The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing

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.

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Notes

  1. 1.

    The company is Quotient Sciences and its development platform is referred to as Translational Pharmceutics®

  2. 2.

    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).

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Acknowledgements

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.

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Authors

Contributions

JAD designed the study. JAD and MW constructed study datasets. JAD analyzed the data. JAD and MW contributed to writing the manuscript.

Corresponding author

Correspondence to Joseph A. DiMasi PhD.

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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

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Keywords

  • Drug development time
  • Biopharmaceutical R&D cost
  • Biopharmaceutical net returns
  • Flexible dosage design
  • Real-time manufacturing