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Tuesday, February 11, 2025
10:00 am ET / 15:00 UTC

Featuring: Dan Roberts, MS - Director of Business Development & Sales, Toxys

ABSTRACT: To advance NAMs from being scientifically justified endpoints to regulatory necessities takes trust, validation, and guideline creation. Together we will discuss this journey for ToxTracker, a murine stem cells-based genotoxicity NAM. This platform uses GFP-tagged reporter genes on endogenously regulated bacterial artificial chromosomes that when induced, can discriminate between direct and indirect mechanisms of genotoxic stress. The assay has ~10 years of use across industrial sectors and has been used for everything from screening programs to “weight of evidence” justification in regulatory dossiers to support a non-DNA reactive mode of action (MOA).

The journey begins with an interlaboratory validation and culminates with creation of an OECD test guideline, which is presently under review by the WNT. Data from the larger interlaboratory ring trial will be presented with emphasis on the specificity of the ToxTracker platform as compared to existing genotoxicity endpoints. These existing genotoxicity assays report on phenotypically stable mutant cell induction or gross chromosomal damage but lack information on molecular initiating events that leads to such damage. ToxTracker addresses this by informing on oxidative stress and protein damage, which are predominant MOAs that induce false positive test results in historically used in vitro assays (when benchmarked to in vivo findings). Case studies showing how the panel of reporter genes is used across industries will be shared, as utility should be the defining factor of bringing a NAM into the regulatory spotlight.

ABOUT THE PRESENTER: Dan Roberts has 20 years of experience in the applied genetic toxicology field across pharma, biotech, and CRO industries. He has a MS from Johns Hopkins and was a PhD candidate in the Toxicology program at Rutgers University. Dan is presently a volunteer to the Genetic Toxicology Association (GTA) and was a past Chair of the GTA BOD (2016). He is active within HESI’s Genetic Toxicology Technical Committee (GTTC) and the Applied Genotoxicity (AGT) Special Interest Group of the Environmental Mutagen and Genomics Society (EMGS). Dan’s experience at the bench and as a Study Director was always focused at understanding genotoxic mechanisms of action. Currently he directs sales and business development opportunities for Toxys in the USA with an emphasis on using NAMs to achieve this focus. 

For your convenience, the materials and resources from this webinar will also be posted to https://PCRM.org/NAMSpotlight.

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