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Innovation in medical countermeasures as a critical enabler for biodefense

Biodefense is one of the most pressing national security issues of our time. The director of National Intelligence has cited proliferation of materials that can contribute to biological weapons programs as a major concern of his agency. Lawmakers regularly pass bipartisan legislation to authorize biodefense programs. A World Bank-funded study found that only 22 percent of American respondents believe the global health community is prepared to respond to another epidemic like Ebola. 

One of the most achievable ways to take biological threats off the table is through an aggressive program to develop medical countermeasures, or MCMs. These are the diagnostics, vaccines, and therapeutics needed to detect, to prevent, and to treat pathogens of concern. Their dual capacities for deterrence of bioterrorist acts and mitigation of infectious disease make them an excellent investment. 

{mosads}Yet MCM breakthroughs remain elusive. Despite significant public and private sector activities since the anthrax attacks of 2001, we are still not sufficiently prepared – not even to combat additional attacks with anthrax. Just in the last year, two significant instances emphasize how underprepared we are: Ebola crossed the border into the United States, and a devastating avian influenza outbreak ravaged the U.S. poultry industry. In neither case was a single rapid diagnostic, vaccine, or treatment available, even though both of these pathogens were previously determined to be major threats. For months, these outbreaks ran their course with only the most basic interventions available to stop them.  

Urgent national security gaps like these require more innovative solutions and higher risk tolerance than the government has demonstrated thus far. With the right approach in place, we can alter the prevailing paradigm. My colleagues and I on the Blue Ribbon Study Panel on Biodefense took it upon ourselves to examine the national state of defense against intentionally introduced, accidentally released, and naturally occurring infectious diseases, and to offer solutions where we are falling short. 

We found that we are squandering opportunities to innovate, while at the same time getting caught up in bureaucratic red tape that prevents MCMs from moving swiftly through the development process. The private sector thrives on innovation. The public sector tends to shy away from it. Yet a national biodefense enterprise capable of meeting 21st Century threats depends on it. Investment risks must be taken. Certainly, the level of that risk and the technological development approach will vary by pathogen. Non-traditional development and surge models may be appropriate for known threats, while unknown threats will likely require more innovation, and the risk tolerance that must accompany it. Industry abounds with entrepreneurial ideas to diagnose pathogens in minutes instead of hours or days, to develop therapeutics in weeks instead of years, to produce vaccines on demand. But they cannot leapfrog these conceptual technologies into reality without requirements and financial support from the federal government. 

Federal agencies – notably, the National Institute for Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA)  – should work closely with industry to develop new strategies that strike the right balance between stockpiling MCMs against known high consequence/low probability threats, and surge manufacturing of MCMs to address emerging, re-emerging, and unknown threats. Policymakers must also do a better job grasping the importance of market incentives – most notably, long-term funding – that encourage companies to develop these countermeasures. 

In our report, which we issued last month, we offer the following key recommendations for Congress and the administration with respect to the MCM enterprise: 

Prioritize innovation over incrementalism in MCM development. Congress has proposed establishing a National Institutes of Health (NIH) Innovation Fund at $2 billion annually. Ten percent of this fund, if appropriated, should be dedicated to innovation tied to BARDA requirements. Agency leaders should also identify at least five promising novel technologies to apply to MCM development for material threats; establish an antigen bank for a plug-and-play strategy on proven platforms; and establish a program to develop MCM rapidly for emerging infectious diseases with pandemic potential.

Fully prioritize, fund, and incentivize the medical countermeasure enterprise. Only through a firm and long-lasting commitment to MCM development can we successfully address the full spectrum of biological threats. This commitment must include funding BARDA and the BioShield Special Reserve Fund to authorized levels. Congress should reestablish the ten-year advance appropriation for BioShield. 

Incentivize development of rapid point-of-care diagnostics. We are needlessly behind in development of these lifesaving and MCM-sparing tools. BARDA must prioritize their development and acquisition, and implement a plan to work with industry and academia to achieve success in this arena.  

Reform BARDA contracting. We must return contracting authority to the Director of BARDA from the Assistant Secretary for Preparedness and Response. We should also eliminate the time-wasting step of Office of Management and Budget sign-off on BARDA contracts.  

Prioritize and align investments in medical countermeasures among all federal stakeholders. We must ensure that all partners of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) are working to achieve the same ends. To do this, we need annual and detailed spend plans from the NIAID, assurance that NIH research is supporting civilian MCM priorities, and allocation of funding sufficient to meet the need. 

It is well within the reach of Congress and the administration to implement these recommendations. We hereby offer them as critical parts of a blueprint for biodefense.

Greenwood is the president and CEO of the Biotechnology Industry Organization (BIO). He served in the House from 1993 to 2005 as a Republican representative from Pennsylvania.

The Blue Ribbon Study Panel on Biodefense is co-chaired by former Sen. Joe Lieberman (I-Conn.) and Gov. Tom Ridge (R-Pa.), who are joined by former Secretary of Health and Human Services Donna Shalala, former Sen. Tom Daschle (D-S.D.), former Representative Greenwood, and former Homeland Security Adviser Ken Wainstein.


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