At BARDA We Seek Innovation in Science…. and in the way we do business! BARDA has a long history of driving innovative programs, to accelerate innovative ideas and deliver promising countermeasures to protect Americans.
At BARDA, we focus not only on great science but also on driving a culture of Innovation, which starts with each project we invest in, with each novel program we launch and in the way we do business with all of our industry partners. Not only does BARDA invest in innovative projects, including promising technologies or platforms across our portfolio; we also launch novel innovation programs and are designed to accelerate and foster smaller innovative projects. Our goal at BARDA is to build innovation into every project and program we invest in.
Innovative projects often promote technologies that have shown promise for filling a particular countermeasure need, but have not been widely adopted in research, development, and manufacturing practice and thus will benefit from further BARDA support and evaluation. These projects often have a broad array of potential uses as countermeasures and technologies rather than responding to a single threat. Check out Innovation Spotlight that highlights just a few of the promising innovative products and technologies in which we are investing.
While individual innovation awards can make a difference in driving promising products and technologies, in certain situations, we recognize that there are more complex barriers and a coordinated investment is necessary. In these situations, BARDA designs, builds, implements, and sustains novel innovation programs to address complex multi-factor challenges. BARDA accomplishes this by establishing hyper-focused programs designed to address the innovation gap and build any infrastructure needed to facilitate innovation. Learn more about BARDA’s (5) five Innovation Programs, led by our program divisions across BARDA.
HHS’s first venture capital partnership to develop transformative technologies to combat future pandemics, other health emergencies. This new novel partnership is leveraging venture capital practices to transform health security.
How can we help protect people most vulnerable to COVID-19? Normally after COVID-19 vaccination, the body can produce adequate amounts of antibodies for a substantial time which provide protection from hospitalization and death. But for people whose immune systems may not generate a sufficient response from COVID-19 vaccination, and others with severe allergy to ingredients in all COVID-19 vaccines, an additional prevention approach is needed. Monoclonal antibodies (mAbs) are laboratory-made antibodies which work like those made in the body naturally and can help fill the immune system gap. AstraZeneca applied their platform technology to engineer mAbs against SARS-CoV-2 to provide longer lasting protection than conventional mAbs. BARDA is partnering with AstraZeneca to develop these long-acting mAbs to help protect the immune compromised population. See how AstraZeneca’s innovative technology is filling the prevention gap and providing an additional means to protect the most vulnerable.
Triaging quickly and accurately is key to saving lives in the wake of a public health emergency such as a mass casualty incident, when medical resources are limited and wait times for imaging machines are long. BARDA is working with Philips to support the development of new artificial intelligence (AI) enabled triage capabilities for the Philips Lumify point‐of‐care handheld diagnostic ultrasound device which can be deployed across a variety of settings to help improve the timeliness and quality of care. The device can be paired with a smartphone or tablet, allowing it to be used anywhere from the field to the Emergency Department to quickly evaluate internal organs for injury caused by smoke inhalation, illness or infectious diseases (such as from SARS-CoV-2), or as a result of blast trauma. See how BARDA and Philips are working together to help save crucial time and empower caregivers to provide the best possible patient care in any situation.
What if the next time you sought medical care for a cough or stuffy nose, a hand-held device could tell you within minutes if you’re suffering from a bacterial or viral infection? BARDA is working with RizLab Health, Inc., to develop the CytoTracker, a portable diagnostic device that uses a microchip to draw in a finger-prick of blood and provide a differential white blood cell count (WBC) in less than two minutes. The results are then analyzed by a machine learning algorithm that can determine if the infection is viral or bacterial. This diagnostic tool could put actionable health information in patient’s hands and help inform the most appropriate treatment course, reducing the chance of unnecessarily prescribing antibiotics. See how BARDA and RizLab are partnering to develop rapid, intelligent, multi-use diagnostics that can be deployed across a variety of settings.
Regular COVID-19 testing helps keep you and communities safe – but getting to a testing site can be a complex process, and valuable time is lost while waiting for results. BARDA continues to support OraSure Technologies in developing a self-administered COVID-19 rapid antigen test (branded InteliSwab) that provides accurate results in approximately 30 minutes without requiring a full diagnostic laboratory. This painless, three-step process utilizes an innovative integrated swab that anyone can use. BARDA supported development of the OraSure InteliSwab test from inception through FDA Emergency Use Authorization (EUA) in June 2021 for over-the-counter (InteliSwab COVID-19 Rapid Test), prescription home use (InteliSwab COVID-19 Rapid Test Rx), and professional point-of-care use (InteliSwab COVID-19 Rapid Test Pro), and will continue to partner on obtaining 510(k) FDA clearance. Explore how BARDA and OraSure have partnered to support the safe reopening of schools, workplaces, and gathering places through fast and accurate self-testing.
For decades, scientists imagined developing vaccines to stop deadly pathogens within weeks or months instead of years. Messenger RNA (mRNA) platform technology makes that vision reality. Shortly after the publication of the SARS-CoV-2 genetic sequence in January 2020, researchers at Moderna and NIH used this BARDA-supported technology to begin collaborating on the development of mRNA-1273, a vaccine targeting the "spike" protein of the virus. Clinical trials began in March 2020, and in November, Moderna announced its vaccine had an efficacy of 94% against symptomatic infection and was found to have a clinically-acceptable safety and tolerability profile. Since the FDA’s Emergency Use Authorization in December 2020, more than 64 million people in the U.S. and millions of others around the world have received mRNA-1273. See how BARDA and Moderna have been working together on development programs with the goal of accelerating the availability of vaccines during public health emergencies.
Chemical threat agents cannot be tested in human trials, and non-clinical studies are slow, costly, and have limited utility. But what if there was a simpler way to evaluate potential therapeutics that involves human tissue exposure and also reduces the need for non-clinical testing? Researchers could instead utilize 3D biophysical platforms, also called “organs-on-a-chip”, to model the structure and function of vital human tissues and organs (such as the lungs) to safely and quickly test a drug’s effectiveness in treating chemical agent exposure. A current BARDA partnership with the Wake Forest Institute for Regenerative Medicine (WFIRM) could help bring organ-chips to the forefront of human trials-based MCM development. Read on to find out how BARDA is leveraging this novel technology to study toxic chemical exposures and quickly identify treatments for chemical injuries.
What if a sensor worn on your wrist could continuously monitor pertinent host response biomarkers in your sweat and detect changes due to an infection? A current BARDA partnership with EnLiSense has made it possible to measure inflammatory cytokines in sweat using their non-invasive Sweatsenser Dx device. Learn more about how BARDA and EnLiSense are working together to make a wearable device that offers real-time continuous reporting and delivers vital health information to individuals and health care providers to help them make informed healthcare decisions.
The COVID pandemic has highlighted the limitations of respirator supply chains and the inappropriate reuse of masks not intended for multiple uses. Reusable respirators exist, but they are not designed for healthcare workers. BARDA is working with Applied Research Associates (ARA) to develop a reusable respirator that can be disinfected and used by healthcare workers for up to thousands of wear cycles. Explore how BARDA and ARA are partnering to equip health care workers with effective, reusable respirators while solving respirator supply shortages.
How can platform technology help to tackle disease outbreaks? By utilizing high-throughput antibody identification, development, and manufacturing platforms like Regeneron’s, researchers can rapidly generate effective therapeutics against emerging pathogens. See how BARDA and Regeneron have been collaborating to rapidly develop life-saving treatments that counteract emerging pathogens since 2015.
Visualize engineering a targeted antibiotic that can overcome drug-resistant infections. BARDA is working with Locus Biosciences to combat antibiotic-resistant E. coli with bacteriophages, harnessing natural predators of bacteria to treat urinary tract infections (UTIs). An estimated 150 million UTIs occur each year worldwide – the majority of which occur in women – highlighting the severity of this issue to women’s health. Explore how BARDA’s investment in Locus’s bacteriophage therapeutic will address the need for innovative treatments for drug-resistant infections that can complicate a public health emergency.
What if we could identify COVID-19 hot spots using technology that’s accessible to anyone? BARDA is working with 98point6 and its primary care telemedicine platform to develop a program that records de-identified, suspected COVID-19 cases, and uses this information to better understand disease transmission, potential hot spots, incidence of COVID-19 cases among different population groups, and self-reported vaccination status. Find out how BARDA supports 98point6 to provide near real-time data analysis about the COVID-19 pandemic.
Visualize a diagnostic laboratory, small enough to hold in the palm of your hand. BARDA is working with Cue Health to make that possible, with their Monitoring System for COVID-19: a portable, rapid molecular test that provides the power of lab-quality testing at point-of-care. Cue’s COVID-19 test is administered by healthcare professionals and delivers results to a smartphone in about 20 minutes. Find out how BARDA is supporting Cue Health to simplify the COVID-19 testing process and enable a rapid domestic response to health emergencies.
Imagine your next vaccination: What if your annual flu shot could be mailed to your house, where you could self-administer it without using needles or needing refrigeration? A current BARDA partnership with Vaxxas could make that a reality. Explore how BARDA continues to invest in the development of the Vaxxas needle-free patch vaccine administration technology for influenza immunizations.
A donor-independent, on-demand emergency source of platelets is needed to serve as a medical countermeasure (MCM) for mass casualty incidents. See how BARDA is investing in Platelet Biogenesis’s advanced manufacturing platform to develop synthetic platelet-like cells.
Patients suffering from COVID-19 have widely variable prognoses. Some are mildly affected, while others experience severe outcomes, hospitalizations, sepsis, and death, making triage critical.
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The CIADM program was established in 2012 by HHS to strengthen the nation’s capacity to produce drugs and vaccines during health emergencies. Each CIADM was established as a public-private partnership leveraging the innovative ideas of small biotech firms, the training expertise of academic institutions, and the development and manufacturing experience of large pharmaceutical companies. BARDA supported the construction and retrofitting of pharmaceutical manufacturing facilities to utilize state-of-the-art, flexible, and innovative manufacturing platforms. The partnerships were successful in expanding U.S.-based manufacturing capacity across the CIADM network. Currently, BARDA is funding one remaining Center at Texas A&M University. Management and leadership of the remaining CIADM effort and the next-generation initiatives to strengthen U.S.-based MCM manufacturing is now part of the National Biopharmaceutical Manufacturing Partnership (BioMaP) jointly led by BARDA and the U.S. Department of Defense (DoD).
BioMaP is working to enhance the nation’s response capability through a unified, U.S. whole-of-government approach that supports the development of new drugs and vaccines. To help the country build manufacturing capabilities needed to produce population-scale vaccines and therapeutics, BARDA, under the BioMaP initiative, released in November 2021 a Request for Information (RFI). Through the RFI, BARDA gains industry feedback to assemble a next-generation manufacturing capabilities network that leverages consortiums of partners to sustain U.S.-based MCM manufacturing capacity over time and fortify U.S. preparedness against future public health threats, such as pandemics and emerging infectious diseases. BARDA will continue to look for new opportunities to partner with industry, build on the lessons learned from our prior and existing partnerships, and work with industry to strengthen U.S.-based MCM manufacturing capacity and capability.
In 2014, the United States Government released the National Strategy for Combating Antimicrobial Resistant Bacteria. A component of the National Strategy was to establish a “biopharmaceutical incubator” for combating antibiotic-resistant bacteria, a novel concept proposed by BARDA, to revitalize the pipeline of product developers focused on pre-clinical and Investigational New Drug (IND)-enabling research and development. The proposed concept was designed to provide wrap-around services and early development activities that would help progress candidate therapeutic and vaccine products from the hit-to-lead stage through Phase 1 development, and support diagnostics products through early development. In 2016, BARDA, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and Wellcome, launched the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) with the mission to “accelerate a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with funding, expert support, and cross-project initiatives.” Through CARB-X, BARDA is revitalizing the pipeline of early-stage AMR candidates from which the U.S. government or international advanced development programs may select for future funding.
Based out of Boston University, CARB-X now represents the world’s most diverse pre-clinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and preventatives, including microbiome and vaccine candidates. CARB-X continues to diversify their portfolio through contributions from Germany’s Federal Ministry of Education and Research, the UK Government’s Global Antimicrobial Resistance Innovation Fund, and the Bill & Melinda Gates Foundation. They also provide support to projects through their Global Accelerator Network and subject matter experts, many of whom have held senior positions at the US Food & Drug Administration, emerging biotechnology companies, global pharmaceutical companies and academia. This international partnership oversees a unified investment strategy that identifies and fills gaps in critically needed antibiotics and other life-saving products to combat the most dangerous drug-resistant bacteria. In its first five years, CARB-X invested more than $360 million in 92 projects in 12 countries around the world. As of June 2021, CARB-X has supported many successful candidates, including 9 products in first-in-human studies. Two companies have gone on to receive BARDA advanced research and development funding following the conclusion of their CARB-X contract.
BARDA’s Division of Research, Innovation, and Ventures (DRIVe) was established in 2018 to advance rapid development of innovative approaches to medical countermeasures otherwise not typically considered, utilizing both non-dilutive and dilutive funding. DRIVe manages and oversees BARDA’s Accelerator Network, which has established (13) thirteen forward-deployed teams throughout the U.S. to assess market landscapes, rapidly identify promising solutions to long-standing and emerging health security challenges, and ultimately develop a robust pipeline for future BARDA investing. Additionally, DRIVe has developed the EZ BAA, enabling BARDA to make new awards to promising innovators at unprecedented speed, often in less than 30 days. DRIVe Impact Areas
Response to COVID-19: In 2020, the nation faced the threat of COVID-19, DRIVe’s innovative team and Accelerator Network were positioned to pivot to support the COVID-19 response. DRIVe rapidly leveraged advances in the ENACT and Solving Sepsis portfolio to quickly pivot to COVID-19 response, particularly in the development of pre-symptomatic diagnostic and disease severity tools, and other innovative technologies. DRIVe also pivoted their staff to provide surge support to BARDA during the pandemic and utilized the Accelerator Network to identify and build a pipeline of promising COVID-19 technologies. Whether during normal operations or during a pandemic, the DRIVe team and Accelerator Network are designed to push the boundaries of innovation to tackle the biggest health security challenges.
Blue Knight, a collaboration between Johnson & Johnson Innovation and BARDA, seeks to reach the global innovation ecosystem through residency opportunities and customized educational programming focused on improving health security and our nation’s response to medical threats and emerging infectious diseases. This collaboration is dedicated to and aimed at anticipating health security threats, activating the global innovation community, and amplifying technological advancements to prepare for and respond to our rapidly evolving global health environment. As part of this collaboration, JLABS and BARDA will host a series of Blue Knight symposia to convene thought leaders, innovators and entrepreneurs working to improve our nation’s response capacity and capabilities to address 21st century health security threats. Although this collaboration was initially focused at the new JLABS @ Washington, DC,
Blue Knight recently expanded beyond its hub to three additional JLABS locations in New York City, San Diego, and Toronto as well as opened up the opportunity for virtual residency. Through BARDA’s commitment to Blue Knight, BARDA and JLABS are further leveraging their expertise and resources with the aim to develop programs and initiatives that catalyze a new community of entrepreneurs, investors and thought leaders committed to meeting the nation’s medical countermeasure needs. Is your company ready to answer the call?
Our newest Innovation Program is BARDA Ventures's. Launched in June 2021, BARDA Ventures is a partnership with the nonprofit organization Global Health Investment Corporation (GHIC) to accelerate development and commercialization of technologies and medical products needed to respond to or prevent public health emergencies, such as pandemics, and other health security threats. The new public-private partnership that brings together the venture capital community with the U.S. Government, leveraging authorities provided in the 21st Century Cures Act.
Through this partnership, BARDA intends to provide GHIC with a minimum of $50 million over five years with potential for up to $500 million over 10 years. GHIC will launch a global health security fund with matching capital from other investors. This partnership will allow direct linkage with the investment community and establish sustained and long- term efforts to identify, nurture, and commercialize technologies that aid the U.S. in responding effectively to future health security threats.
“While we tackle the pandemic’s impact, we’re exploring how the U.S. can better prepare for future public health emergencies, whether it’s the next pandemic or a bioterrorism incident,” said HHS Secretary Xavier Becerra. “The pandemic has demonstrated that the U.S. needs transformative technology that is not only available but also widely accessible. Today we are announcing an innovative, cost-effective approach that puts us on a better path to take on the next public health crisis and improve U.S. health care."
In establishing the program, BARDA leveraged its culture of innovation and deep experience with wide-ranging public-private partnerships to change the way it invests in promising products with the potential to strengthen health security. As the technologies and companies generate investment returns, proceeds from BARDA Ventures funding will be returned to GHIC for reinvestment to sustain a robust pipeline of innovation.
BARDA Ventures expands the range of investment tools that BARDA has available to advance novel medical countermeasure development. BARDA DRIVe Director Sandeep Patel tells how BARDA Ventures will help critical public health emergency preparedness and response technologies find a path to commercialization and invite matching investments from the private investment community.
Revolutionize the way we prevent, detect, and respond to major 21st century health security threats. DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation’s health security through a few key impact areas: