As part of BARDA’s Medical Countermeasures Clinical Studies Network (MCM-CSN), we have had sponsors ask us about funding collaborations for their infectious disease programs, including COVID-19. We understand that it can be confusing to navigate this process, and we are happy to provide some guidance based on our experience working within the BARDA network.
While it depends on your program, typically we recommend looking into the BARDA’s Broad Agency Announcement, or BAA, and taking advantage of the TechWatch meetings that are offered. Under the BAA, BARDA is soliciting proposals for the research and development of MCMs, such as vaccines, therapeutics, diagnostics and devices to address several threats, including pandemic influenza and emerging infectious diseases.
The BAA submission requires a Quad Chart and White Paper, which provide BARDA with a brief overview of your project, including a technical discussion of your objective, approach, level of effort, and nature and extent of the anticipated results. Prior to your submission, BARDA also offers the opportunity to participate in a TechWatch meeting , which we highly recommend taking advantage of. While not a prerequisite for the BAA, it is an invaluable experience, which allows sponsors to hear expert advice from a panel of scientific, technical, and contracting professionals from BARDA, and potentially other agencies (e.g. National Institute of Health, Center for Disease Control, Department of Defense, and Food and Drug Administration). Getting this feedback and incorporating it into the White Paper/Quad Chart submission may increase your chances of moving forward in the acquisition process detailed in the graphic below.Due to the 2019 Novel Coronavirus, BARDA is currently focusing on COVID-19 responses only; however, the process is the same, and you can request a CoronaWatch meeting in place of the TechWatch meeting. Additionally, with the CARES Act recently being passed, BARDA’s Other Transactions Authority Agreements (OTAs) program might also be a good avenue for funding, as there is no longer a cap on the funding proposed for each project. OTAs also tend to offer more flexibility than other federal contracting mechanisms. These agreements are not subject to typical federal laws and regulations and give the contractor and BARDA the most contracting flexibility to advance research and development.
If you need help preparing for your TechWatch/CoronaWatch meeting, White Paper, or OTA, Rho experts can provide guidance on operational considerations and risk mitigation strategies that will better support your program.
Meagan Spychala, DrPH, Assistant Vice President of Patient Engagement and Program Strategy at Rho, serves as Rho’s advisor on patient-focused clinical research activities and works to incorporate the patient and caregiver voice and experience into the clinical development program. She serves as the co-PI for the Medical Countermeasures Clinical Studies Network (MCM-CSN), a federal contract that provides support for clinical studies relevant to the Biomedical Advanced Research and Development Authority’s (BARDA) vision to create a nation with the capability to respond quickly and effectively to deliberate, natural, and emerging threats by providing a range of clinical study services.
Arlo Grady, MBA, Assistant Director of Business Development at Rho, is a former Army combat medic, with over 15 years of experience selling to both federal and commercial clients. In his CRO experience, he has regularly participated in communications with Biomedical Advanced Research and Development Authority (BARDA) Contracting Officers (COs) regarding contract competitive range negotiations, modifications, extensions, and authorizations (COAs). Mr. Grady also works with commercial sponsors seeking federal funding for early Phase 1 and Phase 2 clinical trials and has supported their efforts in securing BARDA, DoD, and DARPA funding.