PHILADELPHIA - Garret FitzGerald, MD, FRS, chair of the Department of Pharmacology and Director of the Institute for Translational Medicine & Therapeutics, Perelman School of Medicine at the University of Pennsylvania, has long said the current drug-development system in the United States is in need of change, "representing an unsustainable model."
Even though the number of drugs approved has risen in the last three years, overall, roughly the same number of drugs have been approved by the Food and Drug Administration (FDA) each year since 1950 while the estimated cost, mostly because of the failure to bring new medicines all the way to market - has exploded.
As the dominance of large pharma erodes and the process of drug discovery and development moves to a more modular approach, initiatives such as the NIH's Clinical and Translational Science Awards are designed to enhance the ability of academia to play in this space.
Novel approaches to raising capital and to distributing intellectual property are also emerging.
However, most failures in drug development now occur during phase 2 clinical trials, when the mechanism of drug action is discovered and the factors that contribute to variability in drug response are parsed. We are challenged by a paucity of those individuals who integrate knowledge of preclinical science with an understanding of the complexity of drug action in humans. The relative absence of such individuals who serve as catalysts in drug development is apparent in big pharma, academia and at the FDA.
A politically uncontroversial role for NIH's National Center for Advancing Translational Sciences would be to address this problem, giving academia incentives to couple initiatives in translational medicine and therapeutics and in regulatory science to create a cadre of such individuals. This interdisciplinary group could catalyze drug development by including strategies focused on a more personalized approach, improving prediction of efficacy and safety and becoming a source of information about therapy for prescribers and consumers that exceeds the "objectivity" of direct to consumer advertising.
FitzGerald will present "A New Paradigm for Therapeutics Discovery" at the 2013 American Association for the Advancement of Science Annual Meeting in Boston, as a part of the Sunday, February 17th session, "Cultivating the Science and Scientists for 21st Century Drug Discovery and Development."
Sunday, February 17, 2013
8:00 AM-9:30 AM
Room 207 Hynes Convention Center
Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.3 billion enterprise.
The Perelman School of Medicine is currently ranked #2 in U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $398 million awarded in the 2012 fiscal year.
The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania -- recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report; Penn Presbyterian Medical Center; and Pennsylvania Hospital — the nation's first hospital, founded in 1751. Penn Medicine also includes additional patient care facilities and services throughout the Philadelphia region.
Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2012, Penn Medicine provided $827 million to benefit our community
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