RFA-AI-11-014
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Transcript RFA-AI-11-014
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