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Pathophysiology Meets Modeling: Development of Disease Progression Models*
Wednesday, November 14
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-545-L04
After participating in this roundtable session, participants will be able to define the nomenclature used in disease progression modeling activity, describe cutting edge examples of disease progression models and understand the basic principles to be followed in the development of disease progression models. Rationale: Although long used in the fields of epidemiology, public health, and drug safety, modeling of disease progression has had limited use in traditional drug development. Quantification of the impact of disease progression is an important component of model-based drug development, thus allowing more efficient and informative study designs as well as simulation of potential scenarios. Pharmaceutical scientists may not have received formal education on the procedures for disease progression models, the sources of useful data and possible limitations of the resulting models. Participating in this roundtable session will serve to introduce the topic and provide the direction to get started in a first project. It will include a discussion of the modeling approaches to be used for diseases with different progression pattern (monotonic vs. episodic vs. cyclic disease progression) and will provide successful examples for the application of disease progression modeling in the drug development process.
Moderators
Joan M. Korth-Bradley, Pharm.D., Ph.D.
Wyeth Pharmaceuticals
Bernd Meibohm, Ph.D.
University of Tennessee
Introduction to Models of Disease Progression
Joan M. Korth-Bradley, Pharm.D., Ph.D.
Wyeth Pharmaceuticals
Modeling of Short-term Disease Progression
Dolly A. Parasrampuria, Ph.D.
Johnson & Johnson Pharmaceutical R&D
Modeling of Long-term Disease Progression
Marc R. Gastonguay, Ph.D.
Metrum Research Group
*Session tentatively scheduled to be recorded.
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