At this year’s SOT in Nashville (March 19-23, 2023), Instem will be organizing two workshops related to cancer assessments.1
In the first workshop, to be held on Tuesday, March 21, 4:30 PM – 5:30 PM (CT) in Room 101B, we will discuss carcinogenicity assessments aligned with the ICH S1B guideline2, specifically focusing on the weight of evidence (WoE) factors outlined in the addendum. The workshop will describe a new collaborative working group to develop a framework and pragmatic consensus procedure to support these WoE factors, which is being coordinated by Dr. Arianna Bassan, Principal Consultant at Innovatune. In addition, Dr. Frances Hall will outline a recent project undertaken at Instem to support an ICH S1B regulatory submission and review different ways to collaborate with Instem on this important topic.
The second workshop, Assessing N-nitrosamine Potency Classes, will be held on Wednesday, March 22, 12:00 PM – 1:00 PM (CT) in Room 101D. Dr. Kevin Cross will review recent regulatory and industry updates in the assessment of N-nitrosamine potency classes based on various international collaborations. The workshop will outline new defendable methods, including SAR and read-across approaches, based on a mechanistic understanding of N-nitrosamine carcinogenicity. Dr. Arianna Bassan will also present an example of how in silico approaches can be used to support risk assessment of nitrosamines.
If you are unable to attend these workshops, please get in touch (Glenn Myatt; glenn.myatt@instem.com) and we would be happy to discuss these projects.
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