Contracting Office Address

Other Defense Agencies, Defense Advanced Research Projects Agency, Contracts Management Office, 3701 North Fairfax Drive, Arlington, VA, 22203-1714

Description

Predicting Health and Disease (PHD) SOL BAA 06-19, Addendum 4, DUE: June 22, 2006 (white papers)/August 21, 2006 (full proposals) TECHNICAL POC: Dr. Geoffrey Ling, DARPA/DSO, Ph: (571) 218-4674, Email: baa06-19@darpa.mil; URL: www.darpa.mil/dso. Website Submission: http://www.sainc.com/dso0619/


DESCRIPTION

The Defense Sciences Office is seeking proposals for the new Predicting Health and Disease (PHD) program. In the civilian community, if a person becomes ill they are able to call in sick. This does not hold true for military operations, in which missions depend on the ability each member of a team to perform at peak performance. The PHD program will develop methods to assess whether an individual will develop an infectious disease, prior to the onset of disease symptoms. Such a capability will allow for early preventative treatment and/or infection control, and allow potential adjustments to critical mission profiles thus significantly increasing the probability of a successful operation.

Current methods are reasonably capable of diagnosing a specific infectious disease after the onset of a patients symptoms. The PHD program seeks to alter this paradigm by identifying changes in the baseline state of human health that indicate the onset of disease prior to typically manifested signs and symptoms. Achieving this will require a multi-disciplinary approach to diagnostics that includes, at the minimum, innovative data analytic methodologies coupled with traditional and non-traditional medical diagnostic parameters. DARPAs end goal is to create the technological breakthroughs required for the development of a field portable, point of care health assessment system. Such a system must be able to handle large throughput (one hundred or more analyses), in short time spans (under a three hour turn around), at low costs.


BACKGROUND

We are soliciting approaches that address the following challenge problem:

The basal state of a human is the state of health. After encountering a pathogen at time t = 0, the host-response to the pathogen causes a set of symptoms to emerge. The appearance of these symptoms occurs at time t*. Using existing or novel techniques, detect the transition from the state healthy to the state ill prior to the onset of symptoms at ft* where f << 1. As f approaches 1, models should become more predictive, with Pd (probability of detection) approaching 1, and Pfa (probability of false alarm or false positive) approaching 0. We seek general methods that are applicable to multiple infectious agents.

PHD is envisioned as a two-phase program with an optional third-phase. The first phase will consist of development of a diagnostic method and supporting analysis. Successful efforts will find solutions to the challenge problem that meet an accuracy level of Pd = .7 and Pfa = .05 at f = .1 and Pd = .95 and Pfa = .01 at f = .8. Authors of the proposals should be aware that meeting the Phase 1 goal is one determining factor in the decision to proceed to Phase 2. Prior to Phase 2, there may be a down selection of performers. The second phase will consist of refinement of the model to an accuracy level of Pd = .9 and Pfa = .01 at f = .1 and Pd = .99 and Pfa = .001 at f = .8. Programs that are successful in the second phase may enter an optional third phase. This optional phase will support the final research and development of any new devices or technologies used in the model for submission for FDA approval.

Proposals should detail aggressive timelines to meeting these milestones. Timelines must include a clear path to reaching the goals of Phase 1 and Phase 2. Successful proposals will establish expeditious means for addressing the viability of their methodology. Phases will be limited to twelve months. However, proposals with phases longer than twelve months will be accepted but only with appropriate justification
Research efforts should address the following areas in developing the model. We are only interested in research in these areas as a pathway to attaining the milestones and are not interested in exploration of these areas in isolation.


1. Pathogens of interest: We are mainly interested in viral, upper respiratory pathogens that have the potential for decreasing warfighter mission readiness, and occasionally result in aborted missions and significant warfighter morbidity. Pathogens of interest include influenza, parainfluenza, adenovirus, respiratory syncytial virus, and other similar viruses.

2. A data collection effort that assesses biometric ddata at multiple points pre- and post-exposure. We are interested in a wide range of sources for this data, including traditional, non-traditional, and entirely novel parameters.

3. Mathematical methods and analysis tools to determine the signatures that predict the transition from the basal state to the final state

4. Robust descriptions of virus/host interactions through multiple phases of disease that improve our understanding of this dynamic host: pathogen system.

5. Generation of a baseline model of health that must acknowledge the demographic composition of the American warfighter.

6. Intra-individual and inter-individual variability: reduction of false positives by such mechanisms as greater understanding of cell-mediated host immunity and stress responses.

In addition, proposed models should be applicable to multiple disease agents. An approach that will only work for a single disease is not of as much interest as a universal approach. DARPA is not interested in proposals which focus solely on pathogen based diagnostics, for example, viral PCR

PROGRAM GOALS AND MILESTONES

We anticipate a two stage source selection. It is STRONGLY ENCOURAGED that a white paper be submitted according to the guidelines provided below.


White Paper and Full Proposal Deadlines

White papers will be accepted until June 22, 2006 NO LATER THAN 4:00 PM ET. All white papers will be reviewed no later than July 21, 2006 and recommendations for full proposals will be provided at that time. Full proposals will be due August 21, 2006 NO LATER THAN 4:00 PM ET. White papers and proposals submitted by fax will not be accepted. All full proposal submissions will be evaluated regardless of the disposition of the white paper. Note that a full proposal may be submitted at anytime before the close of the solicitation without having submitted a white paper.

White Paper Submission Guidelines

White papers of eight pages or less will be reviewed for the purpose of recommending the submission of full proposals. The white paper must include the following sections:

1. An executive summary. A clear statement of the uniqueness of the idea. We are looking for ideas that will revolutionize the field of diagnostics if the proposed work is successfully completed.
2. A concise statement of the approach to the problem, the scientific and technical challenges inherent in this approach, and possible solutions for overcoming potential problems. This statement will also serve to demonstrate an understanding of the state-of-the-art in the field.
3. A first-order analysis of the changes in diagnostic models necessary to achieve this approach both in terms of analysis and collection of data and the source of measurement of biologic change.
4. Timelines and milestone achievements by which progress can be measured. These timelines and milestones should be as detailed as possible. Milestones must be associated with demonstrable metrics.
5. A notional means of deploying this methodology in an active and deployed warfighter force.
6. A detailed cost estimate for resources over the proposed timeline. This cost estimate should include both labor and materials costs.
7. A summary of expertise of the key personnel on the project relevant to the challenge problem. If the team is multi-organizational, a proposed management structure should also be included.
8. Brief list of relevant references

Full Proposal Guidelines

Guidelines for full proposal submission can be found in BAA06-19 (http://www.darpa.mil/baa/baa06-19pt2.html). The technical sections of the full proposal must include:

1. An executive summary. A clear statement of the uniqueness of the idea. We are looking for ideas that will revolutionize the field of diagnostics if the proposed work is successfully completed.
2. A detailed description of the approach to the problem, the scientific and technical challenges inherent in this approach, and possible solutions for overcoming potential problems. This description will also serve to demonstrate an understanding of the state-of-the-art in the field.
3. A comprehensive analysis of the changes in diagnostic approach both in terms of analysis and collection of data and the source of measurement for biological change.
4. Timelines and milestone achievements by which progress can be measured. These timelines and milestones should be as detailed as possible. Milestones must be associated with demonstrable metrics.
5. A description of implementation of the proposed approach in the warfighter community that addresses the challenges of an active deployed force.
6. A detailed cost estimate for resources over the proposed timeline. This cost estimate should include both labor and materials costs.
7. A detailed overview of expertise of the key personnel on the project relevant to the challenge problem. If the team is multi-organizational, a proposed management structure should also be included.
8. Brief list of relevant references

In addition, all proposals should be supplemented by a one page Quad chart describing the program objectives, relevance to the military population, performers, technical milestones, and Fiscal Year total budget. This quad chart will not count against total page count.

EVALUATION OF PROPOSALS

Evaluation of the proposals will be in accordance with BAA06-19. For general administrative questions, please refer to the original FEDBIZOPPS solicitation, BAA06-19, of February 8, 2006. http://www.darpa.mil/dso/solicitations/solicit.htm.

Address for Proposal Submission:
DARPA/DSO, ATTN: BAA06-19, Addendum 4
3701 North Fairfax Drive
Arlington, VA 22203-1714

Web address for Proposal and White Paper Submission: http://www.sainc.com/dso0619/

General Information

In all correspondence, reference BAA06-19, Addendum 4.

Technical Point of Contact

Geoffrey S.F. Ling, DARPA/DSO; Phone: (571)218-4674; Email: geoffrey.ling@darpa.mil

Point of Contact

Brett Giroir, Deputy Director, DSO, Phone (571) 218-4224, Fax (571) 218-4553, Email brett.giroir@darpa.mil

Point of Contact

Brett Giroir, Deputy Director, DSO, Phone (571) 218-4224, Fax (571) 218-4553, Email bgiroir@darpa.mil