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Category: Medical Countermeasures

BARDA adds new antibiotic to treat drug-resistant bacterial infections in order to protect the American public

Author: Mark Albrecht, Project Officer, Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 8/30/2017 1:21:00 PM
Category: Medical Countermeasures; Public Health Preparedness; Innovations; National Health Security;

Antibiotics underpin nearly every facet of modern medicine. You can’t have a hip replacement or a caesarean section without effective antibiotics to prevent or treat bacterial infections. The same holds true in a mass public health emergency involving a chemical, biological, radiological or nuclear (CBRN) threat. During a biodefense emergency, people may be hospitalized for prolonged periods, potentially exposing them to secondary infections including drug-resistant infections that are occurring at an alarming rate.

That’s why BARDA is focused on development and approval of  Read more…

New Frontiers and Extreme Environments: BARDA and NASA Join Forces to Better Protect the American Public and Astronauts from Radiation Injury

Author: Mary J. Homer, PhD, Chief of Radiological and Nuclear Countermeasures Branch, HHS/ASPR/BARDA and Lynne Wathen, Biodosimetry Team Leader in the Diagnostics and Medical Devices Division, HHS/ASPR/BARDA
Published Date: 8/2/2017 10:22:00 AM
Category: Medical Countermeasures; Innovations; Public Health Preparedness;

Although an odd couple at first glance, NASA and the Biomedical Advanced Research and Development Authority in the office of the HHS ASPR share a common interest: protecting people from radiation injury.

  Read more…

Powering the next generation of antibacterial innovation to enhance national security

Author: Tyler Merkeley, MS, MBA, CARB-X Program Manager, BARDA
Published Date: 3/30/2017 11:50:00 AM
Category: Public Health Preparedness; Medical Countermeasures; Innovations; National Health Security;

It’s about the people. Picture a worried mother from Arizona walking into the hospital with her 11-year-old daughter. The girl had gone from tired to intense hip pain and a high fever in just a few days. A blood test revealed a potentially fatal condition called sepsis from a Staphylococcus infection. The infection had begun as an abscess in her hip muscle, spread into her blood, and eventually caused a devastating antibiotic-resistant bacterial pneumonia in her lungs.

Mom sat day-in and day-out watching her daughter’s health rapidly fade; tubes ran all over her body, and a   Read more…

Next-Generation Burn Care Products and Strategies Draw on Innovative Ideas

Author: Narayan Iyer, Ph.D., Chief, Burn MCM, CBRN, BARDA; Julio Barrera-Oro, Ph.D.; Danielle Turley, Ph.D.; David Simon, Ph.D.; Oxana Selivanova, Ph.D.; Joe Larsen, Ph.D. Director (Acting), CBRN, BARDA; and Gary Disbrow, Ph.D. Deputy Director (Acting), BARDA.
Published Date: 2/6/2017 9:46:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Thousands of people could need burn care following a nuclear detonation (which produces intense heat resulting in severe burns) or in a massive explosion. In addition to those catastrophic threats, between 2010 and 2014, emergency departments treated approximately 486,000 people for non-fatal burn injuries and in 2014 alone, fires took the lives of 3,275 people. Specialized treatment resources are limited, with only 127 burn centers nationwide; a mass casualty incident easily could overwhelm the nation’s burn care infrastructure.

Within ASPR, the Biomedical Advanced Re  Read more…

BARDA-supported Zika vaccine candidate enters clinical trial

Author: Rick Bright, Director, Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 1/9/2017 5:24:00 PM
Category: Innovations; Medical Countermeasures; Public Health Preparedness;

The U.S. government has marked another significant milestone in its effort to better protect Americans against the Zika virus: the first ASPR-supported Zika vaccine has begun a Phase I clinical trial, which will evaluate the general safety of the vaccine in people and provide information on the ways that different doses of the vaccine impact immune response.

The investigational vaccine developed by Moderna Therapeutics of Cambridge, Massachusetts, utilizes a novel messenger RNA (mRNA) vaccine technology. Moderna’s vaccine consists of a small piece of mRNA that when injec  Read more…

Ensuring a coordinated response to Zika and other public health threats

Author: George W. Korch, Jr., Senior Science Advisor, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 12/5/2016 12:41:00 PM
Category: Public Health Preparedness; Innovations; Hospital Preparedness; Medical Countermeasures; Response & Recovery;

When the first confirmed case of Zika transmission was reported in Puerto Rico on December 31, 2015, there were no vaccine candidates for Zika. Today there are at least a dozen approaches in the US alone that are being evaluated to someday be available for general use. Diagnostic assays to help patients make informed decisions about their health are also under development.

How have so many medical countermeasures advanced so quickly to fight a threat that few people were worried about just last year?

The partners in the Public Health Emergency Medical Enterprise (PHEM  Read more…

Better preparing for future Ebola outbreaks globally

Author: David Boucher, Health Scientist, ASPR/BARDA’s Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasures and Dr. Richard Hatchett, acting director, ASPR’s Biomedical Advanced Research and Development Authority
Published Date: 10/13/2016 10:27:00 AM
Category: Public Health Preparedness; Innovations; Medical Countermeasures;

While the Ebola virus disease is not in the news as much now as it once was, we cannot afford to let down our guard. Ebola cases flared up again as recently as this March in West Africa, causing eight deaths in Guinea and one death in Liberia, and more than 30 other outbreaks of the disease have been recorded in the last 40 years.

The Ebola outbreak of 2014-2016 highlighted the urgent need for therapeutics that could increase the survival rate of infected patients and also aid response organizations in their efforts to limit the spread of this deadly virus. ZMapp, developed  Read more…

From the front lines of the anthrax investigation to pre-staging our future health response

Author: Dr. Rick Jaffe, Director, Medical Countermeasures Strategy and Requirements, ASPR’s Office of Policy and Planning
Published Date: 9/29/2016 4:28:00 PM
Category: Innovations; Medical Countermeasures; Public Health Preparedness;

Fifteen years ago this month, anthrax was used as a terrorist weapon against our nation. As a microbiologist with experience in dealing with Bacillus anthracis, the bacteria that causes anthrax illness, I was called in to be on the front lines of the investigation into the attack. Today, I help ensure our nation is best prepared for and can respond to a future one.

Soon after September 11, 2001, an attacker mailed letters laced with anthrax spores causing the deaths of five people and sickening 22 others. As part of the response, I donned a hazmat suit to investigate  Read more…

Why some emerging infectious diseases cause epidemics

Author: George W. Korch, Jr., Senior Science Advisor, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 9/15/2016 10:32:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Forty years ago, a patient exhibiting symptoms believed to be from malaria sought treatment in a small village in the Republic of the Congo in Africa. Later, it was determined this patient didn’t suffer from malaria, but from a virus that would cause a major disease outbreak decades later and more than 1,000 miles away: Ebola.

When the Ebola epidemic struck in 2014, it claimed the lives of thousands. However, it also served as a reminder that nearly all emerging infectious diseases may not be altogether new to the medical community, but certain factors may have changed sinc  Read more…

Anticipating Threats, Investing in Solutions

Author: Brian N. Tse, Ph.D., Health Scientist, Antibacterials Branch, Division of Chemical, Biological, Radiological, & Nuclear Medical Countermeasures, Biomedical Advanced Research & Development Authority (BARDA), HHS Office of the Assistant Secretary for Preparedness & Response
Published Date: 6/7/2016 3:53:00 PM
Category: Innovations; Medical Countermeasures; Public Health Preparedness;

Deadly new strain of bacteria? BARDA’s already working on it.

For the first time, the bacterial gene mcr-1, which confers resistance to the “antibiotic of last resort,” colistin, was found in a bacterium isolated from a patient in the United States  Read more…

PHEMCE-supported drug achieves FDA approval

Author: Dr. Richard Hatchett, Acting Director of ASPR’s BARDA
Published Date: 3/21/2016 10:12:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Today, the FDA licensed the monoclonal antibody drug Anthim, developed by Elusys Therapeutics of Pine Brook, New Jersey, to treat inhalational anthrax. This drug’s approval not only diversifies our available medical countermeasures for use after an anthrax attack but also further demonstrates the effectiveness of partnering among federal agencies through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and the success of BARDA’s model of partnering with private industry.

  Read more…

Would old vaccine work if needed during a pandemic?

Author: Ruben Donis, Deputy Director, BARDA Influenza Division
Published Date: 3/17/2016 1:24:00 PM
Category: Public Health Preparedness; Medical Countermeasures;

One of ASPR’s goals is to protect our nation against future flu pandemics. Even before ASPR was created in 2006, our nation started stockpiling millions of doses of flu vaccine to protect Americans against the H5N1 avian flu that spread in Asia beginning in 2004.

But, would the vaccine that was stockpiled more than a decade ago still be safe and effective to use if this pandemic flu strain spread in the U.S. today?

We believe so, but this aged vaccine has not been tested in humans, so we’re going to find out.

Unknown Shelf Lives

Most seasonal flu v  Read more…

BARDA seeks to launch a novel partnership, a product accelerator to address antimicrobial resistance

Author: Joe Larsen, Ph.D. Deputy Director BARDA Division of CBRN Medical Countermeasures HHS/ASPR/BARDA
Published Date: 2/19/2016 10:17:00 AM
Category: Innovations; Medical Countermeasures;

Today the Biomedical Advanced Research and Development Authority (BARDA), in collaboration with our colleagues at the National Institutes of Allergy and Infectious Disease (NIAID) released a Funding Opportunity Announcement to establish the Combating Antibiotic Resistant Bacteria (CARB) Biopharmaceutical Accelerator.  The Accelerator represents a novel public private partnership that will support research and development to accelerate candidate products (drugs, vaccines, and diagnostics) into clinical development.

Infections with bacteria that are resistant to e  Read more…

Better protecting our nation against future anthrax attacks

Author: Robin Robinson, Ph.D., Director of BARDA and Deputy Assistant Secretary for Preparedness & Response
Published Date: 12/21/2015 3:32:00 PM
Category: Medical Countermeasures; Public Health Preparedness;

Almost 15 years ago, an attacker mailed three letters containing a deadly form of anthrax, killing five people and sickening 17 others. At the time, people who were exposed or who may have been exposed had few treatment options available and no vaccine at-the-ready to prevent illness. Today, that’s changed. On November 23, FDA announced licensure of a vaccine to prevent illness after exposure to anthrax. After a bioterrorism incident, a licensed vaccine could save countless lives.

The vaccine, BioThrax® (also called Anthrax Vaccine Adsorbed or AVA), had been licensed only f  Read more…

Join the Conversation on Meeting Next-Generation Challenges in Medical Countermeasures

Author: Paige Ezernack, ASPR Project Lead for the Stakeholder Workshop
Published Date: 12/3/2015 3:03:00 PM
Category: Medical Countermeasures; Public Health Preparedness;

Safe and effective drugs, vaccines, therapeutics and diagnostics help us tackle a wide range of public health threats from emerging infectious diseases to terrorist threats. As we saw during the recent Ebola outbreak, developing next-generation medical countermeasures to respond rapidly to these threats takes a many smart people who are committed to working together to solve tough problems.

To meet these challenges, we need the commitment of experts from the pharmaceutical industry, hospitals and healthcare coalitions, the first responder community, as well as federal, stat  Read more…

Fighting Antibiotic Resistance: The Long Road to New Solutions

Author: Melissa Stundick, PhD, Chief, Anti-Infectives Program, BARDA & David Simon, PhD, Project Officer, Anti-Infectives Program, BARDA
Published Date: 11/19/2015 3:44:00 PM
Category: Innovations; Medical Countermeasures;

Clinicians have relied on antibiotics to treat bacterial infections ever since they were discovered in the early 20th century. As a result, mortality and hospitalization rates that resulted from common infections went down. So did the Western world’s urgency to pursue alternative methods of fighting bacteria.

Since the discovery of antibiotics, western researchers have instead focused on developing drugs that block an essential enzyme or process that bacteria require to survive or replicate. At first, this approach was successful. Several new classes of antibiotics were dis  Read more…

Innovative partnerships support antibiotic development

Author: Christopher Houchens, PhD, Project Officer, Anti-Infectives Program, ASPR’s Biomedical Advanced Research and Development Authority
Published Date: 9/23/2015 6:36:00 AM
Category: Medical Countermeasures;

Can a federal agency engage in long-term strategic partnerships with business? Yes.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA), for instance, is pioneering an innovative approach to collaboration that uses Other Transaction Authority (OTA for short) to create flexible business partnerships between government and industry. Partnerships formed under OTA allow both parties to invest in the development of a portfolio of products for biodefense and to combat the growing public  Read more…

Collaborating to bring the nation new medical products for emergencies

Author: Joanna M. Prasher, Ph.D., Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Branch Chief, Medical Countermeasures Strategy and Requirements Division Office of Policy and Planning, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
Published Date: 2/24/2015 4:04:00 PM
Category: Medical Countermeasures;

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 agencie  Read more…

BARDA Continues Efforts to Make Ebola Therapeutics Available for Response

Author: Robin Robinson, Ph.D., Director of the Biomedical Advanced Research and Development Authority, Deputy Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
Published Date: 2/24/2015 9:52:00 AM
Category: Medical Countermeasures;

​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 p  Read more…

Strong Partnerships are Helping Bring Next Generation Antibiotics to Market

Author: Melissa Stundick, PhD. Acting Branch Chief of BARDA’s Broad Spectrum Antimicrobials Program
Published Date: 2/18/2015 10:51:00 AM
Category: Medical Countermeasures;

BARDA and its partners are coming closer to bringing new drugs to market to help in the fight against antibiotic resistance.  Four of BARDA’s partners have met major milestones in the development of new antibiotics, and with increased funding, BARDA is poised to further strengthen the antibiotic pipeline.

Two of these drugs could be coming to market soon and both of them may be able to overcome antibiotic resistance that is threatening existing classes of drugs. The first new product is eravacycline, which was developed by Tetraphase Pharmaceutical to treat complicated int  Read more…

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