Preclinical Presentations

Does SEND Pave the Way for Creating Virtual Control Groups?

SEND-format data is a required submission standard, but practically, what else can we do with highly formatted and controlled datasets? The industry's universal adoption of standardization and quest for improvement opens the door to exciting, innovative data-reworking applications. This session will discuss the opportunities for data use beyond submissions, specifically in the area of constructing virtual control groups.

Presented by Marc Ellison, Director of SEND Solutions, Instem & Brenda Finney, PhD, Instem’s VP of Translational Science

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Future Proofing Drug Safety: Target Carcinogenicity Risk Assessment Meets ICH S1B(R1) Standards

In the fast-paced and cost-conscious 'drug to market' race, momentum can be gained by implementing a Weight of Evidence (WoE) to negate unnecessary preclinical testing. We will present results from a collaboration to standardize a procedural framework supporting the ICH S1B(R1) integrated assessment. Specifically, target biology (WoE #1) will be presented.

Presented by Frances Hall, PhD, Scientific Application Director, In Silico and Translational Science Solutions, Instem

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Using the Carcinogenicity Potency Categorization Algorithm to Predict N-Nitrosamine Carcinogenicity

This session will describe the Carcinogenicity Potency Categorization Algorithm (CPCA) that is used by regulators for quickly predicting carcinogenicity potency of N-nitrosamines under ICH M7. It will also present a Health and Environmental Sciences Institute (HESI) nitrosamine QSAR workgroup where Instem is co-leading a collaboration with health authorities, academics, and industry to address current and future nitrosamine regulatory issues.

Presented by Kevin Cross, PhD, VP, Regulatory Science, Instem

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610 941 0990

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+44 (0) 1785825600

Office Address

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ST15 0SD
United Kingdom