Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997–2020)

Eric NormanJuly 7, 2021FoCUS, Publications

Ivica NA, Young CM. Healthcare. 2021; 9(8):1062. Chimeric antigen receptor and T-cell receptor (CAR-T/TCR-T) cellular immunotherapies have shown remarkable success in the treatment of some refractory B-cell malignancies, with potential … Read More

Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop

Eric NormanMarch 8, 2017Publications

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

The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions

Eric NormanDecember 1, 2014Adaptive Licensing, Publications

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

Legal Foundations of Adaptive Licensing

Eric NormanSeptember 1, 2013Adaptive Licensing, Publications

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

Eric NormanAugust 28, 2013Publications

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

Eric NormanJuly 1, 2013Adaptive Licensing, Publications

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

Eric NormanMarch 24, 2012Adaptive Licensing, Publications

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

The future of drug development: advancing clinical trial design

Eric NormanDecember 1, 2009Publications

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