The Predictive Safety Testing Consortium (PSTC) launched its 15th anniversary celebration with a virtual public workshop. Scientists and experts from the U.S. Food and Drug Administration (FDA), the pharmaceutical industry, academia, and Critical Path Institute (C-Path) discussed PSTC’s work in the regulatory space, its current efforts in researching fluid biomarkers as predictive tools of drug-induced organ injury, the future of biomarker research, and opportunities for industry, consortia and other organizations to collaborate with PSTC to identify and qualify novel safety biomarkers for use during drug development.
| Presentations | Speakers |
|---|---|
| PSTC 2021 Workshop: Welcome | John-Michael Sauer, Critical Path Institute (C-Path) |
| PSTC 2021 Workshop: Keynote Video: Jeff Jacob | Jeff Jacob, Cancer Prevention Pharmaceuticals |
| PSTC 2021 Workshop: Keynote Video: Jon Mirsalis | Jon Mirsalis, SRI International |
| PSTC 2021 Workshop: Keynote Presentation: 15 Years and Still Ticking! | Ameeta Parekh, US FDA |
| PSTC 2021 Workshop: PSTC: A Public-Private Partnership | Nick King, C-Path |
| PSTC 2021 Workshop: The Power of Collaboration | John-Michael Sauer, C-Path |
| PSTC 2021 Workshop: The importance of PSTC to Industry | Jiri Aubrecht, Sarepta Therapeutics |
| PSTC 2021 Workshop: Q&A Panel Discussion |
Moderators: Nick King, C-Path Panelists: Ameeta Parekh, US FDA |
Following the public workshop, a series of webinars will be offered in the coming months during which scientists from PSTC member companies, health authorities and other key opinion leaders will share information about collaborative cutting-edge science taking place within the consortium’s working groups, answer questions from attendees, and engage in discussion on the complexities and opportunities surrounding safety biomarkers and biomarker qualification.
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.
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, answer questions from attendees, 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.
May 26, 2021 – 10:00 AM US ET
Clinical Kidney Safety Biomarker Composite Measure
July 28, 2021 – 10:00 AM US ET
Alternative Solutions in Safety Assessment
September 29, 2021 – 10:00 AM US ET
Biomarkers of Effect: Safety Biomarkers as Disease Biomarkers
November 3, 2021 – 10:00 AM US ET
Data Sharing—Continued Dialog on Advancing Biomarker and Drug Development
through Data Sharing: Industry, Academia and Regulatory Insights
January 26, 2022 – 10:00 AM US ET
Collaboration Begets Innovation—PSTC relationships leading the way
for collaborative work outside the consortium
Registration: Click here to register for the PSTC Webinar Series
