AAPS Workshop on Quantitative Pharmacology: A Roadmap for Rational, Model-based Drug Development
November 10, 2007
San Diego Convention Center
San Diego, CA
ACPE #073-999-07-590-L04
Background Information
Quantitative pharmacology constitutes a multi-disciplinary approach that integrates the relationships between disease, drug characteristics, and individual variability (getting the right drug to the right patient at the right dose and time). At its core, quantitative pharmacology uses model-based drug development to provide a quantitative, data-driven framework that enables rationale decision making in preclinical and clinical drug development. Quantitative pharmacology can be viewed as a cornerstone of the critical path initiative promoted by the U.S. Food and Drug Administration.
Goals and Objectives
During the course of this workshop we will
- Introduce the concept of quantitative pharmacology to the audience;
- Provide examples of the challenges and opportunities for quantitative pharmacology within the framework of industrial and academic drug development efforts;
- Provide insights into the role of quantitative pharmacology in regulatory and translational sciences;
- Illustrate the benefit (and limitations) of the application of quantitative pharmacology and outline its role in critical decision making; and
- Introduce strategies to overcome challenges associated with the implementation of quantitative pharmacology, including silo-structures, interdisciplinary communication and decision-making infrastructure.
Planning Committee Members
Bernd Meibohm, PhD, FCP, University of Tennessee Health Science Center, Co-Chair
Sriram Krishnaswami, PhD, Pfizer Inc., Co-Chair
Stacey Tannenbaum, PhD, Novartis Pharmaceuticals Corporation, Co-Chair
Sandra Allerheiligen, PhD, Eli Lilly & Company
Kevin Dykstra, PhD, Pharsight Corporation
Amita Joshi, PhD, Genentech Inc.
Richard Lalonde, PharmD, Pfizer Inc.
Raymond Miller, DSc, Pfizer Inc.
Vikram Sinha, PhD, Eli Lilly & Company
Liping Zhang, PhD, Bristol-Myers Squibb Corporation
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 - 11:15 am
Section I - The Next Generation of Drug Development
8:00 am
The Role of Model-based Drug Development in Paving the Critcal Path
Lawrence J. Lesko, Ph.D.
U.S. Food and Drug Administration
8:35 am
Using the Quantitative Pharmacology Levers to Develop Smarter Drugs (Overview of Quantitative Pharmacology)
Sandra R. B. Allerheiligen, Ph.D.
Eli Lilly and Company
9:10 am
A Model-based Framework for Quantitative Decision-making in Drug Development
Kenneth G. Kowalski, Ph.D.
Pfizer Inc.
9:45 am
Coffee Break
10:00 am
Introduction of the Interactive Case Studies
Sriram Krishnaswami, Ph.D.
Pfizer, Inc.
Liping Zhang, Ph.D.
Bristol-Myers Squibb Company
10:15 am
Translation of Systems Biology and Quantitative Pharmacology into Clinical Medicine Speaker to be Announced
10:55 am
Panel Discussion
11:15 am - 3:00 pm
Section II - Impact of Integrated Modeling & Simulation on Critical Decisions in Drug Development
11:15 am
A Practical Example of the Application of Quantitative Pharmacology to Design a Dose Response Study
Jaap Mandema, Ph.D.
Quantitative Solutions, Inc.
11:45 am
Archimedes: An Example of Disease Models Using Quantitative Pharmacology
David Eddy, M.D., Ph.D.
Archimedes Inc.
12:15 pm
Lunch
1:15 pm
Integrated Modeling and Simulation to Evaluate the Viability of a Proposed Drug Development Program
Kevin H. Dykstra, Ph.D.
1:45 pm
Decision Analysis in Support of Clinical Program Design
Joseph Kahn, Ph.D.
Novartis Pharmaceuticals
2:15 pm
Panel discussion
2:45 pm
Coffee Break
3:00 pm - 5:00 pm
Section III - Communicating in a Model-based Drug Development Paradigm
Interactive Case Studies in Clinical Drug Development
Two interactive case studies (one in early development and one in late stage clinical development) will be discussed in an interactive-lecture type format to highlight the need for enhanced inter-disciplinary understanding and more effective communication among clinicians, statisticians, clinical pharmacologists and modelers. Principles behind flexible trial design strategies and cost-effective yet efficient analytical methodologies will be briefly reviewed. Participants will be provided two drug development problems along with a number of potential solutions and asked to brainstorm in smaller groups of cross-functional members and provide their recommendations. Results, thought processes, perspectives, language/"lingo" used will be summarized. Finally, concepts applicable to those specific examples and in general will be summarized.
Moderators
Sriram Krishnaswami, Ph.D.
Pfizer, Inc.
Liping Zhang, Ph.D.
Bristol-Myers Squibb Company
3:00 pm
Further Introduction of Case Studies
3:30 pm
Breakout Sessions
4:15 pm
Review of Results and Discussion of Pros/Cons of Each Approach within Each Case Study
5:00 pm
Adjournment
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 |
|
| Quantitative Pharmacology Workshop AAPS Member/CSR Member | $890 |
$890 |
$1,075 |
| Quantitative Pharmacology Workshop Non-member | $1,245 |
$1,245 |
$1,380 |
| Quantitative Pharmacology Workshop Government Member | $450 |
$450 |
$525 |
| Quantitative Pharmacology Workshop Government, Non-member | $500 |
$500 |
$575 |
| Quantitative Pharmacology Workshop AAPS Member, Student | $70 |
$70 |
$80 |
| Quantitative Pharmacology Workshop AAPS Member, Academic | $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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