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Using SCOPE to Identify Potential Regulatory Motifs in Coregulated Genes

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Regulatory Forum.

W Michael Peden¹

¹1 Bristol Myers Squibb Co., Mt. Vernon, IN, USA.

Toxicologic Pathology

|October 19, 2016

Summary

Regulatory authorities are revising guidance on carcinogenicity studies for new drugs. A new approach uses a carcinogenicity assessment document (CAD) to better select which compounds need long-term rat studies.

Area of Science:

Drug development
Toxicology
Regulatory science

Background:

The International Council for Harmonization (ICH) S1 guidance specifies requirements for rat carcinogenicity studies.
Extensive evaluations by industry and regulatory bodies revealed a need for more selective criteria for these studies.
A prospective evaluation study was initiated in 2013 to inform potential revisions to ICH S1.

Purpose of the Study:

To summarize recent changes to the carcinogenicity assessment document (CAD) guidance.
To highlight the importance of Society of Toxicology Pathology (STP) membership participation in CAD submissions.
To inform STP members about the ongoing revision of ICH S1 guidance.

Main Methods:

Sponsors assess pharmacologic and toxicologic findings from chronic toxicity studies.

Keywords:

ICH S1 drug development preclinical safety assessment/risk management regulatory affairs

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A weight of evidence argument is used to predict carcinogenicity outcomes.

Carcinogenicity assessment documents (CADs) are developed to support these predictions.

Main Results:

A revised approach to rat carcinogenicity studies is proposed.
The new method aims to improve the selection of compounds requiring 2-year studies.
The process involves detailed assessment of existing study data.

Conclusions:

The revision of ICH S1 guidance and the CAD process represent a significant shift in drug safety evaluation.
Active participation from STP members in CAD submissions is crucial for the successful implementation of these changes.
This evolving regulatory landscape requires informed engagement from the toxicology pathology community.