The ICH S1B(R1) addendum is a globally recognised guideline that introduces a weight-of-evidence (WoE) approach to assessing the carcinogenic potential of pharmaceuticals. It helps pharmaceutical organisations determine whether a two-year rat carcinogenicity study would provide additional insight into human safety.
In this session, attendees heard directly from former regulatory and industry experts who contributed to the development of ICH S1B(R1). The speakers shared practical experience on best practice, highlighted common challenges in submissions, and explained how WoE assessments are being applied in practice.
The webinar concluded with a case study from Lhasa Limited, demonstrating a structured and transparent approach that supports confident carcinogenicity assessment decision-making, reduces unnecessary animal testing, and accelerates access to safe and effective therapies.
Meet the experts
- Dr Todd Bourcier – Former Regulatory Representative, ICH S1B Expert Working Group; Independent Consultant
- Dr Tim McGovern – Former Regulatory Representative, ICH S1B Expert Working Group; Independent Consultant
- Dr Ron Steigerwalt – Former Industry Representative, ICH S1B Expert Working Group; Independent Consultant
- Dr Alex Cayley – Principal Scientist, Lhasa Limited
Attendees
- Gained first-hand insights from experts who shaped the guideline
- Learned how to address common challenges in ICH S1B submissions
- Heard how industry applies weight-of-evidence approaches in practice
- Discovered a transparent scientific framework to support confident decision-making and regulatory acceptance