Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities
Autor: | Joseph A. DiMasi, Fred D. Ledley, Jennifer M. Beierlein, Michael J. Walsh, Kenneth I. Kaitin, Laura M. McNamee |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
Knowledge management Basic science Process (engineering) 030204 cardiovascular system & hematology Pharmacology Translational Research Biomedical 03 medical and health sciences 0302 clinical medicine Drug Discovery Medicine Humans Pharmacology (medical) Applied research Drug Approval Drug discovery business.industry United States Food and Drug Administration Cardiovascular Agents Maturity (finance) United States 030104 developmental biology Drug development New product development Translational science business |
Zdroj: | Clinical therapeutics. 39(7) |
ISSN: | 1879-114X |
Popis: | Purpose This study examines the complete timelines of translational science for new cardiovascular therapeutics from the initiation of basic research leading to identification of new drug targets through clinical development and US Food and Drug Administration (FDA) approval of new molecular entities (NMEs) based on this research. Methods This work extends previous studies by examining the association between the growth of research on drug targets and approval of NMEs associated with these targets. Drawing on research on innovation in other technology sectors, where technological maturity is an important determinant in the success or failure of new product development, an analytical model was used to characterize the growth of research related to the known targets for all 168 approved cardiovascular therapeutics. Findings Categorizing and mapping the technological maturity of cardiovascular therapeutics reveal that (1) there has been a distinct transition from phenotypic to targeted methods for drug discovery, (2) the durations of clinical and regulatory processes were significantly influenced by changes in FDA practice, and (3) the longest phase of the translational process was the time required for technology to advance from initiation of research to a statistically defined established point of technology maturation (mean, 30.8 years). Implications This work reveals a normative association between metrics of research maturation and approval of new cardiovascular therapeutics and suggests strategies for advancing translational science by accelerating basic and applied research and improving the synchrony between the maturation of this research and drug development initiatives. |
Databáze: | OpenAIRE |
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