News & Events

• April 5, 2022
  

  C-Path Receives Qualification Opinion from EMA on Type 1 Diabetes Biomarker Initiative

  TUCSON, Ariz., April 5, 2022 — Critical Path Institute’s (C-Path) Type 1 Diabetes Consortium (T1DC) today announced that the European Medicines Agency (EMA) has issued a positive qualification opinion for pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) prevention trials. The purpose of this model-based qualification is to make publicly available tools...
• March 28, 2022
  

  C-Path is proud to share our responses to the FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

  The Clinical Outcomes Assessment (COA), Critical Path for Parkinson’s Digital Drug Development (3DT) Initiative, and Type 1 Diabetes (T1D) Consortia all contributed to this effort, resulting in a combined set of comments on behalf of C-Path. By bringing together stakeholders across industry, regulatory agencies, patient groups, academic researchers and clinicians, disease foundations and other organizations...
• May 25, 2021
  

  C-Path Virtual Workshop to Feature Latest Advances in Clinical Trials for T1D

  More than 300 Attendees and 20 Speakers Are Expected to Participate in the International Workshop, June 15-16

  TUCSON, Ariz., May 25, 2021 — Critical Path Institute (C-Path) today announced its schedule for the Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development Workshop, to be held virtually June 15-16. Together with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and in collaboration with Benaroya Research Institute, INNODIA and JDRF, this 2-day public workshop will focus on the implementation of endpoints and outcome measures for clinical trials in new onset type 1 diabetes (T1D). More than 300 researchers, pharmaceutical representatives, academia members, investigators, T1D patients and regulatory experts from throughout the United States and Europe are expected to gather virtually to hear 15 presentations about T1D research and medical product development.

• 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.

• April 28, 2020
  

  C-Path Receives Letter of Support from EMA on Type 1 Diabetes Biomarker Initiative

  The Critical Path Institute (C-Path) today announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to diagnose T1D: insulin autoantibodies, glutamic acid decarboxylase 65, and insulinoma antigen-2 autoantibodies as enrichment biomarkers for T1D clinical trials.