While the number of new therapeutics approved by the FDA has remained relatively constant over the past 60 years, the cost of this endeavor has increased in a log linear fashion. This mainly reflects the exploding cost of failure of a model that is clearly unsustainable. Experience in the altruistic sector has illustrated the temporal and scientific efficiency of a globalized modular approach to drug discovery and development where (i) behavior is incented by altruistic ideals and a pot of money and (ii) intellectual property barriers are collapsed by the perception of there being no money to be made. Can this model be exported to the for-profit sector? There is some movement in that direction as Pharma seeks to outsource some of its activities, although still retaining most of the control -- a touch of perestroika with a whiff of glasnost. However, more radical reform is likely, driven primarily by crisis rather than the prospect of opportunity. This will require a fundamental revision of assumptions around intellectual property, an increased capability of academic medical centers to play in this space, a redeveloped workforce with skills in translational medicine and therapeutics, regulatory reform of incentives in drug development and a bioinformatic infrastructure capable of sharing heterogeneous information in a secure and compliant manner across distinct organizational structures and on a global scale.
Professor of Medicine and Pharmacology, McNeil Professor in Translational Medicine and Therapeutics, Chair Department of Pharmacology, Director, Institute for Translational Medicine & Therapeutics, Perelman School of Medicine, University of PennsylvaniaNo slides available
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