QuintilesIMS, May 2017Jon Resnick In Europe, the concept of ‘adaptive pathways’ offers a faster route to critical medicines for patients with highest unmet needs through an iterative process of early … Read More
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities
Clinical Pharmacology & Therapeutics, December 1, 2016C. Bouvy, P. Jonsson, C. Longson, N. Crabb, and S. Garner Adaptive pathways for medicines have gained momentum and, in Europe, adaptive pathways have … Read More
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
Therapeutic Innovation & Regulatory Science, December 10, 2015Duane Schulthess, Lynn G. Baird, Mark Trusheim, Thomas F. Unger, Murray Lumpkin, Anton Hoos, Sarah Garner, Pamela Gavin, Michel Goldman, Nathalie Seigneuret, Magda … Read More
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients
Clinical Pharmacology & Therapeutics, March 2015H-G Eichler, Lg Baird, R Barker, B Bloechl-Daum, F Børlum-Kristensen, J Brown, R Chua, S Del Signore, U Dugan, J Ferguson, S Garner, W Goettsch, … Read More
Adaptive pathways: a future approach to bring new medicines to patients?
Scientists argue that scientific and political changes will make adaptive pathways the preferred approach to make new treatments available “Adaptive pathways should be the preferred approach in the near future … Read More
The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions
Health Policy and Technology, December 1, 2014Mark R. Trusheim, Lynn G. Baird, Sarah Garner, Robyn Lim, Nitin Patel, and Gigi Hirsch Successfully advancing Adaptive Licensing requires coordinated planning and action … Read More
Legal Foundations of Adaptive Licensing
Clinical Pharmacology & Therapeutics, September 1, 2013Oye, L. G. Baird, A. Chia, S. Hocking, P. B. Hutt, D. Lee, L. Norwalk, and V. Salvatore In April 2012, MIT’s Center for … Read More
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
Therapeutic Innovation & Regulatory Science, July 1, 2013Lynn G. Baird, Mark R. Trusheim, Hans-Georg Eichler, Ernst R. Berndt, and Gigi Hirsch This study evaluates whether an adaptive development and licensing … Read More
Adaptive licensing: taking the next step in the evolution of drug approval
Clinical Pharmacology and Therapeutics, March 2012H.-G. Eichler, K. Oye, L. G. Baird, E. Abadie, J. Brown, C. L. Drum, J. Ferguson, S. Garner, P. Honig, M. Hukkelhoven, J. C. W. … Read More