Expand the Role of Modeling and Simulation in Clinical Drug Development.

CONFERENCE OVERVIEW

The FDA Critical Path Initiative has stimulated interest in new tools and ways to improve the efficiency and success rates of drug development programs, including their planning and analysis. Among the opportunities being explored is the increased use of quantitative modeling and computer simulation (M&S) tools and approaches. Although mechanistic and stochastic modeling and/or simulation have long been used for the design and analysis of clinical trials by different stakeholders within drug development, such as statisticians and clinical pharmacologists, the recent trend is to expand the joint understanding of how M&S can be better integrated and utilized into the drug development process. This trend has been associated with some level of confusion in terminology and understanding of the role and scope of M&S. There is, however, broad consensus that M&S has an enormous potential, in many cases already realized, to greatly improve drug development through better clinical study and program design, more effective approaches to dose selection and regimen optimization, as well as better assessment of the risk/benefit of new and existing treatments.

This M&S conference will provide an opportunity for different stakeholders to learn, create greater awareness, share good and bad experiences, identify gaps and opportunities, and clarify terminology and understanding of M&S and its role in clinical drug development.

At the conclusion of this meeting, participants should be able to:

·         Demonstrate a common understanding of what modeling and simulation is, and is not, and of the terminology used in the field;

·         Apply, share and learn about both successful and unsuccessful case studies illustrating the benefits and pitfalls of the use of modeling and simulation in drug development and for regulatory applications;

·         Discuss the role and scope of modeling and simulation in decision making at various stages of the drug development process, for example dose/regimen selection, patient population selection, clinical trial and program design choices, supporting information for regulatory application; and

·         Recognize the value of collaborative multi-disciplinary interactions (across statistical, clinical, harmacometrics, and clinical pharmacology areas) as a centerpiece to effectively realize the benefits of modeling and simulation.

This program will benefit individuals involved in

·         Statistics

·         Clinical pharmacology

·         Epidemiology

·         Regulatory affairs

·         Clinical research

·         Pharmacometrics

·         Health economics

Constance Burnett, Program Developer, Phone +1-215-293-5800 email constance.burnett@diahome.org

The most convenient airport is Reagan National Airport and attendees should make airline reservations as early as possible to ensure availability. The Marriott Bethesda, Pooks Hill is holding a block of rooms at the reduced rate below until October 6, 2009, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.

                    Single $189                  Double $189

Please contact the Marriott Bethesda, Pooks Hill by telephone at +1-301-897- 9400 and mention the DIA event. The hotel is located at 5151 Pooks Hill Road, Bethesda, MD 20814, USA.