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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).
C-Path and Provention Bio Announce Data Sharing Collaboration to Develop Advanced Drug Development Tools in Type 1 Diabetes
The Critical Path Institute (C-Path) and Provention Bio, Inc. 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.
C-Path Appoints Two New Members to Board of Directors
Tucson-based Critical Path Institute (C-Path) today announced the appointment of two new members to its Board of Directors: James W. Newman, CPA, former Executive Chairman of Victory Pharma, Inc. and Tomas Salmonson, Ph.D., M.Sc., former Chair of the Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA).
C-Path ePRO Consortium and PRO Consortium Announce COVID-19 Risk Assessment and Mitigation Strategies
Recommendations provided for sponsors and eCOA providers to facilitate the continued collection of PRO data in clinical trials. TUCSON, Ariz., April 29, 2020 — In collaboration with Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium, the Electronic Patient-Reported Outcome (ePRO) Consortium announces “Coronavirus Disease 2019 (COVID-19): Risk Assessment and Mitigation Strategies for the Collection […]
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C-Path Successes
- >>First preclinical safety biomarkers (7) qualified by the FDA, EMA and PMDA
- >>First imaging biomarker for trial enrichment qualified by the EMA
- >>FDA and EMA reach landmark decisions on C-Path’s Simulation Tool for Alzheimer’s disease
- >>C-Path’s Alzheimer’s Disease Simulator Featured in the Wall Street Journal
- >>C-Path and CDISC partnership delivers therapeutic area standards
- >>FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
- >>EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- >>Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- >>C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- >>C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD