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
MIT’s NEWDIGS Launches New Program in Healthcare Data
The inaugural meeting of the NEWDIGS Data Program was held in January 2015, and brought together international experts from academia, government, information technology, and the healthcare sector. A series of … Read More
Adaptive pathways: a future approach to bring new medicines to patients?
Scientists argue that scientific and political changes will make adaptive pathways the preferred approach to make new treatments available “Adaptive pathways should be the preferred approach in the near future … 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
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