BARDA OTA Programs to Lead Development of Future National Health Security Countermeasures
As we emerge from a global pandemic, it is imperative to ensure we are well-equipped for the next one. With a renewed prioritization on preparedness and response, the last few years of medical advancement have demonstrated the need for existing, established partnerships to rapidly scale and execute when a public health emergency transpires.
As COVID-19 progressed, Operation Warp Speed (OWS) leveraged existing acquisition authorities – most notably Other Transaction Authority (OTA) – that enabled government and industry to collaborate and respond quickly to a global health crisis. Through JPEO-CBRND’s Medical CBRN Defense Consortium (CWMD), the government was able to rapidly contract with industry for the development of vaccines, personal protective equipment, therapeutics and more.
Over the last few months, BARDA has launched two separate programs designed specifically to aid in the development of medical countermeasures with an emphasis on national health security, and the establishment of a manufacturing and industrial base for medical countermeasures. Both programs take the form of a government-sponsored OTA Consortium, a collaborative model where industry, academia and non-profit partners across the supply chain are able to join purpose-built ecosystems and bid on opportunities that are competed through these vehicles.
The Rapid Response Partnership Vehicle (RRPV) focuses on the “acceleration of products and technology development, regulatory approval, commercialization, and sustainment” and has already its first solicitation for the implementation of novel solutions to cGMP manufacturing hurdles and enablement of clinical trials for the next generation of COVID vaccines.
The Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) features a 10-year agreement to expand the drug and vaccine manufacturing base in support of public health crises. This includes manufacturers and suppliers of materials, drug substance manufacturing suppliers and fill finish services, and innovative manufacturing firms. The first of many requirements has been released for the production of biologically derived small molecule regulatory starting materials.
Both RRPV and BioMaP consortia are managed by Advanced Technology International (ATI), a non-profit organization with the most experience as a consortium management firm in supporting US government-sponsored OTA consortia. For more information about these consortia and how to get involved, please visit rrpv.org and biomap-consortium.org.
*Information and solicitations referenced were current at the time this article was written (01/2024)
