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April 23
ASPR Team Developing Economic Evaluation Tool for Public Health Emergencies

Officials at the Office of the Assistant Secretary for Preparedness and Response (ASPR) are not only looking for ways to best protect Americans’ health during times of crisis, they’re also looking for ways to do more with less.

Ensuring good stewardship of taxpayer money can prove challenging when no guide exists that helps decision makers identify the most cost-effective medical countermeasures — drugs, vaccines and medical devices — to prepare for disasters. So an innovative team within ASPR’s Division of Medical Countermeasures Strategy and Requirements (MCSR) is setting out to create a guidebook that accounts for risk in cost-effectiveness analysis.

By developing a standard methodology to determine the cost-effectiveness of various medical interventions, the team believes ASPR will be able to maximize the value of the resources maintained within the Strategic National Stockpile.

Their idea has attracted the attention of and, perhaps more importantly, support from HHS. The HHS IDEA Lab awarded the MCSR team $111,500 earlier this week to take their idea to the next level.

With funding to further develop their idea, the team is performing a case study into the potential economic value of innovative thermal burn therapies that have applications for other patients.

The team also will work on developing methods for economic evaluations to help identify higher return-on-investment projects and acquisitions. If the idea realizes its promise, the tool could eventually be used by state public health professionals and state and local emergency management planners.

I am pleased to be serving as the Designated Project Lead. We are excited for this opportunity and look forward to starting this project to better enhance national emergency preparedness, provide significant return on investment, and enable program managers to be more effective stewards of taxpayer monies.

Assistant Secretary for Preparedness and Response Dr. Nicole Lurie will be the project’s Executive Sponsor, and the thought leads for the team will be Dr. Scott Nystrom, Dr. David Howell, and Stuart Evenhaugen.

The Secretary of Health and Human Services created the IDEA Lab in 2013 to improve how the Department delivers on its mission by engaging HHS leadership at the highest levels to support the testing of new ideas and equipping HHS employees who have an idea and want to test it with new business practices, mentoring and innovation programs.

April 10
Student Health Volunteers:  Building Community Health during Disasters and Every Day

Preparing for the next emergency starts long before a disaster strikes and student health volunteers can play an important role in helping communities prepare, respond and recover.  When students make the choice to volunteer, they are giving an important gift to their communities and while opening the door to so many opportunities, such as developing valuable professional skills, learning things about the field that aren’t in their textbooks, and meeting new friends or future colleagues.

When it comes to health preparedness students have a lot of opportunities.  For example, they can staff vaccination clinics, donate blood, help with public education campaigns, and more.  By volunteering before a disaster strikes, you are better equipped to help your service organization and your community if there is an emergency in your area.

As a college student, it is often hard to find time to volunteer and balance classes, but I find that it is worth making the time to serve my community. Once a week I volunteer at Prince George’s County Hospital and donate my time to help in a busy healthcare setting. Every day I help doctors and nurses treat their patients in the emergency room. Sometimes that means answering patient questions, raising their concerns to their healthcare providers or just listening to the problems that they are having. Because I have been volunteering at hospitals for years, I decided to get CPR certified. After my CPR certification I then became a Certified Nursing Assistant. 

My experience as a health volunteer has taught me about how to communicate with patients effectively and juggle multiple tasks efficiently.  I have learned about the different healthcare roles in the hospital and have seen firsthand the impact providers have on a patient’s life. This has given me a well-rounded perspective on the healthcare field. Also, it has inspired me to one day become a doctor that provides the excellent care that I have witnessed as a health volunteer.

This week is National Volunteer Week and I encourage you to take some time to consider how you can volunteer in your community.  If you are not sure how to get started or want to learn more about volunteering, join our upcoming twitter chat on student health volunteers on April 21st from 1-2pm ET.  

Topics will include:

  • Why volunteering matters to students and how it helps you and your community
  • When is the best time to make the choice to volunteer and how volunteering before a disaster strikes makes your community more healthy when disaster strikes
  • What are some common barriers to volunteering and how to overcome them
  • What is unique about student volunteers and what special skills they bring to preparedness, response and recovery programs
  • Where young people can learn more about volunteering

Come join the chat by using the hashtag #NHSSchat and share your opinions on the importance of student health volunteers! To learn more about the Twitter chat, visit www.PHE.gov/NHSSchat.

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April 02
HHS Progress in Meeting the Needs of Children during and after Disasters

Children make up approximately 25 percent1 of the United States (US) population, but when disaster strikes, they more vulnerable – physically and psychologically – than many other groups. By changing the way we respond to disasters, however, we can work towards ensuring that children receive the help they need during and after an incident. This includes informing and empowering parents and caregivers on how to make better choices that impact their children’s health and implementing strategies that better address the needs of at-risk children and their families such as supporting breastfeeding and filling gaps in child care.

Through the Children’s HHS Interagency Leadership on Disasters (CHILD) Working Group, HHS is working to translate these ideas into common practice.

The goal of the CHILD Working Group, an interagency working group co-led by the Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Administration for Children and Families (ACF), is to improve the way we integrate children’s needs across disaster preparedness, response, and recovery activities. As part of these efforts, the CHILD Working Group is excited to announce the publication of the 2012-2013 Report of the Children’s HHS Interagency Leadership on Disasters (CHILD) Working Group: Update on Departmental Activities and Areas for Future Consideration. This report describes the significant progress HHS has made to meet the needs of children in disasters and highlights three new program areas: pregnant and breastfeeding women and newborns; children at heightened risk; and interdepartmental and non-governmental organization (NGO) collaboration. For each focus area, the report provides background information, lists programs and activities underway, and discusses areas for future consideration.

Highlights of HHS progress in these areas include:

  • Better Communication: During a disaster, it can be hard for people to know what services are available to them and their children. HHS is using of prenatal care records and mobile phone messaging to support women’s disaster preparedness, resilience, and access to services.
  • Providing Critical Services for At-Risk Families: Families who are stressed before a disaster strikes are more likely to have a hard time effectively coping with the impacts of the disaster. HHS has collaborated with state partners in the formation of Children and Youth Task Forces in Disasters to support at-risk children and families and restore critical services including child care, Head Start, behavioral health, and financial assistance.
  • Working to Restore Child Care: HHS continually partners with NGOs to address disaster-caused gaps in child care after disasters.

We don’t know when the next disaster will strike, but we do know that supporting the unique needs of children is critical to successful disaster preparedness, response, and recovery. This report and future versions demonstrate HHS’s commitment to tracking and demonstrating the significant progress made towards improving our nation’s ability to respond to children’s needs in disasters. The CHILD Working Group will continue to meet on a regular basis to ensure integration and coordination of children’s needs across HHS and to provide updates on key initiatives so it remains a high priority for HHS leadership.

1Population by Age and Sex: 2010.http://www.census.gov/population/www/socdemo/age/age_sex_2010.html




March 27
Red Cross provides comfort and care in disasters – and you can too

Red Cross prepares every day so that they can – and do – provide comfort, help keep people healthy, and save lives when disaster strikes. Over the course of a year, Red Cross responds to about 70,000 disasters, gets blood donations from nearly 4 million people, and trains over 9 million people health and safety courses, such as CPR and first aid. Red Cross’s healing presence is felt throughout disasters - from the bystander who knows enough to apply pressure to the wound to the doctor who has the blood needed to treat an injured patient to the family who gets the shelter and maybe even the counseling they need to get through a tough time.

In recognition of all that Red Cross does during disasters and every day, March is Red Cross Month. As we reflect on American Red Cross Month, we thank those who serve as part of the organization that has helped so many people throughout the country and around the world during large-scale disasters and every day emergencies.

Everybody can become a part of something that helps people when they need it most. As we think about what Red Cross has done for others, we can also think about the role we’ve played in our communities. What have we done recently? Have we donated our efforts to a worthy cause? Helped a neighbor in need? Donated blood? If the answer is no, we can use this time to change some of those answers.

We are all a part of a larger community, whether that is our neighborhood, religious group, school, or workplace. What we bring to the table impacts the people in our communities. By becoming a positive example we can help those around us to become a stronger, both individually and as a community.

What can you do to help others this month? Each act of kindness is infectious. When one person commits to sharing their time and talents, the whole community benefits.

You can commit to helping out in small ways that can make a big difference. For example, donating blood doesn’t take very long and it saves lives. Committing to be a better bystander – the kind that knows how to help when people need it – is pretty simple. For example, you could start by taking a first aid and CPR class so that you can provide care when every second counts.

Or you can serve your community on an ongoing basis by volunteering. Consider volunteering with your local Medical Reserve Corporation (MRC). MRC volunteers can assist with activities to improve public health in their community by increasing health literacy, supporting prevention efforts and reducing health disparities.

Joining your local Community Emergency Response Team (CERT) is another great way to strengthen community ties. CERT members are educated in disaster preparedness and are trained in basic disaster response skills, such as fire safety, light search and rescue, team organization, and disaster medical operations. These valuable skills can then be used to assist your community before a professional responder can reach an emergency.

Healthier, more resilient communities contribute to our overall national health security and we can support community health in many ways, including the ones outlined above. Earlier this year, ASPR released the National Health Security Strategy 2015-2018 to help create more prepared, protected and resilient communities. That is a very big – very important – goal and volunteering to serve our communities is one way that we can work together to help make it a reality.

Before American Red Cross month concludes, take a few minutes to consider ways that you can serve. When we take the time to serve our communities and commit to making them stronger and more resilient, we can see the benefits during disasters and every day.




March 23
Scientific Preparedness:  The Role of Scientific Collections

In just the past decade multiple infectious diseases – SARS, H1N1, and most recently Ebola – “jumped” to humans from other animal species. Public health emergencies like these often challenge the preparedness and response of the public health and medical community in the U.S. and worldwide. As scientists are we as ready as we can be to help?

Some studies suggest that as many as 60 percent of emerging infectious diseases originated in non-human animal species, and another 17 percent originated from insects or other types of vectors. As soon as outbreaks occur, epidemiologists, public health workers, researchers, and clinicians begin research tied to the infectious disease cycle. They isolate and identify the infectious agent and perform genetic analyses. They use diagnostics to detect and track the disease. They develop or dispense lifesaving drugs or vaccines and provide guidance on the best medical treatment.

While this cycle might seem routine, each outbreak presents unique research challenges to mitigating the spread of disease, protect health and save lives. To meet these challenges, ASPR undertook a science preparedness initiative because we need the scientific community to answer timely questions during response, but also research results can enable a more educated and informed response to similar future events, maximizing recovery.

We’ve learned how critical it is to be able to perform rapid scientific research during the limited time window when the nation and the world are responding to public health emergencies, be it an emerging infectious disease outbreak, a hurricane, or an oil spill. The science preparedness effort aims to ensure that such research needs are prioritized and to support needed infrastructure for such research.

This is where scientific collections come into play.

Knowing the tools and resources available at any given point during a response and making them accessible to researchers are essential to science preparedness. Scientific collections contain a cornucopia of objects from lunar rocks to bacteria and span scientific study and disciplines.

Today, collections form a significant base of support for scientific study that informs regulatory, management, and policy decisions yet many collections are distributed across federal, state and local agencies. The White House’s Office of Science and Technology Policy created an Interagency Working Group on Scientific Collections to support policy development, identify a systematic approach to safeguarding these valuable scientific resources and make them more readily available and accessible to the research community.

Building on this working group’s findings and recommendations, a new organization called Scientific Collections International (SciColl Exit Icon) seeks to improve the rapid access to science collections globally across disciplines, government agencies and ministries, and private research institutions. Through a joint partnership, SciColl Exit Icon offered a novel opportunity for ASPR to explore the value of scientific research collections under the science preparedness initiative and integrate it as an important research resource at each stage in the emergence of infectious diseases cycle. We were impressed.

We also jumped at the opportunity last fall to participate in a workshop led by SciColl’s executive secretariat at the Smithsonian Institute. The workshop drew together multiple federal and international partners to explore the intersections of the infectious disease cycle and the role scientific collections could play in mitigating the disease risks.

We covered how specific collections of mammals and parasites provide evidence and understanding of disease emergence in human populations; the needs and possible ways to capitalize on the use of collections; practical research applications; policy issues surrounding use of collections in outbreaks, and more. The workshop report Exit Icon offers specific recommendations for data management, innovative approaches to cross-disciplinary research, communication and sample sharing.

At ASPR, we’ll continue to work toward greater collaboration and integration of scientific collections to mitigate, prevent, respond to, and prepare for emerging infectious diseases. By emphasizing the importance of scientific research and strengthening initiatives like science preparedness, we can develop policies and systems that fully realize the practical application of scientific collections.

Join us in this growing moment. Encourage your private and public research institution to get involved with SciColl and be part of the global effort toward a more systematic approach for sharing, managing, and using scientific collections. Every institution, agency, and scientific discipline is vested in the improvement and development of this vast network.

We look forward to our continued collaboration with SciColl to strengthen engagement with the stewards of scientific collections at home and abroad. From our perspective, health and safety, even our nation’s health security, depend on it.

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March 20
AHRQ Issue Brief Shows How Simulation Can Help Protect  Ebola Patients, Health Care Workers

Simulation has long been recognized as an important tool for promoting safety in high-risk industries. Our aerospace, transportation, and power-generation industries have become steadily safer over the years, in part by training workers through simulation.

As the Ebola virus disease is amply demonstrating, health care is also a high-risk industry. As part of preparedness efforts in responding to Ebola, simulation can detect threats to safety and establish high levels of individual and team performance.

Two imported cases, including one resulting in death, and two locally acquired cases in health care workers were reported in the United States in 2014 according to the CDC. In March 2015, a U.S. health care worker infected with the virus was admitted to the National Institutes of Health for treatment. The dedicated health providers who treat Ebola patients should not be expected to risk their lives when caring for the sickest patients.

A recently released AHRQ issue brief Health Care Simulation to Advance Safety: Responding to Ebola and Other Threats, underscores the potential of simulation to help prepare for Ebola and other emergent epidemics. The brief addresses simulation's essential features and benefits, approaches and uses, the concept of mastery learning, and AHRQ’s programmatic focus on simulation.

Several simulation centers have already initiated simulation-based preparations to improve readiness for Ebola patients. AHRQ’s new brief highlights progress at Northwestern University Feinberg School of Medicine, Chicago, where a team has demonstrated the value of using simulation-based preparations in addition to valid, detailed protocols.

Jeffrey H. Barsuk, M.D., M.S., associate professor of medicine at Northwestern, said using simulation to identify gaps in Ebola safety protocols found breaches in sterile technique when providers were fully donned in personal protective equipment, transporting Ebola patients, drawing blood from a peripheral intravenous catheter, and placing a central venous access line. Realistic drills and honest feedback allowed clinicians to address gaps and improve aspects of their preparedness to respond to real patients.

AHRQ’s new issue brief also includes key lessons that demonstrate the value of simulation in today’s complex health care settings. They include—

  • Recognizing that simulation is not just for residents and nursing students— Educating and training health providers is a lifelong process, especially as new technologies, less invasive procedures, and new protocols make their way into clinical practice. Veteran clinicians might not fully appreciate the perils of climbing the learning curve with respect to patient safety as new and different skill sets are learned.
  • Managing the unexpected—It is not possible to develop step-by-step protocols for every possible event related to rapidly emerging conditions. But simulation offers the chance to operationalize and test resiliency concepts, as well as learn about their anticipation and mitigation, before events worsen and create harm.
  • Ensuring the effectiveness of simulations— Just as it takes considerable practice to acquire new skills, AHRQ-funded simulation investigators are learning that it takes practice and trial-by-error development for patient safety investigators to maximize the effectiveness of their simulations.

While the lessons learned are yet to be fully recorded and digested, the relevance of simulation extends not only to the immediate Ebola response but to other serious viral outbreaks and influenza threats. Although the number of patients with the Ebola virus to be admitted to U.S. hospitals is expected to be very low, the recent admission of the Ebola-infected health worker reminds us that this threat remains. 

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March 10
Your Roadmap to Protecting Health in Disasters

When disaster strikes, we want one basic question answered: Is everybody okay? As a husband and father, I want to know that my family is safe and healthy. I also want to know that my neighbors and friends are okay. Because I work for an agency dedicated to health security, I have a broader focus, too; I want to know that residents in every community across the country can continue to receive the care they need and that the community’s health care and public health systems can recover quickly.

Others may frame their worries a little differently. Hospitals and healthcare facilities know that more people will need care and they want to be sure they can handle a flood of new patients who may come in for help. People with health chronic conditions who rely on durable medical equipment or dialysis want to know if they will be able to continue receiving the care they need to stay out of the hospital. State, local, tribal and territorial officials want to know if they have all the information they need to make sound decisions when every second counts.

These are all aspects of health security, a term which means that healthy individuals, families, and communities have access to health care and the knowledge and resources to know what to do to care for themselves and others in routine and emergency situations. Communities help build resilience by implementing policies and practices to ensure the conditions under which people can be healthy, by assuring access to medical care, building social cohesion, supporting healthy behaviors, and creating a culture of preparedness in which bystander response to emergencies is not the exception but the norm.

Many of the things that health departments and hospitals across the country do every day enhance health security. They plan how to handle a surge in the patients and how staff special media needs shelters after disasters. They pull all the health related groups in their community together as healthcare coalitions and run emergency drills together. They are forever on alert for outbreaks or clusters of infectious diseases, like measles, so they can educate residents on how to protect health. They sponsor annual flu vaccination clinics, and much more.

Yet, it’s not just health care facilities and health departments that contribute to our nation’s health security. Every business, every place of worship, every neighborhood association, every civic organization, and every resident can make a difference. Everyone can take steps that protect health – their own, their neighbor’s, their community’s health – in an emergency. For example, individuals can get trained in CPR and be ready to be an active bystander who can assist when an emergency strikes.

Hundreds of organizations and people participated in identifying actions they could take to enhance health security. These actions roll up into an entire strategy, a national health security strategy.  Ultimately, the strategy is a roadmap that leads to health that’s secure no matter what comes our way.




March 03
Using big data to improve resilience

What do people need to know to make solid decisions about health after a disaster? What would help people recover fast from a disaster? What information would help healthcare systems recover? A few weeks after Hurricane Sandy made landfall in New York these burning questions and others became the focus of intense discussion among a group of scientists and subject matter experts who gathered at the New York Academy of Medicine.

They developed a set of research priorities. Many of the priorities identified by the group - including questions about the health outcomes of evacuated patients, the morbidity and mortality among at-risk populations, and the health system response to the storm - are most effectively answered by examining large sets of data - big data - about health services.

Past studies that use administrative claims data make assumptions about a patient’s exposure to the storm, often using county-level damage assessments. While such studies can yield valuable public health information, their findings are imprecise because not everyone in a given county or other geographic region is impacted equally by a disaster.

For Hurricane Sandy recovery researchers, ASPR found a way to improve the research process: linking the data available through multiple federal agencies so that the outcomes for individual (but unidentified) patients can be followed using various non-medical criteria. These datasets are compiled from patient data and medical and housing claims data in a way that protects patient privacy. As such, they do not include fields for such information as patient name, but can include de-identified data on the amount of damage sustained by a patient’s home, or the length of time a patient was without electricity.

This ASPR Sandy dataset promotes research efficiencies by coordinating researcher access to the data and reducing duplicative requests for data. The Hurricane Sandy researchers will have access to a single, consolidated data source that can be used by multiple investigators, now and in the future.

This Sandy dataset represents the first time ASPR has compiled and linked this type of data for researchers. The lessons learned from this process will pave the way for similar research projects to be initiated more swiftly after future disasters. It’s an important step toward ensuring that health services researchers can gain prompt access to important sources of data to answer pressing – potentially lifesaving – questions about response, recovery, and preparedness.

ASPR recently funded four new projects, collaborative grants that utilize the ASPR Sandy Dataset to build upon, augment, or enhance the original ASPR, CDC, and NIEHS Sandy recovery studies.

In the first one, a New York State Department of Health researcher is using big data to assess the health impacts of Hurricane Sandy on elderly residents in affected areas of New York State, evaluate the infrastructure and surge capacity of nursing homes and assisted living facilities, and develop a predictive model and risk assessment tools to predict and mitigate the impact of future storms on the elderly.

The second is being conducted by a researcher from Rowan University in collaboration with another researcher from Virginia Polytechnic and State University. These scientists are using big data to determine how environmental changes impact older adults’ health care utilization in the months following a disaster, and inform healthcare providers and policy makers of the unintended downstream health consequences of disaster-related disruptions in housing and community-based healthcare facilities.

A researcher from the Feinstein Institute of Medical Research is using administrative claims data to investigate the differential health effects of Hurricane Sandy between Medicare/Medicaid and non-Medicare/Medicaid populations. This study is called “Post Hurricane Sandy Implementation of a Regional Public Health Surveillance System in Long Island.”

In the last study, a New York University School of Medicine researcher is using the dataset to determine whether early, real-time data from prehospital, emergency department, and overall healthcare utilization can predict the geographic regions and vulnerable populations most affected by natural disasters.

Even if you’re outside the Hurricane Sandy impact zone, the results from these studies may have important implications so watch for their findings. The studies could help your community plan and respond to disasters in ways that help everyone recover faster. And when that happens, your community become more resilient and our nation’s health becomes more secure. 

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February 24
Collaborating to bring the nation new medical products for emergencies

It’s true. Making sure the nation has the drugs, vaccines, and medical devices needed to protect health in an emergency requires more money, authority, and technical expertise than any one federal agency has alone. But by collaborating, federal agencies are making it happen. Take the Ebola outbreak as a recent example.

As the Ebola outbreak spread to multiple countries in West Africa and became a public health emergency of international concern, federal agencies in the United States pulled together to review quickly, the vaccines, diagnostics, and therapeutics the agencies were supporting. Collectively known as medical countermeasures, these products were in various states of early development; none had reached clinical trials.

The agency representatives made fast decisions about how to use the authority, funding, and technical expertise from each agency to move as many products, as rapidly as possible, into clinical trials and get them into the hands of doctors and patients to prevent or treat this deadly infection.

That collaboration, speed and empowerment is the beauty of the Public Health Emergency Medical Countermeasure Enterprise, or PHEMCE. In one way or another, all of the agencies involved in the PHEMCE, support the development of medical countermeasures for military or civilian use or both.

This group plans together to be sure that development takes place as fast as possible without funding redundant efforts, and that there aren’t gaps in addressing health threats from chemical, biological, radiological or nuclear agents. That’s where the PHEMCE Strategy and Implementation Plan come into play.

Like all strategies, the PHEMCE Strategy and Implementation Plan published this month identifies goals and objectives. This one also describes the activities and programs these agencies will undertake to have the medical products our nation will need when confronted with health threats from chemical, biological or rad/nuc incidents, whether from bioterrorism or naturally occurring incidents like this current Ebola epidemic.

The Strategy and Implementation Plan becomes a business plan that these agencies follow in the near-term and long-term to make the best use of available resources to enhance national health security.

Through the PHEMCE, HHS was able to estimate the funding requirements for NIH, ASPR, FDA, and CDC to pursue medical countermeasure development and purchase in fiscal years 2014-2018, and provided this information to Congress. Agency-specific spending in these years is estimated to be: NIH/NIAID - $9.2 billion; ASPR/BARDA - $5.0 billion; CDC/SNS - $3.1 billion; and FDA - $13.7 million. The out-year funding estimates (FY 2017 & 2018) included in the report were developed without regard to the competing priorities that are considered in the annual development of the President’s Budget and must be considered as budget submissions to Congress are developed in these out-years. So these estimates are subject to change in the future.

The Strategy and Implementation Plan also evaluates progress against the group’s previous priorities, describes progress in developing products to meet the medical needs of at-risk populations, summarizes the development that’s underway, and outlines what’s been purchased by the agencies and now available to local communities in a public health emergency.

The drugs, vaccines, and medical devices doctors prescribe or use every day require years, often decades, to develop, and private industry spends billions of dollars bringing these products to market. For each product that reaches the market, eight others failed because the science just didn’t work. Developing products needed for public health emergencies can be even more difficult.

Yet, by collaborating through the PHEMCE, federal agencies have made tremendous progress. More than 160 products have reached advanced development stages; a dozen types of products have been added the Strategic National Stockpile in just eight years, and since 2012, FDA has approved eight new products from our pipeline. These products will help combat pandemic influenza viruses and other emerging infectious diseases, anthrax, smallpox, botulism, radiological and nuclear events, and chemical nerve agents.

To ensure the safest and most effective use of limited medical countermeasures following an attack, PHEMCE partners developed up-to-date clinical guidance for using anthrax countermeasures in children, pregnant women, and the general population under mass casualty conditions. They did the same for products that would be used in a mass casualty incident involving botulism or to treat blood-related injuries after a radiological or nuclear incident.

That’s just a snapshot. Learn more about what’s being done under the 2014 PHEMCE Strategy and Implementation Plan.


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February 24
BARDA Continues Efforts to Make Ebola Therapeutics Available for Response

​The Biomedical Advanced Research and Development Authority (BARDA) today took an exciting next step in implementing a three-prong strategy to develop, manufacture, test, and make available Ebola monoclonal antibody therapeutic candidates as part of the U.S. Ebola response. BARDA now is partnering with Medicago and Fraunhofer to produce Ebola monoclonal antibodies similar to ZMapp from Mapp BioPharmaceuticals to study efficacy in nonhuman primates and then potentially for clinical studies in humans.

These studies will help to determine whether Ebola monoclonal antibodies produced by other tobacco biopharmaceutical companies are as effective as ZMapp. ZMapp is now entering clinical trials in West Africa. If they are as effective, the U.S. could increase the overall manufacturing capacity for ZMapp and similar products.

Medicago is a Canadian company that develops and produces plant-based vaccines and therapeutics; Fraunhofer is a non-profit research and development organization. They will utilize their own proprietary tobacco expression systems in producing the antibodies, which will be compared to ZMapp. BARDA is collaborating with the Department of Defense using existing DoD contracts with Medicago and Fraunhofer to expedite the manufacturing of the product for use in studies and to conduct the animal studies.

BARDA has taken other steps to implement the three-prong strategy:

  • Supporting Mapp BioPharmaceuticals in developing and manufacturing ZMapp for clinical trials.
  • Partnering with Regeneron and Genentech to develop and manufacture new Ebola monoclonal antibodies using specialized CHO mammalian (Chinese hamster ovary) cell lines for nonhuman primate studies and potentially clinical studies.

Together these three prongs will help make safe, effective therapeutics – known as monoclonal antibody therapeutics – available as quickly as possible in the ongoing fight against Ebola. Since the beginning of the Ebola outbreak in West Africa, BARDA has been working with our private industry partners to explore all possible means to speed development and production of therapeutics and vaccines. We are leaving no stone unturned.




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