Current Opportunities and
Future Trends at NIAID
Carole A. Heilman, Ph.D.
Director, Division of Microbiology and
Infectious Diseases
NIAID, 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
Division of Microbiology and
Infectious Diseases







>293 pathogens; $1.6 billion
Fundamental biomedical research
Product development
Clinical trials
Global health
Microbial genomics
Emerging and reemerging diseases
NIAID Infectious Disease Research: A
Dual Mandate
Maintain and “grow”
a robust basic and
applied research
portfolio in
microbiology,
immunology, and
clinical research
Slide Source: A. S. Fauci
Respond rapidly
to new infectious
disease threats
October 2, 2009
NIAID Research
and
Development
Totalcases:
Cases:343,000+
343,298
Total
TOTAL DEATHS:
Total
Deaths:
Total
Deaths:4,108
4,108
4,108
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)
IC
NCI
NIAID
NHLBI
NHGRI
NCRR
Other ICs
Subtotal
OD
B&F
Total
FY 2010
Enacted
$5,103,388
4,818,275
3,096,916
516,028
1,268,896
15,007,197
$29,810,700
1,177,300
100,000
$31,088,000
FY 2011
CR Appr.
$5,058,578
4,775,968
3,069,723
511,497
1,257,754
14,875,962
$29,549,482
1,166,962
49,900
$30,766,344
Percent
Change
-0.9%
-0.9%
-0.9%
-0.9%
-0.9%
-0.9%
-0.9%
-0.9%
-50.1%
-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)
IC
NCI
NIAID
NHLBI
NHGRI
NCRR
Other ICs
Subtotal
OD
B&F
Total
FY 2011
CR Appr.
$5,058,578
4,775,968
3,069,723
511,497
1,257,754
14,875,962
$29,549,482
1,166,962
49,900
$30,766,344
FY 2012
PB
$5,196,136
4,915,970
3,147,992
524,807
1,297,900
15,322,202
$30,405,007
1,298,412
125,581
$31,829,000
Percent
Change
2.7%
2.9%
2.5%
2.6%
3.2%
3.0%
2.9%
11.3%
151.7%
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
Initiative development
and release of
solicitation
Review and
award
Concept
development
and Council
review
FY11
FY12
FY13
NIAID Council-Approved Concepts
http://funding.niaid.nih.gov/researchfunding/council/concepts/pages/default.aspx
NIAID Funding Opportunities
http://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-DMIDNIHAI2010103)
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-AI11-009)
 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-DMIDNIHAI2010103)
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-AI11-009)
 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-DMIDNIHAI2010103)
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 (RFAAI-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)
Partnership Program
 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
History of Biodefense Partnerships






FY2002
FY2003
FY2004
FY2005
FY2006
FY2007



FY2008
FY2009
FY2010

FY2011
Category A-C
Category A-C
Category A-C/SARS
Category A-C
Category A-C
Category B (Diagnostics and Therapeutics)
Influenza
Toxins
Category A-C
Category A-C
Antibiotic Resistance (Therapeutics and Diagnostics)
Food- and Water-borne Pathogens
Viruses (Therapeutics and Diagnostics)
Category A-C
Next Generation Diagnostic Technologies
Partnerships for Biodefense
 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
Outline
 Background and Budget
 Funding Opportunities
– The Process
– Current Opportunities
• Contracts and Grants
• Resources for Researchers
 Future Trends
Resources for Researchers
Product Development Pathway
Basic Research
Hypothesis
Development and
Testing
Preclinical Development
Discovery
Clinical Evaluation
IDE- and INDEnabling Activities
Trials
Research Tools and Technologies
►Research tools and technologies
►Preclinical and clinical services
to facilitate product development
Diagnostics
Vaccines
Therapeutics
Research Tools and
Technologies
Product Development Pathway
Basic Research
Hypothesis
Development and
Testing
Preclinical Development
Discovery
Clinical Evaluation
IDE- and INDEnabling Activities
Trials
Research Tools and Technologies
• Biological resources repository
• Sequencing, genotyping, and protein
biomarker discovery
• Data, databases, and bioinformatics tools
• Biocontainment facilities and core
services
Diagnostics
Vaccines
Therapeutics
Preclinical Services to Support
Product Development
Product Development Pathway
Basic Research
Hypothesis
Development and
Testing
Preclinical Development
Discovery
Clinical Evaluation
IDE- and INDEnabling Activities
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
Trials
Diagnostics
Vaccines
Therapeutics
Clinical Services to Support
Product Development
Product Development Pathway
Basic Research
Hypothesis
Development and
Testing
Clinical Evaluation
Preclinical Development
Discovery
IDE- and INDEnabling Activities
Trials
Research Tools and Technologies
• Clinical trials
• Support for clinical
programs
Diagnostics
Vaccines
Therapeutics
www.niaid.nih.gov
Outline
 Background and Budget
 Funding Opportunities
 Future Trends
Translational Research Models
Basic
Research
Translational
Product
Development
FDA
Licensure
• Concept Acceleration Program (CAP)
• Resources for Researchers
• Maximizing current therapies
Optimal
Utilization
Strategies
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 malariaendemic 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-DMIDNIHAI2010103)
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-AI11-009)
 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-NIAIDDMID-NIHAI2010103)
– Product Delivery
– Product Manufacturing
– Stabilization
Product Delivery
Photo Credit © Glide
Pharma
 Cutaneous
– Needle-free/microneedle
– Electrode array
– Patch
Photo Credit Zosano:
Macroflux®
Photo credit Iomai Corp.
Photo Credit Ichor:
TriGrid™
Photo Credit: Emory
University
Photo Credit biovalv: Mini-ject
Product Delivery
 Mucosal
Edible vaccines
Spray injectors (new adjuvants,
mucoadhesives)
Optinose: Breath-powered nasal delivery
Photo Credit :MedImmune
Photo credits Mystic Pharmaceuticals: VeriDoser
Photo Credit Optinose
–
–
–
–
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
Stabilitech, Pharmathene
Protein coated
microcrystals
Excipient enhanced
Lyophilization
Xstalbio
Stabilization
Glassification
Nanoparticles
NanoBio
Cambridge Biostability
A Delicate Balance:
The Perpetual Challenge
In the Next Round of Budget
Talks, Big Cuts for Health
Research Are Coming
April 11, 2011