Clinical Pharmacology & Therapeutics, November 2, 2018Gigi Hirsch Successfully delivering on the promise of emerging science in a world of value-driven healthcare requires that we fundamentally reengineer biomedical innovation processes … Read More
Alternative State-Level Financing for Hepatitis C Treatment—The “Netflix Model”
JAMA, October 29, 2018Mark R. Trusheim, William M. Cassidy, and Peter B. Bach Drug prices in the United States remain the highest in the world.1 New payment approaches are needed, … Read More
Improving Management of Gene and Cell Therapies: The Orphan Reinsurer and Benefit Manager (ORBM)
D. Han; D.S. Mytelka; G.L. Warren; M. Ciarametaro; M. Trusheim. PharmaExec.com, 2018 After decades of anticipation, 2017 saw the approval of the first of a new generation of durable and … Read More
Improving Management of Gene and Cell Therapies
Pharmaceutical Executive, September 10, 2018Michael Ciarametaro, Mark Trusheim, Daniel S. Mytelka, Gregory L. Warren, and Donald Han After decades of anticipation, 2017 saw the approval of the first of a … 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
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
“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