When: August 25, 2021, 10 – 11:30 a.m. 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 alternative solutions in safety assessment in drug development, including microphysiological systems (MPS) and In Vitro models. Pre-recorded presentations will provide an overview of current alternatives being used throughout Industry, highlight how alternative solutions are being investigated for use within specific PSTC working group studies and collaborations, offer a regulatory perspective on these alternatives, and offer insights into emerging and future work in this area. Presenters and panel members will engage in real-time discussion about these alternative solutions, the role of these emerging alterative play in drug development decision making, and the regulatory impact and future of alternative solutions such as MPS and various In Vitro models. Ample time will be provided for attendees to ask questions and engage in discussion.
Presenters:
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.
| Presentation | Speakers |
|---|---|
| Application of Complex In Vitro Models in Discover and Development | Deidre Dalmas, GlaxoSmithKline |
| PSTC Nephrotoxicity Working Group in the in vitro space | Lauren Lewis, Takeda |
| Understanding the Utility of Complex In Vitro Models in Therapeutic Development | Madhu Lal-Nag, US FDA |
| Q&A/Panel Discussion |
Moderator:
Nicholas King, C-Path
Panelists: Deidre Dalmas, GlaxoSmithKline Shuyan Lu, Johnson & Johnson Warren Glaab, Merck Co., Inc. Keith Tanis, Merck Co., Inc. Lauren Lewis, Takeda Madhu Lal-Nag, U.S. FDA |
