Inactive

**Amendment 1 provides responses to questions received by the July 14, 2023 deadline. The Attachment section has been updated accordingly. Within the Administration for Strategic Preparedness and Resp... **Amendment 1 provides responses to questions received by the July 14, 2023 deadline. The Attachment section has been updated accordingly. Within the Administration for Strategic Preparedness and Response (ASPR), the Biomedical Advanced Research and Development Authority (BARDA) has created a Strategic Plan for 2022- 2026 focused on strengthening the health security of the nation and embracing lessons learned from the COVID-19 pandemic. During the COVID-19 response, BARDA spent considerable resources screening and selecting candidate organizations to make substantial investments in COVID-19 vaccine, therapeutic, diagnostic, and other medical countermeasure (MCM) technology development, reviewing over 4500 market research submissions, conducting close to 700 meetings with potential organizations, and issuing $65 billion in awards to 140 organizations for COVID-19 research and development. While these investments were crucial to receiving Emergency Use Authorization from the Food and Drug Administration for countermeasures and providing hundreds of millions of lifesaving COVID-19 MCMs to the public, multiple approaches were needed to accelerate MCM research and development. This Prize Vehicle seeks to catalyze, in complement traditional contract-based funding mechanisms, the research and development (R&D) and commercialization of MCMs, to meet ambitious goals set by BARDA and other relevant stakeholders including goals in the BARDA Strategic Plan and national initiatives, such as the National Biodefense Strategy and Implementation Plan and Project NextGen. This Prize Vehicle will enable BARDA to establish clear success metrics and offer cash prizes contingent on meeting clear sets of success criteria among competing R&D organizations as well as help to 1) create high visibility to address health security problems, sometimes when the approach or development path is not known 2) increase the diversity and reach of organizations to engage in MCM R&D development and 3) develop solutions that meet bold and ambitious goals that thrive beyond prize award. The resulting awards from the Prize Vehicle will be issued as an Other Transaction, leveraging BARDA’s Other Transaction Authority (OTA). BARDA, through this Prize Vehicle, seeks to partner with an organization with the expertise to design, promote, and administer effective prize competitions to catalyze product development and address ambitious BARDA goals. Specifically, BARDA is seeking to partner with an organization who will achieve the following objectives: Design: Work with the government and other stakeholders to design incentive prize competition(s) to catalyze the research and development of products and capabilities to meet ambitious goals set by BARDA Promote: Provide outreach 1) to eligible participant communities (e.g. product developers) to increase diversity of participants or teams of participants; 2) to partnering organizations to increase additional public/private investment and interest; and 3) to the public to raise awareness and create high visibility to address a product development problem or gap Administer: Coordinate and administer the prize competition(s) with BARDA and participants, including awarding of cash prizes and other rewards. Project NextGen seeks to accelerate the development of the next generation of COVID-19 vaccines, therapeutics and enabling technologies including a plan to launch a $50 million international competition to catalyze the development of clinical evidence, regulatory approval and commercialization of patch-based vaccine delivery for a combination vaccine product, such as COVID-19 and seasonal influenza or vaccines for other respiratory pathogens in addition to COVID-19. Patch-based vaccine technologies have the potential to reduce the amount of antigen needed in a safe and effective vaccine dose, reduce cold-chain requirements, improve the experience of vaccination that could drive up adoption rates, and provide added convenience with the potential for self-administration. The first award under the BARDA Prize OT is assumed to design, promote, and administer this competition. The structure of the competition is anticipated to be a first-to-finish competition, consisting of multiple rounds with multiple intermediate finalists and a single final winner that’s focused on milestones tied to advanced clinical development, regulatory approval, and/or commercialization. Additional information is available in the attached solicitation.