Method Developers Forum 2024
New Approach Methodologies for Carcinogenicity Testing
The first ICCVAM Method Developers Forum was held virtually in August 2024 and focused on new approach methodologies NAMs for carcinogenicity testing. The webinar featured presentations by selected method developers describing their methods and proposing how they may be useful for regulatory and/or industry stakeholders. Stakeholders representing potential government and industry users of the NAMs or the data they generate also participated in the webinar.
Presentations: Method Developers Forum on NAMs for Carcinogenicity Testing
The Chicken Egg Model: An Alternative Model for Detection of Genotoxic Carcinogens
Tetyana Cheairs, Department of Pathology, Microbiology and Immunology, New York Medical College
ToxTracker Discussion: A Potential New Approach Method for Carcinogenicity Testing
Dan Roberts, Toxys, Inc.
Validation of Cell Proliferation as a Key Event in the Assessment of Non-Genotoxic Carcinogenicity
Christian Strupp, Gowan Crop Protection Ltd. / Miriam Jacobs, UK Health Security Agency
Clonal Expansion of Cancer Driver Mutants by CarcSeq: A Biomarker of Carcinogenicity
Barbara Parsons, U.S. Food and Drug Administration National Center for Toxicological Research
Human Relevant Genetic Toxicology for Risk Assessment
Leslie Recio, ScitoVation / Jamie Scaglione, ScitoVation
BioMAP® Assay Panel for Test Agent Prioritization: Support for Carcinogenicity-related Assessments
Ellen Berg, Alto Predict, LLC
ReCAAP: A Reporting Framework to Support a Weight of Evidence Safety Assessment Without Long-term Rodent Bioassays
Gina Hilton, PETA Science Consortium International / Amber Goetz, Syngenta Crop Protection, LLC
γH2AX/pH3 Method for Genotoxicity Mode of Action Determination
Marc Audebert, UMR1331 ToxAlim, French National Institute for Agriculture, Food, and Environment (INRAE)
A Platform for Next Generation Carcinogenicity Assessments
Chris Barber, Lhasa Limited / Adrian Fowkes, Lhasa Limited
Error Corrected Sequencing for Clonal Expansion
Connie Mitchell, Health and Environmental Sciences Institute (HESI) / Jesse Salk, Green Umber, LLC
Videos from the August 2024 webinar are available below. Additional videos summarize regulatory and industry stakeholders’ information requirements and/or decision frameworks relevant to carcinogenicity. The stakeholder videos were provided to guide presentations given by method developers. Developers also used these questions that correspond to the key considerations in the ICCVAM report as a guide to prepare a proposal submission on their methods.