Timelines of translational science: From technology initiation to FDA approval

While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by th...

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Bibliographic Details
Published in:PloS one 2017-05, Vol.12 (5), p.e0177371-e0177371
Main Authors: McNamee, Laura M, Walsh, Michael Jay, Ledley, Fred D
Format: Article
Language:English
Subjects:
Absorptivity
Acceleration
Antibodies
Bibliometrics
Bioactive compounds
Biocompatibility
Biology and Life Sciences
Biomedical materials
Biotechnology
Bradykinin
Cancer
Chimpanzees
Computer applications
Cost analysis
Cycle protein
Cystic fibrosis
Deceleration
Documents
Drug approval
Drug Approval - legislation & jurisprudence
Drug delivery
Drug development
Drug discovery
Drugs
Economics
Entrepreneurship
Evolution
Gene therapy
Genetics
Genomes
Growth hormone
Growth hormones
Hepatitis
High-throughput screening
Humans
Hypothalamus
Identification
Innovations
Inventions
Lead
Lead compounds
Licensing, certification and accreditation
Life cycles
Mathematical models
Medical research
Medicine and Health Sciences
Monoclonal antibodies
Permeability
Pharmaceutical industry
Pharmaceutical research
Pharmaceuticals
Pharmacoeconomics
Pharmacology
Physical Sciences
R&D
Regression analysis
Research & development
Research and Analysis Methods
Science
Solubility
Surgical implants
Technology
Technology assessment
Translation
Translational Medical Research
United States
United States Food and Drug Administration
Viruses
War
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Summary:While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve) maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0177371