Driving Our Commitment to Biodefense

United States preparedness against the threat of terrorism is a topic widely discussed. As a nation, we take national security seriously and have a shared commitment to protecting the safety and security of Americans. But does our commitment go far enough?

Bill Gates has most recently brought this question to the forefront, raising concerns regarding our preparedness to combat a bioterrorism attack and urging action — calling on governments “to prepare for these epidemics the same way we prepare for war.” These are strong words from one of the brightest minds of our time.

Traditionally, when considering our national security, we tend to think largely about the protection of our people from traditional attacks — those like the horrible atrocities that transpired on Sept. 11, 2001, or in Nice, France, last year. Preparation against these threats is critical, and it is important that our government focus time and attention on developing measures to mitigate such events.

However, the biosecurity of our nation also requires attention and focus. The protection of our country and people against the threat of intentional chemical, biological, radiological and nuclear (CBRN) attacks, is an essential component of a robust national security approach, although it is an area often taken for granted. In fact, according to a study last year from Morning Consult, only half of Americans are confident in the ability of the U.S. government to protect our nation against a significant biosecurity threat. But, according to that same poll, more than 80 percent believe the government should invest more to combat such a threat.

Despite this public support, biosecurity investment lags, leaving the U.S. vulnerable to the next attack. And, as seen with the recent Ebola outbreak, it is nearly impossible to halt the spread of a threat once an attack is initiated. Now, to be clear, the Ebola outbreak was not initiated as an attack, but imagine the impact of the release of a biological agent such as anthrax or smallpox within the U.S. The impact would be devastating and any response would take days to coordinate and execute, leaving millions at risk of infection.

To date, 13 material threats have been identified by the United States Department of Homeland Security (DHS). These threats include both bioweapons, as well as infectious diseases which threaten the livelihood of our country.  The government has several functions that are focused on mitigating these biosecurity threats, however greater attention and a commitment to long term investment is of paramount importance.  Specifically, investment is needed to spur new Medical Countermeasure (MCM) development as well as to provide assurance that the government is prepared to procure these MCMs once they have sufficiently advanced in development.

Companies, such as Pfenex, are committed to protecting our national security, but drug and vaccine development is costly and time-consuming, and no commercial market currently exists for some of these vaccines and therapeutics. In order to make the long-term commitment to develop MCMs, companies rely on government investment and support via funds that are appropriated by Congress consistently and over an extended time horizon. These funds support key organizations such as the Biomedical Advanced Research and Development Authority, and provide resources to the BioShield Special Reserve Fund and the Strategic National Stockpile, to name a few. They also ensure that all necessary stockpiles at the Centers for Disease Control and Prevention remain replenished and up-to-date in the event of an attack. These funds are critical to the safety and security of all Americans, including the men and women bravely serving in our military, many of whom receive essential vaccinations prior to deployment to dangerous regions. It is essential that these funds are appropriated in a timely manner to maintain biosecurity investment, however many remain underfunded.

The recently passed 21st Century Cures legislation identifies specific incentives to attract investment in the development of MCMs. One of these incentives is the availability of a Priority Review Voucher to those organizations that successfully achieve regulatory approval for an MCM to one of the material threats defined by DHS.  The PRV can be applied to any other product requiring FDA review; it shortens the FDA review timeline for a new application from 10 months to six months. The PRV can also be sold to a third party, thereby providing a significant financial incentive. The availability of PRVs will encourage greater participation by organizations in the biodefense sector.  

This legislation must be implemented, and funds to support BARDA, the SRF, the SNS among others must be allocated via advanced appropriations. Recent legislation has been a positive step, but now congressional action is urgently needed to ensure uninterrupted and long-term funding.

At Pfenex we are committed to leveraging our unique production platform to help fulfill the government’s unmet demand for increased quantity, stability, and dose sparing regimens of anthrax vaccine. However, like others in the space, we rely on the US government as a partner with whom we work together to potentially provide top-quality products to the SNS, helping to ensure the future safety of all Americans and our allies against any man-made or environmental biological threats. We encourage Congress to recognize the importance of these public-private partnerships in protecting all Americans and act with urgency to ensure adequate funding for these essential programs.

Patrick Lucy is the interim CEO, president, and secretary and member of the founding team of Pfenex Inc., a clinical stage biotechnology company in San Diego, Calif.

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