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
NICE announces collaboration with NEWDIGS
NICE (the UK National Institute for Health and Care Excellence) has joined a global group of organisations whose goal is to speed up the development and delivery of new, effective … 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
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
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