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
The future of drug development: advancing clinical trial design
Nature Reviews Drug Discovery, December 2009John Orloff, Frank Douglas, Jose Pinheiro, Susan Levinson, Michael Branson, Pravin Chaturvedi, Ene Ette, Paul Gallo, Gigi Hirsch, Cyrus Mehta, Nitin Patel, Sameer Sabir, Stacy … Read More
Drug Safety Futures 2020
Healthcare reforms currently unfolding in the United States are driving the marketplace toward a more value-based system designed to optimize health outcomes per dollar expended. Such a system has major … Read More