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Full-Text Articles in Translational Medical Research
Timelines Of Translational Science: From Technology Initiation To Fda Approval, Laura M. Mcnamee, Michael Jay Walsh, Fred D. Ledley
Timelines Of Translational Science: From Technology Initiation To Fda Approval, Laura M. Mcnamee, Michael Jay Walsh, Fred D. Ledley
Natural & Applied Sciences Faculty Publications
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 …
Modeling Timelines For Translational Science In Cancer; The Impact Of Technological Maturation, Laura M. Mcnamee, Fred D. Ledley
Modeling Timelines For Translational Science In Cancer; The Impact Of Technological Maturation, Laura M. Mcnamee, Fred D. Ledley
Natural & Applied Sciences Faculty Publications
This work examines translational science in cancer based on theories of innovation that posit a relationship between the maturation of technologies and their capacity to generate successful products. We examined the growth of technologies associated with 138 anticancer drugs using an analytical model that identifies the point of initiation of exponential growth and the point at which growth slows as the technology becomes established. Approval of targeted and biological products corresponded with technological maturation, with first approval averaging 14 years after the established point and 44 years after initiation of associated technologies. The lag in cancer drug approvals after the …