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

 >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: 4,108 Total Cases: 343,298 Total Deaths: 4,108 NIAID Research and Development Slide Source: A. S. Fauci

National Institutes of Health Budget Comparison by Institute/Center (Dollars in Thousands)

National Institutes of Health Budget Comparison by Institute/Center (Dollars in Thousands)

NIAID FY 2011 Fiscal Policies  Noncompeting grants/contracts – FY 2010 level minus 1%  Payline  10 th percentile (R01, non-new PI)  14 th percentile (R01, New PI/ESI)  10 th 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 FY11FY12FY13 Concept development and Council review Initiative development and release of solicitation Review and award

NIAID Council-Approved Concepts

NIAID Funding Opportunities

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-NIHAI )  Development of Technologies That Accelerate the Immune Response to Biodefense Vaccines (BAA-NIAID-DMID- NIHAI ) Grants:  Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (RFA-AI )  Partnerships for Biodefense (RFA-AI )  Targeting Resistance in Select Gram-Negative Pathogens (RFA-AI )  Chemical Approaches to Target Validation for Drug Resistant Pathogens (RFA-AI )  Systems Approach to Immunity and Inflammation (RFA-AI )

Current Funding Opportunities of Interest Contracts:  An Integrated Approach to Understanding Host-Pathogen Interactions (NIAID-DMID-NIHAI )  Development of Technologies That Accelerate the Immune Response to Biodefense Vaccines (BAA-NIAID-DMID- NIHAI ) Grants:  Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (RFA-AI )  Partnerships for Biodefense (RFA-AI )  Targeting Resistance in Select Gram-Negative Pathogens (RFA-AI )  Chemical Approaches to Target Validation for Drug Resistant Pathogens (RFA-AI )  Systems Approach to Immunity and Inflammation (RFA-AI )

Genomics Blue Ribbon Panel Report topics/PathogenGenomics

DMID Systems Biology Program

Current Funding Opportunities of Interest Contracts:  An Integrated Approach to Understanding Host-Pathogen Interactions (NIAID-DMID-NIHAI )  Development of Technologies That Accelerate the Immune Response to Biodefense Vaccines (BAA-NIAID-DMID- NIHAI ) Grants:  Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (RFA-AI )  Partnerships for Biodefense (RFA-AI )  Targeting Resistance in Select Gram-Negative Pathogens (RFA- AI )  Chemical Approaches to Target Validation for Drug Resistant Pathogens (RFA-AI )  Systems Approach to Immunity and Inflammation (RFA-AI )

 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

 FY2002Category 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  FY2009Category A-C  FY2010 Antibiotic Resistance (Therapeutics and Diagnostics) Food- and Water-borne Pathogens Viruses (Therapeutics and Diagnostics)  FY2011Category 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

DiagnosticsVaccinesTherapeutics 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

DiagnosticsVaccinesTherapeutics 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 DiagnosticsVaccinesTherapeutics 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

DiagnosticsVaccinesTherapeutics 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

Outline  Background and Budget  Funding Opportunities  Future Trends

Optimal Utilization Strategies Basic Research Translational Product Development Translational Research Models FDA Licensure 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-NIHAI )  Development of Technologies That Accelerate the Immune Response to Biodefense Vaccines (BAA-NIAID-DMID- NIHAI ) Grants:  Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (RFA-AI )  Partnerships for Biodefense (RFA-AI )  Targeting Resistance in Select Gram-Negative Pathogens (RFA-AI )  Chemical Approaches to Target Validation for Drug Resistant Pathogens (RFA-AI )  Systems Approach to Immunity and Inflammation (RFA-AI )

Current Funding Opportunities of Interest Contracts:  Development of Technologies That Accelerate the Immune Response to Biodefense Vaccines (BAA-NIAID- DMID-NIHAI ) –Product Delivery –Product Manufacturing –Stabilization

Product Delivery  Cutaneous –Needle-free/microneedle –Electrode array –Patch Photo Credit biovalv: Mini-ject Photo Credit 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 Credit :MedImmune Photo Credit Optinose 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

Stabilization Glassification Cambridge Biostability 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