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From Adaptive Licensing to Adaptive Pathways: Delivering a Flexible Life-Span Approach to Bring New Drugs to Patients

Published on Mar 1, 2015in Clinical Pharmacology & Therapeutics6.336
· DOI :10.1002/cpt.59
H G Eichler8
Estimated H-index: 8
(European Medicines Agency),
Lynn G. Baird5
Estimated H-index: 5
(MIT: Massachusetts Institute of Technology)
+ 38 AuthorsGigi Hirsch7
Estimated H-index: 7
(MIT: Massachusetts Institute of Technology)
Sources
Abstract
The concept ofadaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name ofAL should be broadened.Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future.The key drivers include: growing patient demand for timely access to promising therapies, emerging scienceleading to fragmentation of treatmentpopulations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drugdevelopment. We also discuss a numberof environmental changes that will enable an adaptive paradigm.A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.
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