News & Events
June 16, 2020
C-Path’s Transplant Therapeutics Consortium Receives Acceptance of Letter of Intent for iBox Scoring System (Composite Biomarker Panel) as a Reasonably Likely Surrogate Endpoint
TUCSON, Ariz., June 17, 2020 — Critical Path Institute (C-Path) announced today that its Transplant Therapeutics Consortium (TTC) has received a positive response to its Letter of Intent (LOI) from the U.S. Food and Drug Administration (FDA) detailing the decision to accept the Composite Biomarker Panel (iBox Scoring System) into the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program (BQP).
June 11, 2020
From the Regulatory Affairs Professional Society (RAPS): FDA’s CURE ID app gets a COVID-19 refresh
An online case reporting platform has been optimized for COVID-19 and will be the springboard for a new public-private drug repurposing collaboration.
The CURE ID online platform was developed to allow clinicians to report off-label uses of drugs to treat infectious diseases, with the goal of generating hypotheses for further study of difficult-to-treat infectious diseases. The internet repository of these cases can also be accessed by clinicians and other users, with the option to view aggregated datasets as well as the individual case reports. The platform can be used via a computer browser or Apple and Android-based smartphone apps. Full article here.
June 9, 2020
Webinar: FDA Drug Topics: CURE ID: Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies in the Era of COVID-19
This new webinar from the Center for Drug Evaluation (CDER), Division of Drug Information (DDI) is now available at:
The webinar is a demonstration of the CURE ID mobile app and web platform, developed by the U.S. Food and Drug Administration (FDA), in collaboration with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). CURE ID gives the global clinical community the opportunity to report novel uses of existing drugs for patients with difficult to treat infectious diseases, including COVID-19. C-Path’s CURE Drug Repurposing Collaboratory (CDRC) is working directly with the FDA and NCATS/NIH on this initiative.
- May 27, 2020
May 13, 2020
C-Path and Provention Bio Announce Data Sharing Collaboration to Develop Advanced Drug Development Tools in Type 1 Diabetes
TUCSON, Ariz., and OLDWICK, N.J. May 13, 2020 — The Critical Path Institute (C-Path) and Provention Bio, Inc. (Nasdaq: PRVB) are proud to announce their collaboration to significantly improve the scientific community’s insight into type 1 diabetes (T1D) through Provention’s contribution of data from the Phase III Protégé study of teplizumab to the T1D Trial Outcome Measures Initiative (TOMI) integrated database. The Protégé study evaluated teplizumab on the preservation of beta cell function in newly onset T1D patients and generated the largest disease modifying interventional clinical trial dataset in T1D with more than 500 patients.