TUCSON, Ariz., March 9, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces the qualification of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) by the U.S. Food and Drug Administration (FDA). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support symptom-based efficacy endpoints in clinical trials for products intended to treat constipation-predominant IBS (IBS-C) in adults. Qualification of the DIBSS-C represents a major milestone for the IBS Working Group and is the PRO Consortium’s fourth clinical outcome assessment (COA) to be qualified through the COA Qualification Program within FDA’s Center for Drug Evaluation and Research.Continue reading→

The Critical Path to Therapeutics for the Ataxias will optimize clinical trials for inherited ataxias

TUCSON, Ariz., February 26, 2021 — Critical Path Institute (C-Path) today announced the launch of the Critical Path to Therapeutics for the Ataxias (CPTA) Consortium, a public-private partnership focused on optimizing clinical trials for inherited ataxias. CPTA is a collaborative effort between C-Path, Ataxia Global Initiative, the National Ataxia Foundation, Ataxia UK and key partners in the industry and academic research communities, including Biohaven Pharmaceuticals, Ionis Pharmaceuticals, Roche Pharmaceuticals, Servier Group, Triplet Therapeutics, uniQure, and Vico Therapeutics.Continue reading→

TUCSON, Ariz., February 4, 2021 — Critical Path Institute (C-Path) today has announced the appointments of David Fajgenbaum, M.D., M.S., M.B.A., and Marco Schito, Ph.D., as co-directors of the advisory committee for C-Path’s CURE Drug Repurposing Collaboratory (CDRC) program.Continue reading→

Multi-stakeholder event will focus on national innovation ecosystem for pediatric medical device development

TUCSON, Ariz., January 14, 2021 — The Critical Path Institute (C-Path) in collaboration with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders, is proud to announce the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) Virtual Workshop to be held on February 9-11, 2021. The workshop will focus on the acceleration of medical device development for the unique needs of children.

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TUCSON, Ariz., January 7, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces that clinical study results using the Consortium’s Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) were recently included in the expanded label for the drug LINZESS^® (linaclotide). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support the evaluation of both primary and key secondary endpoints related to improvements in IBS-C signs and symptoms within the context of clinical trials and is currently in FDA’s Clinical Outcome Assessment Qualification Program. Although the DIBSS-C was not specifically mentioned, results from its abdominal symptom scale were included in the updated label for LINZESS^®. This is the first time a PRO Consortium measure has been used to support a label claim.

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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→