1
Introduction

This chapter provides the context of the Institute of Medicine's (IOM's) role in support of the National Prion Research Project (NPRP). The 107th U.S. Congress established NPRP (Senate Committee on Appropriations, 2001), directing the U.S. Army Medical Research and Materiel Command (USAMRMC) to administer the program and allocating $50 million to fund it. Congress ultimately reduced the allocation to $42.5 million. USAMRMC manages NPRP through the preexisting Congressionally Directed Medical Research Program.

DOD asked IOM to provide independent advice on the state of prion science and the field's most pressing research needs (Box 1-1). In June 2002, IOM formed an 11-member committee supplemented by six consultants who are internationally recognized experts in prion research. The committee members were selected for their expertise in infectious disease, prion molecular biology, microbiology, neurology, epidemiology, blood banking, veterinary medicine, and food safety. The consultants provided essential technical insight. The committee evaluated information from the sponsor, peer-reviewed journal articles provided by committee staff, and presentations by invited guests with expertise relevant to TSE diagnostics (Appendix).

The contract for this study, which lasts from May 1, 2002, until September 30, 2003, requests an interim report from IOM on or before January 15, 2003, to help guide the panel evaluating the programmatic merit of prion research proposals submitted to NPRP. This is that report.



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1 Introduction This chapter provides the context of the Institute of Medicine's (IOM's) role in support of the National Prion Research Project (NPRP). The 107th U.S. Congress established NPRP (Senate Committee on Appropriations, 2001), directing the U.S. Army Medical Research and Materiel Command (USAMRMC) to administer the program and allocating $50 million to fund it. Congress ultimately reduced the allocation to $42.5 million. USAMRMC manages NPRP through the preexisting Congressionally Directed Medical Research Program. DOD asked IOM to provide independent advice on the state of prion science and the field's most pressing research needs (Box 1-1). In June 2002, IOM formed an 11-member committee supplemented by six consultants who are internationally recognized experts in prion research. The committee members were selected for their expertise in infectious disease, prion molecular biology, microbiology, neurology, epidemiology, blood banking, veterinary medicine, and food safety. The consultants provided essential technical insight. The committee evaluated information from the sponsor, peer-reviewed journal articles provided by committee staff, and presentations by invited guests with expertise relevant to TSE diagnostics (Appendix). The contract for this study, which lasts from May 1, 2002, until September 30, 2003, requests an interim report from IOM on or before January 15, 2003, to help guide the panel evaluating the programmatic merit of prion research proposals submitted to NPRP. This is that report.

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NPRP issued a call for research proposals in August 2002 (DOD, 2002). To evaluate the proposals submitted, it is using the two-tiered approach that IOM recommended in 1993 (IOM, 1993). Proposals first undergo peer review for scientific merit. Those that pass that review then undergo another level of review evaluating how well the proposed research would support NPRP's objectives. Subject-matter experts, clinicians, and consumers chosen by DOD will conduct the programmatic review (DOD, 2002). This report is designed to guide them. BOX 1-1 Statement of Task Committee on Transmissible Spongiform Encephalopathies: Assessment of Relevant Science The Committee will assess the state of science regarding transmissible spongiform encephalopathies (TSE) and advise the Medical Research and Materiel Command (MRMC) and its Congressionally Directed Medical Research Program (CDMRP) Office. Specifically, the Committee will: Recommend research that will best lead to sensitive, reproducible and inexpensive methods for detecting prions and in diagnosing prion diseases/TSE. This will be based on an assessment of critical technologies (current and novel) needed to detect prions. Assess the status of currently available assays and their detection limits based on strains and biological system employed. Assess the availability of standardized and reference reagents as well as physical facilities required to validate assays. Recommend key opportunities for collaboration with foreign investigators that would facilitate the development of effective prion detection methods. Assess the availability of trained investigators and specialized facilities dedicated to prion research and identify any critical gaps. Assess the role that prion diseases pose for the military force including but not limited to the military's food and blood supply. Recommend relevant surveillance efforts and public health policies at home and abroad regarding TSEs in humans, livestock, and wildlife that impact on military health or that urgently require further research. Provide recommendations for future TSE research.

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The IOM committee's recommendations suggesting areas of prion research deemed most critical could be useful to the integration panel at this point in the research review process. The final committee report, which will be delivered in the fall of 2003, could also have great utility because it could help shape future DOD program objectives and research announcements if funding is continued. This interim report concentrates on TSE diagnostics, the focus of both the law establishing NPRP and the program announcement. The law states: "The priority goal of the Project's first phase is to rapidly develop a diagnostic test to detect the presence of prion disease." The investment strategy and guidance published in the NPRP program announcement reflect this imperative (DOD, 2002). Nearly 50 percent of the funds allocated in fiscal year 2002-$20 million-will support investigator-initiated research designed to do the following: develop a rapid, sensitive, and reproducible test for the detection of prions suitable for use as an antemortem diagnostic test; develop a rapid, sensitive, and reproducible test for the detection of prions suitable for use as a screening assay; and study the prevention, transmission, inactivation, or pathogenesis of transmissible spongiform encephalopathies (TSEs), including chronic wasting disease (Table 1-1). This report recommends research priorities in these three areas. The committee's final report will have a broader focus and will address each of the committee's subtasks in greater depth and detail.

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TABLE 1-1 NPRP Award Mechanisms Award Mechanism Experience of Principal Investigator Key Mechanism Elements Dollars Available Idea Awards All levels of experience • Reward innovative ideas and technology • No preliminary data required $375K for direct costs over a 3-year performance period, plus indirect costs as appropriate Investigator-Initiated Research Awards Independent investigators at any level. • Sponsor basic and clinically oriented TSE research Maximum of $2.5M, inclusive of direct and indirect costs, for a performance period of up to 5 years (with optional Nested Postdoctoral Traineeship[s]) Nested Postdoctoral Trainees: Recent doctoral graduates with 3 years or less of postdoctoral experience • Preliminary data required • Encourage development of partnerships between academic and industry researchers or between an established TSE researcher and a researcher from another discipline to leverage diverse expertise and resources toward development of antemortem diagnostics Nested Postdoctoral Traineeships: Maximum of $60K per year inclusive of direct and indirect costs for a maximum of $180K per trainee over 3 years

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Career Transition Awards Postdoctoral fellows Encourage scientists or clinicians currently in postdoctoral and/or fellowship training positions to pursue a TSE-related research career Postdoctoral fellow (years 1-2): Average of $60K/year, inclusive of direct and indirect costs, for a maximum of $ 120K Junior faculty (years 3-5): Average of $100K/year in direct costs, for a maximum of $300K, plus indirect costs as appropriate Prion Techniques Fellowship Awards • Postdoctoral trainees, medical residents, or clinical fellows; or • Researchers with independent program of prion research; or • Researchers with established independent program of research with limited or no experience in prion field Offer investigators the opportunity to work in the laboratory of established TSE researchers in order to acquire critical skills or learn new methods relevant to TSE research Up to $125K for up to 1 year, inclusive of direct and indirect costs NOTE: K=thousand, M=million SOURCE: Adapted from Department of Defense Fiscal Year 2002 National Prion Research Program, Program Announcement, Part 1. http//cdmrp.army.mil/funding/archive/02nprp.pdf.

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REFERENCES DOD (U.S. Department of Defense). 2002. Department of Defense Fiscal Year 2002 National Prion Research Program-Program Announcement, Part 1. Fort Detrick, MD: Headquarters, U.S. Army Medical Research and Materiel Command. IOM (Institute of Medicine). 1993. Strategies for Managing the Breast Cancer Research Program: a Report to the U.S. Army Medical Research and Development Command.IOM Committee to Advise the Department of Defense on Its Fiscal Year 1993 Breast Cancer Program. Washington, D.C.: National Academy Press. Senate Committee on Appropriations. 2001. Senate Report 107-109. Department of Defense Appropriation Bill, 2002 and Supplemental Appropriations, 2002. Title VI. Public Law 107-117, H.R. 3338. Washington, D.C.: U.S. Congress.