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
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
Stop-Loss Insurance or Reinsurance for Multiyear Contracts
In previous Research Briefs, we have discussed challenges faced by payers when contemplating using multiyear performance-based contracts. In this brief, we extend the discussion to include additional difficulties that may … Read More
Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop
Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine, March 8, 2017 Read the meeting … 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
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 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
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
Adaptive licensing: taking the next step in the evolution of drug approval
Clinical Pharmacology and Therapeutics, March 2012H.-G. Eichler, K. Oye, L. G. Baird, E. Abadie, J. Brown, C. L. Drum, J. Ferguson, S. Garner, P. Honig, M. Hukkelhoven, J. C. W. … Read More
Catalyzing the Transformation of Healthcare Innovation
The expectations of the pharmaceutical industry are high. We look to the drug makers to find cures to our diseases, to relieve us from pain or discomfort, to ease the … Read More