News & Events
May 14, 2020
Serum Glutamate Dehydrogenase Activity Enables Early Detection of Liver Injury in Subjects with Underlying Muscle Impairments
King, Amy C. Porter, Jane Owens, et al. “Serum Glutamate Dehydrogenase Activity Enables Early Detection of Liver Injury in Subjects with Underlying Muscle Impairments.” PloS One 15, no. 5 (2020): e0229753. https://doi.org/10.1371/journal.pone.0229753.
April 10, 2020
ePRO Consortium Announces COVID-19 Risk Assessment and Mitigation Strategies for Sponsors and eCOA Providers for Collection of PRO Data through Clinical Sites
In collaboration with C-Path’s PRO Consortium, the ePRO Consortium has developed the presentation titled “Coronavirus Disease 2019 (COVID-19): Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome (PRO) Data through Clinical Sites.” This presentation focuses on the current challenges of capturing PRO data originally intended to be collected electronically (i.e., ePRO) from study participants during in-person visits to study sites. Recommended risk assessment and mitigation strategies for consideration by trial sponsors and eCOA providers to facilitate the continued collection of PRO data in clinical trials are provided.
September 9, 2019 - September 10, 2019
Solutions to Drug Development Challenges Workshop: Utilizing Quantitative Approaches, Data Sharing, and Novel BiomarkersTitle Presenter Presentation Link Introduction Dr. John-Michael Sauer (C-Path) Keynote Address Dr. Joseph Scheeren (C-Path) Welcoming Remarks Dr. Janet Woodcock (US FDA) Session 2: Benefits of DDT progression to regulatory acceptance Moderators: Dr. Inish O’Doherty (C-Path) and Dr. Ameeta Parekh (US FDA) 2.1 A perspective on the history and evolution of drug development......
September 17, 2018
Critical Path Institute and SIGNATOPE GmbH Team Up to Advance Research on Biomarkers for Drug-induced Organ InjuriesTUCSON, Ariz. and REUTLINGEN, September 17, 2018 — Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) and SIGNATOPE GmbH are excited to announce a new project, joining efforts on analyzing and qualifying promising protein safety biomarkers in mouse, rat, dog, monkey, and human. The work is expected to increase understanding of drug-induced toxicities......
June 28, 2018
Parent Project Muscular Dystrophy (PPMD) 2018 Annual ConferenceJane Larkindale, Executive Director of D-RSC, attended the Parent Project Muscular Dystrophy (PPMD) 2018 Annual Conference in Scottsdale, AZ on June 28 – July 1. She participated on a panel, Today’s Tomorrow: Looking at the Future and presented two posters: Accelerating drug development: data sharing and developing quantitative tools through the Duchenne Regulatory Science Consortium (D-RSC)......