By Michael Krug and Alexandria Tepper
On November 14th, 2018, the Blue Ribbon Study Panel on Biodefense presented a discussion session entitled “Biodefense Indicators: Progress in Implementing the National Blueprint for Biodefense”. The five-hour event was composed of a series of expert panels spanning multiple fields, agencies, and backgrounds. The panels were moderated by five co-chairs from the Blue-Ribbon Study Panel, including: Senator Joseph Lieberman, Governor Thomas Ridge, Senator Tom Daschle, Representative Jim Greenwood, and Kenneth Wainstein. The discussion centered around the steps being taken to bring the strategies mentioned in the White House’s 2018 National Biodefense Strategy to a reality.
The panel’s initial remarks involved assessing the progress of the federal government to the threat of a biological element, whether it be naturally-occurring, man-made, or accidental, since the release of the panel’s Blue Ribbon Blueprintin 2015. Senator Lieberman was determined to reinforce the idea that the Blue Ribbon Blueprint should “provide a roadmap to improving how we prepare for, defend against, and respond to biological threats of all natures.” The tone reflected by the chairs acknowledged that the progress made by the federal government has been promising but incomplete. The recent release of the 2018 National Biodefense Strategywas a major step forward in attempting to recognize and fix the shortcomings surrounding the biological threat facing the United States. Gov. Tom Ridge explained the difficulties facing the Blue Ribbon’s cause, saying “The threat is real. It’s not sexy. Nobody’s talking about it. Whether it’s natural or generated by design, it’s a real problem. I’m interested in discussing today how we go forward as a country.” This statement reverberated the purpose of the panel and the uphill challenges facing the implementation of the National Biodefense Strategy process.
Tim Morrison, JD
Special Assistant to the President and Senior Director, Weapons of Mass Destruction and Biodefense, National Security Council
Tim Morrison, considered one of the top White House biodefense officials, started his remarks by acknowledging that many portions of the National Biodefense Strategy were “very much informed” by the Blue Ribbon Blueprint. Mr. Morrison also quickly addressed the reasons behind the delay in the White House’s National Strategy, originally intended for 2017, stating that the administration wanted to understand the coordination of biodefense agencies. “We have 15 departments and agencies, we have the agencies of the intelligence community; all of which play a role in biodefense. Why don’t we harness everything that they do?” Mr. Morrison admitted that a wholistic agency approach from the federal government was necessary to combat the emerging threats facing our highly globalized world. Furthermore, he specified that building on past administration strategies and learning from the 2014 Ebola outbreak were key in framing the current Strategy. Lastly, Mr. Morrison finished by stating the deadlines and metrics that will help monitor the progress of the Biodefense Strategy, the first of which will define and approve all of the roles in the Strategy by the deputies and appropriate departments by the end of January 2019. Most of the co-chairs quickly jumped on this point in the Q&A section of the panel, asking how the Strategy would hold accountability and present authority while being led by a peer agency (the Office of Health and Human Services). Many of the members challenged the appointment of a peer agency to lead this Strategy by referring to the Blueprint’s recommendation that the Vice President oversee U.S. biodefense programs. Mr. Morrison countered these points by stating that the President will review and assess the progress at each of the predetermined deadlines moving forward, presumably holding agencies responsible if the Strategy is underperforming.
Panel One – Biosurveillance and Biodetection
Anne Schuchat, MD (RADM, USPHS – Retired). Principle Deputy Director, Centers for Disease Control and Prevention.
Dr. Schuchat presented three actionable recommendations: 1) accelerate public health’s adoption of new systems for more real-time, accessible data in support of timely biosurveillance, 2) encourage government hiring of a workforce of 21stcentury analysts – data scientists, and 3) keep the Laboratory Response Network at CDC, where they have resident science staff, and strong relationships with state and local entities. Dr. Schuchat also reviewed the progress in several CDC biosurveillance programs that have increased the breadth, speed, and utility of their systems. The Syndromic Surveillance system, which has coverage from 65% of the emergency rooms in the country (2.6 million visits a day). PulseNet, a system for tracking foodborne disease that interfaces with FDA’s genome tracker – leading to finding outbreaks earlier. And an influenza system that detects unusual viruses that could be the beginning of a new pandemic, and assess vaccine effectiveness.
James F. McDonnell, Assistant Secretary, Countering Weapons of Mass Destruction Office, Department of Homeland Security.
Secretary McDonnell discussed leveraging the DHS Customs and Border Protection (CBP) National Targeting Center’s surveillance systems, and integrating biosurveillance analysts there, and across several federal agencies. He also discussed the plans to replace BioWatch in the next couple years. He recently stood up a rapid capabilities office that is fielding a “Bio Detection 21” program that addresses some of the recommendations in the National Blueprint for Biodefense. It is designed to support real-time detection of anomalies that trigger a first-responder dispatch to the site for further sample collection resulting in presumptive analysis within 30 minutes. A positive response would lead to incident management operations and dispensing of medical countermeasures if required. Challenges that remain are developing CONOPs at the state and local levels, but the greatest impedance is not having budget authority for the program to allow his office the flexibility to move funds as needed.
Kathryn Godfrey, Assistant Director, U.S. Government Accountability Office
Ms. Godfrey noted that the GAO’s past work (since 2009) resonates with the Blue Ribbon Panel’s findings, so the GAO has followed the Panel with interest. Two of the recommendations in the Panel’s National Blueprint for Biodefense were centralized leadership, and implementing an integrated biosurveillance capability. GAO’s recommendations mirror this by calling for better leadership, and a strategy across the biodefense enterprise to address duplicate and fragmented efforts. Ms. Godfrey expressed GAO’s concern specifically with the BioWatch program. GAO found that DHS forged ahead with the BioWatch program without clear requirements or testing. GAO questioned the considerable uncertainty of the likelihood and magnitude of a biological attack with one of the limited number of aerosolized pathogens BioWatch is designed to detect.
Panel Two- Medical Countermeasures and Diagnostics
George Poste, DVM, PhD, DSci
Chief Scientist, Complex Adaptive Systems Initiative; Regents’ Professor, Del E. Webb Chair in Health Innovation; Ex Officio, Blue Ribbon Study Panel on Biodefense
Geoffrey Ling, MD, PhD
Chief Executive Officer, Sun-Q LLC; Founding Director, Biological Technologies Office, Defense Advanced Research Projects Agency (DARPA)
Both Dr. Poste and Dr. Ling provided insight into the important step of building capability through innovation. The current outlook by both panel members was pessimistic, as both agreed that there was lack of incentive and drive to create an innovative market for diagnostics, let alone biodefense diagnostics. Dr. Poste proposed that the future of diagnostics should revolve around sequencing and “genetic fingerprints” of an organism. Furthermore, the next-generation of diagnostic tests should “in addition to detecting the organism, also be able to detect features indicative of drug or vaccine resistance, potential changes in virulence markers, and whether or not there has been deliberate engineering with nefarious intent.” Yet, these complex solutions are a pipe-dream of where the U.S. currently stands in preparation for such innovative diagnostic technologies. Nonetheless, Dr. Ling vehemently believed that supporting agencies, like DARPA and BARDA could spark a shift in culture. Dr. Ling exemplified that “agencies like DARPA are unafraid to be innovative” and are “looking for reasons to say yes”, however the small budget of DARPA limits their reach. More specific to diagnostics, Dr. Ling proposed the development of a “DARPA-like agency in the HHS” to reinvigorate the innovative diagnostic market in the private sector. Also stating that a strong relationship with the private sector could lead to sustainable technological innovations.
Panel Three – Intelligence and Information Sharing
Kathleen Reilly (Chief, U.S. Navy – Retired) Senior Professional Staff, Select Committee on Intelligence, U.S. Senate.
Ms. Reilly provided strong backing of the Blueprint’s Recommendation 6– Improve management of the biological intelligence enterprise by creating a National Intelligence Manager (NIM) for Biological Threats. Ms. Reilly stressed that implementing this recommendation will focus biodefense in the Intelligence Community. Currently, within the Office of the Director of National Intelligence, biodefense is a sub-project in the WMD group, but needs to be brought out into the light. Recognizing the nation’s biothreat vulnerabilities, susceptibilities, and assessing adversary’s intent is vital to our national security. It is paramount to identify someone and “pin the rose on their lapel.” This person would be in an executive-level position to assess the government’s Duty to Warn, along with local law enforcement’s Duty to Warn, and share information with first responders.
Duncan McGill, PhD (Lieutenant Colonel, U.S. Army – Retired) Dean, Ridge College of Intelligence Studies and Applied Science, Mercyhurst University.
Dean McGill supports the idea of a NIM for biological threats. He sees bioweapons as a complex, multivariable problem. To have a proactive intelligence program would require understanding a system of systems: research, science, engineering, management, production, storage, logistics, weapons design, educational, and doctrine of use, policy, financial activities, medical preparation and response. The key to understanding biothreats is integration of these disciplines into a task organized team that can understand how to map the threats, identify intelligence gaps, and prioritize collection. We need an integrated systems approach for studying biothreats. We also need to increase intellectual diversity of our analysts to spur increased creativity. The NIM would have the ability to create such an interdisciplinary team.
Lawrence Kerr, PhD. Director, Pandemics and Emerging Threats Office, Office of Global Affairs, Department of Health and Human Services.
Dr. Kerr spoke very directly about how budgetary changes can destroy a solid, successful counter biological threats intelligence collection and analysis program. His former program produced a review of the Intelligence Community’s policies and programs to counter biothreats. From this, they produced a national biosurveillance strategy that set the vision, goals, objectives and milestones for the collection, analytic and science & technology disciplines across the IC agencies. However, within a few years, that budget was moved, and the office was dissolved. Any new effort will be starting from scratch, but they have a blueprint for success for any future program. Dr. Kerr closed stating that any new program must be sustained with leadership empowered with authorities and resources.
Final Remarks on the Event
This Blue Ribbon event represented a checkpoint in the long road to implementing a well-funded, well-represented U.S. biodefense infrastructure. Although it is hard to evaluate the current National Biodefense Strategy only a few months after its release, this study panel defined two critical criteria to ensure a successful strategy: 1) accountability and 2) engagement of the private sector. The accountability of the Strategy will depend heavily on inter-agency cooperation and while the release of the Biodefense Strategy is a strong starting point; the implementation will depend on the push from leadership, including the White House. The engagement of the private sector was a topic of heavy discussion throughout the panel and should continue. It’s up to agencies, like DARPA, NIH, and NSF, to stimulate innovation and capability. This relationship between the public and private sectors is key for the successful implementation of programs, tools, and medical countermeasures to better prepare against a biological threat. Furthermore, the sustainability of these relationships can help avoid a cycle of technology depreciation, similar to what happened with the BioWatch program.
Within the biodefense community, biosurveillance and biodetection systems are haphazard. On one hand, CDC has made “exciting progress” as Senator Lieberman remarked at the conclusion of Dr. Schuchat’s testimony. On the other hand, there is still concern from the GAO and the Blue Ribbon Panel that advanced environmental detection of pathogens will not come to fruition. The idea of a National Biosurveillance Integration Center to produce analysis and warning from multiple sources of technical collection (ie. BioWatch), open source, and public health systems has not been demonstrated. The sources of information remain disparate and stove-piped. The concept of what an “analyst” is must also change dramatically. We’re no longer talking about curating information and intelligence from a narrative (published papers, interviews, open source). The information and ‘intelligence’ in the biosurveillance world is raw data – from virus genomes, syndromic and environmental surveillance, epidemiological data, and animal, and plant pathogen detection. The biodefense community must impress upon the government to recruit and retain data scientists with accelerated hiring practices and comparable benefits to the private sector.
Perhaps the most actionable and forward-leaning next step the Blue Ribbon Panel is taking is to reach out to the Director of the Office of National Intelligence and propose standing up a National Intelligence Manager for Biodefense. Placing the right person in this position, someone with a known history of building relationships in the biodefense community, and getting buy-in for implementing innovative processes and ideas (saying ‘yes’), would jump-start the integration the biodefense community needs.
“We want the American people to never have to think of biodefense”