TUCSON, Ariz., and STOCKHOLM, Sweden. December 16, 2020 — The Critical Path Institute (C-Path) and Diamyd Medical (DMYD B; Nasdaq First North Growth Market) are proud to announce their collaboration to significantly improve the scientific community’s insight into type 1 diabetes (T1D) through Diamyd Medical’s contribution of fully anonymized data from a European Phase III trial to the Trial Outcome Markers Initiative (TOMI-T1D) integrated database. The Phase III trial evaluated the use of the diabetes vaccine Diamyd®, an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. The Data Contribution Agreement (DCA) between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project.Continue reading→

DUBLIN, Ireland, December 3, 2020 — Critical Path Institute, Ltd. (C-Path, Ltd.) announced today a new contract with the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). The new project will leverage C-Path’s global expertise in developing novel product development tools.Continue reading→

TUCSON, Ariz., December 2, 2020 — The Critical Path Institute (C-Path) today announced it has been awarded a U.S. Food and Drug Administration (FDA) contract in support of the development of open-source tools to improve the efficiency of trial design for three neuroscience diseases: Alzheimer’s disease (AD), Parkinson’s disease (PD) and Duchenne muscular dystrophy (DMD). C-Path’s Quantitative Medicine (QuantMed) Program will carry out the project through its work in collaboration with its three C-Path Public-Private Partnerships: the Critical Path for Alzheimer’s Disease (CPAD), the Critical Path for Parkinson’s (CPP) and the Duchenne Regulatory Science Consortium (D-RSC).Continue reading→

CPAD will partner with ADDI to build better tools for researchers around the world to access, use and share dementia-related data to accelerate the development of new and more effective treatments for Alzheimer’s disease

TUCSON, Ariz., November 17, 2020 — The Critical Path Institute’s (C-Path) Critical Path for Alzheimer’s Disease (CPAD) Consortium today announced its participation as a Partner with the Alzheimer’s Disease Data Initiative (ADDI), a 501(c)(3) medical research organization which launched today. ADDI is dedicated to advancing scientific breakthroughs in the treatment of Alzheimer’s disease (AD) and related dementias.Continue reading→

Pilot project will include the development of a Real-World Data and Analytics Platform

TUCSON, Ariz., October 27, 2020 — Arizona-based Critical Path Institute (C-Path) is pleased to announce it has been awarded a multi-year grant by the U.S. Food and Drug Administration (FDA) to advance standards and methodologies designed to generate real-world evidence (RWE) from real-world data (RWD) through a neonatal pilot project through the International Neonatal Consortium (INC).Continue reading→

C-Path, NORD, FDA and more come together to showcase the importance of data sharing in rare disease drug development

TUCSON, Ariz. and WASHINGTON, D.C. October 21, 2020 — The Critical Path Institute (C-Path) and the National Organization for Rare Disorders (NORD^®) hosted the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) 2020 Virtual Workshop on Monday, October 19. The platform, funded by a cooperative agreement through the U.S. Food and Drug Administration (FDA), serves as a centralized and standardized infrastructure to support data sharing and data analysis to aid in the understanding of rare diseases.Continue reading→

September is National Sickle Cell Awareness Month

TUCSON, Ariz., Sept. 17, 2020 — The Critical Path Institute (C-Path) today announced the launch of the Critical Path for Sickle Cell Disease (CP-SCD) Consortium to support collaboration and regulatory endorsement of new medical product development tools for sickle cell disease. These tools will help to optimize and de-risk clinical trials to increase efficiency in developing and delivering safe, effective treatments for people living with sickle cell disease.Continue reading→

Safety biomarkers aim to provide an additional tool for detecting acute drug-induced skeletal muscle injury in phase 1 clinical trials.

TUCSON, Ariz., July 22, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) issued a positive response to the Letter of Intent (LOI) developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC), for a panel of four safety biomarkers of acute drug-induced skeletal muscle injury.

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Biomarker aims to provide an additional tool for detecting the onset of hepatic injury in clinical trials involving patients with inherited muscle disorders.

TUCSON, Ariz., July 21, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) from the U.S. Food and Drug Administration (FDA) issued a positive response to the Qualification Plan (QP) for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury (DILI), developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC).

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