TEAMSS

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TEAMSS (Transforming Expanded Access to Maximize Support and Study) seeks to advance clinical care and translational research by improving patient access to experimental therapies. This federated, national consortium for Expanded Access interventions is a partnership led by the University of Michigan with Duke University, University of Rochester and University of Texas Southwestern.  Expanded Access provides an opportunity for patients who either lack therapeutic options or who are ineligible for clinical trials to potentially benefit from the clinical use of experimental drugs, biologics, and medical devices. By developing this national consortium, we will build a positive impact by, for the first time, creating a foundation for an integrated, nationwide approach to Expanded Access that can improve care for the most vulnerable patients.

Publications

Right now, in the right way: U. S. Food and Drug Administration’s expanded access program and patient rights - Holbein, M., Weatherwax, K., Gravelin, M., Hutchinson, R., & Mashour, G. (2018). Right now, in the right way: U. S. Food and Drug Administration’s expanded access program and patient rights. Journal of Clinical and Translational Science, 2(3), 115-117. doi:10.1017/cts.2018.318

The Critical Role of Medical Institutions in Expanding Access to Investigational Interventions - Spector‐Bagdady, Kayte, Weatherwax, Kevin J., Gravelin, Misty, and Shuman, Andrew G., “The Critical Role of Medical Institutions in Expanding Access to Investigational Interventions,” Hastings Center Report 49, no.2 ( 2019): 36– 39. doi:10.1002/hast.991

 

 

Upcoming Important Dates

Expanded Access Summit
Monday, January 27, 2020
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Introduction To Preapproval Access To Investigational Medical Products
Wednesday, November 20, 2019
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November 20, 2019, 1:30-2:30 p.m. ET, please join us for a Free webinar 

Covering non-trial access to drugs, biologics, and vaccines. The webinar will explain the two pathways for preapproval access to investigational medical products in the United States: expanded access and right to try. There will be time for questions.

To reserve your spot for this free WebEx event, please email Kelly Folkers at kelly.folkers@nyu.edu . Visit our website for more information about CUPA:

https://med.nyu.edu/departments-institutes/population-health/divisions-sections-centers/medical-ethics/research/working-group-compassionate-use-preapproval-access 

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