What we learned at Day 2 of BARDA’s 2022 Industry Day Conference

For those in the Life Sciences space – check out Part Two of our series on key takeaways from the Biomedical Advanced Research and Development Authority (BARDA) Industry Day annual conference. As a follow-on to Part One of our BARDA Industry Day Takeaways, this summary provides an overview of essential policies advising BARDA’s strategic direction in the development of Medical Countermeasure (MCM) to support infectious disease outbreaks and future pandemics. 

BARDA Industry Day 2022 presented an opportunity to understand the organization’s priorities and strategic initiatives as they seamlessly integrate their continued involvement in the COVID response with comprehensive Medical Countermeasure (MCM) development requirements. The BARDA Strategic Plan, the American Pandemic Preparedness Plan (APP) and the National Biodefense Implementation Plan are key drivers informing the direction and mission of BARDA.  

One of the goals identified in the APP is to rapidly produce vaccines for any human virus family within 130 days after the threat appears in the U.S. population and 200 days for the global population. As part of BARDA’s response mission, the Pharmaceutical Countermeasure Infrastructure (PCI) Division is focused on addressing population manufacturing capacity and end to end supply chain scalability through the Biopharmaceutical Manufacturing Partnership (BioMaP), Contract Development and Manufacturing Organization (CDMO) Network and the Pandemic Vaccine Preparedness and Readiness Capabilities (PVPCR) Branches. 

The Biopharmaceutical Manufacturing Partnership (BioMaP) branch is a new initiative identified in the BARDA Strategic Plan focused on establishing large-scale vaccine manufacturing capacity and supporting manufacturing innovation. To accomplish the goals of the APP, BioMaP is tasked with targeting investment in the manufacturing supply chain and establishing a network of large-scale pharmaceutical manufacturers, known as the Biopharmaceutical Manufacturing Consortium (BioMaC). The BioMaC will be a consortium of domestic population scale manufacturers working collaboratively to address specified BARDA requirements as well as supply chain and manufacturing innovation.  A Request for Proposals (RFP) for the BioMaC is expected to be released in late spring 2023. 

The PCI/CDMO Network Branch is a non-funded network of drug product and fill/finish manufacturers. BARDA seeks to shore up fill/finish capacity to support production of 100M doses/month. To expand capabilities in the CDMO network to meet this goal, a solicitation is expected for BSL-2 fill/finish capabilities. Of note, BARDA is also very interested in flexible technologies that can transition rapidly between antigens or threats to address a diverse array of pathogens. 

PVPCR is BARDA’s branch overseeing initiatives to support domestic industrial base expansion (IBx) and supply chain security. This includes manufacturing capacity for vials, needles, syringes, glass tubing, raw materials and supporting services. To address identified gaps in some of these areas, RFPs for sterilization facilities and raw materials are planned. 

In fulfilling its core mission, each of these initiatives sponsored by the PCI Division will bolster BARDA’s ability to prime its position as a preparedness and response organization.