Understanding the Utility of Complex In Vitro Models in Therapeutic Development

Presenters and panelists: Nick King, MS, Critical Path Institute; Madhu Lal-Nag, MBS, PhD, US Food and Drug Administration; Deidre Dalmas, PhD, GlaxoSmithKline; Lauren Lewis, PhD, Takeda Pharmaceuticals; Shuyan Lu, MS, Janssen Pharmaceutical Companies of Johnson & Johnson; Warren Glaab, PhD, Merck & Co., Inc.
C-Path’sPredictive 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.
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ABOUT C-PATH: Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.
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