TUCSON, Ariz. and AMSTERDAM, April 26, 2023 — As an organization that generates regulatory-endorsed solutions and methodologies to accelerate drug development, Critical Path Institute (C-Path) today shared a year-in-review of its European-focused activities to advance global regulatory science.Continue reading
Author Archive: Roxan Olivas
C-Path Appoints Key Scientific Leaders to Executive Roles
TUCSON, Ariz., March 29, 2023 — Critical Path Institute (C-Path) announced today the appointment of three accomplished leaders to key executive roles within the organization. Cheryl D. Coon, Ph.D., joins C-Path as the Vice President for the Clinical Outcome Assessment (COA) Program. Shu Chin Ma, Ph.D., M.Sc., M.Phil., EMBA, has been named Vice President of Model-Informed Drug Development (MIDD) and the Quantitative Medicine (QuantMed) Program. Alexandre Bétourné, Ph.D., Pharm.D., has been promoted to Executive Director of the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP).Continue reading
C-Path Receives Letter of Support from EMA on Duchenne Muscular Dystrophy Clinical Trial Simulation Platform
TUCSON, Ariz., Jan. 25, 2023 — Critical Path Institute (C-Path) today announced that the European Medicines Agency (EMA) has issued a letter of support for the Duchenne Regulatory Science Consortium’s (D-RSC) Model-based Clinical Trial Simulation Platform for Duchenne Muscular Dystrophy (DMD).Continue reading
C-Path Receives Letter of Support from EMA for Parkinson’s Disease Clinical Trial Simulation Platform
TUCSON, Ariz., Dec. 20, 2022 — Critical Path Institute (C-Path) today announced that the European Medicines Agency (EMA) has issued a letter of support for the Critical Path for Parkinson’s (CPP) Consortium’s Model-based Clinical Trial Simulation Platform to Optimize Design of Efficacy Evaluation Studies in Parkinson’s Disease (PD).Continue reading
C-Path’s Transplant Therapeutics Consortium Receives EMA Qualification Opinion for iBox Scoring System
The iBox Scoring System is available for use in kidney transplant clinical trials as a novel secondary endpoint prognostic for allograft loss.Continue reading
C-Path and Ultragenyx Announce Data Sharing Agreement to Support Rare Disease Treatment and Novel Therapies
TUCSON, Ariz., Dec. 1, 2022 — Critical Path Institute (C-Path) and Ultragenyx Pharmaceutical, Inc., (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today announced a data sharing agreement to incorporate rare disease patient data into C-Path’s Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP®).Continue reading
C-Path and Eisai Data Sharing Collaboration to Include Lennox-Gastaut Syndrome Registry and Clinical Trial Data
TUCSON, Ariz., Nov. 2, 2022 — Critical Path Institute (C-Path) and the Eisai Co., Ltd. (Eisai) today announced a joint collaboration to significantly promote data sharing and incorporate Lennox-Gastaut Syndrome (LGS) clinical trial data, into C-Path’s Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP®).Continue reading
C-Path Appoints Neuropharmacology Expert as New Vice President – Rare and Orphan Disease Programs
Dr. Collin Hovinga will lead two public-private partnerships at C-Path — the Rare Disease Cures Accelerator Data and Analytics Platform (RDCA-DAP®) and the Critical Path for Rare Neurodegenerative Diseases (CP-RND).Continue reading