The creative talent of inventors and entrepreneurs across the entire country is the heartbeat of our economy and our nation’s well-being. At BARDA, we’d like to tap this energy to solve a critical challenge for our country: the design of comfortable, protective facemasks for the general public. Scientific evidence shows that masks can be useful in curbing the spread of respiratory infections, yet we know that actual use is not up to the same standard as intended use. Research shows the most common reasons people don’t wear masks or don’t wear them properly: fit, comfort – including fogging glasses – and lack of confidence in the effectiveness.
Last week we launched a contest called the Mask Innovation Challenge: Building Tomorrow’s Mask to design effective, comfortable masks for the public. We’re offering $500,000 in cash prizes because we’re certain American ingenuity can design and build better masks that people are more willing to wear and trust.
In the first phase, up to 10 winning ideas will split $100,000 for winning design ideas. Ideas are due by 5 p.m. ET, April 21, 2021. In the second phase, up to five winning prototypes will split $400,000.
This contest is different from previous challenges sponsored by the private sector in that prototypes from phase 2 will be tested by the National Institute for Occupational Safety and Health or partner labs to determine how well the prototypes meet the performance criteria. Winners have to meet a specified filtration level. That doesn’t mean the mask will automatically receive NIOSH certification; additional development for certification would be needed through the NIOSH certification process which is independent of this competition.
We also want the winning masks to be easy to manufacture because a good idea becomes great when it hits the commercial market, and everyone starts using the product. We’re offering BARDA scientific mentorship to guide winners in completing development.
You could help solve one of the biggest problems we’re facing today and into the future. We can’t wait to see where American ingenuity leads in solving the mask challenge. Check out
Challenge.gov to learn more about the contest rules, criteria, and how to participate.
Launching an innovative product or technology takes more than a good idea, and there are many actions startups can take to strengthen their offering and overall chance of success as they develop the latest innovations to bolster health security, including battling COVID-19. Over the last year, the global scientific community has proven critical to our collective ability to combat the pandemic, and Blue Knight™ offers a new way to build the kinds of partnerships needed to advance potentially life-saving technology during public health emergencies.
Blue Knight is a joint initiative between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority (BARDA) that aims to forge a path to a more prepared and protected future by providing support for strategically aligned start-up companies and elevating important topics through expert programming.
At the close of 2020, we joined the culminating session of the
BLUE KNIGHTSymposium to discuss strategies for investing in and nurturing early-stage innovation to improve health security. At the Symposium, we witnessed first-hand that when worldwide experts come together, we are able to probe deeper to address challenges and identify priorities to strengthen preparedness and health security.
We were joined by internationally recognized innovation leader, Geoffrey Ling, M.D., Ph.D., for a forthright dialogue that provided early-stage innovators with tips for overcoming barriers. The panel was led by entrepreneur Stephanie Culler, Ph.D., Co-Founder and CEO of Persephone Biosciences, a
Blue Knight company. Here are key takeaways from the discussion.
To fuel early-stage, high-risk innovations, we look for ideas with the potential to cross the ultimate finish line: meeting the unmet needs of patients. By offering transparent advice, we hope to help those on the frontlines of innovation develop stronger proposals, foster connections, and access the support needed to make their next big move.
If you are interested in taking a deeper dive into any or all of these concepts, check out the full remarks in our
At the end of the day, even with the right science, the right target market, and the right funding, the path to bringing an idea to market is prone to detours and roadblocks. Success requires creativity and unwavering passion. We believe that entrepreneurs who build a network of diverse stakeholders – all passionate about their success and who will be there to help pivot and persevere – may have a stronger chance at getting their solutions to patients.
By finding partners and mentors in the early stages, entrepreneurs can gain the expertise and insights to look ahead to anticipate and mitigate risks.
If you’re working on the frontlines of innovation with the aim to improve health security, we want to hear from you. Our
Blue Knight collaboration was formed with a keen interest in sourcing innovation that has applications for today, while improving our readiness to combat unknown threats of tomorrow. United, we are able to provide promising startups with the robust, multi-specialty mentorship and resources from both the Johnson & Johnson Family of Companies and BARDA networks.
It’s never too early to start making connections and building the foundation and support that may help propel your science or technology forward. If you’re ready to progress your compelling idea for improving preparedness and response to health threats, visit the
Blue Knight website to get connected or apply to join.
Disclaimer: The content covered in this blog is intended for educational and informational purposes only and may contain opinions by persons and organizations not affiliated with Johnson & Johnson Innovation LLC, and/or its parent or affiliated companies (hereinafter collectively referred to as “JJI”). JJI makes no representations, warranties, express or implied, as to the content, the views, advice, or the information presented. This content is not intended to influence the use, sale, recommendation, or promotion of any products or services of JJI, Johnson & Johnson or its affiliates.
Source: Johnson and Johnson Innovation - JLABS
“For every minute spent in organizing, an hour is earned.” – Benjamin Franklin
Robert Daley, logistics section chief of the Incident Management Team-East, is no stranger to managing the complex logistics of an emergency response with the National Disaster Medical System (NDMS). He has a long career of being a paramedic and a firefighter before joining NDMS in 1996, and has responded to many major emergencies over the past few decades including the major earthquakes in Iran and Haiti; the response to 9/11; and Hurricanes Katrina, Irma and Maria. Just like many of us, Bob has been contending with the pandemic since the very beginning and over a year later he continues to support the logistics of the federal government’s response. Bob has helped with every aspect of this pandemic from the early days of PPE shortages and flattening the curve to the different requirements for medical care during a pandemic as well as antibody infusions and vaccine administration.
Immediately after supporting the January 2020 State of the Union, Bob was called upon to help support the logistical aspects of repatriating hundreds of Americans and their families from Wuhan, China. He is one of our everyday heroes that helps make disaster response at HHS happen. He and more than 2,800 responders from across the country have deployed, often multiple times, to support the whole of government pandemic response. While many who have been impacted by disaster know about our NDMS medical professionals, none of the work they do would be possible without the many people behind the scenes, like Bob, who are making sure that assets, resources, and people get where they need to be, stay safe, and are available to provide the best of care in the worst of times.
Following the repatriation mission, Bob helped coordinate surge support at the Kirkland Nursing Facility in Washington State and then continued from there to the Javits Center in New York City. Since then, Bob has deployed to 12 states supporting different NDMS missions, including hospital surge support, monoclonal antibody infusion support, and vaccine administration.
The logistics team that Bob helps lead has one mission during disasters and public health emergencies and that is to support the deployed medical teams. Without logistics, our doctors and nurses would have no PPE, no medical supplies and pharmaceuticals, no computers, phones or power. They wouldn’t even have a place to sleep at night. Logistics is the backbone of our deployments, working around the clock often days before our medical personnel arrive and days or even weeks after our medical personnel return back home.
Often times, a hospital will be damaged by a hurricane, tornado, or other natural disaster, and logistics will be called upon to set up a temporary facility. Once these facilities are established, logistic personnel make sure they are fully equipped to care for COVID-19 patients. This includes securing beds, linens, food and water, and medical supplies and medical equipment – including personal protective equipment (PPE) testing supplies, ventilators, oxygen and pharmaceuticals. If using temporary tents to care for patients, logistics personnel must acquire everything from light towers and hand washing stations to generators and fuel. Once the site is no longer operational, logistics personnel are responsible to make sure all equipment and supplies are accounted for and returned or moved to support the next site.
Most recently, Bob deployed to the Tucson Medical Center to lead the logistics of the federally supported monoclonal antibody treatment center. This was the second of what would become four federally supported infusion sites. He dove right into the challenge, securing space for patients, resources for the infusions, and even going above and beyond to deliver more COVID-19 tests to the hospital’s clinic so that more patients could be tested and referred for antibody infusions. The four federally supported infusion centers directly prevented over 1000+ COVID positive patients from needing to be treated for severe illness, including
Ms. Joyce Sonday who was the 500th patient to receive the treatment in Tucson. Bob presented Joyce with a logistics challenge coin, a small token of his appreciation to mark that she was the 500th patient to receive the monoclonal antibody treatment. In fact, thanks in part to his leadership, ASPR was able to replicate this success and build a
digital toolkit for communities across the country to set up these infusion sites.
The COVID-19 pandemic has presented extraordinary challenges to every American and the logistics team Bob assists in leading helped ASPR meet those challenges at every step of the way. He’s been on the front lines since the pandemic was declared to help accomplish an unprecedented mission through sweat and a determination to succeed and a must not fail attitude during this unprecedented national public health crisis. He is extremely proud of being able to contribute to the whole-of government response and continues to have total respect for his colleagues and the stamina that they bring to help the American people. For more information about NDMS, visit
Joyce Sonday of Tucson, Arizona, loved walking her property and the neighborhood regularly, visiting with family and cooking for her husband, but all of that changed when she contracted COVID-19. She became exhausted and lost her taste and sense of smell. She wasn’t sure what was wrong but her husband experienced the same symptoms. At first she thought they had sinus infections but decided to go to their local clinic where she and her husband tested positive for COVID-19.
Fortunately they knew a treatment was available, and that they were eligible to receive the treatment. They qualified under the FDA Emergency Use Authorization criteria because they are in their 60s and had underlying medical conditions that placed them at high risk of developing severe infections and becoming hospitalized. Less than a day later she and her husband had appointments to receive infusions of COVID-19 monoclonal antibody therapeutics at the Tucson Medical Center, one of several federal infusion sites launched at the beginning of the year.
Monoclonal antibody therapeutics help eligible high-risk adults and children (12-17) who have tested positive for COVID-19 and have mild to moderate symptoms. These therapeutics have been granted Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) to treat eligible COVID-19 patients. The treatment, which takes a total of about two hours (Joyce reports she was able to comfortably watch her favorite football game while she was being treated), and the treatments can help boost the body’s immune response, keeping patients out of the hospital. The Tucson Medical Center, which was one of the first federally-supported COVID-19 infusion centers, is one of more than
4,800 sites across the country where these FDA-authorized treatments are available.
Medical professionals from the National Disaster Medical System partnered with Tucson Medical Center to set up an infusion center that could see up to 40 COVID-19 patients per day. Ms. Sonday happened to be the 500th patient seen across several federally-supported infusion centers. She and her husband are among the thousands of patients who have recovered and are feeling better after being treated. To date, none of the patients treated at the federal-supported infusion centers have needed to return for further COVID-19 treatment and none have required hospitalization related to COVID-19.
Joyce and her husband are happy to report that they are feeling much better, and they are relieved to be able to get this treatment. Joyce is happy to be back to doing the things she loves to do. After getting treated, she regained her sense of taste and smell, and with it her joy of cooking. She says she and her husband are registered to get the COVID-19 vaccine when their turn arrives. They have no desire to experience the effects of COVID-19 again, and they can’t wait to see their family when allowed.
Joyce is not alone in her story. Providers across the country can learn lessons from the NDMS-launched infusion centers which the local hospital systems were able to take over, as originally planned, with a small staffing requirement. ASPR has a
toolkit and other resources to help providers and communities set up similar sites to reduce the burden on their hospitals and help COVID-19 patients recover. While the COVID-19 vaccines are the proverbial light at the end of the tunnel, therapies like monoclonal antibodies are available today to help treat patients and potentially save lives.
The dedicated individuals of the National Disaster Medical System (NDMS) - known for their expertise, their teamwork, and their selfless commitment to saving lives during disasters and emergencies - have worked tirelessly on the front lines of health to fight COVID-19. More than 2,500 NDMS responders have deployed since the beginning of the pandemic in 2020 and continue to deploy to support federal, state, local, territorial, and tribal partners, providing hospital surge support, administering COVID-19 monoclonal antibody therapeutics, supporting mass vaccination efforts, and more.
The breadth and scope of their missions has been nothing short of amazing and I would like to take a moment now to thank all of the men and women of NDMS for their dedication to service. NDMS responders have been on the frontlines of health from the beginning of the response and they continue to serve.
Here are just a few of their extraordinary efforts in response to COVID-19:
When President Biden recently set the goal of administering 100 million shots in 100 days and expanding access to vaccines to more Americans, NDMS teams deployed to support mass vaccination efforts in Nevada and Arizona, getting shots into the arms of thousands of eligible individuals.
Following the FDA authorization of
monoclonal antibody therapeutics for treating patients with mild to moderate cases of COVID-19, NDMS supported temporary infusion clinics in Arizona, California, and Nevada to administer these treatments that can help eligible high-risk adults and children avoid hospitalization.
NDMS teams deployed to hospitals and healthcare facilities across the country to bolster capacity. From major urban cities to small rural communities, from New York City to the Navajo Nation to Alaska to Guam and points between, NDMS deployed to help frontline healthcare workers provide vital medical care in their communities.
When, during the initial stages of the pandemic, Americans needed to be brought home from places with high risk for coronavirus infection, such as Wuhan, China and the cruise ship quarantined at Yokohama, Japan, NDMS teams were on the scene. In total, more than 3,000 individuals were brought home during various repatriation and quarantine missions.
Responding to COVID-19 was not their only mission. Last year, NDMS responders were deployed to lead and support field operations in the aftermath of nine hurricanes, an earthquake, wildfires that ravaged two states, and seven National Security Special Events (NSSE); often responding within hours of being called.
When these heroes aren’t providing necessary care and services in areas impacted by disasters and other health emergencies, they are the physicians, registered nurses, dentists, paramedics, and other medical and support professionals who we trust with our health on a daily basis. When called upon, these professionals rise to the challenge, carrying on NDMS’s long and proud history of going to where they are needed to protect health and save lives.
When NDMS deploys during a disaster, they make a real difference to the communities they serve. They set up temporary medical facilities and provide help that can transform hospital operations. They have helped get shots of COVID-19 vaccine into arms. They have treated more than a thousand eligible COVID-19 patients with monoclonal antibody therapeutic treatments. During this pandemic, they have saved lives, supported frontline healthcare workers, treated patients, and more. Thanks to each and every NDMS professional for your service.
“Alone we can do so little; together we can do so much” – Hellen Keller
If you work for a community-based organization (CBO) , you may have seen demand for your services rise during the COVID-19 pandemic – often without a corresponding rise in the resources required to meet the demand. In many areas, the COVID-19 pandemic has hit populations who were already at-risk especially hard, often resulting in an increased need for services.
Community health centers, childcare providers, food banks, low-income housing providers, home visiting programs, shelters and other service providers who address domestic violence, homeless services providers, and members of aging and disability networks all perform vital services in their communities – and many providers are trying to find creative solutions to rapidly evolving problems. To guide you through some of these complex issues, we have developed a series of resources to help you build stronger relationships, return to work safely, use innovative approaches, and more.
ASPR’s At-Risk Individuals Program
developed a toolkit with four tools that professionals in CBOs can use to more effectively leverage or grow existing resources and have a greater impact their your communities.
During the holidays, we at ASPR are especially grateful for the dedication that CBOs have to their communities and for the services they provide throughout the year. Thank you for your support at a time when it is urgently needed. The work that you are doing to provide for others during this trying time is important to the physical, mental and emotional wellbeing of many people in your community . We encourage you to check out the resources above to help your organization work more effectively, and ultimately continue to serve at-risk individuals during the holidays and throughout the year.
HHS emPOWER Program (emPOWER) has officially launched the
HHS emPOWER Program Platform, a new mobile-ready technical assistance platform that provides public health, health care, and emergency management organizations, first responders, power companies, and many other partners with emPOWER data, tools, training, and informational resources to help them anticipate, plan for, and respond to incidents, emergencies, and disasters in their communities.
The Platform was developed in response to partner requests and provides readily meaningful, consumable, and actionable information and resources in a centralized location. Anyone can now rapidly access, adopt, download, and operationalize emPOWER tools, resources, and HHS emPOWER Map de-identified data to help protect the health of electricity- and health care-dependent at-risk populations living independently in communities across our nation. Partners can learn about the history of emPOWER on the
About page and rapidly access the Platform’s
Resources page to find new fact sheets, job aids, quick reference resources, and more tools that have been and will continue to be developed with their unique needs in mind. Partners can also discover how rural-to-urban communities across the nation have used emPOWER tools to enhance their health care situational awareness, coordinate planning activities across community partners, and innovatively conduct life-saving outreach activities using the
emPOWER in Action interactive map and by reviewing detailed
Stories from the Field.
The Program has also re-launched an improved, mobile-ready
HHS emPOWER Map that can be found at a new website address,
https://empowerprogram.hhs.gov/empowermap. Based on partner feedback, emPOWER updated the Map to include new capabilities that enable users to download data and perform advanced cross-jurisdictional data aggregations. The Platform also features an
informational HHS emPOWER Map page with historical HHS emPOWER Map datasets to support those seeking to perform analyses to better understand historical trends in electricity-dependent population density by geography in their community.
In addition to launching the Platform and new HHS emPOWER Map, emPOWER has released new and enhanced versions of emPOWER tools. The enhanced
HHS emPOWER Representational State Transfer (REST) Service_Public enables users to readily access and apply the map data layer to their own geographic information system (GIS) application to support national, state, territory, local, and community-based GIS analyses. The
award-winning, artificial intelligence (AI) tool,
emPOWER AI puts the HHS emPOWER Map data right in the palm of the user’s hand, leveraging Google Assistant and Amazon Alexa to help enhance the user’s situational awareness of electricity-dependent populations. In addition, emPOWER has expanded its
emPOWERing State/Territorial Medicaid and Children’s Health Insurance Program (CHIP) Data Pilot to advance states’ and territories’ understanding of pediatric and other adult at-risk populations in their communities. To help users better understand how to implement these tools effectively, we have released a comprehensive
web-based training and created a robust suite of
The new HHS emPOWER Platform is advancing the Program’s commitment to providing the right data, in the right tool, to the right person, at the right time. Leveraging the data, tools, and resources on the Platform will help federal to community partners
in most critical infrastructure sectors, support, and advance emergency preparedness, response, recovery, and mitigation activities to protect the health and meet the needs of at-risk individuals in their communities. To learn more, please visit the new
HHS emPOWER Program Platform or check out the
HHS emPOWER Program Platform Fact Sheet
As COVID-19 infection rates rise, hospitals and healthcare facilities are understandably focused on protecting patients, staff, and providers from the virus – but COVID-19 is not the only rising threat to the healthcare industry. While healthcare providers continue to focus on responding to the pandemic, cyber threat actors are taking full advantage of healthcare vulnerabilities by perpetrating scams and phishing attacks, which largely depend on the target’s sense of fear and urgency.
According to an
annual report by Coalition Cyber Insurance published in September, the most common type of cyber incident across all industries was ransomware, which accounts for an estimated 41 percent of all cyber-attacks in the past year. The average ransom demand has increased by 47 percent from 2020 Q1 ($230k) to Q2 ($339k). This increase happened at the same time as COVID-19 cases in the U.S. surged throughout Q2. In September, the Cybersecurity and Infrastructure Security Agency (CISA) within the Department of Homeland Security issued
a new alert, coauthored with the Federal Bureau of Investigation and the U.S. Department of Health and Human Services, warning of ransomware activity targeting the Healthcare and Public Health Sector.
For many facilities, the most common vulnerability to their IT security comes from their own employees. Social engineering attacks, including phishing scams that may be conducted by email, are the most frequently used techniques, accounting for 60 percent of all incidents, and do not require advanced technical skill. No matter how robust the network infrastructure and security controls the actions of one careless or mislead employee can result in significant damage. Service and communication disruptions in healthcare can be a life or death situation, and cyber criminals are exploiting this sense of urgency.
Threat actors are ramping up their attacks across all sectors, but appear to be specifically targeting healthcare systems. Over the course of this year, Coalition Cyber Insurance
reported that the healthcare industry had the 3rd most ransomware claims across all sectors. When you combine that with the fact that hospitals and healthcare facilities are in the middle of a pandemic, and those facilities are on the front line of the global response, these cyber threats take on particularly dire consequences.
The vast majority of cyber-attacks can be prevented by training employees and maintaining protective software. However, you also need to be ready to respond in case your prevention strategies fail. If your facility does become a victim of a ransomware attack, a complete, up-to-date backup can help ensure your patients the continuity of care they need and protect your organization financially.
Regularly backing up all mission-critical data can help facilitate improved recovery time and mitigate the severity of an attack. In general, maintaining anti-ransomware best practices like the 3-2-1 backup strategy or conducting regular vulnerability scanning to identify and address vulnerabilities will help protect your organization against future threats from other ransomware operators. The 3-2-1 backup strategy simply states that you should have three copies of your data (your production data and two backup copies) on two different storage media (disk and tape) with one copy off-site for disaster recovery. Having a 3-2-1 backup of all mission-critical data could allow a facility to operate while under attack and recover much more quickly without having to pay the ransom. It is crucial that these backups are stored offline and are disconnected to any other systems when not in use or else they could also be infected by ransomware and rendered useless.
The federal government has many resources to assist the private sector in both preparing for and responding to cyber incidents:
So, while everyone is reminded to wear a mask, wash their hands, and maintain a social distance, people and organizations should also prioritize good cyber-hygiene on both an individual and organizational basis. Be extra vigilant about social engineering techniques like phishing scams and keep all operating systems and security software updated per your organization’s recommendations.
If your organization is the victim of a cyber attack, be sure to report it. Reporting cyber incidents is vital to helping the interagency, state, local, and private sector partners better understand the cyber threat landscape. To report suspicious or criminal activity, contact your local
FBI field office, call the FBI’s 24/7 Cyber Watch (CyWatch) hotline at (855) 292-3937, or e-mail at
MCyWatch@fbi.gov. To request incident response resources or technical assistance related to these threats, contact CISA at
Central@cisa.dhs.gov. For potential medical device impacts related to a cyber-attack affecting your hospital system, please contact
HHS/Assistant Secretary for Preparedness and Response’s (ASPR) Division of Critical Infrastructure Protection (CIP) continues to actively track cyber threats and other emerging issues at the intersection of disaster health and critical infrastructure protection. To learn about the latest resources and tools to optimize your organization’s ability to respond, recover, and prepare for threats and incidents impacting the nation’s health critical infrastructure, subscribe to the ASPR CIP mailing list. For more information on this subject or how to participate with the healthcare and public health (HPH) Sector, contact us at
How can we make sure our country has the vaccines, therapeutic treatments, diagnostics and other technology that are needed to save lives in a public health emergency? Part of the answer is encouraging innovators and entrepreneurs to partner with the federal government, and doing so requires rethinking the typical government approach to research, development and acquisition. Over the last decade, the success of HHS, ASPR, and BARDA has been to partner with the most innovative, fearless, and best partners in industry. These partnerships have helped push preparedness efforts farther along.
As part of the Office of the Assistant Secretary for Preparedness and Response, BARDA continually invests in advanced stages of development to bring forward critical technology and products to protect Americans’ health security. To date, BARDA’s support for product development has resulted in 56 FDA approvals, clearances, and licensures for critical countermeasures such as vaccines, point-of-care diagnostics, and lifesaving therapeutic drugs. We’ve established novel public-private partnerships with companies of all sizes and experience levels, from global pharmaceutical giants to innovative startups, to accelerate the development of medical countermeasures to save lives.
The foundation of these collaborations vary from traditional contracts to flexible agreements under Other Transaction Authority to allow us to transition immediately from long-standing health security threats to address immediate threats like COVID-19. While BARDA holds a unique role as the only part of the federal government dedicated to advanced stages of development for medical countermeasures the American people need in public health emergencies, we realized that to combat a unknown and ever-evolving threats, we needed a stronger pipeline of transformative technologies and products.
In 2016 we founded CARB-X, now the world’s largest public-private partnership to accelerate new countermeasures to combat antimicrobial resistant infections, which has now supported 45 novel technologies with seven graduating into advanced stages of development or regulatory approval. In 2018, we stood up DRIVe, the Division of Research, Innovation, and Ventures (DRIVe) dedicated to improving health security and enhancing our preparedness posture by specifically investing in potentially breakthrough technologies and capabilities to address systemic challenges across all health security threats, such as early notification of illness before symptoms occur, solutions for sepsis, and other disruptive innovations.
In this short time, DRIVe has partnered with 13 accelerators across the country to better source innovation across America. BARDA’s objective, to move strategically and quickly on acquisition and management activities, has fueled DRIVe’s success and resulted in 41 new public-private partnerships.
BARDA Ventures is our next step to bring medical countermeasure development up to the speed of innovation. To do so, BARDA Ventures will engage the private sector by seeking matching investments from non-governmental sources and thus multiply the impact of taxpayer dollars provided by the U.S. government.
DRIVe built a robust team of biotech, investment, and health security experts who thoroughly examined every aspect of venture capital industry practices. Our approach is based on hundreds of conversations with leading venture capital experts and through responses to two requests for information and culminated in an announcement for a non-profit fund manager with which we can partner to carry out venture capital style investments that support medical countermeasure development to help the United States prepare and respond better to future health security threats.
We ask all interested parties from the venture and investment community to join us and help identify, nurture, and commercialize transformative technologies with the required speed and flexibility that traditional government funding is not designed to do. Immediately, we are looking for a managing partner to help us transform the American health security landscape through equity-based investing. That partner would be an existing nonprofit entity with a demonstrated track record of successful healthcare and life science related venture capital investments that can establish and manage a private-public partnership with us. Learn more on the BARDA Ventures website.
Antibiotic resistance is one of the greatest global health threats of our time. Antibiotics are vital tools for addressing bacterial infections and save untold millions of lives each year. However, the increasing prevalence of resistant strains of bacteria threatens the usefulness of antibiotics and can cause untreatable infections. CDC’s 2019 Report on Antibiotic Resistance Threats estimates indicate that each year, more than 2.8 million Americans develop a drug-resistant infection, and more than 35,000 die from them.
Globally, drug-resistant infections kill over 700,000 people every year, and in the United Nations’ report No Time to Wait, the United Nations warns that without a sustained effort to contain antimicrobial resistance, this figure could increase to 10 million lives lost per year by 2050, with 2.4 million deaths occurring in high-income countries between 2015 and 2050.
Last month, the U.S. government released the National Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB), 2020-2025. This pivotal strategy lays the foundation for how agencies across the U.S. Government will collaborate over the next five years to equip the United States to continue its One Health response to the antibiotic resistance threats of today and prepare for new resistance that might emerge tomorrow.
The new plan builds on the successes realized under the 2015 National Action Plan for CARB. After five years of coordinated federal response, the nation is better positioned to combat the emergence, spread, and impact of antibiotic resistance, but more can and needs to be done during the next five years.
BARDA plays a critical role in the federal government’s response to combatting antibiotic-resistant bacteria and is responsible for targeted actions to meet multiple objectives within the National Action Plan for CARB. BARDA serves as the lead agency for investing in the innovation, advanced research and development (R&D), manufacturing, and procurement of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats and save lives.
Currently the private sector has too few innovative antibacterial products in development to address highly resistant infections. Making new antibiotics is difficult and expensive, and many manufacturers have shifted their efforts away from developing new antibiotics, which typically have a low return on investment, to more profitable products. BARDA is supporting the world’s largest antibacterial portfolio by incentivizing companies to focus on antibiotic development by providing non-dilutive funding to offset high R&D costs and technical assistance to reduce R&D risk. These critical attributes, along with BARDA’s flexible and nimble authorities, enable BARDA to enter into public-private partnerships that bring critical new antimicrobial products to market.
Together with our counterparts at the National Institutes of Health, Centers for Disease Control and Prevention, and the Department of Defense, BARDA will continue to invest in projects to propel research and development for therapeutic, diagnostic, and preventative products. BARDA will support antimicrobial products from development all the way through marketing approval and will work to ensure that antibiotics used to treat infections from biothreat pathogens are appropriately stockpiled. Our efforts recognize the importance of preparing for all public health emergencies, and we seek to reduce the morbidity and mortality caused by antimicrobial-resistant bacterial infections that stem from mass casualty incidents and disease outbreaks.
Preparing for the threats of tomorrow means investing in transformative, next-generation antibacterial approaches. Having recently celebrated our 10-year anniversary, the BARDA Antibacterials program is proud of having invested over $1.3 billion dollars thus far, with partner cost-share in excess of $3.5 billion, and seeing 3 FDA approvals of new antibiotics.
Our strategy is a holistic one in terms of product type. In seeking to maximize the impact of our investments, we emphasize innovation, new classes of antibiotics, novel mechanisms of action, host-directed therapeutics, small molecules that address priority forms of resistance or unmet clinical needs, and vaccines. We are currently funding development of 60 antibacterial therapeutics, diagnostics, and vaccines: 45 in early stages of development through the CARB-X program and 15 in BARDA's antibacterial portfolio for advanced R&D, which includes 7 products in Phase 2 or Phase 3 clinical development.
BARDA also supports non-traditional approaches, which have the potential to open up new modes of treatment, circumvent known forms of resistance, reduce side effects, and augment existing medical practice. This year, we are pleased to welcome two new partners to BARDA’s antibacterial portfolio, both of whom are developing nontraditional candidates that represent firsts for us: Vedanta Biosciences for BARDA’s first live bio-therapeutic product and Locus Biosciences for a CRISPR-engineered bacteriophage therapy.
As we look to the future, we also recognize that preparedness does not stop with U.S. Food and Drug Administration (FDA) approval. As always, we must continue to improve on our existing preparedness posture. Last year we awarded our first Project BioShield contract in the antibacterials program to Paratek Pharmaceuticals, supporting both the acquisition of their FDA-approved antibiotic NUZYRA for the national preparedness and its continued development as a countermeasure for biothreats. BARDA anticipates making a second Project BioShield award in FY2021, increasing our preparedness to treat biothreat pathogens.
Antibiotic resistance continues to harm hundreds of thousands of American lives every year, and combating this health security threat remains a priority for the U.S. government even amid the current COVID-19 pandemic. As we have seen with the response to COVID-19, tools for surveillance, early detection, containment, treatment, and prevention are key to addressing the spread of infections and treating disease. BARDA remains as committed as ever to fostering public-private partnerships to revitalize the antibacterial pipeline and combat antibiotic resistance.