Regulatory and business leader will help accelerate system-wide biomedical innovation CAMBRIDGE, MASSACHUSETTS, 1 MARCH 2017—The MIT New Drug Development Paradigms Initiative (NEWDIGS) announced today that Hilary Malone, Chief Regulatory Officer … Read More
Adaptive Pathways create win-win scenarios for patients and pharma
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
Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop
Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine, March 8, 2017 Read the meeting … Read More
MIT NEWDIGS Hosts Design Lab on Clinical Trial Innovation
Biomedical Innovation Initiative Supporting New NIH-Funded Trial Innovation Center CAMBRIDGE, MASSACHUSETTS—The MIT NEW Drug Development ParadIGmS (NEWDIGS) initiative, an international biomedical innovation “think and do tank”, co-hosted an “Efficacy to … Read More
Kay Larholt joins MIT NEWDIGS as Director of Integrated Knowledge Solutions
Industry veteran will lead development of new decision support technologies CAMBRIDGE, MASSACHUSETTS—The MIT New Drug Development Paradigms Initiative (NEWDIGS) announced today the hire of Dr. Kay M. Larholt as their … Read More
OpEd: Mark Trusheim & Peter B. Bach on How the US Can Beat Hepatitis C
How the US Can Beat Hepatitis C: Don’t buy the pills, buy the company Pharma veteran and physician advance provocative solution to overcome treatment costs CAMBRIDGE, MASSACHUSETTS—In an article published … Read More
Special Issue of Clinical Pharmacology & Therapeutics spotlights Adaptive Biomedical Innovation
Expert views on strategies for getting new science to patients faster, safely, and affordably CAMBRIDGE, Mass., Nov. 9, 2016—Clinical Pharmacology & Therapeutics (CPT), a cross-disciplinary journal in experimental and clinical … Read More
Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation
Clinical Pharmacology & Therapeutics, December 1, 2016R. Stewart, P. W. Barone, A. Bellisario, C. L. Cooney, P. A. Sharp, A. J. Sinskey, S. Natesan, and S. L. Springs Despite the … Read More
Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan
Clinical Pharmacology & Therapeutics, December 1, 2016A. Oye, H. G. Eichler, A. Hoos, Y. Mori, T. M. Mullin, and M. Pearson This article describes recent developments in licensing and reimbursement … Read More
A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer
Clinical Pharmacology & Therapeutics, December 1, 2016K. Raju, K. Gurumurthi, R. Domike, D. Kazandjian, G. Blumenthal, R. Pazdur, and J. Woodcock Drug regulators around the world make decisions about drug … Read More