Medical Diagnostics NIAID Funding Opportunities Maria Y. Giovanni, Ph.D. Assistant Director for Microbial Genomics and Advanced Technologies National Institute of Allergy & Infectious Diseases Department of Health and Human Services July 14, 2003

National Institute of Allergy and Infectious Diseases, NIH Mission Supports basic and applied research to prevent, diagnose and treat infectious and immune- mediated illness, including HIV/AIDS, and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

NIAID Medical Diagnostics Identify infectious agents in clinical samples including SARS coronavirus, NIAID Category A, B, C agents, other infectious agents, genetically engineered or manipulated organisms and toxins Rapid, highly sensitive, specific, easy to use and interpret, reliable, multi-plexed, and cost effective medical diagnostics for public health laboratories or point-of-care agents or their toxins. Identify early infection or exposure for early detection and intervention Identify/distinguish the agent from common infections Fully integrated systems from front end sample preparation to molecular detection systems with data acquisition and analysis.

Medical Diagnostics Emerging, Innovative Technologies Dev Technologies Early Stage Product Dev Technologies Later Stage Product /Platform Dev/Validation Cooperative Initiative Partnership Initiative SBIR/STTR Early Diagnosis/Pre-Symptomatic Pathogen/Host Monitoring Infection and Treatment Pathogen/Host R Platform

NIH/NIAID Support basic and applied research by peer- reviewed grants and contracts to public or private institutions and for-profit and non- profit organizations Two approaches –Investigator-initiated grants –Targeted initiatives supporting both grants and contracts-PA, RFA, RFP Allows support for diverse research projects

NIAID Cooperative Research Program for Biodefense & SARS Goal Support research projects that will advance the development a product in a cooperative program with NIAID - Vaccines - Adjuvants - Therapeutics - Diagnostics - Resources

NIAID Cooperative Research Program for Biodefense & SARS Key Components Five year award Support research for early stage of product development. Proposed plan for further development of product including goals, milestones and timeline, and potential product to be completed during funding period. Development of the appropriate partnerships among government and the biotechnology, chemical, or pharmaceutical industries. Substantive involvement of in industry.

NIAID Biodefense & SARS Partnerships Goal Assist private sector in further development of high priority products for biodefense in a cooperative program with NIAID - Vaccines - Adjuvants - Therapeutics - Diagnostics - Resources

NIAID Biodefense & SARS Partnerships Key Components Five Year Award Identified candidate product or have a proven technical approach in one of the high priority areas Proposed plan for further development of product including goals, milestones and timeline, and potential product to be completed during funding period. Development of the appropriate partnerships among government and the biotechnology, chemical, or pharmaceutical industries. Substantive involvement of industry.

NIAID Small Business Biodefense Grant Program Goal To support Small Business Innovation Research and Small Business Technology Transfer Research grants to stimulate technological innovations to develop: - Vaccines - Adjuvants - Therapeutics - Diagnostics - Resources

NIAID Small Business Biodefense Grant Program Key Components Phase I - To establish the technical merit and feasibility of proposed R/D efforts 2 years/$500,000 total costs/year Phase II - To continue the R&D efforts 3 years/$2,000,000 total costs/year Three receipt dates/year April 1, August 1, and December 1

Strain Identification Molecular Genotyping Early Identification of Targets Vaccines, Drugs and Diagnostics Tech.Dev. Microbial Biology Pathogenesis Host Response Human Genetic Variations Target Identification Basic Research Microbial Sequencing Centers Genomic Data Bioinformatics Centers Data Warehouse Data Analysis PFGRC Resources Reagents Proteomic Centers Early Target Ident. HT-Cloning/Expression

Goal: Rapid and cost efficient production of high quality genome sequences of human pathogens and invertebrate vectors of diseases Features: –NIAID-supported Contract Sequencing Facility –Capacity to sequence genomes for: Scientific community Responding to national needs Other government agencies –Anticipated Funding: Late 2003 NIAID Microbial Genome Sequencing Centers

NIAID Pathogen Functional Genomics Resource Center Goal: Develop and distribute technologies and resources for functional analysis of pathogens at whole genome or whole cell/organism level

NIAID Pathogen Functional Genomics Resource Center Genomic Resources Provided: –cDNA microarrays –Genetic Variation/SNP analysis –Develop computational tools for array and comparative genomic data analysis –Web site –Distribute organism-specific arrays and protocols to scientific community –Provide reagents-microbial strains, clones or isolates, libraries, PCR primers

NIAID Pathogen Functional Genomics Resource Center Microarrays Available 2002/2003 Streptococcus pneumoniae Staphylococcus aureus Salmonella typhimurium Chlamydia Neisseria gonorrhoeae Mycobacterium tuberculosis Plasmodium falciparum

Goal: Provide the Scientific Community with a robust point of entry for access of genomic and related data in a user-friendly format. Components - Database Genomic and Related Data - Analysis Center Develop and Provide Software Tools - Multi-disciplinary Team Bioinformatics and Database Experts and Organism- Specific Biologists NIAID Bioinformatics Resource Centers

Initiative Integral part of NIAID’s program in Biodefense and Emerging and Re-emerging Diseases Initiatives Contract Mechanism: Request for Contract Proposals NIAID Anticipates Awarding 5-8 Bioinformatics Resource Center Five year award

NIAID Proteomics Initiative Title: Biodefense and Emerging And Re-emerging Proteomics Research Programs: Identifying Targets for Therapeutic Interventions Using Proteomic Technology Goal: Characterize the pathogen and/or host cell proteome, identifying proteins associated with biology of microbes, mechanisms of microbial pathogenesis, and host response to infection with the goal of discovering targets for potential candidates for the next generation of vaccines, therapeutics, and diagnostics.

NIAID Proteomics Initiative Proteomics Research Programs : Integral part of NIAID’s program in Biodefense and Emerging and Re- emerging Diseases Initiatives Request for Contract Proposals NIAID Anticipates Awarding 5 – 10 Proteomics Research Programs Five year award Identify Protein Targets using Existing Technologies Augmenting Existing Technologies Creating Novel Proteomic Approaches Includes Early Validation Phase of Targets Includes bioinformatics and computational infrastructure for management and analysis of large amounts of proteomic data