Table 3.
Overview of key decision points in medical countermeasure development
| Description | Key considerations | |
|---|---|---|
| Response tools | Select a combination of diagnostics, vaccines, and therapeutic products on the basis of the epidemic response and control strategy | Epidemic or pandemic potential of the pathogen (eg, virulence, latency, pathophysiology); technical feasibility (eg, similarity to known pathogen, antigenic diversity, biomarkers); availability of other public health or epidemic control measures (eg, vector control, social distancing) |
| Product strategy | Generate a product-specific target product profile to define essential product performance specifications | Indication for use (eg, pre-exposure or post-exposure prophylaxis, suppressive therapy); vaccination strategy and target population (eg, herd vs ring vaccination, use in paediatric populations or pregnant women, geographical considerations); durability of protection, product formulation stability and storage, route of administration, production, co-administration or combination therapy |
| Target selection | Identify and prioritise potential targets for vaccine and drug candidate development that meet the target product profile | Understanding of the natural history, biology, pathogenesis, and genetics of the pathogen (eg, viral life cycle, entry mechanisms, hosts, genomic sequence); mechanism of action or immunological response, and product development biomarkers |
| Animal model | Select and develop well-defined and standardised animal models that recapitulate the pathogenesis of human disease to do efficacy studies | Correlation of animal and human response, ease of use, animal rule requirements; availability, standardisation, and validation of reagents and related assays; toxicology studies or data required for drug repurposing |
| Platform selection | Vaccine type (eg, attenuated and recombinant protein with or without adjuvants), therapeutics (eg, small molecules, antibodies), diagnostics (eg, lateral flow, nucleic acid technology) | Safety profile, speed of development, complexity, ability to culture pathogen, immunological response (eg, humoral vs cellular, duration); availability of verification specimens |
| Manufacturing | Select suitable platform for manufacture of quality product at required scale | Biocontainment requirements, scalability, available capacity, formulation, dose selection, regulatory requirements for release assay validation, and qualification or validation of good manufacturing practices |
| Clinical development plan | Define clinical trial design (geography, sites, sample size, control groups) including clinical endpoints (survival vs disease prevention) | Expertise of clinical trial sites, capacity, disease incidence or epidemiology studies; established infrastructure (including patient recruitment and enrolment, data collection and management); coordination between operational (ie, outbreak response) and research groups |
| Manufacturing partner | Identify qualified partners with the required manufacturing capabilities of good manufacturing practices and the capacity to meet product specifications | Technology transfer plan, requisite infrastructure (capital equipment, talent, vendor support), access to raw materials, fill-finish capability |
| Delivery | Define product access and delivery methods across the supply chain | Supply chain requirements (cold chain or thermostability); in-country operations, transfer and import or export agreements; means of dissemination (eg, fixed posts vs house-to-house campaigns) |