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A modelling framework for improved design and decision-making in drug development

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  • Stig Johan Wiklund

Abstract

The development of a new drug is an extremely high-risk enterprise. The attrition rates of development projects and the average costs for each launched product are daunting, and the completion of a development program requires a very long time horizon. These facts imply that there are huge potential gains, should one be able to improve efficiency and enhance decision-making capabilities. In this paper, we argue that substantial gains can be achieved by adapting a holistic view of drug development. Historically, too much planning, design and decision-making in the pharmaceutical development has been based on locally optimising separate parts of the development program, and too often important sources of uncertainty are ignored. We propose instead a model-based approach built on two essential pillars; (1) an integrated holistic view of the development program, including post-launch marketing and sales, with all parts evaluated simultaneously; (2) an explicit appreciation of all relevant sources of uncertainty. Computer simulations are utilised to evaluate the properties of the program options at hand, and to provide valuable quantitative decision support. Applications of this modelling approach have proven to add large value to development projects in terms of better program options being generated and more value-adding decisions taken.

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  • Stig Johan Wiklund, 2019. "A modelling framework for improved design and decision-making in drug development," PLOS ONE, Public Library of Science, vol. 14(8), pages 1-22, August.
    • Handle: RePEc:plo:pone00:0220812
    DOI: 10.1371/journal.pone.0220812
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    References listed on IDEAS

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    1. DiMasi, Joseph A. & Grabowski, Henry G. & Hansen, Ronald W., 2016. "Innovation in the pharmaceutical industry: New estimates of R&D costs," Journal of Health Economics, Elsevier, vol. 47(C), pages 20-33.
    2. Zoran Antonijevic, 2015. "Need for Optimal Design of Pharmaceutical Programs and Portfolios in Modern Medical Product Development," Springer Books, in: Zoran Antonijevic (ed.), Optimization of Pharmaceutical R&D Programs and Portfolios, edition 127, chapter 0, pages 3-16, Springer.
    3. Richard Nixon & Blair Ireland, 2015. "Using Decision Analysis to Support the Design of Clinical Trials Within a Program," Springer Books, in: Zoran Antonijevic (ed.), Optimization of Pharmaceutical R&D Programs and Portfolios, edition 127, chapter 0, pages 105-122, Springer.
    4. Cong Chen & Robert A. Beckman & Linda Z. Sun, 2015. "Maximizing Return on Investment in Phase II Proof-of-Concept Trials," Springer Books, in: Zoran Antonijevic (ed.), Optimization of Pharmaceutical R&D Programs and Portfolios, edition 127, chapter 0, pages 141-154, Springer.
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