BARDA Industry Day Brings Together Partners to Discuss Future Directions
Author: Adam Clark, Ph.D., Division of Strategic Science and Technology Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness & Response
Protecting the nation from chemical, biological, radiological and nuclear (CBRN) threats and pandemic influenza takes critical medical countermeasures. Making these countermeasures available means having a robust pipeline of medical countermeasures in development.
Next generation medical countermeasures start with today’s partnerships and plans. To help strengthen those partnerships and discuss those plans, BARDA brought together over 500 partners from government, industry, academia and other organizations for this year’s BARDA Industry Day, which took place November 12-14, 2013 at the Ronald Reagan Building and International Trade Center. During this event, participants learned about the strategic plans, core services, advanced development priorities, and upcoming procurement priorities that will help maintain this pipeline and shape the next generation of medical countermeasures.
As BARDA Director Robin Robinson, Ph.D. noted during his keynote address, BARDA has built an unprecedented pipeline of medical countermeasures products to protect against CBRN threats and pandemic influenza.
Twelve new medical countermeasures have been delivered to the Strategic National Stockpile since 2009 and twelve more are expected by 2019. BARDA has established this robust pipeline by supporting over 150 candidate products against a wide variety of diseases and other threats. Seven medical countermeasures that BARDA has supported achieved FDA approval in 2012 and 2013, including a rapid point-of-care diagnostic device for influenza and respiratory syncytial virus; cell-based, recombinant-based, and adjuvanted influenza vaccines; a next generation portable ventilator; and antitoxins for anthrax and botulism. BARDA anticipates making a number of new acquisitions under Project BioShield in coming years as products mature to the point that they are ready for inclusion in the Strategic National Stockpile.
Even with these successes, there is still more work to do. During the coming year, BARDA will be looking for products and technologies needed to protect the nation from existing and emerging threats and fill remaining gaps in our preparedness. BARDA will focus on funding development of therapeutics for hemorrhagic fever viruses; thermal burn products; biothreat diagnostics; innovative technologies for administration of medical countermeasures; and antigen-sparing vaccines. As part of its longer term strategy, BARDA is working towards a goal for a broadly protective or universal influenza vaccine.
BARDA presenters outlined the strategy, goals, and R&D areas of interest for FY14 and beyond. BARDA recently released three Broad Agency Announcements (BAA) to invite industry partners to collaborate on developing needed medical countermeasures. BARDA programs will maintain a balanced portfolio for specific and multiple threats while placing a high priority on sustainable life cycle management and improved preparedness against unknown threats.
Participants also learned about the set ofcore services BARDA offers to support product development. BARDA brings a great deal of expertise to its partnerships with industry through its Regulatory and Quality Affairs, Clinical Studies, Manufacturing, Facilities & Engineering, and Analytical Decision Support groups. BARDA has also made substantial investments in infrastructure by establishing the Centers for Innovation in Advanced Development and Manufacturing, a Fill and Finish Manufacturing Network, a Non-Clinical Development Network, and a planned Clinical Studies Network, each of which can provide critical services to medical countermeasure developers. Collectively, these core services provide the infrastructure and critical capabilities needed to produce medical countermeasures, such as vaccines and therapeutics, in support of the BARDA’s advanced research and development programs.
With a record number of attendees this year, BARDA Industry Day continued to be a great way to engage and build public-private partnerships. If you missed it, or just are interested in viewing the presentations, view the slide presentations online. To stay up to date on BARDA and its programs and to receive the announcement for BARDA Industry Day 2014, follow BARDA via RSS.
Author: Elizabeth Jarrett, Office of the Assistant Secretary for Preparedness and Response
The holidays can be fun, but they can also be stressful. Personally, I am stressing out about how to make a Thanksgiving dinner for one person who doesn’t eat turkey, one person who can’t eat wheat, and one person who is really attached to family traditions (which involve both turkey and wheat). But there is one thing that I’m not too stressed about: getting the flu.
Everybody who is coming to my holiday dinner has gotten their flu shot – which is a good thing since we’ve got a bunch of vulnerable people in our family. My family includes folks who are at-risk for the flu and flu complications, including elderly grandparents, a toddler, and one person who is diabetic. Of course, these aren’t the only high risk groups – pregnant women, people with disabilities, and those with many other health conditions are at an increased risk for getting the flu or having complications associated with the flu. To learn more about at-risk groups, check out Flu.gov’s Who’s At Risk.
Thankfully, it’s really easy to get vaccinated. Check out the Flu Vaccine Finder and find a clinic, grocery store or pharmacy where you can get your flu shot.
Of course, when you get together, you still need to be a little more careful about transmitting other germs as well, so wash your hands regularly; avoid touching your eyes, nose and mouth; cover your nose and your mouth when you sneeze.
By taking some simple precautions, you can have a more fun when you get together with loved ones this holiday season. Getting your flu shot won’t make your turkey turn out perfect or help you make it through holiday traffic with ease, but it will help you enjoy the time you have with loved ones.
Novartis Team at Holly Springs recognized for innovation and advancements in pharmaceutical manufacturing technology
Author: Robin Robinson, Ph.D., Director, Biomedical Advanced Research and Development Authority
Congratulations to the Novartis team in Holly Springs, N.C. Last week the vaccine manufacturing facility there earned the 2013 Facility of the Year recognition from the International Society for Pharmaceutical Engineering. I’m proud that BARDA has been an integral part of the public-private partnership that established the facility.
In 2006 as part of our overall pandemic preparedness strategy we began investing in Novartis and other major vaccine companies to drive influenza vaccine manufacturing from traditional egg-based technology toward modern technologies like cell-based vaccines. This investment led, in 2012, to FDA licensure of the first cell-based seasonal influenza vaccine – Novartis’ Flucelvax. This approval marked the first change in influenza vaccine manufacturing in the United States in 50 years.
As part of this investment, we partnered with Novartis to build the vaccine manufacturing facility in Holly Springs, which was completed in 2011, became capable of producing pandemic influenza vaccines in 2012, and is making H7N9 vaccine currently. The facility also manufactures adjuvants that may be used with vaccines. Additionally the facility serves as a national pre-pandemic influenza vaccine stockpile manufacturer and storage site.
In a pandemic, the facility may be able to produce 25 percent of the vaccine needed in the United States. In addition, cell-based technology used in this facility for manufacturing seasonal and pandemic influenza vaccines may be adapted in an emergency to produce vaccines and biological products for other emerging infectious diseases or man-made threats.
In 2012, we designated Novartis and this flexible manufacturing facility as one of the three domestic Centers for Innovation in Advanced Development and Manufacturing. The centers will provide core service assistance in product development and manufacturing to CBRN medical countermeasure developers on a routine basis.
In an influenza pandemic, the centers will provide at least 50 million doses of pandemic influenza vaccines using cell- or recombinant-based vaccine technologies within four months of pandemic onset. The centers also will manufacture vaccines or biological products to other threats in a public health emergency and will provide workforce training to the next generation of biopharmaceutical and vaccine developers and manufacturers in the United States.
These advancements are part of BARDA’s strategic aims to provide more and better influenza vaccine quicker for the nation in a pandemic. We’re also expanding the manufacturing surge capacity in the United States. We’ve worked with industry to retrofit facilities and to create a new fill finish network, which covers the final steps in the vaccine manufacturing process (embed link). We also ensured year-round supplies, such as eggs, used in developing traditional flu vaccine.
The International Society for Pharmaceutical Engineering says their annual award showcases shared commitment and dedication to enhancing patient health and safety through innovation and advancements in pharmaceutical manufacturing technology. To me, the award validates the level of excellence and scientific advances that can be made when government and private industry work together toward a common goal.
Author: Ashley Small, Public Affairs Specialist,Office of the Assistant Secretary for Preparedness and Response
This Veteran’s Day, as we honor all the brave men and women who have served our nation, let’s take time to look at how we can serve our communities and help one another.
|When disasters strike and incidents happen, the need for lifesaving and life sustaining medical assistance can be significant. If you are a health professional, the ability to lend a helping hand can make all the difference in an individual’s capacity to quickly recover from a public health emergency.
You will find there are many flexible programs supported by HHS that provide an opportunity for health experts to serve the country. Organizations like the Medical Reserve Corps (MRC), the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), the National Disaster Medical System (NDMS), and the U.S. Public Health Service Commissioned Corps offer professionals the chance to use their medical skills and capabilities to support communities when they need it most.
If you are looking for a grassroots community-based program to volunteer, the MRC can be a great opportunity. The MRC is a community-based program which organizes and utilize local medical and public health professionals who want to donate time and expertise to help prepare and respond to emergencies within their own communities and across the nation. MRC volunteers assist throughout the year in promoting healthy living.
At the state level, the ESAR-VHP is a good option. ESAR-VHP is a program that verifies health specialist’s identification and credentials so that they are able to respond when disaster strikes. By registering through ESAR-VHP, volunteers' identities, licenses, credentials, accreditations, and hospital privileges are all verified in advance through the state, saving valuable time in emergency situations.
The NDMS is a federally coordinated system that supports a nation-wide medical response capability. If you are interested in working to help impacted communities across the country, NDMS may be a great choice for you. NDMS staff can deploy anywhere within the continental U.S. and its territories; providing medical support to supplement state and local authorities dealing with medical impacts of disasters. In addition to serving communities, NDMS also provides support to the Nation’s military, caring for casualties evacuated back to the U.S. from overseas armed conventional conflicts.
If you are looking to serve your country in uniform and want to be part of the Nation’s fight against disease and poor health conditions, then consider the U.S. Public Health Service Commissioned Corps. This team of elite, well-trained, highly qualified public health professionals dedicate time to delivering the Nation's public health promotion and disease prevention programs and advancing public health science. With duty stations throughout the country, Commissioned Corps members have the freedom and flexibility to choose their own career path.
Everyday health professionals serve the country by helping to support communities in need. You can too! If you are interested in joining any of the organizations mentioned in this blog, check out Joining the Health Response.
Improving Sheltering Options for the Elderly and Patient Tracking in Nursing Homes
Author: Natalie N Grant, MPH , Health & Social Services Recovery Support Function Field Coordinator ,Office of the Assistant Secretary for Preparedness and Response
In the wake of Hurricane Sandy, many responders, planners and individuals wondered how we could best take care of vulnerable populations, like the elderly, as part of our efforts to keep everybody safe and healthy. ASPR is working with its partners on two critical initiatives that could help keep elderly people safe and provide peace of mind for their loved ones following a disaster. We are improving sheltering options for elderly individuals and patient tracking for people in nursing homes.
Hurricane Sandy struck one of the fastest growing elderly populations in the world: the people of Nassau County. As part of the response, elderly people evacuated to general population shelters in the local community college. The elderly have special challenges in a disaster – like mobility issues, dependence on portable ventilators or respirators, or vision and hearing problems – and a general population shelter may not be the best place to accommodate these needs.
That’s why we are working with Nassau County, FEMA and the US Army Corps of Engineers to find better ways to support elderly populations following a disaster. We are looking at new and innovative ways to use the existing infrastructure to better meet the needs of older adults in the wake of disasters.
We are also working with our partners to make sure that we have excellent tracking systems for elderly patients in nursing homes and long-term care facilities – not just those in hospitals. When Hurricane Sandy struck, HHS had a patient tracking system for patients evacuated from hospitals as part of the overall federal response. However, the city and state did not have a system for tracking other evacuated populations, such as the residents of nursing homes or long-term care facilities. Although the state had identified the need to track these patients, it didn’t have the funds that to put a system in place.
Now, the Department of Health and Human Services and the Department of Housing and Urban Development are working with the New York Department of Health and the New York State Office of Child and Family Services to improve client tracking in evacuations. ASPR’s Regional Emergency Coordinators have worked with their state-level partners to develop a system known as E-FINDS (Evacuation of Facilities in Disasters System). We are supporting the roll-out of the system to the provider network so that they can access the barcode scanner system and better track vulnerable populations in nursing homes and long-term healthcare facilities.
Every year brings new challenges and new disasters. But with improved sheltering techniques and patient tracking, we are better able to keep the some of the community’s most vulnerable, including the elderly, safe when disaster strikes.
Author: Ashley Small, Public Affairs Specialist,Office of the Assistant Secretary for Preparedness and Response
Disasters happen. Communities, regardless of size, often face hard questions that impact their ability to rebuild, recover, and become more resilient. Many communities make these choices based on their own past experience or lessons learned from others. But with research and sound science, communities can have the scientific evidence needed to support critical long-term recovery decisions.
ASPR has collaborated with the New York Academy of Medicine and the Institute of Medicine to engage the research community and examine how the response to Hurricane Sandy and recovery could be enhanced through scientific research. Experts from state health departments, community health organizations, federal government, and academic institutions identified rapid research areas that impact long-term recovery, like social connectedness in a community, and medical supply chain resiliency.
Over the next two years, ASPR will dedicate $8.6 million from the Hurricane Sandy Recovery and Rebuilding Supplemental Appropriations Act of 2013 to support research that examines long-term recovery of health systems and communities in areas of the country hard hit by Hurricane Sandy last year.
Check out what Dr. Lurie had to say about the importance of this research.
Author: Darrin Donato, Senior Policy Analyst, Division for At-Risk Individuals, Behavioral Health, and Community Resilience (ABC),Office of the Assistant Secretary for Preparedness and Response
When you think about being prepared for an emergency, you might consider important things like assembling a disaster kit, making sure our homes can weather storms, and having enough food, water, and medicine on hand for three days. But did you also know that simple things like knowing your neighbors can help you get through a disaster or emergency?
There are a wide range of things we can do to withstand, adapt to, and recover from adversity – things that we can do to make ourselves more resilient in the face of a disaster. Being more connected to each other and to our communities is a great way to build resilience. Social scientists call this belonging and affiliation “social capital.” Some studies are showing that greater social capital may help us recover from disaster faster as well as support us through our day-to-day challenges.
Improving our social capital can start with answering some simple questions. For example, how many people do you know within a 5 or 10 minute walk from your house? Are there vulnerable people, such as older adults living alone in your neighborhood that you could help following a disaster? Are you able to reach out to your neighbors to get support if you need it? Of course, it’s also very important to know how to get help from emergency responders in your community. But in the overwhelming majority of emergencies, immediate assistance is provided by someone other than emergency responders, so knowing your neighbors and checking in on each other can be invaluable. Neighborhoods can also come together and create disaster plans. The combined resources and skills of a group of neighbors will be much more effective than an individual or family trying to weather the adversity alone.
Our involvement in community groups—be they civic, religious, voluntary, or interest-based—expands our range of social capital beyond our families and neighborhoods and may help bolster recovery from disaster. How could the organizations you belong to become more involved in preparedness and resilience? Things like encouraging group members to learn emergency skills such as CPR or First Aid, identifying and planning to assist members who may need help following a disaster, and building ties with community emergency management, fire departments, or other public safety organizations are good ways to start. For more detailed information on building community resilience, see RAND's Building Resilient Communities: An Online Training.
Our face-to-face connections are very important for disaster resilience, but internet and the phone can connect us in daily life and in disaster. Before a disaster strikes, talk to friends and family members and know who you count on – and who is counting on you – in an emergency. Plan on a ways that you will contact one another following a disaster. Phone lines may be jammed and internet access might be down following a disaster, so pick a primary and secondary communication method. Text messages are a great way to communicate when phone lines are jammed. If you are able to, plan to post your status on the social media sites that you frequent and let people know that you are okay. And make sure that you and those you count on are familiar with the Red Cross Safe and Well program.
As you work on your personal preparedness, take sensible precautions like making a disaster kit and planning for what to do if we get separated from our loved ones. But also take time to build your resilience level by thinking about our connections with the people around us and in our community.
Author: Elizabeth Jarrett, Office of the Assistant Secretary for Preparedness and Response
For most Americans, losing power during a storm is an inconvenience, but for those who rely on electrically powered durable medical equipment (DME), like oxygen concentrators or portable ventilators, electricity is a matter of life or death.
Thousands of people in the United States rely on electrically powered DME to meet their medical needs at home. In prolonged power outages, they often must seek help in shelters or emergency rooms to power the equipment or recharge the battery.
Today, ASPR issued a nationwide challenge, seeking ideas on a system that, in emergencies, can determine the location and status of life-sustaining DME and get help to users. With access to real-time information about the locations and remaining battery life during emergencies, communities could better meet the needs and possibly save lives of people who rely on DME.
We’re looking for your ideas on a system that automatically monitors and electronically communicates the status and location of these life sustaining devices. This information could help these individuals, their caregivers, first responders and emergency planners make better decisions when planning for and responding to a disaster.
The winning entry will be a system that can capture essential data from DME, including loss of power, power level, GPS location, time and date, battery life, and user identifying information. The system should be accessible to all patients who use DME in their homes and must securely send data to other secure information systems.
And we hope that this challenge spurs innovative ideas that can be developed into tools to help communities support DME users during emergencies.
Ideas will be evaluated by a panel of experts and judged by Assistant Secretary for Preparedness and Response Dr. Nicole Lurie. Advisors on the challenge include leaders from the design, device, venture, and government sectors. The person or team with the best idea could receive up to $5,000 from ASPR and may be invited to present the idea publicly.
For details and to register to participate in the Ideation Challenge, visit challenge.gov and search for this ASPR challenge. We can’t wait to hear about your ideas!
How Sound Science, Strong Partnerships and Advance Planning Promote Next Generation Medical Countermeasures
Author: Adam Clark, Ph.D., Division of Strategic Science and Technology
Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness & Response
How do we make a universal flu vaccine? How can we get more vaccines sooner, so that we can save more lives in an emergency? Or develop a robust domestic medical countermeasure (MCM) manufacturing infrastructure? How can we advance therapeutics for hemorrhagic fever viruses? Or innovate and create timely and accurate biothreat diagnostics? These are just a few of the tough questions that the Biomedical Advanced Research and Development Authority (BARDA) is tackling with its partners.
Keeping the nation safe from a wide range of threats – from radiological and chemical nerve agents to infectious disease threats such as pandemic influenza, anthrax, or other emerging diseases – will take three things: sound science, strong partnerships and advance planning. BARDA convened the Broad Agency Announcement (BAA) Pre-Proposal Conference to facilitate those three crucial elements of success. The conference brought together over 200 professionals representing more than 150 companies who were eager to learn about the changes that are taking place in BARDA’s advanced development program. If you are interested in learning more about the conference, the slides and meeting materials are available online.
The three BAAs that make up the core of BARDA’s advanced development program are dedicated to the Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures, the Advanced Development of Medical Countermeasures for Pandemic Influenza, and the development of Science and Technology Platforms Applied to Medical Countermeasures (Innovations). Using these BAAs, BARDA encourages the development of a robust medical countermeasures pipeline and it supports the development of MCMs for specific threats as well as platform technologies that enhance capabilities for development and manufacturing of MCMs.
BARDA relies on its partners to help develop and sustain this pipeline of medical countermeasures. During the conference, BARDA outlined its model for public-private partnerships with industry to achieve these goals. BARDA supports public-private partnerships through the Centers for Advanced Development and Manufacturing and the Non-Clinical Development Network. In addition, BARDA is in the process of establishing the Finish Manufacturing Network and the Clinical Studies Network.
In the next funding cycle, BARDA will emphasize filling gaps such as therapeutics for hemorrhagic fever viruses, thermal burn products, biothreat diagnostics, innovative technologies for the administration of medical countermeasures, vaccine strategies that include antigen-sparing, and a broad-acting or universal influenza vaccine. BARDA also will focus on a number of overarching challenges, including potential threats from bioterrorism; needs of special populations such as children, elderly, or immunocompromised individuals; product sustainability; and effective management of rising life cycle maintenance costs associated with stockpiling MCMs.
BARDA has a history of working with its partners to face tough challenges and create success. In the last year, a BARDA-supported influenza vaccine made with novel technology achieved FDA licensure. It has supported the first drug for the treatment of anthrax through the FDA licensure. BARDA formed a new kind of public-private partnership to develop drugs to combat bioterrorism and antibiotic resistance simultaneously. In addition to these projects, BARDA also supports funding for proof-of-concept studies for the development of a small molecule to protect DNA from damage after exposure to high levels of radiation and it also supports the advancement of broad spectrum antibiotics. BARDA is even working with its partners on a more effective skin grafting technique that could help patients heal more effectively following a radiological or nuclear event. And these are only a few of the innovations that BARDA is helping to make a reality.
Just think of what the next year will bring.
Author: Gregg Lord, MS, NRP, Director, Emergency Care Coordination Center, U.S. Department of Health and Human Services
Most emergency managers and health responders believe that time is not their friend. When someone is hurt, these professionals know that the injured person needs help now. Right now. Not in the 5 minutes or 10 minutes or 15 minutes that it will take you to get to that person. This is particularly true in an emergency, when there may be too many injured people and too few responders or the injuries, which often include severe bleeding or cardiac arrest, are likely to cause death in the first 5-8 minutes.
So, what if there was some way that planners and responders could shorten the time to life saving intervention in the victim’s favor? What if there was some way to start getting people the help that they urgently need more quickly? Better yet, what if the solution was low cost and helped your community become more resilient in the face of disasters? Would you be interested in supporting it?
By supporting bystanders who want to help in an emergency, responders can support faster response times and stronger communities. As the name implies, bystanders are right there – standing by. And sometimes, if we are very lucky, they don’t stand by – they jump in to help. They call 911, apply pressure to the wound, perform CPR or do one of countless other actions that can either save the person’s life or help give the responders a few more minutes to get to the injured person.
And these bystanders aren’t just trying to help responders and injured people during emergencies – they successfully help people who urgently need it. Mounting evidence – from emergencies like the Boston Marathon Bombing as well as more local events like people stuck in car fires or drowning in flooded areas – suggests that bystander response saves lives. Although some professional responders are concerned that bystanders actually could hinder the professional response, there’s no scientific evidence to support this idea. During an emergency response, seriously injured peopleneed all the extra minutes they can get, EMS providers, although quick can and usually do take several minutes. Incorporating bystanders into response plans could be a key part of the answer.
Of course, some people don’t feel comfortable helping out. When asked, bystanders will express concern over fears that they could harm the victim, may not know what to do or how to help, and fears that they would be held liable or may be injured.
At the core, education of the average citizen will alleviate many of the impediments to bystanders acting– and they are issues that many emergency planners, response organizations and hospitals can help fix. By supporting first aid and CPR education for members of your community, you can give them the skills that they need to help someone in an emergency – when seconds count. You’re also letting your community know that they can and should be part of an effective emergency response and that you want them to help protect their loved ones and their communities.
Supporting first aid and CPR training in your community is an investment – it will take time and resources that are often scarce. But the benefits may translate into a more prepared, more resilient community and that is definitely worth the investment.
Do you have other thoughts on ways that responders can help communities become an effective part of the disaster response? If so, let us know in a comment to this blog post.