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.
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. (invited)
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
Gregory D. Sides, M.D.
Eli Lilly and Company
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. (invited)
Archimedes Inc./Kaiser Permanente
12:00 pm
A Strategic Question: “Is it Worthwhile to Develop a New Formulation for an Old Generic Drug?”
Kevin Dykstra, Ph.D.
Pharsight, Inc.
12:30 pm
Panel discussion
12:45 pm
Lunch
1:15 pm
Integrated Modeling and Simulation to Evalute teh Visibility 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
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
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