Bellberry and ASCEPT Roadmap: Guidance for the validation and use of NAMs
Meeting 1 November 2024 Melbourne
The aim:
To understand what’s required to enable the responsible, ethical use of NAMs in the transition from preclinical research to clinical trials.
Perspectives from
· Regulator
· HREC leaders
· Technology developers
· Sponsors
· Researchers
Meeting 2 October 2025 Melbourne
Aims:
· Explore regulatory expectations and acceptance of data from NAMs
· Provide hands-on understanding of applications using NAMs to support FIH trials
· Identify practical barriers and strategies to implement NAMs through case studies and group discussions
· Empower participants to evaluate data from NAMs critically and navigate uncertainties
Meeting 3 July 2026 Melbourne
Launch of practical guidance for ethics review and decision-making using NAM guidance and Delphi methodology. Draft checklist open for consultation until 31 August 2026.
To download the draft checklist and summary reports from these meetings, please enter your details below:
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