News & Events

• 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...
• March 26, 2019
  

  Critical Path Instituteと医薬品医療機器総合機構、初のバイオマーカープロジェクトで協力

  アリゾナ州トゥーソン、2019年1月15日 — Critical Path Institute（C-Path）は本日、Predictive Safety Testing Consortium（PSTC）と日本の医薬品医療機器総合機構（PMDA）との対面助言の結果、8つの新規尿中腎毒性バイオマーカーについて、健康な日本人ボランティアのレベルと、健康な欧米のボランティアで得られているデータをブリッジング試験で比較するという初のアプローチについて合意に達したことを発表しました。このプロジェクトの結果は、早期の臨床試験において試験参加者の安全性を確保するための意思決定の指針として、これらのバイオマーカーの活用が役立つかどうかをPMDAが評価するための臨床的エビデンスを提供するものと期待されます。

• March 26, 2019
  

  Critical Path Institute and Japan’s Pharmaceuticals and Medical Devices Agency Collaborate on First-of-its-Kind Biomarker Project

  Aim is to generate critical data to support safety decisions made in early-stage clinical trials   TUCSON, Ariz., March 26, 2019 — Critical Path Institute (C-Path) announced today that a formal consultation between its Predictive Safety Testing Consortium (PSTC) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has resulted in an agreement on a first-of-its-kind...