The Biomedical Advanced Research and Development Authority (BARDA) is
) probably best known for its role in Operation Warp Speed and subsequent efforts to accelerate the manufacturing of COVID-19 vaccines. BARDA, formed in 2006, anticipated threats 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 funds. These industry partners, if awarded BARDA funds after submission of Stage I and more intricate Stage II proposals, then contract with the agency to provide an agreed-upon set of project milestones, on a cost-plus basis
, over a period of time. Whether the companies are startup biopharmas or large, established manufacturers, partnering with BARDA is a strategic win for a firm’s investors and shareholders. BARDA funds do not dilute ownership of the company, which is particularly helpful in turbulent economies when raising funds can be more of a challenge. As well as improving public health, a BARDA contract s builds value in a company. A BARDA contract might align with the primary products in a company’s pipeline or might allow pursuit of a new indication.
DSI experts are experienced, successful advisors to manufacturers of pharmaceuticals, biologic therapeutics and medical devices whose backgrounds fulfill the needs of BARDA contractors. DS InPharmatics can help prospective BARDA contractors obtain funds. The range and depth of expertise that DSI consultants offer can assist companies considering submission of a BARDA proposal or companies preparing their proposal submissions. Current BARDA contractors will find useful DSI services at the stages of contract start-up, project operations, execution, and conclusion. DSI can precisely deploy the appropriate resources at the right time to help deliver the contract successfully, leading to further funding opportunities.
DSI’s Services for BARDA Proposal and Contract Operations Support
For a drug development BARDA contract, in a hypothetical example, an initial BARDA award of $10 million dollars or less would allow preliminary development of a new countermeasure followed by a larger contract conditional on successful development. Keeping manufacturing costs down is paramount for contractor and BARDA alike, and DSI experts can suggest appropriate strategies to achieve this. DSI can assist with vendor identification, qualification and auditing. DSI can assist with regulatory planning and documentation. DSI can assist with project management support for proposal submission (statement of work, work breakdown structure, contract milestones/deliverables chart, project management plan, risk management plan, subcontractor management plan, and attachments such as the target product profile and FDA communication plan).
During contract operations, DSI can assist a BARDA contractor with project management. For example, communication with the BARDA contract management team and subcontractors, documentation including meeting minute production, periodic reporting, project management software support, communication with Earned Value Management Systems (EVMS) and finance teams.
DSI can help keep the required periodic reporting and technical documentation on track. DSI is known for its excellence in technical reporting and documentation (including updated reporting of process development, analytical development, manufacturing and regulatory CMC documentation), which is important for BARDA and the FDA alike. 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 with the required quick pace to avoid project delays.
DSI’s CMC HealthChek™ can provide assurance that the program is ready for its IND filing. DSI’s regulatory team is renowned for its expert assistance with FDA interactions. The quality team at DSI can assess and audit vendors and support development and monitoring of a Quality Management System.
For larger BARDA contracts, such as the manufacturing contracts that can range from tens to hundreds of millions of dollars to billions of dollars as seen during the COVID crisis, the DSI team’s familiarity with CGMP manufacturing scale-up for chemical or biological therapeutics would be invaluable, in addition to the services mentioned above. Furthermore, the Supply Chain team at DSI could provide appropriate advice to set up and monitor a robust supply chain in challenging economic conditions.
These examples are just a few of the ways that DSI can help current or prospective BARDA contractors drive their contract to a successful conclusion, leading to overall improved health for the U.S. population.
Contact DSI’s consultants to learn more about how our services can help you meet the necessary regulatory requirements to launch your product onto the market as quickly as possible.