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Jul 06
New Tool to Help Hospitals and Health Care Facilities Decrease COVID-19 related Hospitalizations

This week, we announced a new tool that can help hospitals, health care facilities, and other potential infusion sites make smart choices to better manage and reduce COVID-19 related patient surge: the COVID-19 Monoclonal Antibody Therapeutics Calculator (mAbs Calculator).


The Value of mAb Therapeutics to Patients and Providers

In some parts of the country, where COVID-19 cases are high and vaccination rates are low, many hospitals continue to face patient surge. Other areas are facing new surges in patients as the Delta variant of the virus spreads in their communities. For communities where COVID-19 infection rates are steady or declining, having response plans ready should variants emerge in their communities is critical to enable a rapid response.

An effective COVID-19 mAb therapeutics distribution program can play a major role in helping hospitals and health care facilities fight the pandemic. COVID-19 mAb therapeutics benefit both the patient receiving the treatment, in the form of faster and easier recovery, and health care facilities by reducing the likelihood of a surge in hospitalized patients. We know that not only will patients get better quickly with mAbs, but patients who have received the treatment will also be less likely to spread the virus to their family and other contacts.

The U.S. Food and Drug Administration (FDA) recommends the use of IV administration for mAbs, and current and proposed infusion sites must make critical decisions on staffing and resource use to properly administer the treatment.


Using the mAB Calculator to Establish or Enhance your Infusion Site

To help hospitals and health care facilities make smarter, more informed decisions on the effective use of staff and space, the HHS Office of the Assistant Secretary for Preparedness and Response, in partnership with the Johns Hopkins University Applied Physics Laboratory, developed the mAbs Calculator.

The new mAbs Calculator is a free decision-support tool that enables hospitals and health care facilities to make data-informed choices about the allocation of resources necessary to effectively and efficiently provide monoclonal antibody therapeutics to qualified patients. Using the data from this tool, facilities can establish programs that better meet patient needs, reduce stress on the hospital, and are cost-effective overall. The mAbs Calculator can support planning in a wide range of settings, including large heath systems; emergency departments; medical centers; rural health providers; ambulatory infusion sites; long-term care facilities; urgent care centers; federally qualified health centers ; and mobile infusion units.

The mAbs Calculator was developed using advanced simulation and modeling tools to inform those staffing decisions and resource investments in real-time. The mAbs Calculator is based on criteria that are not specific to any one mAb therapeutic product or combination of products.

More than 162,000 alternative scenarios take into consideration:

  • staffing and capacity levels
  • scheduling protocols
  • patient demand
  • facility service hours
  • infusion durations


A Tool Based on Real-world Data

In late 2020 and early 2021, HHS/ASPR set up temporary mAbs infusion sites in Imperial County, CA (El Centro Regional Medical Center), Clark Count, NV (Sunrise Hospital and Medical Center – Las Vegas), and Pima County, AZ (Tucson Medical Center). While these three sites were focused on providing the highest level of patient care, there was also a team collecting key data points on all aspects of treatment from the time needed to administer the therapeutics to the patients to the staff needed to properly care for each patient. This information makes up the bulk of the mAbs Calculator database.


Planning for the Future

Aside from the immediate benefits, the mAbs Calculator will be an essential tool in the event of a surge in COVID-19 cases. This is a concern based on the percentage of Americans who have/have not been vaccinated and the advent of new COVID-19 variants.

We hope that everybody gets vaccinated and that no new variants materialize. But if things don’t go that way, the mAbs Calculator will help make sure infusion sites can treat as many people as possible.

Think of this tool like you think of having a fire extinguisher in your kitchen. You might never have to use it, but if there’s a fire, you’re glad it’s there. We hope we will not have to deal with surges of COVID-19 infection or new variants; but if we do, we’ll have the mAbs Calculator available to help maximize the distribution of effective therapeutics to the people who need it. And we’ll be glad it’s there.


Where can I learn more?

To check out this new decision support tool, visit the COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites.

Jul 01
Apply Today! Become a Part of a New Federal Advisory Committee Focused on Protecting the Health of Seniors in Disasters

The U.S. Census Bureau projects that by the year 2035 there will be more Americans who are 65 and older than there will be children under the age of 18. As the number of older adults across the country grows, planning to meet the needs of older adults during disasters and emergencies effectively becomes more important than ever. Emergencies like the COVID-19 pandemic have highlighted how older adults can be particularly vulnerable during a disaster or emergency.

Now, the HHS Office of the Assistant Secretary for Preparedness and Response is recruiting new members for a national advisory committee to propose smart solutions to some of the toughest challenges facing older adults during and after disasters. Members of the new National Advisory Committee on Seniors and Disasters (NACSD) will advise the HHS Secretary and other senior officials on meeting the needs of older adults during and after disasters and emergencies.


Choosing to Serve on a Federal Advisory Committee

While committee members have different reasons for serving, according to Dr. Prabhavathi Fernandes, Chairperson of the National Biodefense Science Board (NBSB), “It’s your chance to be heard.”

It’s also a chance to listen. “Learn what is being done. We have access to information that’s not widely distributed to the public. A lot of it is very informative,” offered Dr. Fernandes.

According to Dr. Fernandes, serving on a federal committee also extends your professional contacts, providing an opportunity to collaborate and exchange ideas with public and private sector experts in your field. For example, up to 10 federal, non-voting members, will participate in the NACSD, including the following officials or their designees:

  • The HHS Assistant Secretary for Preparedness and Response
  • The HHS/ASPR Director of the Biomedical Advanced Research and Development Authority
  • The HHS Administrator and Assistant Secretary for Aging
  • The HHS Administrator of the Centers for Medicare and Medicaid Services
  • The Director of the Centers for Disease Control and Prevention
  • The Commissioner of Food and Drugs
  • The Director of the National Institutes of Health
  • The Administrator of the Federal Emergency Management Agency
  • The Under Secretary for Health of the Department of Veterans Affairs


The NACSD Promotes Healthier Outcomes for Older Adults

The NACSD evaluates issues and programs to support and enhance all-hazards public health and medical preparedness, response, and recovery activities related to meeting the unique needs of older adults. Following evaluation, NACSD provides findings, advice, and recommendations to the Secretary of Health and Human Services.


You might be right for NACSD

If you are interested in working on issues related to emergency preparedness, response, and recovery for older adults, the NACSD is looking for at least seven non-federal voting members (including a chairperson). A minimum of two non-federal health care professionals with expertise in geriatric medical disaster planning, preparedness, response, or recovery; and at least two representatives from state, local, tribal, or territorial agencies with expertise in geriatric disaster planning, preparedness, response, or recovery will be asked to join the committee.

Your experience can have a nationwide impact on the health of older Americans. Visit NACSD to learn more about the committee’s membership and mission and to access the application instructions.

Jul 01
Apply Today! Calling on Healthcare and Disaster Experts in Disabilities to Serve on the National Advisory Committee on Individuals with Disabilities in Disasters

According to the Centers for Disease Control and Prevention, there are about 61 million adults in the United States living with a disability – and nearly one in three working-age adults with a disability does not have a health care provider. When disaster strikes, meeting the needs of individuals with disabilities can become increasingly complicated, but effectively planning in advance to take into account the unique health needs of individuals with disabilities can result in better health outcomes.

You may be able to make a national difference by providing advice and guidance to the Secretary of the U.S. Department of Health and Human Services and other senior leaders.

The new National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD) is looking for experts to provide advice on meeting the needs of individuals with disabilities during any disaster or emergency – from the next natural disaster to the next pandemic.


Choosing to Serve on a Federal Advisory Committee

Professionals are motivated to serve on advisory committees for a variety of reasons. “One reason is to bring your expertise to make a difference in policy. It’s an opportunity to shape the way things are done on a national level,” explains Dr. H. Dele Davies who has served on a number of federal committees and boards and is currently a member of the National Biodefense Science Board (NBSB). “It’s also a chance to learn from other incredible people and to bring new ideas back to your organization and the group you represent.”

According to Dr. Davies, serving on a federal committee “is an affirmation of your professional expertise and value.” He also appreciates how serving can grow your circle of influence by “working with other experts in your field.” For example, along with members from the private sector, up to 10 federal, non-voting members will participant in the NACIDD, including the following officials or their designees:

  • The HHS Assistant Secretary for Preparedness and Response
  • The HHS Administrator and Assistant Secretary for Aging
  • The HHS/ASPR Director of the Biomedical Advanced Research and Development Authority
  • The Director of the Centers for Disease Control and Prevention
  • The Commissioner of Food and Drugs
  • The Director of the National Institutes of Health
  • The Administrator of the Federal Emergency Management Agency
  • The Chair of the National Council on Disability
  • The Chair of the United States Access Board
  • The Under Secretary for Health of the Department of Veterans Affairs


The NACIDD Advances the Cause of Americans with Disabilities

The NACIDD meets to evaluate issues and programs to support and enhance all-hazards public health and medical preparedness, response, and recovery activities related to meeting the unique needs of Americans with disabilities. Following evaluation, NACIDD provides findings, advice, and recommendations to the Secretary of Health and Human Services.


You might be right for NACIDD

The NACIDD is looking for at least seven non-federal voting members (including a chairperson). The committee is targeting a minimum of two non-federal health care professionals with expertise in enhancing disability accessibility before, during, and after disasters, medical and mass care disaster planning, preparedness, response, or recovery; a minimum of two representatives from state, local, tribal, or territorial agencies with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities; and a minimum of two individuals with a disability with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.

Visit NACIDD to learn more about the committee’s membership and mission and how to submit your nomination.

Jun 08
BARDA’s Antimicrobial Resistance (AMR) Program Looks to the Future

Although the battle against COVID-19 has been a primary focus over the past 16 months, the Biomedical Advanced Research and Development Authority (BARDA) has remained committed to developing solutions against a wide range of other threats as well.

One critical area of focus is the development of antibacterial medical countermeasures to combat antimicrobial resistance (AMR) through a variety of mechanisms including a global accelerator program BARDA co-founded. This non-profit partnership funds early-stage research of innovative and transformational technologies for the diagnosis, prevention and treatment of life-threatening, AMR bacterial infections to tackle this growing global threat.

As the current effort approaches the end of its planned five-year period of performance, BARDA is reaffirming its support for early-stage AMR product development. Building off the first accelerator’s successes over the past five years ($333 million invested in 89 innovative projects, 59 of which are currently active in 11 countries), BARDA is announcing its commitment to invest in a second iteration of a global AMR accelerator program.


Why is this important?

This program maintains BARDA’s commitment to revitalize the pre-clinical pipeline and ensure that the most innovative and impactful diagnostics, vaccines and drugs are made available to prevent and treat infections caused by the most serious strains of multidrug-resistant (MDR) bacteria. Continued support of this program is critical to ensure that the United States, and the world, does not lose the race against AMR bacteria that threaten both our health and economic security.

According to the 2019 Centers for Disease Control and Prevention (CDC) Report on Antibiotic Resistance Threats, each year more than 2.8 million Americans develop a drug-resistant infection and more than 35,000 die from them. A recent Infectious Diseases Society of America (IDSA) report estimated that the combined cost to treat these community and healthcare associated infections in the US was $4.6 billion in 2017. According to the 2019 report to the Secretary-General of the United Nations, No Time to Wait: Securing the Future from Drug-Resistant Infections, over 700,000 people are killed every year from drug resistant infections globally, and that number could increase to 10 million without proper efforts to contain AMR.


What is compounding the problem?

Developing new antibiotics is difficult, expensive, and typically has a too-low return on investment in the current market paradigm. These factors have played a key role in manufacturers shifting their efforts away from the development and manufacture of new antibiotics to focus their efforts on more financially lucrative therapeutic areas.


AMR and Other Health Threats

Experience shows that effective emergency response for pandemics and other public health emergencies requires effective therapeutics to treat and care for victims following mass casualty incidents; this includes the prevention and treatment of secondary bacterial infections that can arise in these patients as a result of their injuries or illnesses caused by the main incident. The impact of these infections is more pronounced when they are caused by MDR bacteria, which can complicate any public health emergency response, requiring even more resources and patient care than the incident alone would have required.


What is BARDA doing in response?

In addition to founding and supporting a global partnership to accelerate research and development (R&D) of antimicrobial products, BARDA provides non-dilutive funding to offset high R&D costs and technical assistance to reduce R&D risk. Combined, these benefits incentivize and enable companies to focus on the R&D of truly transformative antibacterial candidates for which a stable market does not yet exist.

Through the antibacterial program, BARDA has supported 28 public-private partnerships with industry since 2010, ranging from small biotechnology firms to global pharmaceutical companies, and currently has a portfolio of 16 antibacterial drug candidates across all phases of development including preclinical, Phase 1, Phase 2, Phase 3, and post-approval.

These 16 candidates target drug-resistant bacterial pathogens identified by the CDC in the Antibiotic Resistance Threats in the United States, 2019 (2019 AR Threats Report), as “urgent” threats, as well as a majority of those threats categorized as “serious.” Recognizing the importance of investing in diverse approaches, the BARDA portfolio includes a mixture of traditional small molecule antibiotics as well as non-traditional candidates.

These 16 candidates target drug-resistant bacterial pathogens identified by the CDC in the Antibiotic Resistance Threats in the United States, 2019 (2019 AR Threats Report), as “urgent” threats, as well as a majority of those threats categorized as “serious.” Recognizing the importance of investing in diverse approaches, the BARDA portfolio includes a mixture of traditional small molecule antibiotics as well as non-traditional candidates.


What does the future hold?

The BARDA Antibacterials program recently passed the 10-year anniversary mark and will continue to invest in transformative, next-generation antimicrobial approaches. We will build on the foundation of investments of over $1.5 billion to date (partner cost-share in excess of $3.5 billion) and three U.S. Food and Drug Administration (FDA) approvals of new antibiotics.

Recognizing the capital-intensive nature of post-approval requirements and clinical trials supporting the use of antibiotics in underserved patient populations like pediatrics, the program will work with companies to support these studies and improve the chance of success following a product’s approval and commercial launch.


Conclusion

Every year, hundreds of thousands of Americans are harmed as a result of antibiotic resistance. Even during the ongoing COVID-19 pandemic response, the U.S. government is prioritizing the health security threat posed by AMR bacterial infections.

BARDA remains committed to expanding the development pipeline and accelerating the progression of products that address medical needs and combat AMR infections to save lives. We encourage biotech, pharmaceutical, academic, and healthcare organizations to join us in these efforts, and if your organization meets the criteria for our next antibacterial accelerator, apply under our BARDA broad agency announcement (BAA) Amendment #25, Special Instructions Issuance for the Area of Interest #3.4 Antibacterial Accelerator (PDF) of the BARDA BAA (BAA-18-100-SOL-00003).

Jun 04
Is Your Healthcare Facility Hurricane Ready?

Eight tips to help your healthcare facility avoid supply chain shortages and infrastructure disruptions during hurricane season


The Healthcare and Public Health (HPH) community has tirelessly worked to address supply chain challenges presented over the last sixteen months. Healthcare facilities have had to manage supply chains stressed by the COVID-19 pandemic, worker scarcity, backed-up ports, and the 2021 Texas freeze. The next supply chain challenge facing the HPH community is likely to be the 2021 hurricane season.

The National Oceanic and Atmospheric Administration (NOAA) has predicted that the 2021 hurricane season will have above-normal activity with 13 – 20 named storms, six to ten of those storms becoming hurricanes, with three to five major hurricanes. During hurricane season, healthcare facilities are vulnerable to cross sector infrastructure failures, inadequate supplies to meet demand during medical surge, and lack of redundancy throughout the supply chain. These supply chain challenges may be compounded by existing COVID-related complications and will require healthcare facilities to be aware of current and anticipated shortages and to thoughtfully plan their approaches to acquire and manage products.

Here are eight things you can do at your healthcare facility to keep your organization prepared for supply chain disruptions that could occur this hurricane season.

  1. Review and update hazard, vulnerability, and threat assessments to include hurricane season events that could significantly disrupt supply delivery or compromise current supplies. Identify alternate methods and routes for deliveries based on predicted hazards.

  2. Forecast your healthcare facility’s needs. It will be helpful to analyze the 2020 hurricane season to determine your facility’s supply needs and proactively try to obtain these supplies to help prevent possible shortages. Plan to have discussions with your facilities distributors, wholesalers, and group purchasing organizations so you can factor in their hurricane season plans into your forecasting. Anticipating supply needs, and capacity for receiving and storing them, are key activities leading up to and during hurricane season.

  3. Review mutual aid agreements within your healthcare coalition or with other healthcare facilities. Ensure your facility is ready to activate mutual aid agreements during hurricane season.

  4. Establish Memoranda of Understanding (MOUs) or Memoranda of Agreement (MOAs) with supply chain stakeholders. MOUs and MOAs can help manage additional support expectations needed during hurricane season.

  5. Establish an alternate communications plan with distributors. In case your facilities primary means of communication fails during a hurricane, have communication backup in place with your distributor to ensure your facility understands your distributor’s shortages and delivery issues.

  6. Establish an alternate distributors list for critical supplies. Establishing alternate distributors is key to ensuring supplies during hurricane season. Be sure to understand location, transport time, and potential interruptions in delivery for any alternate distributors.

  7. Define triggers for activation of emergency plans and ensure your facilities’ emergency plans include procedures for requesting supplies and managing disruptions.

  8. Define thresholds for changes to standards of care. Implementing crisis standards of care is a last resort but it is crucial to plan for so healthcare facilities are prepared to manage patient surge and allocation resources effectively.

To learn more about preparing your healthcare facility for possible supply chain disruptions during the 2021 hurricane season check out these resources from ASPR and other federal government partners.

ASPR’s Division of Critical Infrastructure Protection (CIP) is actively tracking the 2021 hurricane season and other emerging issues at the intersection of disaster health and critical infrastructure protection. To learn more about ASPR’s CIP program and how it can help improve your organization’s ability to respond, recover, and prepare for threats and incidents impacting the nation’s health critical infrastructure visit the ASPR CIP webpage.

May 06
Thank You for Your Public Service

Acting Assistant Secretary for Preparedness and Response Nikki Bratcher-Bowman Reflects on the Past Year during Public Service Recognition Week


For over a year, public servants from ASPR and across the government have worked tirelessly to respond to the COVID-19 pandemic, even as we continue to prepare for, respond to, and recover from other disasters and emergencies. Each and every day, I am honored to work with staff from ASPR and other public servants from across the government as we continue to develop medical countermeasures to address health security threats, build healthcare coalitions, deploy healthcare professionals from the National Disaster Medical System to support communities, strengthen supply chains, and much more.

During Public Service Recognition Week, May 2-8, 2021, I would like to take a moment to say “thank you” to our team of dedicated public servants for the important work they do to protect the health and safety of all Americans.

The work that ASPR staff does – both on the frontlines of health and behind the scenes – has been especially impressive with the unparalleled demands of the COVID-19 pandemic. ASPR’s public servants have helped lead the charge in the fight against COVID-19 and their tireless response efforts continue to bolster our nation’s ongoing recovery every day.

The ASPR team has done, and continues to do, exceptional work to protect the health and safety of all Americans. Always prepared to pivot when changes occur, ASPR teams have worked on the end-to-end development of COVID-19 vaccines, therapeutics, and diagnostics; supported our healthcare and public health partners as they worked to address patient surges in communities across the country; collected, analyzed, and distributed critical information to government officials and the American people; responded to natural and man-made disasters and public health emergencies; administered COVID-19 tests, vaccines, and therapeutics; and more.

I am proud and humbled to share with you that members of ASPR have been named finalists for this year’s Samuel J. Heyman Service to America Medal, also known as the Sammies. BARDA’s Ebola Medical Countermeasures Taskforce led by David Boucher, PhD; John Lee, PhD; and Dan Wolfe, PhD, are being recognized for their role in developing vaccines, therapeutics and diagnostic tests that have already been used to halt the spread of the deadly Ebola virus and avert the possibility of another pandemic. While most of the world has focused on COVID-19, this task force has helped protect us all from Ebola. Join me in congratulating David, John and Dan for this outstanding recognition. This prestigious nomination would not be possible without many other ASPR and BARDA staff who facilitated their work.

For many, it’s more than a job; it’s a calling, a drive to serve, and a way to give back to our nation.

During Public Service Recognition Week, please join me in taking a moment to say “thanks” to our devoted public servants in ASPR and across federal, state, tribal and territorial governments in gratitude for their experience, expertise, commitment, hard work, dedication, courage, and irreplaceable contributions.

I am proud to serve with each and every one of you.

May 03
U.S. Federal Responders Vaccinate Some 5600 People in the Republic of Palau to Combat COVID-19

Line outsdie the vaccination center in Palau


Approximately 340 islands in the western Pacific -- more than 4000 miles away from Hawaii -- make up the Republic of Palau, a country with which the United States has deep ties that date back to the end of World War II. Recognizing the success of the COVID-19 vaccine distribution by the U.S. government, Palau requested assistance through the U.S. Embassy in Koror – their largest city – and the U.S. Department of Health and Human Services answered the call. Captain Erik Vincent of the U.S. Public Health Service Commissioned Corps led a team of 14 National Disaster Medical System (NDMS) responders on a three week mission to vaccinate more than 5600 people in Palau.


National Disaster Medical System (NDMS) responders


As the U.S. kept pace to reach and exceed the Biden Administration’s goal of 200 million COVID-19 vaccinations in their first 100 days of the administration, the request from the island nation represented a strategic partnership that has been ongoing since the two countries signed a Compact of Free Association in 1982, where the U.S. agreed to provide various types of support for the islands including defense support as well as health and medical services. In fact, the small group of islands even have two U.S. zip codes. HHS recognized the need to assist Palau’s health and medical service in preventing COVID-19 from reaching the islands, which could devastate the relatively small population of more than 17,000 who rely on tourism, farming and fishing for their livelihood. Especially when, to date, there had been no confirmed cases of COVID-19 in Palau – meaning there was no recorded community or person-to-person spread of the novel virus.


Palau vaccination center


The word ‘Palau’ roughly translates in one of the island’s native languages to “village,” and it certainly took a village to coordinate all the necessary actions required to get a team from NDMS on the ground to help the Palau Ministry of Health. Captain Vincent led the NDMS team through the various requirements including every responder being fully vaccinated prior to departure, a 5-day restricted movement period upon arrival, and multiple negative COVID-19 tests.


NDMS Team members


The team knew that the long trip to the islands and all of the requirements were worth the effort to keep Palau free of COVID-19 cases. Some NDMS team members traveled as far as from the East Coast. After working with the U.S. Embassy and the Palau Ministry of Health to plan out vaccinations across the islands, the vaccinators provided the people of Palau over 300 shots per day of either the Johnson&Johnson or Moderna COVID-19 vaccines – sometimes having to carry the vaccine in coolers as they ventured to more remote parts of the islands.


Folks inside the Palau vaccination center waiting to be registered.


We were able to recently catch up with Capt. Vincent, the team Pharmacist Dr. Sridevi Pochincherla, as well as their fellow teammates Heather Shannon, Stacy McCarthy and Jeff Allen, to speak with them about their deployment to Palau.


NDMS team member registering a patient for vaccination


Capt. Vincent and Dr. Pochincherla were honored that their team was able to work directly with the President of the small island nation and U.S. Ambassador John Hennesey-Niland. President Surangel Whipps Jr. accompanied the team on a hospital boat, where they were able to deliver vaccines in the harbor from the boat and then travel inland to vaccinate home-bound patients. Dr. Pochincherla fondly remembers the joy and excitement people had when they were welcomed into Palaun homes. This mission reminded Dr. Pochincherla of her own grandmother and family in South Asia. “That was a really special moment for me to be able to provide that service and receive that level of appreciation,” Dr. Pochincherla said.


NDMS team member administering the COVID vaccination to a Palau citizen


Nurses Heather Shannon and Stacy McCarthy recalled the amplified sense of purpose the mission gave them, both having worked on the COVID-19 pandemic response in the U.S. beginning with the repatriation missions of 2020. “It felt like we were delivering hope one shot at a time that we will see the light at the end of the pandemic tunnel,” Nurse Shannon said. “It was an unexpected bonus that we were able to experience a little bit of their history, culture and natural biodiversity.”


NDMS team member administering the COVID vaccination to a Palau citizen


For Paramedic Jeff Allen, this was his first COVID-19 deployment, something that is extremely rare among NDMS responders who have frequently deployed more than two or three times for the federal response. Jeff was unable to deploy as frequently as some responders because he was dealing with the beginning of the coronavirus outbreak in the U.S. as part of his everyday job as a paramedic in King County, Washington. Jeff’s was excited to get to go to Palau having seen the devastating impacts of COVID-19 at home from the early days of the pandemic.


NDMS team member checking the vaccination supplies


The team was able to provide more than 5,600 vaccinations to the people of Palau and Nurse McCarthy recalled what it was like to work on the different aspects of the pandemic. “I worked with repatriation of COVID-19 passengers from a cruise ship early last year, in a COVID ICU in the middle of last year, and at a COVID vaccination site earlier this year. It’s been fascinating to see the evolution of the pandemic and be deployed for distinct aspects of it. First, our team was supporting ICUs that were overwhelmed with COVID patients. Now, we’re vaccinating people to, hopefully, put an end to this pandemic. Our NDMS teams have been there every step of the way, supporting all aspects of the fight against COVID.”

Apr 27
Embrace the Challenge: How Startups Can Help Shift the Preparedness Paradigm

In what the Biotechnology Innovation Organization (BIO) is calling a “monumental campaign to combat, and hopefully eradicate, COVID-19,” it’s become evident that small, creative-thinking biotech companies are needed to help lead on the frontline..

Through our joint initiative, BLUE KNIGHT™, the Biomedical Advanced Research and Development Authority (BARDA) and Johnson & Johnson Innovation – JLABS (JLABS) are collaborating with early-stage companies with the goal of bringing leading ideas to patients. By building the Blue Knight community, we aim to be better prepared with even more deployable potential solutions when the next health threat strikes. To do so, we are challenging you, commercial innovators, to explore multi-use opportunities for your technologies that may help shift the paradigm of preparedness and rapid health threat response.


What are “Multi-Use” Technologies?

Multi-use technology* models provoke innovators to think outside the box when conceptualizing market impact. Rather than developing a narrow concept that addresses one commercial need, multi-use technologies have the potential to address multiple gaps. One of the potential utilizations may be a medical countermeasure (MCM)—a product that may be used during or in response to a potential public health threat. Multi-use technologies can help us move out of the “one bug-one drug” mindset towards nimble and more sustainable models of innovation that are capable of addressing routine health needs and have the potential toquickly adapt to a public health threat.

Our portfolio of Blue Knight companies exemplifies the types of potential multi-use solutions we aim to support, including wearable detection devices and platform technologies that may help address emerging infectious disease needs, as well as support broader disease areas.


Three Reasons You Might Consider Identifying a Multi-Use Approach

  1. Expanded markets. Technologies that can support multiple markets are often seen as advantageous because of the potential for increased revenue and manufacturing opportunities. By broadening potential impact, your idea may appeal to a more diverse set of stakeholders, potential partners, and investors, leading to potentially greater impact for more patients. This can also allow you to diversify funding across both dilutive and non-dilutive sources.

  2. Building trust across the healthcare spectrum. Getting your technology to market can be challenging. However, once you’ve navigated the regulatory, manufacturing, and distribution hurdles with one product and application, each subsequent utilization may face fewer barriers. You may be able to leverage and maximize your initial investment in your product by supporting additional indications for that product. Multi-use technologies can help stakeholders across the healthcare spectrum – from regulators and providers to patients – gain familiarity through commercial use of these technologies prior to use as an MCM in emergency settings. When physicians can gain experience with a technology as a standard care therapeutic first, they may have increased confidence using the therapeutic in a crisis compared to something that may be developed in a specific response to the crisis. Further, every time a technology is submitted and approved for a new use, its archive of safety and efficacy data has the opportunity to be strengthened. When it comes time to evaluate for an emergency response, this data archive can become the backing for a stronger regulatory submission. Together, the combination of engaged stakeholders, strong data, and established trust may be key for streamlined adoption and use during a public health emergency.

  3. Accessing greater support. For even the most promising solutions, having a strong support network may be the most critical component in establishing a market share. Developing a multi-use technology can help you to expand your network into the preparedness space to enhance public health security through the development of MCMs. By connecting with both private and public sector mentors, you can access new perspective for anticipating the unexpected and navigating the expected barriers to becoming market ready. With preparedness solutions, developing these partnerships before the next health threat emerges may be critical. By connecting early, you may gain a better understanding of the development process and support for setting expectations while working to position your technology to help address emerging health threats.


How To Get Started: Reimagining the Possibilities of Your Technology

In response to the COVID-19 pandemic, we’ve seen many innovators pivoting or repurposing existing science and technologies to address MCM needs. In 2020, for example, Johnson & Johnson Innovation worked with over 100 global innovators to explore COVID-19 applications for their approaches. While pivoting can help further our repertoire of pandemic solutions, it must happen more proactively because, in emergencies, it’s often the solutions with proven efficacy and safety that can be rapidly scaled to meet new manufacturing demands and deployed in unprecedented timeframes.

For companies already innovating with the aim to address infectious pathogens, pivoting for pandemic preparedness may not be a far stretch. However, if you’re focusing outside the realm of infectious disease, identifying a preparedness utility may require creativity and unorthodox thinking.

While we need solutions for combatting specific threats, it’s also critical to develop end-to-end technologies that may be foundational for improving patient care and responsiveness across routine health challenges. One great example is the safety syringe: a high-performance, retractable needle that evolved in response to an increasing incidence of needle-stick injures among medical professionals. They aren’t often at the forefront when discussing the extraordinary ideas supporting our COVID-19 response, but if the manufacturing supply chain did not already exist and providers were not already trained to use them, the vaccine rollout could have looked very different.

It’s these end-to-end solutions invested in years ago, like the safety syringe, that are now the tools helping us cross the finish line in addressing COVID-19.


Ready to Accept the Challenge?

Looking to the future, it may be the innovations of today that become the solutions for future threats. Blue Knight aims to shift the paradigm of health threat preparedness by developing a rich pipeline of science and technology solutions that can address the innovation gaps. Together, we hope to establish promising technologies now, so that they become the critical tools waiting in our toolbox to deploy during the health threat.

Let’s start reimagining possibilities together: sign up to meet with us!



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.

Acknowledgement: This blog was developed as a collaboration between BARDA and Johnson & Johnson Innovation – JLABS and is also published on HLTH Matters Blog.


Apr 08
Innovation challenge seeks to solve a common hurdle in curbing coronavirus spread: mask design

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.

 Logo for BARDA's Mask Innovation Challenge. Building Tomorrow's Mask.

Mar 17
Innovators: How Diversifying Your Network Can Help Ignite Ideas

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.


Investing in Your Success: Tips for a Strong Pitch

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.

  1. Establish your vision. Having a cutting-edge idea and deep understanding of its scientific basis is key, but it can be even more critical to clearly articulate the transformational impact this science could have on public health. We see a lot of solutions that are lacking a compelling problem. A flashy technology is not attractive if there is no potential application – to have a disruptive idea, you need to be solving an existing or anticipated challenge. What problem is your solution solving? Does your innovation have the potential to improve access and efficiency of diagnoses? Is it a cost-effective solution that may help address disparities in healthcare access? Not all innovative technologies need to be transformational or revolutionary, but they do need to be impactful in addressing a public health need. You must be visionary in the early stages of your company by considering the potential value your innovation brings to the market and articulating that upfront in your pitch.

  2. Diversify your customers. When considering markets for science and technology aiming to address global health threats, identifying a ”dual utility” or multi-use value application is a sustainable and adept approach. Dual utility or multi-use products and technologies are developed to have both commercial and biodefense applications, thus enhancing our ability to respond effectively to a broad array of threats and in emergency situations. Public and private partners are eager to engage with promising ideas that have dual-use potential, because – as Dr. Ling of On Demand Pharmaceuticals explained during the panel – “Dual use products are important from many aspects…selling to the government is a limited market; you have to expand your product’s market potential, so finding an application that the civilian sector would also embrace gives you access to much more capital… and therefore the ability to make further improvements and investments in your product.”

  3. Diversify your partners. A multi-use model also opens the door to a more diverse group of prospective partners, thus expanding the advice and mentorship you may have access to. Potential partners are always looking to mitigate risk when supporting novel ideas, and multi-use applications create a chance to strategically align and share risk across multiple invested stakeholders. By bringing together different stakeholders, all parties involved will expand their knowledge networks.

  4. Strengthen your team. For potential investors, a remarkable team may be as important as a compelling idea. When evaluating a proposal, we aren’t just looking at your science, but also at your management team, founders and external networks of support. A disruptive idea often comes from a strong scientific team, but lack of know-how on the strategy and management side can be a fatal flaw. Getting through the business, legal, and regulatory hurdles that entrepreneurs face in order to have their products reach patients and consumers takes the wisdom of an experienced team. It’s important to be proactive about forging strong and diverse relationships– especially with mentors who have extensive experience accelerating innovation and offer a wide range of backgrounds and perspectives. Veteran innovators can help remove the guesswork and help startups remain forward-thinking when advancing their ideas.

  5. Diversify your funding. It’s also important to remain open to various types of funding. There can be a tension around the balance of dilutive and non-dilutive funding. Non-dilutive funding is often extremely attractive to a startup because it won’t reduce shareholder value for founders and existing investors – and it can potentially lead to more rapid validation. Though, the amount of time it takes to secure non-dilutive funding and the constraints and reporting required are downsides to consider. From a venture perspective, you should always look more holistically at business models and funding options before identifying the best path forward.

If you are interested in taking a deeper dive into any or all of these concepts, check out the full remarks in our on-demand presentation.


Connecting to Catalyze: An Opportunity to Access an Expert Network    

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.


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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

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