# Presentation: 035768

##  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.**

**Notes:**
Fund basic and applied research through intramural laboratories on the campus and mostly by peer-reviewed research grants and contracts, gives us diversity and breathe in what we can fund and support.

Accelerated our biodefense program post 9/11, always been part of our mission.

Enormous responsibilities with large influx of dollars to NIAID.

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**Notes:**
Commitment to basic research –provides fundamental knowledge
Commitment to applied research including clinical research and translational research with product development

New Biosafety level 4 laboratory at Fort Detrich.

Focus on research resources for the scientific community including animal models for product development, repository to provide unique and quality assured reagents in a centralized facility to control reagents to insure high quality and consistency.

In vitro and animal models are needed to ensure the development and testing of v/t/diagnostics and pre-clinical testing to speed the development of new generation of products.  Animal models will be critical for FDA approval,.validate animal models and develop new animal models. 

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## 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.**

**Notes:**

DETECT
CHARACTERIZE 
QUANTITATE THE THREAT AGENT

BROAD BASED INTEREST IN DIAGNOSTICS WITHOUT SPECIFIC REQUIREMENTS  
LARGE NET
NOT ENVIRONMENTAL DETECTION

## 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

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## 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

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## 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.**

**Notes:**
Receipt date;

Receipt date:  Oct 22, 2003, letter of intent  Oct 22, 2003

## 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**

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**Notes:**
As most of you know over the last several years, NIAID NIH has recognized the enormous potential of microbial genomic research and supports a variety of projects on microbial genomics with a goal to enhance the understanding of the pathogen’s biology and its ability to cause disease in diseases such as malaria.  Pathogen genome sequencing leads to new tools for diagnosis, treatment-drugs, prevention-vaccines. With the ultimate goal of the information leading to new strategies to prevent and treat infections. 

The long-term goal of this initiative is identifying novel therapeutic targets for new drugs and vaccines to detect, prevent, and treat infections, translating genomic information into clinical applications. 

Microbial Genomics will be important for many different research investigations-microbial biology, pathogenesis, host-microbe interactions, pathogenesis, drug discovery, diagnosis.

## 	Early Identification of Targets 

- 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

**Notes:**
-NIAID Vision for Genomics/Proteomics-Provide research resources to the scientific communityl
In FY03, NIAID is continuing to expand its genomic related activities and developed three comprehensive genomic, bioinformatic and proteomic initiatives to provide the research community with genomic and proteomic resources to conduct basic and applied research on microorganisms, in particular those responsible for emerging and re-emerging infectious diseases and those considered agents of bioterrorism.  

Genome Sequencing-28 million in FY03 and 34 million in FY02.
Bioinformatic Centers-Data Warehouse and Data analysis
Proteomics-characterize proteomes of pathogen and host cells to discover potential targets for the next generation of v/t/d and some early validation. Development of new technology or enhancement of technologies-invitro mutagenesis, animal models, function of proteins.  

Develop diagnostics that are highly sensitive, robust, specific, inexpensive, easy to use for detecting and identifying multiple organisms; consider problems inherent in clinical specimens and need for clinical validation; Areas of diagnostics include point of care diagnostics and forensic diagnostics;
Genomics/Proteomics-structural, functional comparisons, develop high throughput methods
Comparative genomics to identify new targets
Encourage structural genomics/proteomics for target development for drugs, vaccines and diagnostics.  

**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**

**Notes:**
Multi-use for sequencing data; Forensic strain identification; National needs
Targets for drugs, vaccines, and diagnostics
Biology of microbe and host response to infection

Priorities-Agents of bioterrorism, Cat A-C and emerging and re-emerging diseases

Details of a selection process for evaluation and choosing sequencing projects, subject to final approval by the Project;  . Details of a strategy for sequencing a microbial genome or invertebrate vector, selected and specified by the Project Officer, including determining experimental approaches, designing protocols, setting project milestones, conducting experiments, choosing a sequencing approach and coverage, determining costs, acquiring the appropriate reagents, establishing standard operation procedures for annotation, and establishing a timetable for sequence determination and publication. NOTE 6: It is anticipated that in most cases, investigators interested in obtaining DNA sequencing of a specific microorganism or a group of microorganisms will submit a short web-based application to NIAID describing the project, its importance and its readiness to be sequenced. Sequencing projects will be selected by the Project Officer based on NIAID program priorities, national priorities,  consideration of costs, sequencing capacities of the centers, availability of funds, and input from the Scientific Advisory Committee. The Project Officer will specify the final selection of the particular microorganism, source of DNA, DNA sequencing approach and sequence coverage. The DNA of the organism to be sequenced shall be acquired or produced by the Contractor. 

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## 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

**Notes:**
Center will offer a "menu" of services, including: 
making and distributing sets of relevant, verified primers or amplified cDNA sequences for each sequenced pathogen (or host, as available) 
making microarrays and distributing them to as many departments as feasible; ensuring that the necessary equipment to utilize these reagents (e.g. scanners) is widely available; and providing hybridization and scanning services at the centralized facilities for those without the infrastructure and/or expertise to conduct these activities at their home institutions.  Very flexible contract to meet the needs of the evolving science, technologies and scientists. 

and tools for pro-te-omic analyses,

Have a Scientific Advisory Committee-knowledgeable in the broad range of genomics and microbiology and infectious disease provides advice to the contractor on needs of the research community and technologies and resources needed, updated, etc. 

Mycobacterium tuberculosis
Plasmodium falciparum
Neisseria gonorrhoeae
Chlamydia family
Streptococcus pneumoniae
Staphylococcus aureus
Salmonella typhimurium

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## NIAID Pathogen Functional Genomics Resource Center

**Microarrays Available 2002/2003**
***Streptococcus pneumoniae***
***Staphylococcus aureus***
***Salmonella typhimurium***
***Chlamydia ***
***Neisseria gonorrhoeae***
***Mycobacterium tuberculosis***
***Plasmodium falciparum***

**Notes:**

Mycobacterium tuberculosis
Plasmodium falciparum
Neisseria gonorrhoeae
Chlamydia family
Streptococcus pneumoniae
Staphylococcus aureus
Salmonella typhimurium

**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 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**

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