In a broad survey, payers favor performance based milestone contracts and risk pools strategies to absorb the surge of high cost gene therapy products expected to enter the market over … 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
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
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
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms
Clinical Pharmacology & Therapeutics, September 19, 2016Trusheim, Aa. Shrier, Z. Antonijevic, Ra. Beckman, Rk. Campbell, C. Chen, Kt. Flaherty, J. Loewy, D. Lacombe, S. Madhavan, Hp. Selker, and Lj. Esserman … Read More
The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions
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
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
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
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