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