ICCVAM Method Developers Forum
As a follow-up to publication of the report on "Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies," ICCVAM and NICEATM envisioned a series of Method Developers Forums, each focused on a specific endpoint/toxicity. These forums would provide an opportunity for NAMs developers to present their methods and regulatory issues with relevant stakeholders.
The ICCVAM Method Developers Forum was held virtually in August 2024 and focused on NAMs for carcinogenicity testing. Ten method developers described their methods and proposed how they may be useful for regulatory and/or industry stakeholders in a webinar attended by over 200 viewers. Stakeholders representing potential government and industry users of the NAMs or the data they generate also participated in the webinar. The event was well-received with positive feedback from diverse stakeholders. Suggestions for improvement of future forums included:
- Increase engagement with industry, especially for preregulatory activities.
- Provide more time during the event for discussion between method developers and end users.
- Consider how to prioritize methods that are closer to being ready to apply to a regulatory purpose.
- Clarify evaluation criteria for proposals, which are needed to help both method developers to prepare their proposals and the steering committee come to a consensus on accepting proposals.
Planning for future iterations of the Method Developers Forum is currently underway.