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Lhasa Limited announces the launch of an ICH S1 consortium

Lhasa Limited is excited to announce the launch of an ICH S1 consortium.

The Lhasa-led consortium consists of several industry partners – all with a common goal of supporting meeting ICH S1 and reducing animal testing using Adverse Outcome Pathways (AOPs) within Kaptis.

Within the life sciences industry, there has been a conscious shift away from long term carcinogenicity animal studies – as a result, there is a need for alternative approaches to assessing carcinogenic risk. This is reflected in the draft ICH S1 pharmaceutical guideline addendum which allows a weight of evidence (WoE) assessment to replace a full carcinogenicity animal study, where the evidence shows the animal study adds no value to the overall pharmaceutical assessment.

Lhasa proposes that AOPs can be used to address the WoE approach outlined in the addendum. Framing knowledge within AOP networks allows for transparent and integrated assessments which can be consistently applied across the industry.

If you read our recent blog article on this topic then you may already be familiar with this information; Meeting ICH S1 and reducing animal testing through AOPs; Have you read this?

The aims of the consortium are:

  • To identify and address gaps in the proposed framework
  • To discuss practical aspects related to the implementation of ICH S1B
  • To influence the development of Kaptis
  • To agree and publish best practices.

To join this conversation, send us a message.

You might also be interested in our recent publication on this topic; Employing an adverse outcome pathway framework for weight-of-evidence assessment with application to the ICH S1B guidance addendum. This paper was published in the Regulatory Toxicology and Pharmacology Journal in October 2021.