When: November 3, 2021 – 10 a.m. US ET
C-Path’s Predictive Safety Testing Consortium (PSTC) invites you to this free webinar, the second in its 15th anniversary educational webinar series, to explore the use of safety biomarkers as disease and/or efficacy biomarkers. Pre-recorded presentations will provide an examples of safety biomarkers being explored as disease/efficacy biomarkers throughout Industry, the translational potential of safety biomarkers, and offer a regulatory perspective on the use of safety biomarkers in a translational approach. On November 3 at 10:00 AM US EDT, presenters and panel members will engage in real-time discussion about the expanded use of safety biomarkers, the role these biomarkers play in drug development decision making, and the regulatory impact and future of safety biomarkers. Ample time will be provided for attendees to ask questions and engage in discussion.
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 series will include pre-recorded presentations available to attendees for two weeks prior to the webinar event date. The webinar will then begin with a short summary of the presentations, followed by a live panel discussion comprised of the presenters, PSTC and C-Path members and staff, regulatory agency representatives and others.
The webinars are open to all who have an interest in translational and safety sciences, including PSTC member companies, industry, consortia, academic scientists, and health authorities. A list of these webinars is provided below.
Register Now button hyperlink to for the PSTC Webinar Series
| Presentation | Speakers |
|---|---|
| Biomarkers of Effect: Defining the relationship of safety biomarkers and disease biomarkers with respect to biomarker qualification | John-Michael Sauer, Critical Path Institute (C-Path) |
| GLDH: A journey from biomarker qualification to improving medical care | Jiri Aubrecht, Sarepta Therapeutics |
| SKM biomarkers in drug-induced and disease-related muscle injury: Yesterday and Tomorrow | Tanja Zabka, Genentech |
| Biomarker Discovery: Detection of Injury, Recovery from Injury, to Response to Intervention | Gary Steven Friedman, Pfizer PSTC Representative |
| Q&A/Panel Discussion |
Moderator: Nicholas King, C-Path Panelists: John-Michael Sauer, C-Path Jiri Aubrecht, Sarepta Therapeutics Tanja Zabka, Genentech Ameeta Parekh, U.S. FDA Jeffrey Siegel, U.S. FDA Terina Martinez, C-Path Deidre Dalmas, GlaxoSmithKline Warren Glaab, Merck Co., Inc. |
