News & Events

• September 8, 2022
  

  C-Path’s Kristen Swingle Named President

  Swingle joined C-Path in 2019 and was named interim president in 2021 TUCSON, Ariz., Sept. 8, 2022 — Critical Path Institute (C-Path) today announced that its Chief Operating Officer (COO) and Interim President, Kristen Swingle, M.S., has been named COO and President, effective immediately. Swingle has filled the interim President role since 2021, stewarding C-Path...
• November 10, 2021
  

  C-Path Promotes Nick King and Emily Turner to Executive Directors

  Critical Path Institute (C-Path) today announced it has promoted Nicholas King, M.S., as Executive Director of its Predictive Safety Testing Consortium (PSTC) and Emily Turner, Ph.D., as Executive Director of the Huntington’s Disease Regulatory Science Consortium (HD-RSC).

• July 22, 2020
  

  C-Path’s PSTC, D-RSC Receive Positive FDA Response for Drug-Induced Skeletal Muscle Injury Biomarkers

  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.

• July 21, 2020
  

  C-Path’s PSTC, D-RSC Receive Positive FDA Response to Plan for Liver Safety Biomarker

  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).

• June 11, 2019
  

  C-Path’s PSTC Releases Points to Consider Outlining Recommendations for Analytical Validation of Assays Used in Qualifying Biomarkers

  The document serves as a guide to the analysis of biomarkers in drug development   TUCSON, Ariz., June 11, 2019 — The Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) has released a new consensus paper titled, “Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the...