Thomas M. Polasek , Clinical Pharmacology, Flinders University, Department of Clinical Pharmacology, Adelaide, Australia
Felicia Pradera , Defence Science and Technology Group, Department of Defence, Melbourne, Australia
Shane Seabrook , 4Commonwealth Science and Industrial Research Organisation, Melbourne, Australia
Kashyap Patel , d3 Medicine, A Certara Company, Melbourne, Australia
Emily J Woodward , Synchrogenix, A Certara Company, Nashville, TN
Craig R Rayner , Monash University, Monash Institute of Pharmaceutical Sciences, Melbourne, Australia
Medical countermeasure (MCM) products are defined as diagnostics, vaccines and therapeutics for the protection of military and civilian personnel against chemical, biological and radiological (CBR) threats, emerging infectious diseases and pandemics. Increasing on-shore capability in the development of MCMs is a priority for Australia. Pharmacometrics is the application of modelling and simulation (in silico) to inform product development and/or clinical decisions. The objectives of this study were to understand Australia’s MCM product development capability and capacity, and to identify new opportunities in the ecosystem for pharmacometrics. A national capability audit (NCA) was conducted. In phase 1, an electronic survey of 145 questions based on the US Health and Human Services Broad Based Capabilities (BBC) Tool was opened to the Australian academic, industry, research institute, and government sectors. In phase 2, 30-min structured interviews were conducted to validate the findings of the survey and to ascertain further details. Surveys were analysed using descriptive statistics. For interviews, technology readiness level (TRL)-guided ‘impressions’ of capability and capacity were established, de-identified, and presented using heat maps (individual) and summarized at an aggregate level (national). There were 131 completed surveys. Most respondents were based on the east coast of Australia in Victoria, New South Wales and Queensland (87%). Thirty-nine percent were businesses, 37% universities, 19% research institutes, and 5% government departments. Two-thirds of respondents identified their primary and secondary positions on the MCM product development value chain as ‘translational research/pre-clinical research’. The greatest concentration of activity was at TRL4 and earlier. Late-phase capabilities (i.e., clinical development and manufacturing) were weaker, and very few respondents identified market access as their primary position (5/131). Interviews were conducted with 49 of the survey respondents (37%). These interviews confirmed strong BSL2/3+ in vitro capabilities (static & dynamic, genotypic & phenotypic), but minimal GxP examples in DMPK, immunoassay, bioanalysis, PD or safety. Importantly, in vivo GLP-compliant non-clinical services had limited diversity and availability. The 2 areas of MCM product development that could benefit most from increased pharmacometrics were non-clinical in vivo PK ± PD and toxicology studies (e.g., to replace/inform studies in larger animals that require high level containment, ABSL3/4) and early clinical development (e.g., phase 1 and phase 2a/b). Australia has a dispersed, relatively small but experienced discovery and development community. Pharmacometric approaches could be utilised more broadly to address capability and capacity gaps in the Australian MCM product development ecosystem.