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.
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.
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).
For the data we examined, this integrated development model yielded substantial financial benefits over traditional drug development.
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The company is Quotient Sciences and its development platform is referred to as Translational Pharmceutics®
These values are taken from the stacked bar for 2005–2009 launches in Exhibit 3 of the paper. Labels for the specific values are not presented in the publication, but we obtained those values in a personal communication with the authors (August 15, 2017).
DiMasi JA, Hansen RW, Grabowski HG, Lasagna L. Cost of innovation in the pharmaceutical industry. J Health Econ. 1991;10(2):107–42.
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22(2):151–85.
Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR, Schacht AL. How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nat Rev Drug Discov. 2010;9(3):203–14.
Mestre-Ferrandiz J, Sussex J, Towse A. The R&D Cost of a New Medicine. London: Office of Health Economics; 2012.
DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20–33.
DiMasi JA. The value of improving the productivity of the drug development process: faster times and better decisions. Pharmacoeconomics. 2002;20(Suppl 3):1–10.
DiMasi JA, Smith Z, Getz KA. Assessing the financial benefits of faster development times: the case of single-source versus multi-vendor outsourced biopharmaceutical manufacturing. Clin Ther. 2018;40(6):963–72.
DiMasi JA, Wilkinson M. Assessing the Financial Impact of Translational Pharmaceutics®: A Platform for Accelerating Product Development. Tufts CSDD White Paper, Oct 30, 2019. https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5db98c66888fb410bd326071/1572441204699/Tufts+CSDD+Study_White+Paper+on+Translational+Pharmaceutics.pdf Accessed 13 Feb 2020.
Lobo ED, Argentine MD, Sperry DC, et al. Optimization of LY545694 tosylate controlled release tablets through pharmacoscintigraphy. Pharm Res. 2012;29:2912. https://doi.org/10.1007/s11095-012-0798-1.
Cheeti S, Hou HH, Nelson E, et al. Application of a novel ‘make and test in parallel’ strategy to investigate the effect of formulation on the pharmacokinetics of GDC-0810 in healthy subjects. Pharm Res. 2018;35:233. https://doi.org/10.1007/s11095-018-2516-0.
Moreno O, Butler T, Zann V, Wilson A, Leung P, Connor A. Safety, pharmacokinetics, and pharmacodynamics of ME-401, an oral, potent, and selective inhibitor of phosphatidylinositol 3-kinase P110∂, following single ascending dose administration to healthy volunteers. Clin Ther. 2018;40(11):1855–67. https://doi.org/10.1016/j.clinthera.2018.09.006.
Angi R, Solymosi T, Erdősi N, Jordan T, Kárpáti B, Basa-Dénes O, Ujhelyi A, McDermott J, Roe C, Mair S, Ötvös Z, Molnár L, Glavinas H. Preparation, pre-clinical and clinical evaluation of a novel rapidly absorbed celecoxib formulation. AAPS PharmSciTech. 2019;20:90. https://doi.org/10.1208/s12249-018-1270-2.
Grass GM, Sinko PJ. Physiologically-based pharmacokinetic simulation modelling. Adv Drug Deliv Rev. 2002;54:433–51.
Musther H, Olivaris-Morales A, Hatley OJD, Liu B, Hodjegan AR. Animal versus human oral drug bioavailability: do they correlate? Eur J Pharm Sci. 2014;57:280–91.
Sacks LV, Shamsuddin HH, Yasinkaya YI, Bouri K, Lanthier ML, Sherman RE. Scientific and regulatory reasons for delay and denial of FDA aapproval of initial applications for new drugs, 2000–2012. JAMA. 2014;311(4):378–84.
Berndt ER, Nass D, Kleinrock M, Aiken M. Decline in economic returns from new drugs raises questions about sustaining innovations. Health Aff. 2015;34(2):245–52.
Chit A, Grootendorst P. The effect of government policy on pharmaceutical innovation, in Oxford Research Encyclopedias: Health Economics, Public Economics and Policy. 2019. https://doi.org/10.1093/acrefore/9780190625979.013.77.
This project was supported, in part, by a grant from Quotient Sciences, Inc. The research, writing, and analysis for this article were conducted independently by the authors.
Conflict of interest
The Tufts Center for the Study of Drug development (CSDD) is funded in part by unrestricted grants from pharmaceutical and biotechnology firms, as well as companies that provide related services (e.g., contract research, consulting, and technology firms) to the research-based industry. Tufts CSDD’s financial disclosure statement can be found here: https://csdd.tufts.edu/about/financial_disclosure.
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DiMasi, J.A., Wilkinson, M. The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00172-w
- Drug development time
- Biopharmaceutical R&D cost
- Biopharmaceutical net returns
- Flexible dosage design
- Real-time manufacturing