More than 300 Attendees and 20 Speakers Are Expected to Participate in the International Workshop,
June 15-16Continue reading→

FDA Grant Supports Use of Real-World Data to Generate Real-World Evidence in Neonates

TUCSON, Ariz., May 12, 2021 — Critical Path Institute (C-Path) and Tufts Medical Center have announced a joint venture to integrate the first patient-level clinical trial data to generate actionable real-world evidence (RWE) for neonatal drug development, from real-world neonate data (RWD). This activity, funded by a grant from the U.S. Food and Drug Administration (FDA), is being executed through a neonatal pilot project within C-Path’s International Neonatal Consortium (INC). The data sharing collaboration and transfer also marks the fastest on record for C-Path — starting with the Data Contribution Agreement negotiations and receipt of the data in three months’ time this March.Continue reading→

Dr. Jeff Barrett will lead C-Path’s RDCA-DAP initiative focusing on rare disease data sharing and accelerating therapy development.

TUCSON, Ariz. May 6, 2021 — Critical Path Institute (C-Path) today announced the appointment of Jeff Barrett, Ph.D., F.C.P., as Senior Vice President and lead for its Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP^®) initiative.Continue reading→

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→

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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→

Inish O’Doherty and Sudhir Sivakumaran will lead new programs;
Stephen Joel Coons and John-Michael Sauer move into Sr. VP roles.

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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→