Pharma Panel Discussion

Moderators: Chris Bowman (Pfizer), Ron Wange (Aclairo).

Panelists:

• Regulators: Eryn Dixon (US FDA); Peter Theunissen (CBG-MEB); Fumito Mikashima (PMDA)
• Industry: Kimberly Brannen (Merck); Dinesh Stanislaus (GSK)
• Developers: Jessica Palmer (Stemina), Amer Jamalpoor (Toxys), Arantza Muriana (BioBide)

Chemical Panel Discussion

Moderators: Athena Keene (Afton Chemical), Brian Johnson (Michigan State University)

Panelists:

• Regulators: US EPA: Liz Mendez (US EPA), Tomas Sobanski (ECHA, tentative), Judy Choi and/or Marta Barenys (BfR)
• Industry: Enricha Bianchi (Corteva), Athene Keene (Afton), Nicola Powles-Glover (Exxon), Syngenta – Louise Youngs (Syngenta), Matt Burbank (L’oreal), Iris Müller (Unilever)
• Developers: Jess Palmer (Stemina), Amer Jamalpoor (Toxys), Arantza Muriana (BioBide)
• Kristen Ryan (NIEHS, tentative)

About HESI DART NAMs Workshop

New Alternative Methodology (NAM) Testing for Developmental Toxicity (DevTox) has been used for screening purposes by pharmaceutical and chemical companies for more than 20 years. However, despite the fact that the updated regulatory guidelines for chemicals and pharmaceuticals have created some opportunities to use NAMs for DevTox testing, these have been seldomly used in regulatory submissions. This HESI DART workshop will cover perspectives from the regulatory, industry and NAM developers with focused breakout group discussions designed to help map the next actional steps and a concrete strategy on increasing regulatory confidence and accelerate NAM acceptance). While specific DevTox NAMs will be discussed, a detailed introduction to the various NAMs assays will not be part of the workshop program. Participants should have a cursory understanding of the regulatory framework for DevTox testing and available assays.

You can visit the event website here to learn more.

For an overview on our assays portfolio, you can visit our services and products page. We are happy to tell you more about them at the event.