Current Opportunities and Future Trends at NIAID Carole A. Heilman, Ph.D. Director, Division of...

Current Opportunities and Future Trends at NIAID

Carole A. Heilman, Ph.D.

Director, Division of Microbiology and Infectious DiseasesNIAID, NIH, DHHS

April 28, 2011

Outline

Background and Budget

Funding Opportunities

Future Trends

UTMB

2010 Funding– NIH - $145.3M– NIAID - $49.1M– DMID - $40.1M

U.S. Department of Health and Human Services

Slide Source: A. S. Fauci

Slide Source: A. S. Fauci

Slide Source: A. S. Fauci

>293 pathogens; $1.6 billion Fundamental biomedical research Product development Clinical trials Global health Microbial genomics Emerging and reemerging diseases

Division of Microbiology and Infectious Diseases

NIAID Infectious Disease Research: A Dual Mandate

Maintain and “grow” a robust basic and applied research portfolio in microbiology, immunology, and clinical research

Respond rapidly to new infectious disease threats

Slide Source: A. S. Fauci

TOTAL DEATHS: 4,108

October 2, 2009

Total cases: 343,000+Total Deaths: 4,108Total Cases: 343,298Total Deaths: 4,108

NIAID Research and

Development

Slide Source: A. S. Fauci

Slide Source: A. S. Fauci

Slide Source: A. S. Fauci

National Institutes of Health

Budget Comparison by Institute/Center(Dollars in Thousands)

ICFY 2010 Enacted

FY 2011CR Appr.

Percent Change

NCI $5,103,388 $5,058,578 -0.9%NIAID 4,818,275 4,775,968 -0.9%NHLBI 3,096,916 3,069,723 -0.9%NHGRI 516,028 511,497 -0.9%NCRR 1,268,896 1,257,754 -0.9%Other ICs 15,007,197 14,875,962 -0.9%Subtotal $29,810,700 $29,549,482 -0.9%OD 1,177,300 1,166,962 -0.9%B&F 100,000 49,900 -50.1%Total $31,088,000 $30,766,344 -1.0%

FY 2010 and FY 2011 figures for NIAID include $300M/Yr. for the Global Fund

Figures exclude $150M for Special Type I Diabetes

National Institutes of Health

Budget Comparison by Institute/Center(Dollars in Thousands)

ICFY 2011

CR Appr.FY 2012

PBPercent Change

NCI $5,058,578 $5,196,136 2.7%NIAID 4,775,968 4,915,970 2.9%NHLBI 3,069,723 3,147,992 2.5%NHGRI 511,497 524,807 2.6%NCRR 1,257,754 1,297,900 3.2%Other ICs 14,875,962 15,322,202 3.0%Subtotal $29,549,482 $30,405,007 2.9%OD 1,166,962 1,298,412 11.3%B&F 49,900 125,581 151.7%Total $30,766,344 $31,829,000 3.5%

FY 2011 and FY 2012 figures for NIAID include $300M/Yr. for the Global Fund

Figures exclude $150M for Special Type I Diabetes

NIAID FY 2011 Fiscal Policies

Noncompeting grants/contracts – FY 2010 level minus 1%

Payline 10th percentile (R01, non-new PI) 14th percentile (R01, New PI/ESI) 10th percentile equiv. (R21)

Projected overall success rate – 23%

Average programmatic adjustments – 0%

Type 2 cap – 20% over previous year

Selective pay pool - $9M

Bridge award pool - $18M

Outline

Background and Budget Funding Opportunities

– The Process– Current Opportunities

• Contracts and Grants• Resources for Researchers

Future Trends

FY 2013 Initiative Development

FY11 FY12 FY13

Concept development and Council

review

Initiative development and release of

solicitation

Review and award

NIAID Council-Approved Conceptshttp://funding.niaid.nih.gov/researchfunding/council/concepts/pages/default.aspx

NIAID Funding Opportunitieshttp://funding.niaid.nih.gov/researchfunding/ann/pages/

Outline

Background and Budget Funding Opportunities

– The Process– Current Opportunities

• Contracts and Grants• Resources for Researchers

Future Trends

Current Funding Opportunities of Interest

Contracts: An Integrated Approach to Understanding Host-Pathogen Interactions

(NIAID-DMID-NIHAI2010100) Development of Technologies That Accelerate the Immune Response to

Biodefense Vaccines (BAA-NIAID-DMID-NIHAI2010103)

Grants: Improved Diagnostic Capabilities for Select Biodefense and Emerging

Pathogens (RFA-AI-11-024) Partnerships for Biodefense (RFA-AI-11-014) Targeting Resistance in Select Gram-Negative Pathogens (RFA-AI-11-

009) Chemical Approaches to Target Validation for Drug Resistant Pathogens

(RFA-AI-11-004) Systems Approach to Immunity and Inflammation (RFA-AI-11-017)

Current Funding Opportunities of Interest

Contracts: An Integrated Approach to Understanding Host-Pathogen

Interactions (NIAID-DMID-NIHAI2010100) Development of Technologies That Accelerate the Immune Response to

Biodefense Vaccines (BAA-NIAID-DMID-NIHAI2010103)

Grants: Improved Diagnostic Capabilities for Select Biodefense and Emerging

Pathogens (RFA-AI-11-024) Partnerships for Biodefense (RFA-AI-11-014) Targeting Resistance in Select Gram-Negative Pathogens (RFA-AI-11-

009) Chemical Approaches to Target Validation for Drug Resistant Pathogens

(RFA-AI-11-004) Systems Approach to Immunity and Inflammation (RFA-AI-11-017)

Genomics Blue Ribbon Panel Report

http://www.niaid.nih.gov/ topics/PathogenGenomics

DMID Systems Biology Program

Current Funding Opportunities of Interest

Contracts: An Integrated Approach to Understanding Host-Pathogen Interactions

(NIAID-DMID-NIHAI2010100) Development of Technologies That Accelerate the Immune Response to

Biodefense Vaccines (BAA-NIAID-DMID-NIHAI2010103)

Grants: Improved Diagnostic Capabilities for Select Biodefense and

Emerging Pathogens (RFA-AI-11-024) Partnerships for Biodefense (RFA-AI-11-014) Targeting Resistance in Select Gram-Negative Pathogens (RFA-AI-

11-009) Chemical Approaches to Target Validation for Drug Resistant Pathogens

(RFA-AI-11-004) Systems Approach to Immunity and Inflammation (RFA-AI-11-017)

Translation of basic research

Support for vaccines, adjuvants, therapeutics, diagnostics, and platforms

Focus on product development activities

Multidisciplinary approaches

Performance-based, milestone-driven funding

Clearly delineated Product Development Plans

Partnership Program

FY2002 Category A-C FY2003 Category A-C FY2004 Category A-C/SARS FY2005 Category A-C FY2006 Category A-C FY2007 Category B (Diagnostics and Therapeutics) Influenza Toxins FY2008 Category A-C FY2009 Category A-C FY2010 Antibiotic Resistance (Therapeutics and Diagnostics) Food- and Water-borne Pathogens Viruses (Therapeutics and Diagnostics) FY2011 Category A-C

Next Generation Diagnostic Technologies

History of Biodefense Partnerships

Support preclinical development of lead candidate vaccines, vaccine technologies, adjuvants, therapeutics, immunotherapeutics, or medical diagnostics

Leads defined as candidates for which proof-of-concept data have been obtained

Preclinical development activities are those beyond lead candidate identification (vaccines, adjuvants, therapeutics) or assay/platform/prototype development (diagnostics)

Product Development Strategy

Applications must demonstrate substantive investment by an industrial partner

Partnerships for Biodefense

Outline

Background and Budget Funding Opportunities

– The Process– Current Opportunities

• Contracts and Grants• Resources for Researchers

Future Trends

DiagnosticsDiagnosticsVaccinesVaccinesTherapeuticsTherapeutics

Basic Research Preclinical Development

Discovery IDE- and IND-Enabling Activities

Clinical Evaluation

Hypothesis Development and

Testing

Trials

Resources for Researchers

Product Development Pathway

Research Tools and Technologies

►Research tools and technologies►Preclinical and clinical services

to facilitate product development

DiagnosticsDiagnosticsVaccinesVaccinesTherapeuticsTherapeutics

Basic Research Preclinical Development

Discovery IDE- and IND-Enabling Activities

Clinical Evaluation

Hypothesis Development and

Testing

Trials

Research Tools and Technologies

Product Development Pathway

• Biological resources repository

• Sequencing, genotyping, and protein biomarker discovery

• Data, databases, and bioinformatics tools

• Biocontainment facilities and core services

Research Tools and Technologies

Preclinical Services to Support Product Development

DiagnosticsDiagnosticsVaccinesVaccinesTherapeuticsTherapeutics

Basic Research Preclinical Development

Discovery IDE- and IND-Enabling Activities

Clinical Evaluation

Hypothesis Development and

Testing

Trials

Research Tools and Technologies

• In vitro testing

• In vivo testing

• Lead identification and development

• Chemistry and manufacturing

• Synthesis and optimization

• Preclinical development, planning, and evaluation

Product Development Pathway

DiagnosticsDiagnosticsVaccinesVaccinesTherapeuticsTherapeutics

Basic Research Preclinical Development

Discovery IDE- and IND-Enabling Activities

Clinical Evaluation

Hypothesis Development and

Testing

Trials

Clinical Services to Support Product Development

Research Tools and Technologies

• Clinical trials

• Support for clinical

programs

Product Development Pathway

www.niaid.nih.gov

Outline

Background and Budget

Funding Opportunities

Future Trends

Optimal Optimal Utilization Utilization StrategiesStrategies

Basic Basic ResearchResearch TranslationalTranslational Product Product

DevelopmentDevelopment

Translational Research Translational Research ModelsModels

FDA FDA LicensureLicensure

• Concept Acceleration Program (CAP)• Resources for Researchers• Maximizing current therapies

NIAID International Centers of Excellence for Malaria Research Multidisciplinary approach that integrates clinical and

field aspects with laboratory, molecular and genomic methods for malaria control and prevention

Established research centers in each of the malaria-endemic regions of the world: Central and West Africa East Africa Southern Africa Southeast Asia South Asia Amazonia Latin America other than Amazonia

Current Funding Opportunities of Interest

Contracts: An Integrated Approach to Understanding Host-Pathogen Interactions

(NIAID-DMID-NIHAI2010100) Development of Technologies That Accelerate the Immune

Response to Biodefense Vaccines (BAA-NIAID-DMID-NIHAI2010103)

Grants: Improved Diagnostic Capabilities for Select Biodefense and Emerging

Pathogens (RFA-AI-11-024) Partnerships for Biodefense (RFA-AI-11-014) Targeting Resistance in Select Gram-Negative Pathogens (RFA-AI-11-

009) Chemical Approaches to Target Validation for Drug Resistant Pathogens

(RFA-AI-11-004) Systems Approach to Immunity and Inflammation (RFA-AI-11-017)

Current Funding Opportunities of Interest

Contracts: Development of Technologies That Accelerate the

Immune Response to Biodefense Vaccines (BAA-NIAID-DMID-NIHAI2010103)– Product Delivery– Product Manufacturing– Stabilization

Product Delivery

Cutaneous– Needle-free/microneedle– Electrode array– Patch

Photo Credit biovalv: Mini-ject

Photo C

redit Zosano:

Macroflux®

Photo Credit © Glide Pharma

Photo Credit Ichor: TriGrid™

Photo credit Iomai Corp.

Photo Credit: Emory University

Mucosal– Edible vaccines– Spray injectors (new adjuvants, – mucoadhesives)– Optinose: Breath-powered nasal delivery

Product Delivery

Photo C

redit :MedIm

mune

Pho

to C

redi

t Opt

inos

e

Photo credits Mystic Pharmaceuticals: VeriDoser

Product Manufacturing: Plant-based

Transfection process with agrobacterium

Produces high yield of protein

Project GreenVax: – R&D ongoing for the

development of a candidate H1N1 vaccine

– Large scale clinical trials expected to begin in 2011

StabilizationGlassification

Cambridge Biostability

solvent

Protein coated microcrystals

Xstalbio

Lyophilization

Stabilitech, Pharmathene

Excipient enhanced

Nanoparticles

NanoBio

A Delicate Balance:The Perpetual Challenge

In the Next Round of Budget Talks, Big Cuts for

Health Research Are Coming

April 11, 2011

Budget Freeze Forces NIH to

Slash Electronic Grants Staff April 14, 2011

The Real World Effects

of Budget Cuts

April 8 2011