News & Events
May 24, 2023
Improving the Design of Clinical Trials in T1D: Analysis of Data from the Trial Outcome Markers Initiative (TOMI) CollaborationWith presentations from JDRF, TrialNet and the TOMI-T1D Collaboration The Trial Outcome Marker Initiative brings together data from many contributors in the field comprising more than 10,000 individuals with new onset T1D including 2900 from 21 different clinical trials. Analysis of C-peptide, HbA1c and as well as composite outcomes will be discussed which has provided......
June 15, 2021 - June 16, 2021
VIEW NOW | Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug DevelopmentCritical Path Institute held a free virtual workshop, Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development, June 15-16, 2021. Workshop Summary The purpose of this scientific workshop was to discuss the existing evidence regarding the role of C-peptide in clinical trials intended to support regulatory decision making, unique regulatory considerations......
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......