New Approach Methodologies (NAMs) Workshop 2 Summary Report
Melbourne, 24 October 2025
Bellberry and ASCEPT (Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists) are pleased to release the summary report from the second NAMs workshop.
The workshop focused on the practical use of NAMs to support first-in-human clinical trials, including regulatory, ethical and practical considerations for applicants and HREC members.
The report captures perspectives from Australian consumers and speakers from the NIH and Eurpean Comission. The main focus of the workshop was a case study based on a recent Bellberry-approved study supported by NAM data. The report summarises the discussion and explores how the findings can inform practical guidance for presenting and assessing NAM data in first-in-human clinical trial applications.
Bellberry and ASCEPT are now working with the sector to develop guidance material, expected to be launched in July/August 2026.
To download the report, please enter your details below.
To download your copy of the summary report please enter your details below:
Please read the Bellberry Privacy Policy before submitting.