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
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
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
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
Therapeutic Innovation & Regulatory Science, December 10, 2015Duane Schulthess, Lynn G. Baird, Mark Trusheim, Thomas F. Unger, Murray Lumpkin, Anton Hoos, Sarah Garner, Pamela Gavin, Michel Goldman, Nathalie Seigneuret, Magda … Read More
The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics
Drug Discovery Today, December 1, 2015Mark R. Trusheim and Ernst R. Berndt The stratified medicine companion diagnostic (CDx) cut-off decision integrates scientific, clinical, ethical, and commercial considerations, and determines its … Read More