Author: Sidra Kalsoom, Graduate Intern, ASPR Fusion
Who would have thought that tweets could be useful during a disaster such as Superstorm Sandy? Sandy made landfall along the coast of Brigantine, New Jersey as a post-tropical cyclone on October 29, 2012 resulting in catastrophic storm surge along the New Jersey and New York coastlines. It affected a total of 24 states all the way from Florida to Maine with the greatest impact falling on New York, New Jersey, and Connecticut.
As the storm passed, Twitter was flooded with information, as users sent more than 20 million tweets using the terms Sandy, hurricane, #sandy, and #hurricane. Immediately after the post-landfall hours, 20% of all searches conducted on Twitter were Sandy-related. Both responders and survivors turned to Twitter in an effort to publicly share information within communities, conduct rumor control, share resources, and obtain updates in real time.
An unmatched level of on-the-ground, real-time situational awareness was gathered by using Twitter data due to its free and public availability. Advance notice of Superstorm Sandy allowed ASPR analysts crucial time to better prepare for implementing a Twitter monitoring strategy. As it became clear that Sandy would be making landfall somewhere along the eastern seaboard of the US, ASPR analysts began implementing a two-prong monitoring strategy. The strategy included both Twitter lists and Boolean searches to identify potential public health issues as quickly as possible.
5 important lessons learned from monitoring Twitter during Superstorm Sandy:
- Dynamic and flexible monitoring processes and strategies are a must in order to understand and quickly respond to emerging health needs in the impacted areas.
- Search strategies should be changed and updated as frequently as the unfolding event.
- Twitter lists and Boolean searches should be used together to maximize situational awareness.
- The most important information comes from the impacted population, whether news, local government, or local citizens.
- It is critical to have a verification system in place before you begin monitoring to avoid perpetuating the spread of rumors and inaccurate information.
Maintaining situational awareness during a disaster is challenging and complex, but a balanced approach to dynamic Twitter searches can help give you a clearer, more complete understanding of the way that a disaster unfolds. Interested in learning more? Check out the Evolution of a Search: The Use of Dynamic Twitter Searches During Superstorm Sandy.
When a disaster strikes, some communities come together and help their members find ways to stay safe and healthy in the face of a wide range of threats to physical and mental health. Some do not. A community’s ability to withstand, adapt to, and recover from the health impacts of a disaster is known as community health resilience. Community health resilience includes the community’s ability to prepare the health systems that the community relies on every day, such as the public health and healthcare systems, so that they are ready to protect health and save lives during and after a disaster.
Your community can take actions to increase preparedness while promoting robust day-to-day systems. Some ways that communities can build resilience include:
- Building social connectedness so that communities are better equipped to understand their needs and help each other during and after an emergency;
- Becoming prepared and willing to help during an emergency by getting trained in CPR and first aid before a disaster strikes;
- Using health education to promote health and wellness as well as disaster preparedness;
- Expanding communication and collaboration with community-based organizations; businesses; academia; state and local governments; and public health, healthcare, and emergency management partners;
- Encouraging youth to help their communities by joining civic organizations or volunteerism;
- Building strong partnerships among people and organizations that can be leveraged to improve response and sustain recovery;
- Engaging at-risk individuals and the programs that serve them to develop robust disaster and continuity of operations plans; and
- Strengthening and promoting access to public health, healthcare systems, and social services.
Early next year, HHS plans to publish the National Health Security Strategy (2015-2018), which will emphasize community health resilience as a focus area critical to achieving national health security. By helping your community to increase its level of resilience, you can help our nation become more secure as a whole.
Increasing community health resilience requires the whole community to work together and leverage its diverse assets, such as infrastructure, talents, skills, relationships, technology, and national resources.
Do you have ideas on ways that communities can work together to increase their connectedness so that local health agencies and community-based organizations (such as civic or voluntary services) can promote connectedness before, during and after a disaster? Share your ideas on ASPR’s IdeaScale campaign, Increasing Social Connectedness to Improve Community Resilience.
Authors: Rachel E. Kaul, LCSW, CTS, Senior Public Health Analyst, ASPR Division for At-Risk, Behavioral Health & Community Resilience and
Shulamit M. Schweitzer, MHS, Senior Management Analyst, ASPR Division for At-Risk, Behavioral Health & Community Resilience
Disasters wreak havoc with more than just power lines, roads and homes. People also feel the stress brought by a disaster, and that emotional impact can increase the need for services to help with mental health, substance abuse and stress management. Planning for these needs and recognizing gaps in existing plans and resources before a disaster strikes can help individuals and communities become more resilient and recover more effectively.
Behavioral health services often are provided by multiple agencies. During an emergency, the task of understanding what resources are available and how to provide services to the range of people who need disaster specific behavioral health services or continued mental health services can be daunting. By planning before a disaster strikes, emergency planners at all levels can better understand how they can use resources effectively when every second counts.
The Disaster Behavioral Health Capacity Assessment Tool was designed to help states and localities assess their current capacity to address the disaster behavioral health needs of survivors, responders, those with chronic mental illness, and other at-risk individuals. A capacity assessment conducted at the regional, state, county, city, or agency level, can identify the strengths and gaps of a system, the surge capacity within specific systems, and help target improvement and resource allocation efforts.
The idea for the Tool grew out of a guidance developed by ASPR; the Template for Conducting a State Capacity Assessment or Gap Analysis of Disaster Behavioral Health. The template was produced as a result of a 2009 workshop where representatives from each state in Region I (New England) met with federal representatives to discuss disaster behavioral health capacity in that region. The workshop aimed to improve the integration of behavioral health into public health emergency and disaster preparedness and response. Using the template as a starting point, the new Disaster Behavioral Health Capacity Assessment Tool was enhanced to incorporate stakeholder input and feedback formatted as a checklist with a specific section for provider agencies.
During September, as part of National Preparedness Month activities, we encourage regional, state, county, city, and agency planners to start using the Disaster Behavioral Health Capacity Assessment Tool. The relationships that you build between behavioral health, public health, and emergency management as part of your planning efforts will foster greater integration; promote a more effective response; and can enhance resilience within a region, state, or community.
Author: Nicole Lurie, M.D., M.S.P.H., Assistant Secretary for Preparedness and Response
The threat of antibiotic resistance has the potential to significantly impact public health, and your personal health, so fighting antibiotic resistance is a public health and national security priority. Our nation needs new drugs to combat the spread of antibiotic-resistant infections. At the same time, we need to use current (and future) antibiotics wisely to prevent or minimize resistance.
Over the summer, as part of the blog series called Combatting Antibiotic Resistance, we talked about ASPR’s strategies and programs to develop new drugs that combat antibiotic-resistant infections. In just four years, we've partnered with six companies to develop eight new products to combat antibiotic resistant infections.
Today the President introduced a national strategy on combatting antibiotic-resistant bacteria and issued an executive order to federal departments to implement the National Strategy and respond to a report by the President’s Council of Advisors on Science and Technology report.
With these tools in hand, BARDA will be stepping up to add new drugs and medical products to your doctor’s toolkit. BARDA and the National Institutes of Health will co-sponsor a $20 million prize to facilitate the development of rapid, point-of-care diagnostic tests for healthcare providers to use to identify highly resistant bacterial infections. In the near future, HHS agencies will host a public meeting that will engage stakeholders to ensure that this competition focuses on the type of diagnostic most needed by the medical and public health communities for recognizing and treating antibiotic-resistant bacterial infections.
As we discussed in this summer’s blog series, using public-private partnerships is effective in developing new drugs and medical products, so we’ll continue to bring together the best experts, biotech and pharmaceutical companies to develop new drugs and products to counter this threat. Success, however, depends on individuals, organizations and industry working together.
Each of us plays a critical role in helping combat the spread of antibiotic-resistant infections. Antibiotics aren’t always the answer. We need to be smart about when to use antibiotics and when not to. The FDA and CDC have great tips on using antibiotics.
FDA: Combating Antibiotic Resistance
CDC: Get Smart: Know When Antibiotics Work
BARDA regularly engages strategic advisory boards and organizations working in the area of antibiotic resistance. These entities play a critical role in the publication of documents and strategies that help inform actions taken by the government to mitigate the threat of antibiotic resistance.
BARDA staff members attend industry conferences on drug development, public meetings and are members of the Interagency Task Force on Antimicrobial Resistance and the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR). As mandated by Congress, every year BARDA engages with our industry and academic partners at BARDA Industry Day to discuss medical countermeasure (MCM) development.
The conference is a great opportunity for organizations working in the field to present information or to engage BARDA experts directly. If you want to tell us about your work in this area you can request a meeting today through www.MedicalCountermeasures.gov.
BARDA's Broad Spectrum Antimicrobials Program supports development of novel antibacterial drugs to treat or prevent biological threats and the increasingly prevalent public health threat of antibiotic resistance.
By supporting development of new antibiotics, we can help decrease the impact that antibiotic resistance could have during a public health emergency. This is because antibiotic resistance has the potential to complicate standard health care treatment of infections during a natural disaster or pandemic.
BARDA’s core services, technical assistance and funding can be beneficial to biotech and pharmaceutical companies working on new antibiotics Americans will need in an emergency. If you have an antibacterial drug candidate in development to treat these life threatening drug resistant infections, consider engaging with BARDA through our TechWatch program prior to responding to our Broad Agency Announcement.
To meet the threat of antibiotic resistance, the government and private sector must work together. BARDA’s public-private partnerships with pharmaceutical and biotechnology companies have begun revitalizing the pipeline. But bacteria never stop evolving. Looking to the future, the antibiotic pipeline will need to be refreshed continually. Ongoing partnerships between government, industry and academia will be critical. In the meantime, the efforts and awareness of individual citizens can do much to slow the emergence of resistance and help us preserve the antibiotics we have.
Industry partners are encouraged to visit the BARDA BAA and request a TechWatch meeting.
Authors: Karen B. DeSalvo, M.D., M.P.H., M.Sc., National Coordinator for Health Information Technology, U.S. Department of Health and Human Services and Gregg S. Margolis, Ph.D., NRP, Director, Division of Health System Policy, U.S. Department of Health and Human Services
The question isn’t whether or not we will have another disaster – it is just a matter of when, where and how severe it will be. The recent earthquake in Northern California, centered near Napa, serves as a reminder that we must be prepared for the unexpected no matter where we live.
Northern California’s largest quake since 1989 happened in a large state where ONC has been working for the past year to ensure health data access every day and especially during disasters. In fact, in April of this year, we issued an assessment on available opportunities to address potential disasters in California and along the Gulf Coast.
Based on those assessments and our expectations of a catastrophic event in California, ONC started working with state emergency medical services officials last year to begin connecting the state’s 35 health information exchange organizations (HIEs) and EMS organizations. This effort was launched to help ensure health data access during emergencies.
The program currently focuses on a pilot project in Orange, San Diego and Riverside counties because of the robust HIE services that exist in these areas, coupled with the fact that tens of millions of people live in these parts of Southern California. However, the Northern California earthquake reminds us that there is much work to do, and it must happen faster statewide and nationwide. We simply cannot make assumptions about how best to prepare for emergencies. In recognition of the importance of this initiative, the HHS Idea Lab chose a joint ONC/ASPR proposal for the inaugural HHS Ventures Program. The team has been actively engaged on this project as well as other ways technology can improve the routine delivery of care as well as disaster response – all in an effort to create more resilient communities.
In late July this year, the White House hosted the Innovation for Disaster Response and Recovery Initiative Demo-Day, an event which brought together hundreds of technologists, entrepreneurs, and members of the disaster response community to showcase tools that will make a tangible impact on the lives of survivors in large-scale emergencies. The Demo-Day was part of a larger initiative, a public-private and government-wide effort to find the most effective ways technology can empower first responders and survivors.
At the Demo-Day, HHS announced two new initiatives:
- NowTrending.hhs.gov is an ASPR-sponsored website that gathers data from Twitter to help provide insight to local and state health departments and public health emergency entities on emerging trends in health and disasters. The data presented on this site is used to indicate potential health issues emerging in a population; build a baseline of Twitter trend data; engage the public on trending health or disaster topics; or to cross-reference other data sources.
- The HHS At-Risk Resiliency Interactive Map is an open data map that is being co-sponsored by ASPR and the Centers for Medicare and Medicaid Services (CMS) to show the number of electricity-dependent Medicare beneficiaries at the U.S. territory, state, county, and zip code level. The map also will use NOAA real-time weather-tracking capabilities to identify areas that may be impacted by severe weather and at risk for prolonged power outages. This interactive map is under development and anticipated to launch soon on www.phe.gov.
Technology and health information technology have the power to inform and help survivors, first responders, and local, state, tribal, territorial and federal governments with critical information and resources related to an emergency. The projects outlined above are just a few examples of the many ways we are working towards the goal of better preparing and supporting communities and survivors before, during and following a disaster.
Capt. Tim Davis, M.D., Chief Medical Officer, National Disaster Medical System
I love vaccines. I’ll just admit that up front. As an emergency responder, a military member, a doctor, and a dad, I’ve seen the value of vaccines. There are plenty of things to worry about in a disaster, including any number of vaccine-preventable diseases disaster responders can be exposed to while doing our jobs. The same is true for doctors and other healthcare providers. And dads, too, for that matter! Getting sick doesn’t have to be one of them.
Staying up-to-date on vaccinations means we’re less likely to get sick and less likely to spread illness between our co-workers, patients, family, and members of the community. And it means we’ll be ready when our community and our families need us.
There are only a few immunizations most adults in the United States need: the tetanus/diphtheria/pertussis vaccination every 10 years and a seasonal flu vaccine every year. So staying current is pretty easy. Depending on your age and health, there may be other vaccinations that would be helpful in protecting your health. Check the CDC website for general recommendations and – most importantly – talk to your doctor.
OSHA, CDC and the National Advisory Committee on Immunization Practices also recommend a Hepatitis B vaccination for health care workers who could be exposed to body fluids but aren’t already immunized against Hepatitis B (either you’ve recovered from Hepatitis B or you’ve received the vaccination in the past).
In fact, employers are required by law to provide Hepatitis B vaccine (HBV) at no cost to their full or part-time if the employees plausibly could be exposed to body fluids and are not immunized to Hepatitis B.
Military members and other people who work overseas may need additional immunizations to protect their health. If, like me, you’re in this group, talk with your doctor about what’s appropriate for where you’ll be stationed.
Remember, vaccines drive your body to make antibodies to protect you against the virus or bacteria, and that can put a drag on your body’s energy. But feeling tired, sluggish or a little sore afterward is well worth the long-term benefits, especially for emergency responders and healthcare workers. (And parents, of course!)
Think about it like this: if your body hasn’t built up immunity (by already recovering from the virus or bacteria or by getting vaccinated), and you get exposed to a vaccine-preventable disease, the circumstances must be perfect to keep you from serious illness, death, or spreading the virus or bacteria to your family, co-workers and the people you’re responsible for protecting in your community. These circumstances aren’t always present after disasters.
Those perfect circumstances are:
- you must recognize that you’re sick;
- you must have access to competent medical care;
- that competent healthcare provider must recognize the disease, and sometime have access to diagnostic tests;
- that provider must have access to comprehensive treatments;
- those treatments must be genuine (not counterfeit), not expired, and maintained in an appropriate environment from manufacturer to the healthcare provider; and
- the treatments have to be dispensed or administered in a sterile and hygienic process.
You can risk getting sick and hope those six perfect circumstances happen to occur – or you can just get a shot in advance and live healthier. Plus you’ll have the peace of mind that in a disaster you can focus what you need to be focusing on – like recovering from the incident instead of recovering from illness.
August is National Immunization Month, so it’s a perfect time to check your online electronic health record or your doctor’s records to be sure you’re up to date on your vaccinations and ready to respond when disaster strikes.
Authors: Cheryl A. Levine, Ph.D., Team Lead for At-Risk Individuals, Division for At-Risk Individuals, Behavioral Health, and Community Resilience (ABC) Office of the Assistant Secretary for Preparedness and Response (ASPR) and Tehmina Mall, Graduate Intern in the Division for At-Risk Individuals, Behavioral Health, and Community Resilience (ABC), MPH Candidate 2015, Columbia Mailman School of Public Health
To build resilient communities, we need to make sure that the entire community can withstand disaster and bounce back quickly. We can make a great stride toward resilience and health security by ensuring that emergency plans for hospitals, emergency responders, healthcare providers and government agencies meet the needs of the entire community, including people with access and functional needs, when disaster strikes.
About 20 percent of Americans live with some kind of disability. During disasters, many may require specialized care or different approaches to help them stay safe and healthy. Yet just because a person has a disability doesn't mean they automatically will need help from emergency responders. So in planning for emergencies, we need to consider access and functional needs.
So, what are access and functional needs how can we meet these needs?
Addressing access-based needs means community resources are easy to access by everyone in the community - all of the social services, accommodations, information, transportation, and disaster-related medications. Function-based needs are a person's basic needs - eating, dressing, mobility, and so on. To learn more, check ASPR’s Guidance on Integrating People with Access and Functional Needs into Disaster Preparedness Planning for States and Local Governments.
ASPR provides resources emphasizing the access and functional needs of children and older adults which, in collaboration with other relevant federal agencies, emphasize cross-cutting approaches to disaster preparedness planning for those with access and functional needs.
One of those tools is a cross-cutting framework called CMIST. CMIST highlights the specific areas of communication, maintaining health, independence, services, support, self-determination, and transportation to help communities plan for the needs of community members with access and functional needs.
This framework has been used successfully by communities across the country. State agencies in Kentucky and Massachusetts, for example, used the framework to integrate access to communication during disasters and emergencies. To learn how these states effectively used CMIST, check out the Emergency Management and Preparedness: Inclusion of Persons with Disabilities Webinar Series.
By using emergency planning frameworks and resources that integrate access and functional needs, we can build a social connectedness and bolster health security for everyone. Addressing access and functional needs may be hard to do during a disaster, so planning now is critical to protecting health and safety during an emergency.
Authors: CDR Jyl C. Woolfolk, MPH, CHES, Senior Policy Analyst, Office of Policy and Planning, HHS Office of the Assistant Secretary for Preparedness and Response and
Darrin Donato, Senior Policy Analyst, Division for At-Risk Individuals, Behavioral Health, and Community Resilience, Office of Policy and Planning, HHS Office of the Assistant Secretary for Preparedness and Response
We all hope our communities will be resilient in the face of the many threats to health that strike during a disaster or emergency. But what exactly is resilience? Resilience is the ability to withstand and recover from adversity. Disaster resilience involves all the things that individuals can do to make themselves more prepared for disaster—like making a disaster kit and having a plan—and it also includes the things we can do together to make our communities stronger every day. This sense of individual and collective effort in service of the good of the community is a core principle of our nation. Our communities today are facing a number of threats. We know about the risks of natural disasters, and the damage that can be wrought by hurricanes, floods, and wildfires. But there are other threats to our communities’ health and well-being like chronic disease, poverty, and violence. A resilience approach helps us face the risks of major events like disasters, as well as the day-to-day challenges that are part of the life of any community.
Resilient communities take disaster preparedness seriously. As part of that approach, they strive to foster healthy individuals and families with access to health care, both physical and psychological. These communities work to equip people with the knowledge and resources to care for themselves and others in both routine and emergency situations. Resilient communities know the importance of social connectedness and they understand that that connected and engaged people and groups can work together to help their community resist disaster and recovery faster.
To affirm its commitment to community resilience and to improving the nation's ability to respond to and recover from major public health emergencies, the U.S. Department of Health and Human Services (HHS) asked the National Preparedness and Response Science Board (NPRSB) to examine the issue of resilience and offer recommendations. The NPRSB is an independent scientific body comprised of leading experts and stakeholders in disaster management, community health, and other related fields.
In its Community Health Resilience Report, the NPRSB provided recommendations to the HHS Secretary regarding Departmental actions that can build and sustain community health resilience and help communities better prepare, withstand, and recover from disasters and public health emergencies. These recommendations provide insight into the conceptual framework surrounding community resilience; outreach and communication; technical assistance; policy alignment; and the research agenda.
To learn about the NPRSB’s findings on actionable steps that can help improve our nation’s resilience, please read the Community Health Resilience Report. Please share your feedback on the board’s findings in a comment to this blog post.
Authors: Joe Larsen, Acting Deputy Director, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR)
and Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority, Office of Assistant Secretary for Preparedness and Response
At BARDA, we want to revitalize the antibiotic pipeline. To do it, we’re pursuing an innovative business model and providing incentives for pharmaceutical and biotechnology companies to invest in antibiotic development.
BARDA has successfully established public-private partnerships with industry partners for the development of novel antibiotics and anticipates a long term commitment to this market.
BARDA has seen the companies we partner with raise additional funding in private markets, become more attractive assets for acquisition by larger pharmaceutical companies, enter into co-development agreements, and/or move forward with Initial Public Offerings (IPO). This additional funding can provide critical capital to support expensive Phase III clinical studies. While there are factors that impact each business decision our partners have made, it is clear that those that have partnered with BARDA have continued to accomplish important technical and business milestones. Securing technical guidance and financial resources through a BARDA partnership reduces the risk of drug development, freeing up additional resources to help companies grow and diversify.
We strive to be a collaborator and, as a result of our direct involvement, to mitigate regulatory uncertainty in developing antibiotics and other drugs, vaccines, and diagnostics.
In May 2013, BARDA entered into a unique strategic alliance with GlaxoSmithKline to launch a Portfolio Partnership. This Portfolio Partnership is a five-year, $200 million agreement formed under the Other Transactional Authority (OTA) granted to HHS by the Pandemic and All Hazards Preparedness Act of 2006. Partnerships formed using OTA aren’t traditional government contracts and allow for more flexible partnering arrangements.
In this case, instead of focusing the partnership on a single antibiotic candidate, this partnership supports an entire portfolio of candidate antibiotic therapies. The benefit of basing the partnership on a portfolio of candidates is that the partnership doesn’t end if a particular product fails in clinical trials. BARDA’s agreement with GSK possesses three central tenets: 1) flexibility in technical scope, 2) cost sharing, and 3) joint strategic oversight. This type of flexible, long-term partnership sends a strong signal of commitment to industry.
Currently under the Broad Spectrum Antimicrobial programs, our partners receive reimbursement for drug development activities in real time. This approach contrasts with that of models such as advanced market commitments, where reimbursement is provided only after the purchase of product, and milestone or prize payments, where awards are provided upon advancing a candidate antibiotic to predefined endpoints.
The near real-time direct reimbursement for drug development activities is a preferred structure for products in advanced development prior to approval. The “non-dilutive” funding provided by BARDA to support development activities does not need to be repaid and does not dilute shareholder’s equity. Further, the funding can favorably impact the net present value calculation of our partners when considering whether to undertake antibiotic development projects by reducing their upfront costs.
The rapid growth of the Broad Spectrum Antimicrobial program – from one partnership in August 2010 to six partnerships today, with three progressing in Phase III clinical development – speaks to the success of BARDA’s model.
This post is the fourth part in our series Combatting Antibiotic Resistance. Next week, our blog post wll be on the ways individuals, organizations and industry can do their part to responds to the threat of antibiotic resistance. To stay up to date as new blog posts are published, subscribe to the ASPR Blog on RSS, follow @PHEgov on Twitter or Like us on Facebook.
Author: Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures , Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR)
Combating antibiotic resistance requires new, better antibacterial drugs. BARDA is taking a unique partnership approach to engage industry in antibiotic development in an effort to combat the rise in antibiotic resistance.
BARDA established a Broad Spectrum Antimicrobials (BSA) Program in April 2010 to develop novel antibacterial and antiviral drugs to treat or prevent diseases caused by biological threats. ASPR and BARDA leadership recognized that new antibiotics are needed immediately to address the increasingly prevalent public health threat of antibiotic resistance, as well as the likelihood that antibiotic resistance will complicate the response to a public health emergency.
The BSA program provides non-dilutive funding to support product development and augments our partners existing capital raised from their investors. For laypeople, this means that BARDA provides funding companies can count on and can add to their own funding to develop a drug. If the drug is approved by the FDA, the company can sell it on the commercial market to treat antibiotic resistant infections. The approved antibiotic would then also be available during a public health emergency, if needed.
BARDA continues to establish public-private partnerships with industry to develop novel antibiotics, and we anticipate a long-term commitment to this market. Through these partnerships, we support concurrent development of candidate products for biodefense and commercial indications based on strategic and funding priorities outlined in our Broad Agency Announcement (BAA).
This strategy helps ensure that novel antibiotics progress through the development pipeline to approval for public health and commercial indications. The approach also increases the likelihood that novel antibiotics will be added to the arsenal of possible treatments available to antibiotic resistant infections. Approval of a drug for a commercial indication also helps establish a human safety database and a warm-base manufacturing capability for the drug should it be needed in a biothreat emergency.
By engaging with BARDA, our industry partners are able to receive funding and expert technical advice from BARDA for clinical studies (Phase 1-3), manufacturing, and regulatory activities. Industry partners are encouraged to visit the BARDA BAA and sign up for a TechWatch meeting with BARDA and other U.S. Government subject matter experts.
In just four years our Broad Spectrum Antimicrobials program, has funded six partnerships through the BARDA BAA and we anticipate funding additional programs using this mechanism in the future.
- In August 2010, BARDA entered into a public-private partnership with Achaogen, Inc. for the development of a drug called Plazomicin™. This novel, next-generation aminoglycoside antibiotic is being developed to treat plague and tularemia (known bioterrorism threats) as well as infections caused by carbapenem resistant Enterobacteriaceae (CRE) – which CDC Director Tom Frieden called a “nightmare bacteria”. We’re supporting a Phase 3 study of efficacy against blood stream and pneumonia caused by CRE.
- In January 2012, BARDA entered into a public-private partnership with CUBRC, Inc. in partnership with Tetraphase Pharmaceuticals, Inc. for the development of eravacycline, a novel antibiotic of the tetracycline class. BARDA funding will support studies evaluating the effectiveness [efficacy] of eravacycline against biothreat pathogens as well as Phase I clinical trials to assess eravacycline safety, clinical pharmacology studies, and drug manufacturing. The BARDA contract supports development of oral and intravenous formulations of eravacycline.
- In May 2013, BARDA entered into a public-private partnership with Cempra, Inc. for development of a novel fluoroketolide antibiotic, solithromycin for the treatment of anthrax and tularemia infections. BARDA is also supporting the development of a liquid version of the drug for children. Cempra also is developing solithromycin as a commercial indication for the treatment of community acquired bacterial pneumonia (CABP) and gonorrhea.
- In May 2013, BARDA entered into an Other Transactional Agreement with GlaxoSmithKline (GSK) to support the advanced research and development of a portfolio of novel antibiotic candidates. The Pandemic and All Hazards Preparedness Act in 2006 gave HHS the authority to enter into Other Transactional Agreements and the one with GSK was the first ever awarded by HHS. The agreement is flexible, so that antibiotic candidates can move in or out of the portfolio based on their stage and feasibility. This approach balances risk for the federal government and GSK. At the same time, the approach supports development of multiple drugs simultaneously, increasing the likelihood that one or more will succeed in achieving approval by the U.S. Food and Drug Administration.
- In June 2013, BARDA entered into a public-private partnership with Basilea Pharmaceutica Ltd for the development of BAL30072, a unique monosulfactam antibiotic that could treat a broad range of multidrug-resistant Gram-negative bacteria [including species of Pseudomonas, Acinetobacter, and Klebsiellathat are of great clinical concern]. The new antibiotic also looks promising as a treatment against biothreats like melioidosis and glanders for which there are no currently approved drugs. Under this project, Basilea will conduct clinical and non-clinical studies to evaluate the safety and efficacy of BAL30072. If approved, the new drug would provide doctors with new treatment options for severe and life threatening infections, including hospital-acquired pneumonia and complicated urinary tract infections, as well as for glanders and melioidosis.
- In February 2014, BARDA entered into a public-private partnership with Rempex Pharmaceuticals, a wholly owned subsidiary of The Medicines Company, to support the advanced research and development of a novel drug called Carbavance™, a novel carbapenem/β-lactamase inhibitor combination. During this potential five-year partnership, Rempex will develop Carbavance™ for the treatment of complicated urinary tract infections, hospital-acquired and ventilator-associated pneumonia, and infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae (CRE). BARDA will provide funding for clinical, nonclinical, manufacturing and regulatory activities to support the commercial indications of the drug. In addition, BARDA will fund the assessment of Carbavance as a treatment for melioidosis and glanders.
This post is the third part in our series Combatting Antibiotic Resistance. Next week, our blog post will focus on the specific incentives BARDA is using under the BSA program to revitalize the antibiotic pipeline and engage industryTo stay up to date as new blog posts are published, subscribe to the ASPR Blog on RSS, follow @PHEgov on Twitter or Like us on Facebook.