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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