The NIH Roadmap and the Human Microbiome Project

The NIH Roadmap and the Human Microbiome Project Francis S. Collins, M. D. , Ph. D. National Human Genome Research Institute April 22, 2007

The NIH Roadmap Program • Roadmap projects were initiated in 2003, and are funded from a central NIH source (the “common fund”) • Characteristics: – Must be truly transforming – Must require participation of NIH as a whole, and address a gap that no single IC or entity outside NIH is likely to fill – Ideally must provide a benefit by placing the outcome of the project in the public domain – Must be in need of development in “incubator space” in order to jump start the field

Three Themes for Roadmap 1. 0 New Pathways to Discovery Research Teams of the Future Re-engineering the Clinical Research Enterprise

Initiatives within Roadmap 1. 0 Clinical Enterprise Re-engineering the Clinical Research Enterprise Public-Private Partnerships Molecular Libraries and Imaging Implementation Groups Structural Biology New Pathways to Discovery Bioinformatics and Computational Biology High-risk Research Teams of the Future Building Blocks, Biological Pathways and Networks Interdisciplinary Research Nanomedicine

The NIH Roadmap Program • Roadmap projects were initiated in 2003, and are funded from a central NIH source (the “common fund”) • Characteristics: – Must be truly transforming – Must require participation of NIH as a whole, and address a gap that no single IC or entity outside NIH is likely to fill – Ideally must provide a benefit by placing the outcome of the project in the public domain – Must be in need of development in “incubator space” in order to jump start the field • A new competition for projects (“Roadmap 1. 5”) is currently underway, with funding anticipated to start in FY 08

Roadmap 1. 5: What areas might be included in an HMP Proposal? • Sequencing of a set of reference genomes from specified body sites (possibly, oral, intestinal, nasal/pharyngeal, urogenital, skin) • Deep metagenomic sequencing of those sites to explore microbial complexity and the question of whethere is a core microbiome

Roadmap 1. 5: What areas might be included in an HMP Proposal? • Demonstration projects to test whether changes in the human microbiome can be related to human health – Multiple tissue sites, environmental factors, and disease states • Technology development -- for example, efficient technology to purify genomic DNA from single microbial cells • Development of bioinformatics tools for analysis and data handling

Roadmap 1. 5: What areas might be included in an HMP Proposal? • Data analysis and coordination effort for the entire project, to enhance the utility of the data for the biomedical research community, and to coordinate international efforts • Data repository • Resource repository to store samples, starting material, DNA, etc. • ELSI projects, if needed, to explore challenges unique to the HMP endeavor

Human Microbiome Project: Context and Timeline

Potential for coordination of the HMP on several levels • International coordination — potential EC, Japanese and Chinese projects • Coordination of analysis in different projects • Interagency coordination to develop technologies and data standards that can be used in all metagenomics projects • Interagency cooperation on storage of cultured organisms and metagenomic samples