimation of Given
Enzyme to Total Metabolism
Breakout Session #4
Modeling and Simulation as a Tool to Study DDI
5:25 pm
Panel Discussion
5:55 pm
Concluding Remarks
Reina Bendayan, Ph.D.
University of Toronto
6:00 pm
Adjournment
6:00 pm
Reception
Registration Fees
| Early-Bird Registration Received on or before September 7, 2007 |
Advanced Registration Received by October 5, 2007 |
On-Site Registration Received October 5 – on-site |
|
| Enzyme- and Transporter-Based Drug Interaction Workshop AAPS/CRS Member | $890 |
$890 |
$1,075 |
| Enzyme- and Transporter-Based Drug Interaction Workshop Non-member | $1,245 |
$1,245 |
$1,380 |
| Enzyme- and Transporter-Based Drug Interaction Workshop Government | $450 |
$450 |
$525 |
| Enzyme- and Transporter-Based Drug Interaction Workshop Government, Non-member | $500 |
$500 |
$575 |
| Enzyme- and Transporter-Based Drug Interaction Workshop AAPS Member, Student | $70 |
$70 |
$80 |
| Enzyme- and Transporter-Based Drug Interaction Workshop Academic Member | $510 |
$510 |
$640 |
Cancellation Policy
All written refund requests received by October 12, 2007 will be issued minus an administrative fee ($180 for registrants/$50 government registrants/$15 student registrants). Refund requests received after this date will not be accepted. Registrant substitutions submitted in writing are accepted at any time without penalty. If the membership status of the substitute differs from that of the original registrant, a refund or additional charge may apply.
Fax: (703) 243-5582
Email: registration@aaps.org
Deadline: October 12, 2007
All refunds will be issued after December 21, 2007.
Until you receive a confirmation letter, your registration is not complete. You should receive a confirmation letter by fax or email 5 to 10 business days after payment is received. If not, call (301) 694-5243.
Become an AAPS Member and Save
Save money on this AAPS workshop by taking advantage of AAPS membership. Membership gives you the competitive edge you need to advance your career and keeps you up-todate on the latest in pharmaceutical research. Continue your professional development and take advantage of AAPS membership! Use the registration form to indicate your membership choice and send in payment with your registration fees.
Phone: (703) 243-2800
Email: membership@aaps.org
Regular Membership Fee: $135
Student/Post-doc Membership Fee: $30
Hotel Accommodations
The San Diego Marriott Hotel & Marina is the headquarter hotel for the 2007 AAPS Annual Meeting and Exposition. AAPS is also holding additional room blocks at other hotels. Please visit www.aapspharmaceutica.com/annualmeet/housing.
Registrants are responsible for making hotel reservations. Contact the AAPS Housing Bureau using one of the following options:
Reserve your room online at www.aapspharmaceutica.com/annualmeet/housing.
Fax the Housing Reservation Form using the fax number listed on the form
Phone: (800) 967-4590 US & Canada; International: (847) 282-2529
*Please note: there is a 10 room limit per company at the San Diego Marriott Hotel
Reserve Your Space Early!
Rooms are assigned on a first-come, first-served basis. Reservations should be made by October 12, 2007. After October 12, 2007, all reservations will be accepted on a space- and rate-available basis.
Room Deposit Required to Secure Reservation
All San Diego hotels require a credit card guarantee or a one night’s deposit via check with each reservation request. Requests received without a credit card guarantee or check deposit will be returned. Complete the Hotel Reservation Form with credit card information, or mail the form with a check made payable to the AAPS Housing Bureau.
Travel & Transportation
Discounted air fares are available for attendees traveling to/from San Diego for the 2007 AAPS Annual Meeting and Exposition. To take advantage of these discounts, call the official AAPS travel agency, Carlson Wagonlit, and mention this meeting. You may also call the airlines directly. Certain restrictions apply and seats are limited. Times are listed as Eastern Standard Time (EST).
Carlson Wagonlit
PH: (866) 412-7957 in the U.S.
PH: (304) 876-8635 outside the U.S.
EM: sismith@carlsonwagonlit.com
9:00 am – 5:30 pm, Monday – Thursday
9:30 am – 4:00 pm, Friday
American Airlines
PH: (800) 433-1790
5:00 am – 12:00 pm, Monday – Sunday
Authorization #A60N7AA
United Airlines
PH: (800) 521-4041
8:00 am – 10:00 pm, Monday – Friday
8:00 am – 8:00 pm, Saturday – Sunday
Click here for further detailed travel information including rental car and ground transportation information.
Advertising Opportunity
Increase your visibility! Advertise in the final program and deliver your message to top pharmaceutical scientists. Limited space is available and ad space must be reserved no later than August 3, 2007.
The Townsend Group
Kim Kelemen, National Advertising Director
Phone: (301) 215-6710
Fax: (301) 215-7704
Email: advertising@aaps.org
Deadline: August 3, 2007
Questions?
Meeting Registration – (301) 694-5243 or call toll free at (866) 229-2386 within the U.S. and Canada.
General Meeting – (703) 243-2800, or call toll free at (877) 998-AAPS
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