Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development

Therapeutic Innovation & Regulatory Science
Lynn G BairdGigi Hirsch

Abstract

This study evaluates whether an adaptive development and licensing approach to drug development, compared with approaches widely used today, might have tangible advantages across stakeholder groups, thereby facilitating the future adoption. Details involving actual and modeled clinical development and licensing programs for 3 case studies were used as inputs into a discounted cash flow spreadsheet model. Outputs included net present value and expected net present value, which are metrics considered as key incentives for pharmaceutical developers, and change in patient access over the product life and numbers of appropriately and inappropriately treated patients, which are metrics considered as key incentives for regulators, patients, and prescribers. Actual and modeled development programs were compared using an "adaptiveness" scoring algorithm. Generally, the more adaptive programs correlated with more favorable stakeholder outcomes. However, favorable outcomes may be overwhelmed in some cases, and the causative conditions and stakeholder reactions need to be defined.

References

Dec 3, 2005·Science·Rudi Ansbacher
Sep 13, 2008·Nature Reviews. Drug Discovery·Hans-Georg EichlerAlasdair Breckenridge
Oct 28, 2011·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Zahra HanaiziFrancesco Pignatti
Feb 3, 2012·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Carlotta FranchiAlessandro Nobili
Feb 18, 2012·Clinical Pharmacology and Therapeutics·H-G EichlerG Hirsch

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Citations

Jun 13, 2014·International Journal of Technology Assessment in Health Care·Don HusereauJamil Jivraj
May 1, 2016·Therapeutic Innovation & Regulatory Science·Duane SchulthessGigi Hirsch
Mar 6, 2015·Journal of Comparative Effectiveness Research·Adrian TowseDonna A Messner
Aug 1, 2014·International Journal of Technology Assessment in Health Care·David Grainger
Oct 21, 2016·Clinical Pharmacology and Therapeutics·M R TrusheimL J Esserman

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Software Mentioned

Zelboraf
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Excel

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