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
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
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients
Clinical Pharmacology & Therapeutics, March 2015H-G Eichler, Lg Baird, R Barker, B Bloechl-Daum, F Børlum-Kristensen, J Brown, R Chua, S Del Signore, U Dugan, J Ferguson, S Garner, W Goettsch, … 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
A community consultation survey to evaluate support for and success of the IMMEDIATE trial
Clinical Trials, April 1, 2014Joni R. Beshansky, Patricia R. Sheehan, Kenneth J. Klima, Nira Hadar, Ellen M. Vickery, and Harry P. Selker The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial … Read More