News & Events

• July 21, 2021
  

  WEBINAR | How RDCA-DAP Can Help Inform Optimal Trial Design in Progressive Rare Disease

  When: July 21, 2021, 12 p.m. ET

  Case Study: Northstar Ambulatory Assessment as an outcome assessment in Duchenne muscular dystrophy

  Presenters: Varun Aggarwal, PhD, Director, Statistical and Mathematical Medicine, Quantitative Medicine; Kevin Krudys, PhD, Office of Clinical Pharmacology, FDA

  RDCA-DAP team: Jeff Barrett, PhD, FCP, Senior Vice President, RDCA-DAP Lead; Alexandre Bétourné, PhD, PharmD, Scientific Director, RDCA-DAP

• June 15, 2021 - June 16, 2021
  

  Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development

  Critical Path Institute invites you to the upcoming free virtual workshop, Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development, June 15-16, 2021. The purpose of this scientific workshop is to discuss the existing evidence regarding the role of C-peptide in clinical trials intended to support regulatory decision making, unique regulatory considerations...
• June 14, 2021
  

  Register Now | RDCA-DAP Webinar Series: Value of Integrated Data and Analytics in Rare Disease Drug Development

  When: June 16, 2021, 12 p.m. ET

  Case Study: Modeling disease progression in polycystic kidney disease to inform trial design

  Presenters: Rhoda Muse, PhD, Scientist 1, Quantitative Medicine; Klaus Romero, MD, MS, FCP, Chief Science Officer and Executive Director of Clinical Pharmacology; Jackson Burton, PhD, Executive Director, Quantitative Medicine

  RDCA-DAP Team: Jeff Barrett, PhD, FCP., Senior Vice President, RDCA-DAP Lead; Alexandre Bétourné, PhD, PharmD, Scientific Director, RDCA-DAP

• May 26, 2021
  

  PSTC 15-year Anniversary Webinar Series

  Join scientists from PSTC member companies, health authorities and other key opinion leaders during the PSTC 15-year Anniversary Webinar Series where they will share information about collaborative cutting-edge science taking place within the consortium’s working groups and engage in discussion on the complexities and opportunities surrounding safety biomarkers and biomarker qualification. Each webinar in the...
• May 25, 2021
  

  C-Path Virtual Workshop to Feature Latest Advances in Clinical Trials for T1D

  More than 300 Attendees and 20 Speakers Are Expected to Participate in the International Workshop, June 15-16

  TUCSON, Ariz., May 25, 2021 — Critical Path Institute (C-Path) today announced its schedule for the Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development Workshop, to be held virtually June 15-16. Together with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and in collaboration with Benaroya Research Institute, INNODIA and JDRF, this 2-day public workshop will focus on the implementation of endpoints and outcome measures for clinical trials in new onset type 1 diabetes (T1D). More than 300 researchers, pharmaceutical representatives, academia members, investigators, T1D patients and regulatory experts from throughout the United States and Europe are expected to gather virtually to hear 15 presentations about T1D research and medical product development.