EverGlade Consulting Funding Alert: Biden Administration Announces Launch of Successor Program to Operation Warp Speed Accompanied by the Release of New Funding Opportunities for the Development of Vaccines and Therapeutics
Project Next Gen
Project Next Gen is a new program launched by the Biden administration aimed at accelerating the development of new coronavirus vaccines and treatments. With a budget of over $5 billion, the program aims to protect against the evolving nature of the virus and potential future coronaviruses that may pose a threat.
Drawing on the success of Operation Warp Speed, a Trump-era program that facilitated the rapid development and distribution of COVID-19 vaccines in 2020, Project Next Gen will also partner with private-sector companies to expedite the development of vaccines and therapies.
Amendment to BARDA
In parallel with the Project Next Gen announcement, an amendment to the Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (‘BAA”) BARDA BAA-18-100-SOL-00003 was released, as well as a Request for Information (RFI) from The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) related to the development of advanced manufacturing capability for active pharmaceutical ingredients (APIs).
The following funding areas were updated in the BARDA BAA:
- For Area of Interest #8: Influenza and Emerging Infectious Diseases (IEID) Vaccines:
- Added new AOI 8.4 COVID-19 Immune Assay(s) Development and Implementation, with a full proposal due date of May 3, 2023
- For Area of Interest #9: Influenza and Emerging Infectious Diseases (IEID) Therapeutics
- Added new AOI 9.8 COVID-19 Monoclonal Antibody Therapeutics for Pre-Exposure Prophylaxis (PrEP), with a due date for White Papers of April 21, 2023
- Added new AOI 9.9 COVID-19 Monoclonal Antibody Therapeutics for Treatment with a full proposal due date of May 17, 2023
AOI 8.4: COVID-19 Immune Assay(s) Development and Implementation
BARDA is seeking proposals for advanced research and development of immunogenicity assays and sample collection technologies for COVID-19 vaccine development. The assays should analyze clinical study samples and measure immune responses to both ancestral SARS-CoV-2 and variants of concern. Assays of interest include lentivirus-based virus neutralization assays, multiplexed antigen panels, and MSD-based ACE2 receptor blocking assays. Validation as per FDA guidelines and documentation in the Drug Master File (DMF) is required, and assays should be updated based on emerging SARS-CoV-2 variants.
AOI: 9.8: COVID-19 Monoclonal Antibody Therapeutics for Pre-Exposure Prophylaxis (PrEP)
BARDA seeks to advance the development of monoclonal antibodies (mAbs) as a rapid pre-exposure protection against SARS-CoV-2, particularly for special populations like immunocompromised adults and pediatrics. Proposals should focus on mAbs with potency against MERS-CoV, SARS-CoV, and SARS-CoV-2, targeting 95% conserved residues. A plan for achieving a half-life extension of at least 35 days should be outlined, and mAbs should be potent enough for intramuscular and/or subcutaneous administration with no more than two injections every six months.
AOI 9.9: COVID-19 Monoclonal Antibody Therapeutics for Treatment
BARDA is seeking proposals to support the manufacturing, FDA Emergency Use Authorization (EUA), and regulatory licensure of new monoclonal antibodies (mAbs) for treating SARS-CoV-2 infection, with a focus on special populations. Proposers should have an active Investigational New Drug (IND) with the FDA, safety and toxicology data, and a demonstrated manufacturing process for clinical trials.
The regulatory strategy should target EUA in Q3 2023, with supporting documentation for FDA buy-in on regulatory flexibilities. Priority will be given to U.S.-based manufacturers, and in vitro potency data against human coronaviruses, a manufacturing strategy for commercial availability by the end of 2023, and risk mitigation plans are required.
“Given the success of Project Warp Speed, it is no surprise that BARDA would try to build on that success,” stated EverGlade Consulting Founder, Eric Jia-Sobota.
In addition to the new opportunities outlined in the BARDA BAA, the RFI released by JPM CBRN is aimed at expanding U.S. manufacturing of pharmaceutical ingredients for military medical countermeasures against chemical and biological threats.
They seek innovative technology to improve processes that currently rely on foreign suppliers and large-scale batch manufacturing. The request for white papers targets U.S. companies with advanced manufacturing capabilities that can develop APIs and drug products meeting cGMP requirements within a time frame of 36 months.
If you are developing a product that you think might fall under one of the areas mentioned above, EverGlade can help you make that determination and pursue a successful contract.
