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.
The CIADM program was established 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 currently funds two Centers with long-term contracts, reflecting our long-term commitment to our industry partners and to our Nation’s capability to produce MCMs. Management and leadership of the CIADMs is provided through the National Biopharmaceutical Manufacturing Partnership (BioMaP) jointly led by BARDA and the U.S. Department of Defense (DoD).
Through BioMaP, the CIADMs have constructed new or retrofitted existing facilities to utilize state-of-the-art, flexible, and innovative manufacturing platforms. Today, the CIADM facilities are capable of using modern cell- and recombinant-based technologies that can produce vaccines and therapeutics for not only pandemic influenza but also other threats more quickly and economically. BioMaP also works 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, but also serve as a rapid turn-on switch that would function as surge capacity for the nation.
Response to COVID-19: BARDA and BioMaP have leveraged our CIADM investment as part of USG comprehensive COVID-19 response effort. Here are a few examples:
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 Accelerator for Combating Antibiotic-Resistant Bacteria [Accelerator], a novel concept proposed by BARDA, to repopulate the pipeline of product developers focused on pre-clinical and IND-enabling Research and Development. The proposed accelerator was designed to provide wrap-around services and early development activities that would help progress candidate products from the hit-to-lead stage through Phase 1 development. In 2016 BARDA, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), pre-clinical services Division, and The Wellcome Trust launched the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X); whose mission is 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 early stage pipeline to increase the number of potential candidates from which NIAID’s early R&D and BARDA’s advanced development programs may select.
Based out of Boston University, CARB-X now represents the world’s largest pre-clinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and preventatives, including microbiome and vaccines. CARB-X continues to diversify their portfolio through expanded donor 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 and a global network of 7 accelerator partners. This international partnership oversees a unified investment strategy that identifies and fills gaps in critical need antibiotics and other life-saving products to combat the most dangerous drug-resistant bacteria. Since establishment, CARB-X has invested nearly $250 million in 67 projects around the world. As of August 2020, CARB-X continues to produce success; including four therapeutic products that have completed Phase 1 studies, one diagnostic company that has gone on to receive advanced research funding by BARDA , and one diagnostic company that is preparing for commercial launch.
In December 2020, the BARDA-founded CARB-X program received the Global Health Technologies Coalition’s 2020 Innovating for Impact Partnership Award.
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. BARDA is launching BARDA Ventures a 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. BARDA Ventures is currently soliciting proposals to identify an existing nonprofit partner (Managing Entity) that will manage and invest in promising products and technologies and drive them to the marketplace with the goal of enhancing U.S. response to health security threats including COVID-19, chemical, biological, radiological and nuclear threats, pandemic influenza, and emerging infectious diseases. BARDA Ventures, as part of the DRIVe portfolio, will address gaps in preparedness and areas within the continuum of response that require innovative and entrepreneurial approaches not otherwise considered under traditional medical countermeasure development.
The CIADM program was established 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 currently funds two Centers with long-term contracts, reflecting our long-term commitment to our industry partners and to our Nation’s capability to produce MCMs. Management and leadership of the CIADMs is provided through the National Biopharmaceutical Manufacturing Partnership (BioMaP) jointly led by BARDA and the U.S. Department of Defense (DoD).
Through BioMaP, the CIADMs have constructed new or retrofitted existing facilities to utilize state-of-the-art, flexible, and innovative manufacturing platforms. Today, the CIADM facilities are capable of using modern cell- and recombinant-based technologies that can produce vaccines and therapeutics for not only pandemic influenza but also other threats more quickly and economically. BioMaP also works 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, but also serve as a rapid turn-on switch that would function as surge capacity for the nation.
Response to COVID-19: BARDA and BioMaP have leveraged our CIADM investment as part of USG comprehensive COVID-19 response effort. Here are a few examples:
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 Accelerator for Combating Antibiotic-Resistant Bacteria [Accelerator], a novel concept proposed by BARDA, to repopulate the pipeline of product developers focused on pre-clinical and IND-enabling Research and Development. The proposed accelerator was designed to provide wrap-around services and early development activities that would help progress candidate products from the hit-to-lead stage through Phase 1 development. In 2016 BARDA, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), pre-clinical services Division, and The Wellcome Trust launched the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X); whose mission is 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 early stage pipeline to increase the number of potential candidates from which NIAID’s early R&D and BARDA’s advanced development programs may select.
Based out of Boston University, CARB-X now represents the world’s largest pre-clinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and preventatives, including microbiome and vaccines. CARB-X continues to diversify their portfolio through expanded donor 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 and a global network of 7 accelerator partners. This international partnership oversees a unified investment strategy that identifies and fills gaps in critical need antibiotics and other life-saving products to combat the most dangerous drug-resistant bacteria. Since establishment, CARB-X has invested nearly $250 million in 67 projects around the world. As of August 2020, CARB-X continues to produce success; including four therapeutic products that have completed Phase 1 studies, one diagnostic company that has gone on to receive advanced research funding by BARDA , and one diagnostic company that is preparing for commercial launch.
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. BARDA is launching BARDA Ventures a 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. BARDA Ventures is currently soliciting proposals to identify an existing nonprofit partner (Managing Entity) that will manage and invest in promising products and technologies and drive them to the marketplace with the goal of enhancing U.S. response to health security threats including COVID-19,chemical,biological,radiological and nuclear threats,pandemic influenza, and emerging infectious diseases. BARDA Ventures, as part of the DRIVe portfolio, will address gaps in preparedness and areas within the continuum of response that require innovative and entrepreneurial approaches not otherwise considered under traditional medical countermeasure development.
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:
