Dr. Susanne Stalford, Lhasa Principal Scientist, presented within a Pharmaceutical & BioScience Society workshop, on the topic of Nonclinical Carcinogenicity Studies.
The workshop included presentations from regulatory and industry perspectives, on topics relating to carcinogenicity assessment of pharmaceuticals, including:
- The challenges faced with carcinogenicity assessments, in the development of pharmaceuticals
- Regulatory and industry perspectives on the ICH S1B(R1) carcinogenicity guideline
- Protocols to support an ICH S1B weight of evidence (WOE) assessment
- High dose selection by clinical exposure rations, in the rasH2-Tg mouse study
- Use of a carcinogenicity adverse outcome pathway (AOP) network to conduct a WOE assessment.
Susanne’s contribution was to the topic of using of a carcinogenicity AOP network to conduct an ICH S1B WOE assessment, which included a case study example.