Medical Diagnostics NIAID Funding Opportunities

Maria Y. Giovanni, Ph.D.Assistant Director for Microbial Genomics

and Advanced TechnologiesNational Institute of Allergy & Infectious Diseases

Department of Health and Human ServicesJuly 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

TechnologiesDev

TechnologiesEarly Stage

Product Dev

TechnologiesLater Stage

Product /PlatformDev/Validation

Cooperative Initiative

Partnership Initiative

SBIR/STTR

Early Diagnosis/Pre-SymptomaticPathogen/Host

Monitoring Infection and TreatmentPathogen/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

GoalSupport research projects that will advance the

development a product in a cooperative program with NIAID- Vaccines- Adjuvants- Therapeutics- Diagnostics- Resources

NIAID Biodefense & SARS Partnerships

GoalAssist private sector in further development of high

priority products for biodefense in a cooperative program with NIAID- Vaccines- Adjuvants- Therapeutics- Diagnostics- Resources

NIAID Small Business Biodefense Grant Program

GoalTo support Small Business Innovation Research and

Small Business Technology Transfer Research grants to stimulate technological innovations to develop:

- Vaccines- Adjuvants- Therapeutics- Diagnostics- Resources

StrainIdentification

Molecular Genotyping

Early Identification of Targets Vaccines, Drugs and

DiagnosticsTech.Dev.

MicrobialBiology

Pathogenesis

HostResponse

HumanGenetic

Variations

Target Identification

Basic Research

Microbial Sequencing CentersGenomic Data

Bioinformatics Centers

Data WarehouseData Analysis

PFGRCResourcesReagents

ProteomicCenters

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

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

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.