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U.S. Department of Health and Human Services

Category: Medical Countermeasures

Expanding Your Partnerships to Enhance Medical Surge: Seven Ways to Engage Outpatient Care Settings

Author: ASPR TRACIE
Published Date: 8/13/2019 11:09:00 AM
Category: Medical Countermeasures; Response & Recovery; Hospital Preparedness;

Outpatient care settings  - including federally qualified health centers (FQHCs), rural health clinics (RHCs), urgent care centers, home health and hospice agencies, and primary care provider practices - have a wide range of capabilities that could be used to save lives in an emergency, but are they integrated into our nation’s emergency healthcare response system? How can healthcare coalitions better engage outpatient healthcare providers to enhance disaster response?

These are just some of the questions the experts from ASPR’s Technical Resources, Assistance Cen  Read more…

Crossing the Finish Line: Project BioShield is Transforming the Nation’s Health Security with Cutting-Edge Innovation, Sound Investments, and Strong Partnerships

Author: Rick A. Bright, Ph.D., BARDA Director
Published Date: 8/7/2019 10:53:00 AM
Category: Medical Countermeasures; Innovations; National Health Security;

Project BioShield is revolutionizing the way we protect Americans from 21st century health security threats. Think back almost 18 years ago to the anthrax attacks of 2001. That crisis highlighted just how few medical countermeasures our nation had to respond to a bioterrorism incident. The anthrax attacks taught us important lessons that still guide our thinking:  innovation is critical, partnerships matter, and the threats that we face are very real and very serious.


21st Century Health Security Threats: From Anthrax to the Unknown

Alth  Read more…

Novel Partnerships, Payment Shifts, and Emerging U.S. Leadership for Antimicrobial Drugs

Author: Rick A. Bright, Ph.D., BARDA Director
Published Date: 8/5/2019 9:01:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Antimicrobial resistance (AMR) is an increasingly serious threat to America’s public health and national security. The resources necessary to discover, develop and commercialize innovative, life-saving antimicrobials are similar to other disease areas; however, the relative return on investment is exceedingly low.

In May, I highlighted the need for an immediate paradigm shift in the antimicrobials marketplace. I specifically called out the importance of building new business models, developing novel partnerships,  Read more…

Building a Better Pipeline of Candidate Products for Project BioShield

Author: By Rick A. Bright, Ph.D., BARDA Director
Published Date: 7/31/2019 9:38:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Project BioShield has revolutionized the way we protect Americans from 21st century health security threats. Our ultimate goal is to save lives during a national disaster; we prepare for this eventuality by pursuing FDA approval and availability of countermeasures in preparation for such emergencies. The government alone cannot fill the need for medical products to save lives in public health emergencies and disasters; public-private partnerships are essential every step of the way.

BARDA’s approach to public-private partnerships is remarkable. We reduce business risk  Read more…

Fifteen Years, Fifteen Stockpiled Medical Countermeasures: Leveraging Project BioShield to Build an Unprecedented Array of Drugs, Vaccines, Therapeutics, and More to Enhance Health Security

Author: Gary Disbrow, Ph.D., BARDA Deputy Director
Published Date: 7/24/2019 8:36:00 AM
Category: Medical Countermeasures;

When Project BioShield was signed into law 15 years ago, the nation had few medical countermeasures to rely on in national emergencies. In the interceding years, BARDA has worked with its partners throughout government and industry to find creative solutions to address health security threats. Together, we have developed safe and effective medical countermeasures to protect the public in emergencies.

BARDA has supported 27 projects using Project BioShield authorities and funding. We’ve added 15 products to the Strategic National Stockpile. We’ve worked with industry pa  Read more…

Project BioShield Evolution: Fifteen Years of Bridging the ‘Valley of Death’ in the Medical Countermeasures Pipeline

Author: By Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response
Published Date: 7/17/2019 12:15:00 PM
Category: Innovations; Medical Countermeasures; National Health Security;

Saving lives in a public health emergency requires cutting-edge medical countermeasures: medications, vaccines, diagnostics, and more. In some types of emergencies, like an act of bioterrorism, some of those medical products have no commercial market. People don’t use an anthrax antitoxin every day – thank goodness. Yet that lack of commercial market also means pharmaceutical or biotech companies had only one possible buyer for their products: the federal government for stockpiling.

In 2004, Congress passed the Project BioShield Act to create a market for products   Read more…

BARDA-supported Zika Virus Test Receives FDA Clearance; Ready for Clinical Laboratory Use

Author: Rodney L. Wallace, Director, Detection, Diagnostics, and Devices Infrastructure Division, HHS/ASPR Biomedical Advanced Research and Development Authority
Published Date: 6/6/2019 10:36:00 AM
Category: Innovations; Medical Countermeasures; Hospital Preparedness;

The first commercially available Zika virus diagnostic, a product BARDA supported through its advanced research and development program, received authorization for marketing from the U.S. Food and Drug Administration (FDA) on May 23. The test provides results from a blood sample in about four hours. Called the ZIKV Detect 2.0 IgM Capture ELISA, the test exemplifies the progress that is possible with public-private   Read more…

A Critical Crash Course in Chemical Decontamination

Author: Efrain E. Garcia, Ph.D.,Health Scientist, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness & Response
Published Date: 5/24/2019 9:29:00 AM
Category: Medical Countermeasures; Exercises & Trainings;

​What EMS Professionals Need to Know about Mass Chemical Decontamination

In communities across the country, people rely on Emergency Medical Services (EMS) professionals to make quick, life-saving decisions.  Becoming an EMS professional takes years of training that you can directly apply during most disasters and emergencies, such as hurricanes, floods and earthquakes.

However, do you know how to effectively decontaminate yourself or patients following a chemical event? 

Straightforward Guidance to Help Save Lives

Decontaminating people   Read more…

Project BioShield: Enhancing Preparedness, Ensuring Treatment Options

Author: Brian Tse, Oxana Selivanova, Claiborne Hughes, and Mark Albrecht
Published Date: 5/13/2019 9:42:00 AM
Category: Public Health Preparedness; Medical Countermeasures; National Health Security;


Stockpiling Novel Antibiotics Safeguards Nation, Sustains Commitment to Industry

Bacteria evolve and change, becoming more dangerous and deadly, and often developing resistance to existing medical countermeasures. Consider some of the resistance problems we face today. In recent years, we’ve seen increasing incidences of multi-drug resistant salmonella, gonorrhea, and typhoid, just to name a few examples. Now, think about what would happen if evolution or terrorists created antibiotic-resistant strains of biothreat agents, such as anthrax, plague, tularemia, mel  Read more…

Combating and Containing the Ebola Outbreak

Author: Robert Kadlec, MD, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
Published Date: 3/14/2019 4:13:00 PM
Category: Public Health Preparedness; Medical Countermeasures; Response & Recovery; Innovations;

ASPR’s Strategic Approach to Ebola Medical Countermeasure Development and Utilization in the 2018 Ebola Outbreak

Blog Series:  Battling the Ebola Epidemic

Ebola reemerged as a health threat in 2018, in the Democratic Republic of the Congo (DRC), where two outbreaks of Ebola virus disease have occurred since May 2018. The first of these two outbreaks, in western DRC, was quickly contained. However, the second outbreak, in eastern DRC, has yet to be contained due in large part to the volatile security situa  Read more…

Protecting the Nation from Emerging and Pandemic Infectious Diseases and CBRN Threats

Author: Darrin Donato, Senior Policy Analyst for the Office of Strategy, Policy, Planning, and Requirements within HHS’ Office of the Assistant Secretary for Preparedness and Response and Michael Fucci, Jr. Management Analyst with Aveshka Inc. in support of the Office of Strategy, Policy, Planning, and Requirements, HHS Office of the Assistant Secretary for Preparedness and Response
Published Date: 2/13/2019 9:26:00 AM
Category: Medical Countermeasures; National Health Security;

National Health Security Strategy:  Blog 3

As we scan the threat landscape as a new year begins, we find that we face a range of evolving threats to national health security. Among these risk are emerging infectious diseases that could lead to pandemic and the potential for chemical, biological, radiological, and nuclear (CBRN) emergencies.

An increasing number of immunocompromised and/or unvaccinated people (especially children), global mobility, population density acceleration, urbanization, and a growi  Read more…

Pandemic Influenza Vaccine: An Investment in Preparedness that Lasts More Than a Decade

Author: By Ruben Donis, Ph.D., Pandemic Influenza Medical Countermeasures Division, Biomedical Advanced Research and Development Authority (BARDA), HHS Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 12/13/2018 9:13:00 AM
Category: Medical Countermeasures; Innovations; National Health Security;

As part of our nation’s overall pandemic preparedness strategy, HHS set a preparedness goal of establishing and maintaining a stockpile of bulk vaccine antigen and adjuvants for influenza viruses with pandemic potential to vaccinate 26 million people immediately after a pandemic is declared. BARDA began pre-pandemic influenza vaccine procurement in 2005 for vaccines that would provide protection against emerging avian influenza H5N1 viruses posing a significant pandemic threat.  But a decade later we were compelled to ask how long would those stored vaccine components   Read more…

FDA approval of anti-seizure drug provides a new tool for protecting Americans during a chemical attack

Author: Judith Laney, Ph.D., Chief, BARDA Chemical Medical Countermeasures programs, and LTC Matthew Clark, Ph.D., Joint Product Manager, Chemical Defense Pharmaceuticals, Medical Countermeasure Systems
Published Date: 10/31/2018 10:35:00 AM
Category: Medical Countermeasures;

With the recent U.S. Food and Drug Administration approval of the drug Seizalam® (midazolam injection) as an anti-seizure medication, the United States took a step forward in protecting Americans from a potentially deadly health effect of chemical weapons.

Over the last 25 years, there has been increased use of chemical weapons. Delivering effective medical countermeasures against nerve agents is essential to saving civilians’ lives in the United States, and is necessary to ensure that the Joint Force maintains mission effectiveness to protect the nation.

H  Read more…

ASPR and the Defense Advanced Research Projects Agency (DARPA) forge new partnership to deliver novel and robust health security capabilities

Author: Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services and Steven H. Walker, Director, Defense Advanced Research Projects Agency
Published Date: 10/1/2018 3:06:00 PM
Category: Innovations; Medical Countermeasures;

On September 18, marking seventeen years since the first anthrax attack in the United States, the President unveiled a National Biodefense Strategy and signed a National Security Presidential Memorandum which directed federal agencies to collaborate on biodefense, including budgets, to make the nation safer.

That spirit of interagency collaboration is reflected in a new partnership forged between ASPR and the Defense Advanced Research Projects Agency – DARPA – to strengthen the capa  Read more…

BARDA and its partners bring new ammunition to the battle against superbugs

Author: Brian Tse, PhD, Project Officer, BARDA Antimicrobial Medical Countermeasures Branch, and Mark Albrecht, PhD, Acting Chief, BARDA Antibacterial Medical Countermeasures Branch
Published Date: 8/27/2018 5:41:00 PM
Category: Medical Countermeasures;

In 1954, Alexander Fleming, who discovered penicillin, began warning against the potential for bacteria to become resistant to the new antibiotic. Just over a decade later, in July 1968, physicians documented the first human case of a superbug known as MRSA, Methicillin-resistant Staphylococcus aureus. Fast forward 50 years, and MRSA has become just one of many drug-resistant infections healthcare providers and patients battle every day.

Back in the 1950s and 60s, drug manufacturers were developing an array of new antibiotics so resistance did not seem im  Read more…

ASPR’s Vision for Building Readiness: Sustaining Robust and Reliable Public Health Security Capabilities

Author: Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS)
Published Date: 8/10/2018 12:54:00 PM
Category: Public Health Preparedness; National Health Security; Medical Countermeasures; Response & Recovery;

HHS’ Vision for Healthcare Preparedness is a multi-part blog series that describes ASPR’s four pillars to achieving national health security: providing strong leadership, building a Regional Disaster Health Response System, sustaining public health security capabilities, and advancing an innovative medical countermeasures enterprise. This blog focuses on sustaining public health security capabilities. Read the next post in the series here.

A catastrophic health emergency – whether n  Read more…

New Smallpox Antiviral Increases National Health Security

Author: Rick Bright, Director, and Julie Schafer, Acting Director of Strategy, both of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 7/13/2018 4:20:00 PM
Category: Medical Countermeasures; Innovations; Public Health Preparedness; National Health Security;

​​In the 20th century alone, smallpox deaths worldwide numbered in the hundreds of millions. Roughly one-third of people infected with the disease died, while survivors were often left with permanent scars or blindness. After an aggressive global vaccination program in the mid-1970s, the World Health Organization declared smallpox eradicated.

​​But smallpox remains a health security threat in the 21st century. Fears that undeclared stocks of the smallpox virus might exist and that they could be used as weapons of bioterrorism spurred the U.S. government’s Biomedical Advance  Read more…

From 1918 to 2018: BARDA’s Role in the Evolution of Pandemic Preparedness

Author: Rick Bright, Director, and Julie Schafer, Acting Director of Strategy, both of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR)
Published Date: 5/21/2018 4:56:00 PM
Category: Innovations; Public Health Preparedness; Observances; Medical Countermeasures; National Health Security;

BARDA and its industry partners have made tremendous strides to build better, faster, and more flexible vaccine technologies to enable the right vaccine to be where we need it, when we need it. Combating this age-old problem is an epic challenge, and there is still work to be done to speed availability of life-saving vaccines in a pandemic.

In September 1918, a doctor stationed at Camp Devens, a military base located near Boston, Massachusetts, wrote a letter to a colleague:

Read more…

Decontamination Decoded: Disrobing, Dry Wiping Removes 99% of Chemical Contaminants

Author: Judith Wolfe Laney, PhD, Chief of Chemical Medical Countermeasures, Division of Chemical, Biological, Radiological and Nuclear Countermeasures within BARDA at the Office of the Assistant Secretary for Preparedness and Response
Published Date: 4/11/2018 9:31:00 AM
Category: Exercises & Trainings; Medical Countermeasures; Public Health Preparedness; Response & Recovery; Innovations;

Last month, a truck carrying 4,400 gallons of hydrochloric acid collided with a train in Centerville, PA. For several hours, a column of white vapor floated above the wreckage. Emergency responders acted quickly to evacuate residents in the area and clean up the spill.

On a daily basis, thousands of businesses use our nation’s roads and railways to transport hazardous chemicals used for industrial or household purposes. Whether a chemical is released by accident, such as the case in Centerville, or intentionally by rogue assailants, terrorist organizations, or non-state acto  Read more…

BARDA Supports a Rapid, Deployable, Sensitive Diagnostic Platform to Diagnose Anthrax

Author: HHS/ASPR Biomedical Advanced Research and Development Authority
Published Date: 11/20/2017 1:55:00 PM
Category: Medical Countermeasures; Innovations; Public Health Preparedness;

In the wake of an anthrax attack, medical responders need to quickly determine who has been infected so that they can be effectively treated. A rapid, accurate diagnostic test is an essential tool for doctors and other health professionals to effectively triage people who may be infected with anthrax. Such a tool has been long requested by medical responders as a critical component of anthrax preparedness.

On September 27, 2017, BARDA awarded a $3,199,221 base period of a contract to Tangen BioSciences Inc. of Branford, CT to further advance and expand the ability to combat  Read more…

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