News & Events
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April 15, 2019
Muscular Dystrophy Association 2019 Clinical and Scientific Conference
Jane Larkindale, Executive Director of D-RSC, attended the Muscular Dystrophy Association Clinical and Scientific Conference in Orlando, FL on April 14- April 16. She presented two posters: Development of a Clinical Trial Simulation Tool for Duchenne Muscular Dystrophy Through the Duchenne Regulatory Science Consortium Value of Skeletal Muscle Damage Biomarkers as Pharmacodynamic Biomarkers for Neuromuscular... -
April 9, 2019
C-Path Receives Qualification from FDA for the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD)
TUCSON, Ariz., April 9, 2019 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces U.S. Food and Drug Administration (FDA) qualification of two new clinical outcome assessment tools: the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD). The qualification of the ADSD and the ANSD represents a major milestone... -
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。
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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... -
March 21, 2019
C-Path Selects Global Regulatory Affairs Leader as New President and CEO
After a worldwide search, the Critical Path Institute (C-Path) today announced it has appointed Joseph Scheeren, Pharm. D., as its new President and Chief Executive Officer. Scheeren previously served as Senior Advisor Research and Development for Bayer AG and has had a distinguished 36-year career in the pharmaceutical industry having held positions domestically and internationally in drug development and regulatory approval on three continents.