Past Meetings Archive

The DoD Standing Committee has held eight meetings since 2012, at its inception. Below you can find past meeting titles, a short description of each meeting, and a link to the meeting’s agenda.

Biosurveillance: From Data to Actions and Impact
May 7-8, 2015

For many years, the Department of Defense (DoD) biosurveillance programs have contributed to the development and integration of key capabilities to enhance situational awareness of potential Chemical, Biological and Radiological (CBR) threats that could affect the warfighters and military missions. Over the years, as the whole-of-government concept has evolved, the enterprise has adapted to national level planning and coordination of federal biosurveillance efforts. First, in 2012, the National Biosurveillance Strategy (hereafter Strategy) broadened the definition of biosurveillance to include all-hazards threats or disease activity affecting human, animal, or plant health and focused on improving timely decision-making at all levels. The Strategy’s implementation plan specifies the role and responsibilities of key federal stakeholders, including DoD. More recently, the Global Health Security Agenda (GHSA) called for the enhancement of national and international biosurveillance networks and other measures to prevent, detect, and respond to infectious disease threats. DoD is currently developing an Instruction (DoDI) on BSV to define the roles and responsibilities of different DoD entities, with an overarching aim of coordinating the various BSV elements across the Department.

In a cooperative effort to enhance national and global health security toward the Strategy’s goals, the Office of the Assistant Secretary of Defense for Nuclear, Chemical and Biological Health Programs (OASD(NCB)) and the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) developed a Memorandum of Understanding to prioritize and facilitate biosurveillance capacity building and implementation. The DoD conducts comprehensive health surveillance among military members but also supports global disease surveillance by partnering with foreign governments and others to help build biosurveillance capacity and capabilities, particularly thorugh programs such as the Armed Forces Health Surveillance Center (AFHSC)/Global Emerging Infections Surveillance (GEIS) and Defense Threat Reduction Agency (DTRA) Cooperative Biological Engagement Program (CBEP). DoD does not collect or own other countries’ surveillance data, but partner governments may share their data with DoD. The intelligence community, thorugh the National Center for Medical Intelligence (NCMI), is also involved in biosurveillance collection and analysis, though typically such analyses remain in classified channels. Also under DTRA, the Biosurveillance Ecosystem (BSVE) program is intended to enable data integration and visualization from a large variety of data sources into a Web-based cloud network, to enhance the overall DoD biosurveillance capabilities. Information from the BSVE will be further incorporated into the Biosurveillance Portal (BSP), currently developed by the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), to facilitate unclassified data analysis and information sharing. Basically, the Portal is a controlled-access “one-stop shop” for reports that have already been created. Despite these recent advancements toward meeting the global biosurveillance situational awareness needs within the DoD and beyond into the broader whole-of-government context, challenges remain to the ability to fuse multiple biosurveillance data streams to create information (analysis), derive action-oriented messages (interpretation of analysis) and eventually inform decision-making by all relevant users to achieve desired impact.

The meeting will provide a forum for decision-makers and various contributors and users of BSV information to discuss the potential impacts of biosurveillance activities. The goal of the meeting will be to better understand how DoD can achieve the end states that biosurveillance enables as described in the Memorandum of Understanding between the U.S. Department of Defense OASD (NCB) and OASD (HA).

The first end state highlighted at the meeting will be the early warning of health threats that focuses on detecting indications of potential CBR events through accurate, near-real-time, predictive analyses from multi-sectoral information, and reporting through integrated DoD, national, and international biosurveillance systems. The second end state is improved situational awareness that covers the analysis of a variety of information streams that depicts the steady-state baseline and portrays a dynamic picture of emerging events and circumstances that affect DoD stakeholders. Specifically, the discussion will focus on clarifying the data and information required to make informed decisions. The meeting will not include data tool demonstrations or identification of new data types. Rather, the intent is for interagency contributors from the infectious disease community to discuss ways to make diverse ranges of data streams useful, through accessibility, integration, analysis, interpretation, communication, and coordination in a whole-of-DoD and whole-of-government context.

Participants will be asked to articulate the specific decisions needed to achieve global impacts and discuss challenges to the access, timeliness and utility of relevant information to enable better and faster decision-making. Participants will then discuss current examples of global biosurveillance efforts to provide specificity to the discussion. The discussion between data providers and system developers will explore the current capabilities developed by the DoD and other federal entities to identify, analyze and interpret BSV data to provide outputs that meet users’ needs, as well as the level of integration and coordination of the different BSV efforts. Finally, participants will discuss shortcomings and issues of data-sharing across the federal government and from other governments and how national and international organizations can overcome these challenges.

The full meeting agenda can be viewed here.

 

Implementation and Adoption of Next Generation Diagnostic Systems in Far Forward Military Settings
February 5-6, 2015

The Department of Defense (DoD) has been working on advanced technologies to protect its warfighters against intentional and emerging biological threats for several years. The DoD’s Next Generation Diagnostic Program concentrates its efforts on developing deployable diagnostics that can detect chemical, biological, radiological and nuclear agents as early and accurately as possible. Modern diagnostic technologies have helped all type of healthcare facilities to improve patient outcomes while simultaneously bringing economic benefits. The reality, however, is that a discussion about the added value of such technologies in far forward military settings needs to occur with medical personnel who would be asked to use the technologies in the different echelons of care.

The latest molecular biology and engineering advances included in the Next Generation Diagnostic System (NGDS) Increment (Inc) 1 enable further advances in quality, portability and rapidity of diagnostics. These technologies allow the detection of a wide range of pathogens of operational concern in deployed personnel, to enable effective patient treatment decision making at higher echelons of care. Currently, the DoD is developing the NGDS Inc 2 with advanced capabilities meeting the criteria for use as far as the Point-of-Wounding. The goal of this new generation of diagnostic systems is to increase the range of warfare agents while lowering the logistical burden of using diagnostic systems, to offer advantages over empirical assessment and help with earlier decision making in far forward military settings. Selection criteria will include issues such as the extent to which NGDS Inc 2 should be relied upon and what added advantage they offer over the current standard-of-care in lower echelons of care.

This meeting will provide a forum for a discussion about the added value of NGDSs, bringing together doctors with field experience, scientists who can speak to the promises and shortcomings of the technologies, and experts in the implementation of new scientific technologies into medical standards of care. The hope is that physicians will speak to the concerns they have with implementing the broad use to NGDSs in field-based settings. What would they like to know about the specificity and sensitivity of the tests? What type of new training would this involve? Do they have concerns about integrating test results with their observations? Are there concerns about making decisions on the basis of test results? In summary, the goal of the meeting is to discuss benefits and disadvantages of adopting NGDSs within the DoD infrastructure to help the early detection of biological threats.

The full meeting agenda can be viewed here.

 

Preparing for Medical Countermeasure Needs:  Interim Options and Regulatory Evidence Requirements on the Pathway to Licensure
May 28-29, 2014

The DOD is charged with protecting its warfighters against potential biological threats. In 2008-2010, the National Research Council Standing Committee on Biodefense at the Department of Defense held several meetings to discuss how to prepare for a situation in which medical countermeasures are needed for an emergency, before they have been fully licensed.  The conversations at these meetings paved the way for major changes in thinking and planning at the DOD and FDA, as well as the broader HHS.  Important concepts that originated at this meeting evolved and were eventually articulated in the Medical Countermeasures Initiative (MCMI) developed by HHS and the DOD in 2010.

The DOD mission to prepare for medical countermeasures remains challenging for multiple reasons but one challenge, in particular, is the policy requiring full FDA approval before using countermeasures in warfighters. While this remains a goal we must assess the risks and benefits of this policy in the face of biothreats that do not lend themselves to a “standard” road map for FDA approval.  We should examine whether there are other pathways that might provide transparent and safe mechanisms for using countermeasures.

The last few years have seen advances in the thinking and planning, as a result of the MCMI and other interagency efforts such as the Integrated National Portfolio for CBRN Medical Countermeasures.  Regulatory science practices are also evolving to adapt to scientific advances in technologies that are presenting new challenges to traditional thinking about safety and efficacy.  One advance has been the broader recognition of a “pre-Emergency Use Authorization” concept to enable review of a countermeasures safety and efficacy information in advance of an emergency declaration.  The DOD tested the concept of rapid response capabilities using platform technologies by funding the assessment of a novel Phosphorodiamidate morpholino oligomer (PMO) product directed against the H1N1 Influenza virus.  This compound was demonstrated to be efficacious against H1N1 and H3N7 and has now reached pre-EUA status and is under development, targeting BARDA’s strategic national stockpile. Also in 2013, FDA/CBER released biosimilars guidance for vaccines, articulating FDA thinking on countermeasures with common platforms.

The DOD’s ultimate goal is obtaining fully licensed countermeasures against a large number of threats. Given the time and challenges of developing countermeasures against a number of threats, it is possible and likely that warfighters may face a risk of the CBRN threat before full FDA licensure has been obtained. This meeting will discuss strategies that might lead to expediting limited approval processes and enhancing preparation for such situations by identifying capability benchmarks along the pathway to full licensure and, importantly, describing the research necessary to optimize informed decision making about the appropriate use of therapeutics products that have not yet reached full licensure.

Advances are also being made outside the defense arena, with more consideration being given to targeting licensure for restricted or limited populations based on risk benefit analyses. This thinking may provide insights applicable to DOD’s need to prepare only a small set of warfighters at risk, rather than treat the entire US population. DOD is using the term “interim fielding” to capture its need to have useable countermeasures in place for emergency situations, for a limited subset of warfighters.   This meeting is focused on how to prepare for this interim fielding, asking such questions as:

  • Are there regulatory benchmarks defined by FDA, for interim fielding?
  • What evidence is needed for safety evaluation?
  • What evidence is needed for efficacy evaluation?
  • Are there DOD benchmarks for interim fielding, and what is the evidence needed to reach these benchmarks?
  • Given that approval of countermeasures will ultimately require the comparison of risks and benefits of approving vs. not approving, how can risk of exposure to a biological threat be characterized effectively to enable the risk-benefit comparison?
  • Are there other approaches and frameworks that may yield lesson for interim fielding?

The presentations and the roundtable discussions of this meeting are aimed at understanding the need DOD is trying to meet, as well as both the existing regulatory landscape and what may be within the realm of possibility in the regulatory landscape.  The Committee will also ask whether it is more prudent for the DOD to define and strive towards interim benchmarks instead of full licensure, given that increasingly limited resources dictate that tough choices will need to be made.  The hope is that bringing together thought leaders in this area will stimulate new ideas and help DOD consider its options with a fuller understanding of the possibilities.

The full meeting agenda can be viewed here.

 

Antimicrobial Resistance and Countermeasures
February 12-13, 2014

This meeting will explore:

  • Key issues of antimicrobial resistance and the antimicrobial pipeline
  • DoD needs and goals in this area
  • The antimicrobial program and RFI that DoD is developing
  • Technical challenges and opportunities in antimicrobial drug development
  • Supporting technologies and approaches (such as combination therapies, repurposing licensed drugs and diagnostics) for combating antimicrobial resistance
  • Areas where the DoD may leverage or catalyze the efforts of other stakeholders

The full meeting agenda can be viewed here.

 

Staying Ahead of the Curve on Advanced Development and Manufacturing
July 22-23, 2013

The Department of Defense (DOD) is working to develop advanced manufacturing capabilities that will enable the rapid production of biologics (for example, monoclonal antibodies and vaccines) to counter biological threats faced by warfighters. The DOD manufacturing capabilities are to be agile, flexible, and able to quickly manufacture small quantities of biologics, in response to yet unidentified threats. The National Research Council’s standing Committee on the Department of Defense’s Programs to Counter Biological Threats is organizing a meeting for experts in related areas to share their knowledge and discuss potential approaches and their ramifications.

This meeting will begin with a discussion of the new contract that has been awarded2 for advanced manufacturing capability and DOD’s goals for that contract. This will be followed by a discussion of advanced technologies that enable flexible manufacturing of biologics, focusing on microbial and recombinant mammalian cell systems. Participants will contribute their ideas for how to plan for regulatory assessment of products, including designing for quality, ramifications of platform choice, and how to shave time with new analytical approaches. Last but not least, the committee will consider historical lessons. What are some of the challenges faced in previous industry-government efforts, and what can be learned from them?

In addition to members of the Committee on the Department of Defense’s Programs to Counter Biological Threats, invited participants will include scientists at the forefront of biologics manufacturing, scientists with regulatory experience, and those with relevant management and historical expertise.

Objectives:
1. Discussion of DOD objectives, plans and long term vision.
2. Discuss tradeoffs among quality, cost and time and the ability to do campaigns.
3. Discuss new thinking for demonstrating quality, purity, functionality.
4. Discuss trends in facility design, including the use of single-use (“disposable”) systems.
5. Discuss trends in small scale manufacturing.
6. Discuss implications of platform selection and new options for virus like particles.
7. Discuss trends in regulatory thinking, including approaches for assuring quality and functionality.
8. Discuss potential impact of non-technological factors on success.

The full meeting agenda can be viewed here.

 

Integration of Individual Health Information and Molecular Data for Prediction, Prevention and Treatment
February 21-22, 2013

The morning session is focused on the vision– integration and use of individual health information and molecular data for prediction, prevention and treatment.  (See also, the recent NRC study, “Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease.”  http://www.nap.edu/catalog.php?record_id=13284) How is this happening now and developing for the future?   Discussions will include a description of what’s happening in the civilian world (e.g. oncology is leading the way), but we’ll focus on what’s changing and is possible for areas of CBDP interest (e.g infectious disease and diagnostics).

The afternoon session is focused on what the DoD does now and what resources (e.g. DMSS, serum repository) may be available for research and/or decision making.  Some points to consider for this session are:

  • When should individual health information be collected? (before deployment >> throughout service >> after retirement)
  • When is the information integrated, analyzed, or actionable?  (for deployment decisions >> in the field for triage >> surveillance for bioattack/event >> for MCM research and longitudinal studies >>veterans’ healthcare)
  • Is the information or action focused on an individual or a population?  Can the information be used to put people into subgroups (e.g. everyone with gene profile XYZ needs a higher dose) or for individual decisions  (e.g. this person’s cytokine profile changed from his baseline so he needs treatment or observation).
  • Would the information be collected/analyzed/used by CBDP, by Health Affairs, or others?  What opportunities are there for collaborations?

During the meeting, participants may identify barriers or particular concerns DoD has with using individual health information (e.g., concerns with consent, FDA regulations).  Although we want to hear the challenges, these issues will not be the focus on the meeting.  If the potential benefits make this approach worth considering for DOD, then we may have a later meeting to consider the barriers.

The full meeting agenda can be viewed here.

 

Biosurveillance:  Defining and Meeting DoD’s Needs
December 6-7, 2012

The December 6-7 meeting of the National Academy of Sciences/National Research Council Standing Committee on the Department of Defense’s Programs to Counter Biological Threats will focus on Biosurveillance*. The meeting will look at the needs, current status and next steps for biosurveillance (BSV) related to biothreats that have the potential to interrupt military operations. Under this overarching parameter, the types of threats may include: intentional or naturally occurring; human and relevant zoonotic disease; existing or emerging disease. The meeting will provide a survey of the end-to-end process from defining needs to using BSV data for decisions, and next steps that DoD CBDP might consider. (Although diagnostics is a component of BSV, this meeting will emphasize the role of “detection”.)

This meeting will examine the landscape of BSV and relevant DoD processes and programs, looking at:

  1. Articulation of needs to make decisions – Who in DoD needs what kind of information and how they will use it, DoD requirements-driven and capabilities-based processes to define needs;
  2. Current status of BSV-related science/technologies and related DoD and non-DoD programs;
  3. Current status of BSV integration systems and related DoD and non-DoD programs; and
  4. Future directions and bottlenecks: better use of current science/technologies and integration systems, and/or need for new science/technologies and systems.

The committee will learn more about each of these steps to ask: What are the appropriate processes, science and systems for DoD BSV to protect against operational interruption? What is the appropriate balance between requirements-driven and capability-driven articulation of needs? How well does DoD take advantage of current science? How well does DoD take advantage of current systems? Are the science and systems working in sufficiently integrated fashion towards a unified vision, or is more unity in effort needed? Is information being provided to decision makers (strategic and/or operational) in a way that they can use it? Do decision makers need different types of information or coordination to enable use of the information? Does DoD need to help improve current systems and/or address new science or system needs?

The full meeting agenda can be viewed here.

 

General Biodefense Needs
September 12-13, 2012

Meeting Objectives:

  • Understand charge to committee
  • Become familiar with medical countermeasure development, diagnostics, biosurveillance, and manufacturing
  • Identify potential future meeting topics in each area
  • Prioritize top 3 topics for upcoming meetings

The full meeting agenda can be viewed here.