Managing Challenges to Biological Security

Representatives from industry, NGO’s and the government gathered to discuss ways to manage biological threats at the second day of the 2010 Biosecurity convention.  The session focused on the coordination that would be required to respond to biological incidents. 

Randall Larsen – Chair

Executive Director, Commission on the Prevention of WMD Proliferation and Terrorism
WMD Commission

Larsen drew a distinction between strategic warning (knowing that someone is out to get us) and tactical warning (knowing when and how).  Because we cannot count on tactical warning, there is an increasing need for risk assessment.  How can we implement national strategy?

Gerald Epstein

Director, Center for Science, Technology, and Security Policy
AAAS Science & Technology Policy Fellowship

Epstein discussed the importance of communication between communities that are involved in risk management. Biological risk comes from several sources – chronic disease, accidental release, misadventure/emerging infections, and intentional misuse.  However, many intentional incidents would manifest as disease outbreaks.  As a result, a bioterror incident would bring in a variety of communities, including law enforcement, national security, public health authorities, and scientific research into unknown threats.

As a result, Epstein argues that any approach to preventing and responding to outbreaks must be interdisciplinary and must involve all stakeholder communities.  The challenge here is that biorisks are the only overlap between these responder communities, which have different missions, values, priorities, and approaches.  Better communication and cooperation will be necessary to improve the response to potential infectious disease incidents.

Robert Hooks

Deputy Assistant Secretary, Director Health Threats Resilience
Department of Homeland Security

Hooks manages research and development into the Biowatch program, which seeks to bring together responder communities for surveillance and recognition of threats.  Biowatch places detectors in a variety of locations, and also seeks to bring in information from other federal, state, local, and international responders.

The current system can take 10-34 hours to recognize an attack.  New, faster and automated technology will be needed to provide the best possible information and facilitate a more rapid responses to aerosolized attacks.

Patrick Scannon, MD/Ph.D
Executive Vice President & Chief Medical Officer
XOMA, Ltd (manufacturer of monoclonal antibody therapeutic countermeasures)

Scannon cited the recent National Biodefense Science Board report on CBRN attacks, which once again describes responsiveness as a key challenge to incident response.  The report recommendations call for a unified national strategy, centralized leadership, and adequate and sustained funding.

Scannon feels that biodefense responsiveness is a national security matter, due to the potential consequences of an incident.  He noted that attacks can happen at any time, with limited warning and thus limited opportunity to produce and distribute medical countermeasures.  In Scannon’s view, the government needs a unified national biodefense strategy, with centralized strategic and operational leadership.  Without a clear set of priorities and chain of command, it becomes infeasible to respond to threats in a timely and effective fashion.  Finally, all of these activities require adequate and sustained funding.

Barry Kellman
President of the International Security and Biopolicy Institute

Kellman emphasized that biothreats are violence carried out by people seeking to do intentional harm. In response to this threat, he argued for the promotion of global biopreparedness.  Medical countermeasures should be stockpiled and attached to infrastructure to distribute those countermeasures to affected people.  He noted that medical countermeasures would often need to be administered within 48 hours of an attack, and that the current capacity would not allow that response to happen quickly enough.  Further attacks, or the use of contagious diseases, would worsen the threat.

Beyond saving lives, the cooperation required to build capacity for global biopreparedness could deter an attack by demonstrating the ability to deal with it, improve diplomatic relations, and hasten responses to naturally occurring outbreaks.  However, there are significant legal and logistic issues in this area, such as licensing and regulatory requirements.  He called for streamlining of international regulations to encourage companies to enter the biodefense area.  He noted that larger pharmaceutical companies have been reluctant to enter this area because of the uncertainty involved in incident response.


Dr. Larsen asked the panel for their opinion on lab biosecurity, including the pending legislation before Congress to address the select agent pathogens.  Should security efforts focus on the agents that are most likely to be used in an attack?  Hooks and Kellman both argued for this greater focus on the most immediate threats, while Dr. Scannon argued that the focus should be on countering mechanisms by which pathogens cause disease, rather than specific agents, to avoid a situation where attackers know to focus on specific pathogens that have not yet made the list.

Asked about the role of Biowatch, Hooks noted that the program is intended to pick up specific risks to specific areas.  Though it might only work as one part of a response enterprise, he argued that the program is also setting up infrastructure that will help respond to any incident.  Kellman added that programs such as Biowatch should be considered in reference to other defense and security issues, rather than at the expense of civilian public health.

Asked about incentives for the pharmaceutical industry to get involved in biodefense, Scannon agreed that there historically has not been enough involvement.  In his view, biodefense is perceived as a small and uncertain market opportunity.  He also noted that many companies are no longer actively pursuing infectious diseases in general, and therefore lack the capacity to address biodefense issues.

A representative of the CDC noted that the Federal Select Agent program has implemented an anonymous whistleblower line for concerns about potential misuse of biology.

A final question argued that risk analysis underpins biosafety and biodefense.  Epstein noted that risk analysis can vary greatly for natural outbreaks as compared to biological attacks.  Hooks agreed that this is a question of dealing with a low probability, high consequence event.  Ultimately, someone needs to make an assessment of how much risk can be tolerated.  Scannon noted that we cannot provide risk assessment for all possible scenarios, and asked how we prepare for the unknown.  He stated that drug companies are not so experienced in pursuing the unknown, but said that the approach is beginning to shift toward consideration of what information would have been useful in dealing with past incidents.

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