Timelines of translational science: From technology initiation to FDA approval

• Published in: PloS one Vol. 12; no. 5; p. e0177371
• Main Authors: McNamee, Laura M, Walsh, Michael Jay, Ledley, Fred D
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 08.05.2017; Public Library of Science (PLoS)
• 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; United States > US; Massachusetts
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0177371

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<0.0005). Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.