On January 20, 2022, BARDA, within the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response, is hosting a Biopharmaceutical Manufacturing Consortium (BioMaC) Industry Day. BARDA issued a Request for Information (RFI) in November 2021 that proposed the establishment of the BioMaC to help transform and build core capabilities for biodefense.
The consortium is a planned expansion of the current National Biopharmaceutical Manufacturing Partnership (BioMaP), led by the BARDA Pharmaceuticals Countermeasure Infrastructure (PCI) division. The consortium’s purpose is to optimize the U.S. government and industry’s approach to medical countermeasures (MCM) manufacturing. The BioMaC is proposed to enable the establishment of an effective physical infrastructure to respond to future pandemics effectively and efficiently.
Because a strong domestic industrial supply chain for manufacturing MCMs is vital when responding to any public health emergency, the U.S. must maintain access to manufacturing capabilities for key components of the pharmaceutical industrial base and supply chain. These include such elements as tubing, filters and raw materials used in vaccine production or raw materials and other ingredients required to manufacture life-saving drugs and vaccines. Many of the active pharmaceutical ingredients (APIs) necessary for vaccine and drug production currently are made outside the United States.
Together, BARDA and HHS are engaging with other federal agencies and the White House in a whole-of-government review, update, and transformation of U.S. bio-preparedness capabilities, as outlined in the White House’s September 2021 report, American Pandemic Preparedness: Transforming our Capabilities (PDF – 599 KB). This effort will fundamentally transform the nation’s biodefense and pandemic readiness and address challenges experienced during the COVID-19 pandemic.
Interested persons are invited to participate in the industry day on January 20, 2022, from 2:00-3:30PM EST. The event will center on the supply chain for MCM manufacturing and the role of public-private partnerships in strengthening the nation’s biomanufacturing infrastructure. BARDA wants to hear from industry on issues and roadblocks faced when assisting the nation to respond to public health emergencies. Registration for the BioMaC Industry Day is free.
The RFI will collect feedback from current and potential biopharmaceutical industry partners. Information collected from this RFI will serve as continued market research for the development of a possible program where BARDA would partner with industry to achieve the pandemic preparedness goals set forth by the U.S. government.
For additional RFI information, including eligibility, criteria, and how to submit your responses, see the RFI (PDF – 286KB), and visit the Pharmaceutical Manufacturing in America (PMIA) page. Responses may be submitted until February 28, 2022.