Bioscience and Biosecurity – Priorities of the Obama Administration

The BIO Biosecurity conference is underway, with an opening session featuring a number of senior Obama Administration officials.  This event marks perhaps the highest profile Industry-sponsored look at biosecurity issues, and the Administration appears to be committed to making sure that the discussion gets off to a productive start.

BIO President James Greenwood introduced the meeting.  He highlighted the role of biotechnology in developing countermeasures, specifically mentioning last year’s H1N1 outbreak as an example of the need for rapid response to emerging outbreaks.  From the industry perspective, he called on the Administration to include countermeasures to biological agents in the national security response strategy.  Specifically, he stated that the government needs a longterm plan for ensuring that there will be a market for countermeasures, in order to ensure that investment in this area will pay off for companies.

Laura Holgate

Senior Director for Weapons of Mass Destruction Terrorism and Threat Reduction, Office of WMD Coordinator

National Security Council

Laura Holgate discussed the National Security Council’s recently unveiled response plan for biothreats.  The unifying feature of this plan was the extent to which it requires cooperation from multiple different groups.  For example, recognizing outbreaks and responding to them locally requires coordination with relevant organizations around the country and around the world.  Encouraging the responsible conduct of research requires help from corporations and professional societies.

The key goals of these plans are to ultimately deal with ever evolving risks and improve our capacity to response to diseases, regardless of their origin.

Other DHS initiatives include an interagency review on select agent and toxin policies, the recently released draft guidelines on synthetic biology, an increased focus on microbial forensics, and potentially the development of a website to communicate government activities in biosecurity to the public.

Nicole Lurie

Assistant Secretary for Preparedness and Response (ASPR)

Department of Health and Human Services

ASPR has also recently released a national health security strategy, which seeks to guide the nation to build and sustain response capabilities to varied challenges, from H1N1 to natural disasters.  The strategy is viewed as a national plan, rather than a Federal one, again in recognition of the need for cooperation with other stakeholders.  From Lurie’s perspective, building community resilience is key to helping prepare, for and recover from, emergencies.  This will raise awareness of risks, and, equally importantly, the expected response roles that members of each sector would be carrying out in the event of an incident.

One lesson that ASPR took from the H1N1 outbreak is that countermeasures cannot be effective if the populace is skeptical of their safety or efficacy.  The public also expects equal and uniform protection, with some states vaccinating far more effectively than others.  HHS was frustrated by the time it took to develop an H1N1 vaccine and hopes to improve on this time in the future.

Margaret Hamburg, MD

Commissioner, Food and Drug Administration

FDA/Office of Policy/Office of the Commissioner

The FDA’s biosecurity goal is to prevent contamination of important commodities, such as the food supply, while supporting a nimble public health response using safe and effective medical countermeasure and diagnostics.  When the H1N1 outbreak happened, FDA was responsible for reviewing vaccine candidates.  Emergency use procedures allowed rapid approval of treatments and diagnostics.  This review role affects development and distribution of countermeasures, but also requires more resources (money and personnel).  FDA too requires surge capacity to assess emergency responses.  In particular, the agency requires modernized regulatory science capacity to help provide proactive guidance.

The other area of concern for FDA is food security.  This originally focused on food-borne outbreaks, but now increasingly must address the potential of intentional attacks, sometimes with economic motivations and sometimes aimed at contaminating the food supply to attack people.  The worldwide supply chain presents a large target with many potential vulnerabilities, that must be addressed with new, more proactive action by FDA.  New legislation pending before the US Senate would increase the FDA role in such incidents.

Tara O’Toole

Undersecretary of Homeland Security for Science and Technology

Department of Homeland Security

The Homeland Security Science and Technology goal is focused on near term applied solutions to existing problems.  They have built facilities at Fort Detrick and Manhattan Kansas to study present threats.  The Department is also working on a biothreat risk assessment project, which uses input from a variety of agencies and extensive peer review to determine what interventions would be most effective.  However, one limitation to this effort is that the results are classified, which means that they may not be distributed widely enough.

The other DHS focus is sensing to detect threats, e.g. via BioWatch.  The current technology requires up to 36 hours to recognize an attack, and much faster detection will be required for response to an intentional aerosol attacks.  The goal is to bring national resources to bear on potentially calamitous threats.  O’Toole closed the session on a cautionary note, asking whether we are truly in a place right now where we can recognize and respond to threats before they are realized, with many lives in the balance.

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