Addressing Genetic Toxicology Assessments Across Screening, Regulatory Stages, and Beyond
Genetic toxicology is a pivotal endpoint in the safety assessment of pharmaceuticals and chemicals—directly linked to carcinogenic risk, somatic and potential germline effects, and ultimately to whether a program can progress. As regulatory expectations evolve and impurity challenges such as NDSRIs come into focus, teams must balance sensitive screening tools with human relevance, compound economy, and a defendable path through ICH S2(R1) and ICH M7.
Join Matt Tate, PhD, Managing Director, Genetic Toxicology at Gentronix, part of Scantox Group, for an encore of his session from this year’s American College of Toxicology (ACT) Annual Meeting, “Addressing Genetic Toxicology Assessments Across Screening, Regulatory Stages, and Beyond,” on December 10, 2025 | 15:00 CET (9:00 AM EST) followed by a Q&A session.
In this live presentation, Matt will outline how to design a coherent genotox strategy built around the “Genotox Triangle” (gene mutation, chromosomal damage, DNA damage)—from early in silico and in vitro screening (including 6-well Ames) through ICH S2(R1) Options 1 and 2 and into in vivo mutagenicity testing. He will focus on practical approaches for interpreting and managing Ames-positive outcomes, selecting appropriate follow-up assays (MLA, HPRT, Pig-A, TGR Big Blue®), and tackling complex impurity challenges such as NDSRIs within the current regulatory landscape.
Key Learning Objectives
- Review the “Genotox Triangle” and ICH S2(R1) Options 1 and 2—and how standard genotox toxicology batteries (Ames, in vitro, in vivo) map into development.
- Learn how to build a tiered screening strategy using in silico tools, 6-well Ames, and feedback-driven triage for “minimal compound, maximum impact.”
- Understand how to interpret and manage Ames positives, from impurity/condition-driven findings to fit-for-purpose MLA/HPRT, Pig-A, and TGR/Big Blue® follow-up.
- Explore how to address complex impurity challenges—especially NDSRIs—using mechanistic case examples and TGR Big Blue® data to build regulator-ready packages.
Who Should Attend
- Nonclinical safety & toxicology leads responsible for genotox strategy and regulatory packages.
- CMC, impurity, & analytical teams working under ICH M7 on mutagenic impurities and NDSRIs.
- Discovery and development project leaders seeking to de-risk genotoxicity from early screening through Phase 1 readiness.
- Regulatory affairs, outsourcing managers, and scientific consultants looking for integrated, fit-for-purpose genetic toxicology solutions.
Meet The Presenter
Matt Tate, PhD, is a recognized expert in genetic toxicology with over 20 years of experience at Gentronix, part of Scantox Group. Initially focused on developing advanced screening assays, Matt transitioned into strategic leadership, shaping the company’s growth into a premier predictive toxicology CRO. With a deep operational understanding and extensive engagement with global regulatory bodies, he helps sponsors implement the most effective testing strategies to address mutagenicity concerns. Holding a BSc in Biochemistry from the University of Leeds and a PhD in Genetic Toxicology from the University of Manchester, Matt continues to bridge the gap between cutting-edge toxicology science and practical regulatory applications.