By Laura Powell, Managing Consultant and Eric Jia-Sobota, Founder
CHARLESTON, S.C. , May 19, 2023 /PRNewswire/ — In the latest amendment to its Broad Agency Announcement (BAA), BARDA (Biomedical Advanced Research and Development Authority) is seeking proposals for the development of cost-effective and adaptable therapeutic platforms to treat viral infections, as well as next-generation COVID-19 vaccines. The antiviral platforms may include various technologies such as monoclonal antibodies, nucleic acid expressed antibodies, RNA interference, CRISPR-Cas, and locked nucleic acids. BARDA is particularly interested in products that target multiple viral families and that have a development timeline of less than six months from viral identification to Investigational New Drug (IND) submission. For COVID-19 vaccines, BARDA recognizes the potential advantages of newer candidates in terms of their effectiveness and breadth of protection. Rather than funding the entire development plans for a small subset of vaccines, BARDA aims to de-risk key development efforts and have a broad impact across the vaccine development space. The primary focus is on generating proof-of-concept Phase IIb efficacy data, which will significantly reduce the overall risk and accelerate the development process.
Area of Interest 14: Flexible and Strategic Therapeutics (FASTx) Requirements
Ideal candidates for funding should be at TRL-4 (candidate optimization) or higher, although earlier-stage candidates with the potential to significantly improve existing capabilities may also be considered. The desired antiviral platforms should have the ability to rapidly pivot and develop investigative products against new or re-emerging pathogens. They should also demonstrate applicability to multiple viral infections, possess relevant data from Phase 1 trials, and show pharmacokinetics/pharmacodynamics suitable for treating acute viral infections.
BARDA is specifically interested in proposals that focus on the development of antivirals targeting SARS-CoV-2, filoviruses, and Influenza. However, proposals addressing other respiratory viruses and viruses causing hemorrhagic fever as secondary targets are also welcomed to validate the platform’s flexibility.
Proposals should include development activities necessary to support Phase 1 studies for at least one viral indication, along with options for technology demonstrations targeting additional viral targets. Risk analysis and mitigation approaches, timelines for advancing candidates through IND submission, strategic improvements to the platform, and proposed manufacturing plans and scale should also be addressed.
For proposals involving monoclonal antibody (mAb) platforms, the activities should cover mAb development from discovery to manufacturing, excluding clinical samples. Traditional CHO-based mAb approaches will not be considered. Considerations such as non-intravenous routes of administration, delivery to specific organs, reduced development timelines, innovative manufacturing approaches, and cost reduction should be addressed.
Proposals pursuing a Pre-exposure prophylaxis (PrEP) indication should focus on influenza and SARS-CoV-2, meet specific criteria, and provide protection for at least six months with single-dose administration.
BARDA has a specific interest in submissions related to SARS-CoV-2, with a submission deadline of June 15, 2023. There is currently no deadline for proposals targeting other viral threats.
Area of Interest 15: Next-generation COVID-19 Vaccines Requirements
To be eligible for consideration, vaccine programs must have completed or ongoing Phase 1 clinical trials with safety and immunogenicity data available within six months of proposal submission. They must also have an active IND application with the FDA. The vaccine candidates should possess certain features, such as mucosal administration, inclusion of spike protein and additional non-spike SARS-CoV-2 antigens, or a multi-RBD (receptor-binding domain) approach.
BARDA expects proposals to align with a clinical trial synopsis and compare the sponsor’s candidate to licensed products in a Phase 2b trial. The proposal should include a comprehensive plan, timelines, Gantt charts, and cost-sharing details. Successful proposals will ensure harmonization of study protocols, collection of data and samples for primary and key immune assays, diverse participant enrollment, and adherence to ethical and safety standards.
“The next-generation initiatives by BARDA are a vital next step in the country’s preparedness for future pandemics,” stated EverGlade Consulting Founder, Eric Jia-Sobota.
If you are developing a product that you think might fall under one of areas mentioned above, EverGlade can help you make that determination and pursue a successful contract. For additional information about EverGlade Consulting, visit:
https://www.EverGlade.com
CONTACT: [email protected]
SOURCE EverGlade Consulting
