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U.S. Department of Health and Human Services

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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 necessary for disaster response but with limited or no commercial market. The Act provides HHS with a multi-year special reserve fund to support late-stage development and manufacturing, and the financial resources to buy these life-saving medical products for the American people to use in public health emergencies. In this way, Project BioShield is a critical part of the U.S. strategy for biodefense and our commitment to the American people.

Last month, Congress took action to further strengthen Project BioShield as part of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). PAHPAIA increases the budget authorization and provides ten-year funding for product development. We know next-generation medical countermeasures aren’t developed overnight – in fact, getting a product across the finish line takes many years. Multi-year funding helps BARDA continue building the strong public-private partnerships needed to spur innovation and provide the private sector with the stability needed to produce potentially lifesaving medical countermeasures.

For example, smallpox is one of the most consequential infectious diseases in human history, responsible for nearly 300 million deaths in the 20th century alone. It is also a high-priority threat requiring federal agencies to develop strategies and countermeasures against this threat. Thanks to our partners at NIAID and DoD and the support of Project BioShield, last year our industry partner was issued an FDA approval for a treatment for smallpox via the animal rule. At present, there are now over 2 million treatment courses in ASPR’s Strategic National Stockpile to protect Americans in the event of a smallpox national security emergency.

However, we have found over the past 15 years the most practical and cost-effective approach is, whenever possible, to look at products that not only can be used for emergencies, but also have uses in daily medical care, such as burn care, the radiation effects cancer patients encounter, or seizures.

In some cases, we’ve worked with companies to expand indications for existing products. For example, three medical countermeasures are now FDA-approved to treat patients suffering bone marrow and blood cell damage from acute radiation syndrome. All three of these products were already licensed drugs used to treat patients undergoing radiation therapy for cancer. Project BioShield funding was used to conduct the critical studies needed to expand the indications for these products so they could also be used to treat the damage caused by acute radiation syndrome in a radiation emergency. Using such drugs is helpful in emergencies because healthcare facilities already stock the drugs, and clinicians are already familiar with using them.

We are using Project BioShield to support other new products with commercial market potential. For example, we supported a large study of a seizure treatment because seizures are one of the potentially deadly effects of nerve agents. The product is used commonly in preparing patients for surgery and for epileptic seizures; thanks to Project BioShield, the product is now approved as an antiseizure medication for status epilepticus and has been added to the Strategic National Stockpile for use in a chemical emergency response.

For 15 years, BARDA has been proud to partner with industry to develop cutting-edge medical countermeasures. Our country is better prepared to respond to health security threats because of Project BioShield. We look forward continued collaboration as we work to develop and produce medical countermeasures that can be used to save lives in the event of an emergency.


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