Innovation

Government Can Drive Innovation!

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.

BARDA Programs

Innovation @ the Project and Program Level

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.

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Innovative Projects

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.

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Innovative Programs

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.

MEET BARDA’S NEWEST INNOVATION PROGRAM

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.

A Culture of Innovation

At BARDA, we seek innovation in science and in the way we do business

Select a program to learn more:

Centers for Innovation in Advanced Development and Manufacturing (CIADM)

Established: 2012

Emergent Solutions

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.

CARB-X

Established: 2016

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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.” Over the last six years, CARB-X has built on BARDA’s initial $200 million investment by expanding the partnership to include additional funders, and growing to become the world’s largest public-private partnership dedicated to early development of antimicrobial resistance (AMR) products. In its first six years, CARB-X funded the advancement of 92 innovative projects in 12 countries as part of a scientifically diverse portfolio.

In 2022, BARDA committed an additional $25 million to continue supporting CARB-X, with options to provide up to $300 million over the next 10 years. 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.

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 preclinical 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, CARB-X was launched.

Based out of Boston University, CARB-X now represents the world’s most diverse preclinical 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. CARB-X also provides support to projects through their Global Accelerator Network and subject matter experts, many of whom have held senior positions at the U.S. 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. As of July 2022, CARB-X has invested nearly $400 million and supported many successful candidates, including 11 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.

Antimicrobial Resistance: CARB-X Partners Addressing a Global Health Threat
Virtual Webinar - June 9, 2022 Download Video Transcript
How CARB-X is Addressing AMR

Pre-recorded June 24, 2022 Download Video Transcript

ACCELERATOR NETWORK AND DRIVe

Established: 2018

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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.

2020 Innovation Project

Established: 2019

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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?

BARDA Ventures

Established: 2021

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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

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.

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DRIVing Innovation

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: