View Now: 2021 PSTC Virtual Workshop—March 31, 2021

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
John-Michael Sauer, C-Path

Panelists:

Ameeta Parekh, US FDA
Madhu Lal-Nag, US FDA
Jiri Aubrecht, Sarepta Therapeutics
Tanja Zabka, Genentech
Deidre Dalmas, GlaxoSmithKline
Stefan Sultana, AstraZeneca

 

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

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