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Adaptive Pathways create win-win scenarios for patients and pharma

Eric NormanMay 1, 2017Adaptive Licensing, Articles

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

Eric NormanDecember 1, 2016Adaptive Licensing, Articles

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

Eric NormanDecember 10, 2015Adaptive Licensing, Articles

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

Eric NormanMarch 1, 2015Adaptive Licensing, Articles

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?

Eric NormanDecember 12, 2014Adaptive Licensing, News

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

Eric NormanDecember 1, 2014Adaptive Licensing, Publications

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

Eric NormanSeptember 1, 2013Adaptive Licensing, Publications

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

Eric NormanJuly 1, 2013Adaptive Licensing, Publications

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

Eric NormanMarch 24, 2012Adaptive Licensing, Publications

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


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Center for Biomedical System Design

Our mission is to improve health outcomes by accelerating appropriate, timely, and equitable patient access to biomedical products in ways that work for all stakeholders.

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NEWDIGS Initiative

MIT Center for Biomedical Innovation
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  • About
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Tufts Medical Center NEW Drug Development ParadIGmS (NEWDIGS) is an international “think and do tank” dedicated to delivering more value faster to patients, in ways that work for all stakeholders. NEWDIGS designs, evaluates, and initiates advancements that are too complex and cross-cutting to be addressed by a single organization or market sector. Its members include global leaders from patient advocacy, payer organizations, biopharmaceuti-cal companies, regulatory agencies, clinical care, academic research, and investment firms. For more information, visit https://newdigs.tuftsmedicalcenter.org.