When there is substantial uncertainty about a new product’s expected value, stakeholders may have strong reasons to consider performance-based contracts. One of the hardest tasks in crafting such contracts is … Read More
Role of COE networks in curative cellular oncology therapies
COE networks currently play an important role in the delivery of care for specialized service lines, including but not limited to solid organ transplantation (SOT), hematopoietic cell transplantation (HCT) and … 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
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
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Clinical Pharmacology & Therapeutics, September 14, 2016G Hirsch, M Trusheim, E Cobbs, M Bala, S Garner, D Hartman, K Isaacs, M Lumpkin, R Lim, K Oye, E Pezalla, P Saltonstall, … Read More
The next frontier: Fostering innovation by improving health data access and utilization
Clinical Pharmacology & Therapeutics, November 1, 2015A. Oye, G. Jain, M. Amador, R. Arnaout, J. S. Brown, W. Crown, J. Ferguson, E. Pezalla, J. A. Rassen, H. P. Selker, M. … Read More
Accelerated Access to Innovative Medicines for Patients in Need
Clinical Pharmacology & Therapeutics, November 1, 2014G. Baird, R. Banken, H.-G. Eichler, F. B. Kristensen, D. K. Lee, J. C. W. Lim, R. Lim, C. Longson, E. Pezalla, T. Salmonson, … Read More
Access and availability of orphan drugs in the United States: advances or cruel hoaxes?
Expert Opinion on Orphan Drugs, November 1, 2014Russell Teagarden, Thomas F. Unger, and Gigi Hirsch The Orphan Drug Act of 1983 in the United States collapsed the barrier between patients … Read More
Drug Safety Futures 2020
Healthcare reforms currently unfolding in the United States are driving the marketplace toward a more value-based system designed to optimize health outcomes per dollar expended. Such a system has major … Read More