Joseph A DiMasi1, Michael Wilkinson2. 1. Tufts Center for the Study of Drug Development, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA, 02111, USA. joseph.dimasi@tufts.edu. 2. Tufts Center for the Study of Drug Development, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA, 02111, USA.
Abstract
PURPOSE: Faster drug development times get new therapies to patients sooner and financially benefit drug developers by shortening the time between investment and returns and increasing the time on the market with intellectual property protection. The result is enhanced incentives to innovate. We provide a real-world example of the financial gains from quicker development using recent estimates of drug development costs, returns, and estimates of time reductions from an alternative early-stage drug development paradigm. METHODS: We utilized data obtained from a drug development and manufacturing services organization to estimate the reduction in development time for drug sponsors from using an integrated platform of formulation development, real-time manufacturing, and clinical testing for 19 completed drug product development projects covering three key drug development activities (transitioning from first-in-human to proof-of-concept [FIH-PoC], modified release formulation development [MR], and enhanced solubility formulation development [ES]). A traditional drug development paradigm was taken as the base case and financial impacts of the alternative development program were determined relative to the base case. FINDINGS: The total after-tax financial benefits of shorter development times from integrating formulation development, real-time manufacturing, and clinical testing when applied across a broad portfolio of investigational drugs ranged from $230.5 million to $290.1 million, $196.4 million to $247.5 million, and $102.6 million to $275.5 million, per approved new drug for FIH-PoC, MR, and ES applications, respectively (2018 dollars). IMPLICATIONS: For the data we examined, this integrated development model yielded substantial financial benefits over traditional drug development.
PURPOSE: Faster drug development times get new therapies to patients sooner and financially benefit drug developers by shortening the time between investment and returns and increasing the time on the market with intellectual property protection. The result is enhanced incentives to innovate. We provide a real-world example of the financial gains from quicker development using recent estimates of drug development costs, returns, and estimates of time reductions from an alternative early-stage drug development paradigm. METHODS: We utilized data obtained from a drug development and manufacturing services organization to estimate the reduction in development time for drug sponsors from using an integrated platform of formulation development, real-time manufacturing, and clinical testing for 19 completed drug product development projects covering three key drug development activities (transitioning from first-in-human to proof-of-concept [FIH-PoC], modified release formulation development [MR], and enhanced solubility formulation development [ES]). A traditional drug development paradigm was taken as the base case and financial impacts of the alternative development program were determined relative to the base case. FINDINGS: The total after-tax financial benefits of shorter development times from integrating formulation development, real-time manufacturing, and clinical testing when applied across a broad portfolio of investigational drugs ranged from $230.5 million to $290.1 million, $196.4 million to $247.5 million, and $102.6 million to $275.5 million, per approved new drug for FIH-PoC, MR, and ES applications, respectively (2018 dollars). IMPLICATIONS: For the data we examined, this integrated development model yielded substantial financial benefits over traditional drug development.
Entities:
Keywords:
Biopharmaceutical R&D cost; Biopharmaceutical net returns; Drug development time; Flexible dosage design; Real-time manufacturing
Authors: Joseph A DiMasi; Zachary Smith; Ingrid Oakley-Girvan; Andrew Mackinnon; Mary Costello; Pamela Tenaerts; Kenneth A Getz Journal: Ther Innov Regul Sci Date: 2022-09-14 Impact factor: 1.337