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 5 October 2026.
To download the draft checklist and summary reports from these meetings, please enter your details below:
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