September 30, 2005

Expert Advisory
Penn Researcher Calls for Greater Emphasis on Translational Medicine and Therapeutics
to Transform the Future of Drug Development

Philadelphia, (PA) - Today marks the one-year anniversary since the withdrawal of Merck's Vioxx from the market due to an increased risk of heart attack and stroke. In the wake of this announcement, the pharmaceutical industry, and hence future drug development, has since been in a state of upheaval. Garret FitzGerald, MD, Director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania School of Medicine, proposes that by more seamlessly merging basic science with clinical research, barriers to the development of new medicines could be diminished. He outlines his ideas in an article entitled, “Anticipating change in drug development: the emerging era of translational medicine and therapeutics,” in the October issue of Nature Reviews Drug Discovery.

Within the context of drug development, translational medicine extends from proof-of-concept studies in cells and animal models to pharmacological studies of drug mechanism to human clinical trials for safety and effectiveness. This process ends with analyzing the variability of reaction by individual patients to new drugs, the basis for personalized medicines and doses.

However, as FitzGerald writes, “we are ill prepared for such a paradigm shift in drug development.” To him, the most important feature lacking in making translational medicine a reality is the paucity of physician-scientists trained with the diverse skills necessary to incorporate the molecular and cell biology of a drug's action in animals into studies of drug response in humans.

“The dramatic expansion of high-throughput approaches of drug discovery and the increasingly powerful use of computer-based and animal-model systems to select potential new medicines must now be matched by an understanding of the complexity of human pharmacology, which is in scant supply,” says FitzGerald. “As we move from the era of blockbuster drugs to personalized medicine, researchers will need to explore how genetic and environmental factors interact to influence how drugs act within an individual patient.”

The foundation of a new discipline - Translational Medicine and Therapeutics - is necessary to capture the enthusiasm of a new cadre of investigators for such an interdisciplinary endeavor as is needed to reform drug development, before the business model of the Pharma industry is forced to change, perhaps abruptly in a “Southwest Airlines moment,” says FitzGerald.

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This release is available online at http://www.uphs.upenn.edu/news/News_Releases/sep05/Vioxxann.htm