Incorporating New Approach Methodologies into Regulatory Nonclinical Pharmaceutical Safety Assessment

Victoria Hutter, Pandora Pound, Jan Turner, C Owen, I Hutchinson, Marina Hop, David Chau, Lady Barrios Silva, Michael Coleman, A Dubourg, Gerry Kenna, V Lauschke, Winifred Neuhaus, Clive Roper, Paul Watkins, John Welch, Kevin Taylor, Laura Alvarez, Lorna Harries

Research output: Contribution to journalArticlepeer-review


New approach methodologies (NAMs) based on human biology enabletheassessment of adverse biological effects of pharmaceuticals and other chemicals. Currently,however, it is unclear how NAMsshould be usedduring drug development to improve human safety evaluation. A series of 5 workshops with 13 international experts (regulators, preclinical scientists and NAMs developers) were conducted to identify feasible NAMsand to discuss how to exploit them in specific safety assessmentcontexts. Participants generated four‘maps’of how NAMs can be exploited in the safety assessment ofthe liver, respiratory, cardiovascular,and central nervous systems. Each map showsrelevant end points measured, tools used (e.g.,cells, assays, platforms), and highlights gaps where furtherdevelopment and validation of NAMs remainsnecessary. Each map addresses the fundamental scientific requirements for the safety assessment of that organ system, providing users with guidance on the selection of appropriate NAMs. In addition to generating the maps, participants offered suggestions for encouraging greater NAM adoption within drug development and their inclusion in regulatory guidelines. A specific recommendation was that pharmaceutical companies should be more transparent about how they use NAMs in-house. As well as giving guidance for the fourorgan systems, the maps providea template that could be used for additional organ safety testing contexts.Moreover, their conversion to an interactive format would enable users to drill down to the detail necessary to answer specific scientific and regulatory questions
Original languageEnglish
Publication statusPublished - Jan 2023


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