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A Guide to BARDA: Funding Opportunities for Biotechs

A Guide to BARDA: Funding Opportunities for Biotechs

What Is BARDA?

The Biomedical Advanced Research and Development Authority, or BARDA, is an agency of the U.S. Department of Health and Human Services (HHS). Its mission is to prepare for and respond to public health emergencies, protecting the public against pandemic influenza (the flu), emerging infectious diseases (EID), and chemical, biological, radiological, and nuclear accidents and threats.

BARDA was created in 2006 as a result of the Pandemic and All-Hazards Preparedness Act (PAHPA) and reports to the Administration for Strategic Preparedness and Response (ASPR). ASPR is the federal agency responsible for coordinating the nation’s medical, public health, and emergency management capabilities.

It is part of the HHS alongside the National Institutes of Health (NIH) and National Science Foundation (NSF) which also provide federal grant funding opportunities.

One of the most relevant examples of BARDA in action happened during the beginning of the COVID-19 pandemic. Its involvement in Moderna’s SARS-CoV-2 vaccine development helped accelerate the vaccine’s progress, approval, and manufacturing.

In addition to preparation and response, BARDA also maintains an “integrated system” or medical countermeasures (MCMs) for known and unknown public health emergencies and threats. This includes procuring and stockpiling MCMs, personal protective equipment (PPE), and other types of essential material or inventory needed to respond to threats to public health.

BARDA also acts as a bridge between the Federal Government and the biomedical industry, working to promote and advance the research and the development of various drugs, therapies, vaccines, tests, and diagnostic tools and medical devices necessary to respond to a pandemic or epidemic.

It provides direct funding in the form of non-dilutive funding, technical support, FDA approval support, and more to support the advancement of MCMs and next-generation technology. To date, the agency has established over 500 public-private partnerships.

Over the years, it has increased its funding capabilities, playing a more significant role within the Federal government and drug development.

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BARDA’s Strategic Plan

The agency has a four step plan made of various goals and objectives to accomplish its mission of protecting the public and preparing health emergency responses and preventions: Preparedness, Response, Partnerships, and Workforce.

Preparedness: Develop safe and effective medical countermeasures for all Americans through four objectives:

  • Accelerate the development of MCMs that can be adapted quickly to respond to new public health threats
  • Stimulate innovation in MCM development across the entire development pipeline
  • Identify and handle end-user needs, improving patient care and promoting interventions earlier in disease and injury progression
  • Develop MCMs to meet the needs of the entire population

Response: Increase readiness and responsiveness to new threats, making MCMs that are readily scalable and adaptable through five objectives:

  • Increase BARDA’s responsiveness by evaluating the diversity of its MCM portfolio
  • Build a resilient and flexible manufacturing ecosystem that prioritizes the ability to manufacture during an emergency
  • Provide various services and programs to support industry during an emergency
  • Establish partnerships that enable rapid funding, resources, and response capabilities during public health emergencies; having pre-established contracting vehicles that can be used for research and development, manufacturing, and procurement
  • Ensure that BARDA can address all people within the population and respond effectively to the needs of all segments of the nation

Partnerships: Support businesses with a proven track record by creating new public-private partnerships and identify potential business models, partners, and more through four objectives:

  • Promote adaptable partnership models
  • Sustain and nurture current partnerships and establish new ones
  • Identify ways to promote long-term sustainability of BARDA’s supported products
  • Expand partnerships with socially and economically disadvantaged businesses and increase diversity of MCM portfolio, protecting all segments of the population

Workforce: Build and foster a world class workforce to advance health security and empower both BARDA’s federal workforce and its support contractors through four objectives:

  • Recruit and retain top talent
  • Promote diversity across the entire BARDA organization
  • Support career development and provide mentoring
  • Equip staff with the tools needed to perform to the best of their abilities

BARDA’s Activities, Services, & Programs

In addition to its strategic plan, BARDA relies on six critical areas of activity to accomplish its mission. These activities, programs, and services include:

  • Chemical, Biological, Radiological, and Nuclear (CBRN): Support advanced research and development and procurement of CBRN MCMs that are used to help the US prepare for, respond to, and recover from public health emergencies occurring naturally or intentionally through various investments.
  • Influenza & Emerging Infectious Diseases (IEID): BARDA leverages a large and comprehensive portfolio approach to develop and procure a variety of MCMs that can help combat pandemic influenza and emerging infectious diseases such as COVID-19; vaccines, diagnostics, and therapeutics that can be used to support the domestic manufacturing infrastructure.
  • Core Services: BARDA provides several core services that support the timely, reliable, and cost-effective development and production of supported products.
  • Innovation: Drive innovation through government by supporting projects and programs which accelerate ideas that can deliver on promising countermeasures; invest in innovative projects, promising technologies, and new innovation programs through BARDA Ventures.
  • Detection, Diagnostics, & Devices Infrastructure: Provide a quick response to CBRN and IEID threats by investing in diagnostics and devices from a broad range of R&D, stockpiling, and expand on domestic manufacturing in a time of emergency.
  • Division of Research, Innovation, & Ventures (DRIVe): The aim of DRIVe is to accelerate the development and availability of technologies and approaches with the power to transform and protect Americans from public health risks, while pushing innovation and seeking out new ideas and approaches that can protect and prevent health security threats.
  • Division of Contract Management & Acquisition: Also known as CMA, the Division of Contract Management & Acquisition aims to provide flexible, innovative, and consistent acquisition solutions that support essential MCMs, enhancing the Federal Government’s ability to quickly respond to known and emerging public health threats through a commitment to excellence in contracting, ethics, and transparency.

Funding Opportunities with BARDA

BARDA partners with and supports companies and teams working on solutions to a variety of health security threats in the US. The funding and resources they provide help businesses develop products and technologies that will protect the public from these health risks and potential attacks. It is a component of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

BARDA’s funding opportunities, referred to as solicitations, are listed on its website under the agency’s Broad Agency Announcements (BAA). You can review BARDA’s solicitations in full on sam.gov.

If your biotech is developing a product or new technology to respond to or prevent a public health threat or is focused on a specific area of interest BARDA shares, there may be an opportunity for you to secure federal grant funding and R&D support.

The agency’s active areas of interest (AOIs) include:

  • CBRN vaccines
  • CBRN antivirals and antitoxins
  • Antimicrobials
  • Radiological/Nuclear threat medical countermeasures
  • Chemical threat medical countermeasures
  • Burn and blast medical countermeasures
  • Diagnostics
  • Influenza and emerging infectious diseases (IEID) vaccines
  • Influenza and emerging infectious diseases (IEID) therapeutics

In 2021, HHS announced the creation of the BARDA Ventures, a partnership between the agency and the nonprofit organization Global Health Investment Corporation (GHIC). It is supported through the Division of Research, Innovation, and Ventures, or DRIVe, which was launched in 2018.

It is another way in which companies can partner with BARDA to receive funding and support for R&D focused on public health and developing new medical countermeasures.

BARDA Ventures, the agency’s venture arm, is designed to help companies accelerate technology and product development and commercialization for products that are designed to prevent or respond to public health emergencies.

The partnership between these organizations will potentially create a strong foundation between biomedical research and medical countermeasures and the investment community, establishing a feasible way to fund efforts to identify, develop, and commercialize technologies the US can rely on to effectively respond to or prevent threats to public health.

The agency intends to provide GHIC with a minimum of $50 million over five years, and potentially $500 million over a 10 year period. Alongside BARDA’s commitment, GHIC is going to launch a global health security fund with matching capital from other investors.

Through DRiVe, BARDA supports innovation and new MCMs via its Easy Broad Agency Announcement (EZ-BAA). DRIVe has two funding opportunities under BARDA’s EZ-BAA for awards under $750,000 and + Phase awards up to $20 million, in the form of EZ-BAA grant awards.

BARDA’s funding opportunities are sometimes compared to those offered by venture capital firms and startup accelerators, despite the agency not taking an equity stake in any of the companies or final products it funds.

How Can You Apply?

Single entities or teams from private sector organizations, government laboratories, and academic institutions are all eligible to submit a proposal.

If you’re interested in submitting a proposal to receive an award, or grant, from BARDA, you should first review its solicitations listed under the Broad Agency Announcements. The proposal must focus on R&D activities that relate to BARDA’s area of interest and consist of MCMs for CBRN threats and IEID. You can view BAA solicitations by visiting sam.gov.

However, BARDA recommends that you first register for a TechWatch meeting to present your product, technology, or capability before submitting an application.

Once you have found a solicitation that applies to your idea, product, technology, or capability, you will need to login to BARDA’s stakeholder portal, the BARDA Digital Resources (BDR) Portal, or create an account. This portal allows you to submit proposals in response to BARDA BAA and EZ-BAA and request TechWatch meetings.

From there, you will need to put together a white paper submission or full proposal submission that includes a range of information about your product and business. The information you need to provide will be listed under the solicitation you choose, and will include instructions for submitting the proposal correctly.

After you have successfully submitted a proposal, BARDA will review the application to determine whether or not it qualifies for funding. If your application qualifies, a negotiation will follow, in which the partnership between you and the federal government will be discussed. Once everything has been decided, and both parties are feeling good, you will be awarded funding.

If applying for a grant through BARDA’s BAA is proving difficult, you can reach out to your local Procurement Technical Assistance Center (PTAC). PTACs are official government contracting resources for small businesses that need assistance with contract/funding opportunities. Find your local center.

If you’re interested in a funding opportunity through BARDA and DRIVe’s EZ-BAA, there is a similar process. The first step is to identify a funding opportunity listed under EZ-BAA. You can do so by reviewing the funding opportunities listed on its website. Find one that aligns with your organization. You can review EZ-BAA solicitations through beta.sam.gov.

Additionally, there are several development programs you can apply to as well, including RePAIR, ReDIRECT, Lab at Home, and more.

If you do find an opportunity that aligns with your business, DRIVe asks that you send an inquiry email with a brief description of your technology to the appropriate email address. From there, a call will be scheduled to review alignment if it’s needed. Sometimes alignment can be quite clear, and a call may not be needed.

The next step in the EZ-BAA submission process is to submit your abstract. Once you’ve reviewed solicitations and picked one, you will need to review the full instructions document for creating an account and preparing the abstract. Your submission must conform with the requirements outlined in the instructions document.

Once you’ve submitted an abstract, it’s time to start the application process, which you can do on DRIVe’s website. This involves creating an account on the BARDA Digital Resources (BDR) Portal.

For a full description of the EZ-BAA process, you can review the Easy Broad Agency Announcement document.

Steps to a Better Application

There are some things you can do before submitting your proposal so that it has higher chances of being funded:

  • Make sure your idea is feasible
  • Make sure the project doesn’t overlap with other projects funded by BARDA
  • Make sure your project has potential to save lives

That said, one of the most important steps in securing BARDA grant funding is to determine if your project falls into one of the eligible categories.

The second step is to ensure that you have all the necessary information about your project and its goals before submitting an application. This includes having a detailed budget, timeline, and justification for why your project deserves funding. You should also include any data or studies that show that your project will be successful in achieving its goal.

Most importantly, follow the instruction document listed under the solicitation you’re applying for to ensure you’re conforming with every requirement. Otherwise, your application won’t qualify.

Other Opportunities to Partner with BARDA

In addition to BARDA BAA, EZ-BAA, and BARDA Ventures, there are some other opportunities for companies to partner with the agency. This includes TechWatch Meetings, a platform that reaches a wide range of potential federal partners. While these meetings are used for market research, they are not considered submissions for potential funding.

That said, if you’re interested in partnering with the federal government to develop MCMs, you can submit your ideas to TechWatch Meetings, which provides a single point of entry for the submission of meeting requests. The areas BARDA is currently evaluating for TechWatch meeting requests includes:

  • Chemical
  • Biological
  • Radiological
  • Nuclear

This means a wide range of threats are considered eligible for evaluation, including things like Anthrax, biotoxins, blood agents, coronavirus, influenza, nerve agents, plague, smallpox, viruses, and much more. Programs that are evaluated include DRIVe.

Through your submission, you can access US government experts who will discuss your product, technology, or capabilities and explore the potential for partnering. This includes:

  • Products, technology, and capabilities that are relevant to U.S. government medical countermeasure R&D and emerging infectious disease rapid response.
  • Products, technology, and capabilities that use an already-approved platform, have non-clinical data suggesting efficacy, or have significant manufacturing capability
  • Products, technology, and capabilities that are entirely owned or licensed by your business; you must have full IP rights and Freedom to Operate (FTO)

Submission requirements include a brief description of your product or technology and a slide deck and manuscript, in addition to publications or other non-confidential information you’re able to provide. While the information you provide does get used for market research, it does not guarantee you will secure a meeting or funding.

Furthermore, your submission will be shared with BARDA’s MCM R&D teams. That said, government officials that join in TechWatch meetings are bound by law to maintain confidentiality of everything presented and discussed.

The TechWatch meeting process is as follows:

  • Login or register: login in before you submit; if you’ve never used the site, you must register first.
  • Submit your application: submit basic information about your product, or view/update an existing submission; when you successfully submit, you’ll receive a confirmation code.
  • Evaluate and prioritize: BARDA evaluates your submission, routing it to the most relevant resource in the US government.
  • Notification: if your evaluation is successful, BARDA will arrange a broad or targeted meeting; if it’s not successful, no meeting will be scheduled; the product information will be retained for future use.

Before you submit, it’s important to confirm your area of focus is currently being evaluated by BARDA TechWatch. Do not submit multiple requests for the same product or technology.

Additional Resources for Biotechs In Search of Funding

If you’re interested in additional BARDA and ASPR resources and funding opportunities, you can review other areas of the agency’s website.

This includes DRIVe and BARDA’s Accelerator Network, which connects BARDA to thirteen accelerators across the US in regions focused on developing health security and countermeasure products and technologies in biotechnology, biosciences, life science research, and medical innovations.

The accelerator network supports early-stage companies through their journey from identifying an unmet need to developing a product to commercialization.

BARDA also created the joint initiative, Blue Knight, with Johnson & Johnson Innovation to anticipate potential health security threats, activate the broader global scientific community, and amplify scientific and technological development. Its aim is to prepare for and respond to the quickly evolving global health environment.

This is accomplished through the support and incubation of science and technologies that can improve public health and security but may not have the resources and funding needed to develop and commercialize.

If you’re a business with a proven track record conducting transformational science and/or technology, targeting a significant and unmet medical or market need, and have a mission that is aligned with Johnson & Johnson’s strategic areas of interest, then you might consider applying to become a Blue Knight company.

Companies involved in the program will have access to the JLABS ecosystem, including equipment and resources, which will be covered through BARDA.

Additionally, Blue Knight companies will receive mentorship, customized programming aligned with key areas of interest, and be invited to participate in annual symposia dedicated to bringing together thought leaders, entrepreneurs, and innovators within the Blue Knight community.

You can apply online through Johnson & Johnson Innovation.

Grant Funding Can Free Up Money for Leasing

BARDA grant funding is a great opportunity for organizations and labs in search of non-dilutive capital and business development support. If you’re interested in working with a federal agency, BARDA is a potentially excellent fit.

In addition to BARDA, several other government agencies provide grant funding or participate in grant programs that support specific R&D efforts of early-stage startups and small businesses. This includes the NIH, NIAID, NSF, DOD, CDC, and more.

With funding for your R&D and manufacturing, there will be opportunity to procure additional lab equipment to support your efforts. Rather than use the working capital you have on hand to purchase expensive research or manufacturing equipment, lease what you need instead.

When you lease your lab equipment with Excedr, you save a huge amount of money on significantly lower upfront costs. The money you do reserve can then be used to invest in other areas of business, working together with your BARDA funding to increase your overall business capabilities.

And, because Excedr is dedicated to working with biotechnology companies, you will have a team on your side that understands your needs.