FoCUS participants have identified four payer segments for precision financing: self-insured employers and related organizations; health insurance plans and managed care organizations; Medicare; and Medicaid. Download FoCUS Research Brief_2018F202-014Share the … 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
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
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 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
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
Legal Foundations of Adaptive Licensing
Clinical Pharmacology & Therapeutics, September 1, 2013Oye, L. G. Baird, A. Chia, S. Hocking, P. B. Hutt, D. Lee, L. Norwalk, and V. Salvatore In April 2012, MIT’s Center for … Read More
Curing Consortium Fatigue
Science Translational Medicine, August 28, 2013Magdalini Papadaki and Gigi Hirsch The complex pathology of consortium fatigue provides diagnostic data on how to improve collaboration in biomedical innovation. Read the publication
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
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