TUCSON, Ariz., April 26, 2021 — Critical Path Institute (C-Path) has named Amanda J. Borens, M.S., as Executive Director of Data Science within C-Path’s Data Collaboration Center (DCC), and Jackson Burton, Ph.D., as Executive Director of C-Path’s Quantitative Medicine Program.Continue reading
Author Archive: Roxan Olivas
C-Path Opens Access to Duchenne Regulatory Science Consortium Database
Database will allow sharing of individual-level data with the goal of accelerating therapy development for Duchenne muscular dystrophy
TUCSON, Ariz., April 22, 2021 — Critical Path Institute (C-Path) announced today that it will open access to the Duchenne Regulatory Science Consortium (D-RSC) database to qualified researchers, through its Rare Disease Cures Accelerator, Data and Analytics Platform (RDCA-DAP®). The D-RSC database includes data from Duchenne muscular dystrophy (DMD) clinical trials, natural history studies and clinical data collections. The contributors of these datasets have given permission for this data to be shared externally to accelerate therapy development for DMD.
C-Path Names COO Kristen Swingle Interim President
Joseph Scheeren departing the organization after two years of strong leadership
TUCSON, Ariz., March 19, 2021 — Critical Path Institute (C-Path) today announced that its Chief Operating Officer Kristen Swingle, M.S., has been appointed Interim President, effective immediately. Kristen succeeds Joseph Scheeren, Pharm.D., C-Path’s President and Chief Executive Officer since April 2019. Scheeren cited personal reasons for stepping down after stewarding C-Path through an important time of transformation, which has seen the organization add multiple new programs and its staff more than double.Continue reading
C-Path Program and Consortia Leaders Selected to Serve in Sr. Vice President and Vice President Roles
Inish O’Doherty and Sudhir Sivakumaran will lead new programs;
Stephen Joel Coons and John-Michael Sauer move into Sr. VP roles.
C-Path Receives FDA Qualification for the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C)
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
C-Path and Global Partners Launch Ataxia Consortium
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
C-Path Appoints Co-Directors to CURE Drug Repurposing Collaboratory Advisory Committee
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
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.
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.
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