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Using next generation carcinogenicity assessments to make confident human safety decisions

In this Lhasa webinar we discussed alternative approaches to carcinogenicity assessment with Dr. Todd Bourcier (FDA) and Dr. Gina Hilton (PETA).

Within many sectors of the life sciences industry, animal testing is still considered a primary option for toxicity testing, and as a result is used heavily. The limitations of this model are now well understood and non-animal new approach methodologies (NAMs) present an ideal opportunity to improve on the traditional approach. The challenge lies in validation, combining results and understanding NAMs. This is particularly applicable to carcinogenicity. Did you know that using an alternative approach for ICH S1 assessments can save up to $3.75 M, 2-3 years in testing and regulatory processing?

We were delighted to be joined by Todd and Gina for this event. Todd is the Director of the Division of Pharmacology and Toxicology in the Office of Cardiology, Haematology, Endocrinology, and Nephrology in the Office of New Drugs of the US FDA. He is also a member of the S1 Expert Working Group of the International Council on Harmonization, that evaluated the conditions under which a weight-of-evidence approach to carcinogenic assessment of small molecules may provide an adequate assessment of human carcinogenic risk without data from a 2-year rat study. Gina is a toxicologist and science adviser to PETA Science Consortium International e.V, where she advises on the development and implementation of new approaches and non-animal testing for regulatory risk assessment. Dr. Ioannis Xanthis, Senior Application Scientist, also presented from Lhasa Limited.

Please contact us for a copy of the slides.