Open AccessPerestroika in Pharma: Evolution or Revolution in Drug Development?
Author(s) -
FitzGerald Garret A.
Publication year - 2010
Publication title -
mount sinai journal of medicine: a journal of translational and personalized medicine
Language(s) - English
Resource type - Journals
eISSN - 1931-7581
pISSN - 0027-2507
DOI - 10.1002/msj.20198
Subject(s) - regulatory science , drug development , medicine , pharmaceutical industry , translational medicine , informatics , venture capital , food and drug administration , drug , business , pharmacology , finance , political science , law , pathology
New‐drug approvals have remained roughly constant since 1950, while the cost of drug development has soared. It seems likely that a more modular approach to drug discovery and development will evolve, deriving some features from the not‐for‐profit sector. For this to occur, we must address the deficit in human capital with expertise in both translational medicine and therapeutics and also in regulatory science; utilize regulatory reform to incentivize innovation and the expansion of the precompetitive space; and develop an informatics infrastructure that permits the global, secure, and compliant sharing of heterogeneous data across academic and industry sectors. These developments, likely prompted by the perception of crisis rather than opportunity, will require linked initiatives among academia, the pharmaceutical industry, the US National Institutes of Health, and the US Food and Drug Administration, along with a more adventurous role for venture capital. A failure to respond threatens the United States' lead in biomedical science and in the development and regulation of novel therapeutics. Mt Sinai J Med 77:327–332, 2010. © 2010 Mount Sinai School of Medicine