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
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
NEWDIGS convenes healthcare leaders to pioneer new pharmaceutical financing strategies
CAMBRIDGE, Mass., Oct. 27, 2016 — Patient advocates, healthcare payers, industry, and academic stakeholders gathered today at the Massachusetts Institute of Technology (MIT) to map out a new strategy for … Read More
“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?
Clinical Pharmacology & Therapeutics, September 21, 2016Hans-Georg Eichler A central question in the assessment of benefit/harm of new treatments is: how does the average outcome on the new treatment (the … Read More