The Biomedical Advanced Research and Development Authority (BARDA) is best known for its role in Operation Warp Speed and its endeavors to speed up the manufacturing of COVID-19 vaccines.
Formed in 2006, BARDA predicted dangers such as the COVID-19 pandemic. BARDA’s mission is to develop the necessary response measures to public health emergencies, including pandemic influenza, emerging infectious diseases and other dangers.
On a practical level, BARDA issues announcements soliciting industry partners to compete for funding. If an industry partner is awarded BARDA funds (after submission of Stage I and more intricate Stage II proposals), they contract with the agency to deliver an agreed set of project milestones over a given period of time on a cost-plus basis.
Partnering with BARDA is a strategic victory for a company’s investors and shareholders, whether the firms are start-up biopharmas or large, established manufacturers. BARDA funds do not dilute company ownership, which is especially beneficial in turbulent economies when raising funds can be more difficult.
In addition to improving public health, a contract with BARDA builds value in a company. A BARDA contract may align with the primary products in a company’s pipeline or enable the pursuit of a new indication.
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DSI experts are experienced and successful advisors to biologic therapeutics, pharmaceuticals, and medical device manufacturers, whose qualifications satisfy the requirements of BARDA contractors. DS InPharmatics can assist potential BARDA contractors in obtaining funds.
The range and depth of knowledge offered by DSI consultants can help companies that are considering submitting a BARDA proposal or companies with proposals in preparation. Current BARDA contractors will find useful DSI services at the phases of contract start-up, project operations, execution, and conclusion.
DSI can specifically deploy suitable resources at the correct time to help successfully deliver the contract, allowing the opportunity for further funding.
DSI’s services for BARDA proposal and contract operations support
For a drug development BARDA contract, for example, a primary BARDA award of up to $10 million dollars would enable preliminary development of a new countermeasure, followed by a more substantial contract if this development is successful.
Keeping manufacturing costs down is paramount for the contractor and BARDA alike, and DSI experts can suggest appropriate strategies to achieve this. DSI can help with the identification of vendors, qualification and auditing, and with regulatory planning and documentation.
DSI can also support project management for submission of proposals (such as work breakdown structure, statement of work, contract milestones and a deliverables chart, risk management plan, project management plan, subcontractor management plan, and attachments including the target product profile and FDA communication plan).
DSI can support a BARDA contractor with project management throughout contract operations, such as communication with subcontractors and the BARDA contract management team, periodic reporting, project management software support, documentation including producing meeting minutes, and communication with finance teams and Earned Value Management Systems (EVMS).
Furthermore, DSI can help keep the necessary periodic reporting and technical documentation up to date. DSI is recognized for its superiority in technical reporting and documentation (including updated reporting of process and analytical development and manufacturing and regulatory CMC documentation), which is key for the FDA as well as BARDA.
As well as routine reporting, a strategic shift in direction in product development or a change in subcontracting vendor requires rapid preparation of supporting technical documents and detailed communication with the BARDA contract management team.
Appropriate expert(s) can be identified within DSI’s vast team to author documents at the required quick pace to avoid project delays.
DSI’s CMC HealthChek™ can be used to ensure that the program is ready for its IND filing. DSI’s regulatory team is known for its expert assistance with FDA interactions. The quality team at DSI can assess and audit vendors and support the development and monitoring of a Quality Management System.
For larger BARDA contracts, e.g., the manufacturing contracts that range from tens to hundreds of millions of dollars to billions of dollars (seen during the COVID pandemic), the DSI team’s knowledge of CGMP manufacturing scale-up for biological or chemical therapeutics is invaluable, in addition to the services mentioned above.
Furthermore, the Supply Chain team at DSI is on hand to provide appropriate advice when it comes to the setup and monitoring of a robust supply chain in challenging economic conditions.
These are just a few examples of how DSI can support current or prospective BARDA contractors to successfully obtain a contract, leading to an overall improvement in health for the U.S. population.
To learn more about how these services can assist with meeting the regulatory requirements for quickly launching a product onto the market, contact DSI’s consultants.
Acknowledgments
Produced from materials originally authored by Meranda Parascandola at DS InPharmatics.
References
- https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx
- https://www.gao.gov/products/gao-21-319
About DS InPharmatics
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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