title: Re-engineering drug discovery and development.
abstract: The rate of new drug approvals in the US has remained essentially constant since 1950, while the costs of drug development have soared. Many commentators question the sustainability of the current model of drug development, in which large pharmaceutical companies incur markedly escalating costs to deliver the same number of products to market. This Issue Brief summarizes the problem, describes ongoing governmental efforts to influence the process, and suggests changes in regulatory science and translational medicine that may promote more successful development of safe and effective therapeutics
authors: Clinical & Translational Science Award (CTSA), University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors: Garret A
authors: GA
authors: FitzGerald
mesh_terms: D003299:Cooperative Behavior; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D055808:Drug Discovery / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods* / Q000639:trends; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods* / Q000639:trends; D005544:Forecasting; D033161:Government Regulation; D006801:Humans; D033181:Information Dissemination; D007373:Interinstitutional Relations; D017146:Models, Organizational; D009316:National Institutes of Health (U.S.); D004364:Pharmaceutical Preparations / Q000191:economics; D017149:Private Sector; D017150:Public Sector; D055818:Public-Private Sector Partnerships / Q000191:economics / Q000331:legislation & jurisprudence / Q000639:trends*; D012586:Science / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods* / Q000639:trends; D057170:Translational Research, Biomedical / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration; D014495:Universities
chemical_list: D004364:Pharmaceutical Preparations