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.
May 26, 2021 – 10:00 AM US ET
Clinical Kidney Safety Biomarker, Composite Measure
Presenters and Panelists: Stefan Sultana, MD; Warren Glaab, PhD; Gary Friedman, MD, MS; Aliza Thompson, MD, MS; Steve Piccoli, PhD; and, John-Michael Sauer, PhD
C-Path’s Predictive Safety Testing Consortium (PSTC) invites you to this free webinar, the first in its 15th anniversary educational webinar series, to explore the clinical kidney safety biomarker composite measure qualified by the U.S. Food and Drug Administration in 2018 to aid drug developers in detecting kidney tubular injury in phase 1 clinical trials. Pre-recorded presentations will provide an overview of the biomarker, discuss how the biomarker is applied during drug development, explore case examples from recent studies, and offer insights into emerging and future work in kidney safety biomarkers. On May 26 at 10:00 AM US EDT, presenters and panel members will engage in real-time discussion about clinical kidney safety biomarkers, the role of these biomarkers in drug development, and the regulatory impact of biomarker qualification. Ample time will be provided for attendees to ask questions and engage in discussion.
|Introduction to Urinary Kidney Safety Biomarkers for the Detection of Drug-induced Kidney Injury||John-Michael Sauer, Critical Path Institute (C-Path)|
|Stefan Sultana, AstraZeneca|
|Stefan Sultana, AstraZeneca
Warren Glaab, Merck Co., Inc.
|Future Work to Advance Utilization of Biomarker Panels: Reaching Beyond Phase 1 Study Application||Gary Steven Friedman, Pfizer PSTC Representative|
Live: May 26, 2021
John-Michael Sauer, C-Path
Aliza Thompson, U.S. FDA
Stefan Sultana, AstraZeneca
Warren Glaab, Merck Co., Inc.
Gary Friedman, Pfizer
Steven Piccoli, Sun Pharmaceutical Advanced Research Center
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 NOTE DATE CHANGE
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