C-Path Announces SHIP-MD 2021 Virtual Workshop

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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Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim

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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C-Path and Diamyd Medical Announce Data Sharing Collaboration to Develop Advanced Drug Development Tools in Type 1 Diabetes

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

C-Path Quantitative Medicine Program Awarded FDA Contract to Develop Tools for Neuroscience Diseases

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

Alzheimer’s Disease Data Initiative Launches, Critical Path for Alzheimer’s Disease Consortium to Partner

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

Pediatric IBD Foundation, ImproveCareNow, C-Path to Establish the Children’s Registry for the Advancement of Therapeutics

TUCSON, Ariz., November 5, 2020 — The Pediatric IBD Foundation, ImproveCareNow, and the Critical Path Institute (C-Path) are proud to announce a collaboration establishing the Children’s Registry for the Advancement of Therapeutics (CREATE™). CREATE™ is a drug-agnostic safety registry designed to support the completion of global post-marketing safety requirements, as well as collect safety information on all therapies used in pediatric IBD patients.

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FDA Awards C-Path Grant to Use Real-World Data to Generate Real-World Evidence in Neonates

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

Rare Disease Cures Accelerator-Data and Analytics Platform First Year Milestones Highlighted at Virtual Workshop

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

C-Path Launches Consortium to Accelerate Medical Product Development in Sickle Cell Disease

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