Resources for the Microbiology and Infectious Diseases Research Community

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1 Resources for the Microbiology and Infectious Diseases Research Community Martin John Rogers, PhD Program Officer, Parasitology and International Programs Division of Microbiology and Infectious Diseases NIAID, NIH, DHHS September 11, 2010

2 NIAID Support for Malaria and Neglected Infectious Diseases

3 NIH Funding Opportunities Research Support through Grants and Cooperative Agreements Investigator-initiated Solicited Research Support through Contracts Access to existing contract resources or services Targeted Product Development Solicited contract capability

4 NIH Funding Opportunities and Neglected Infectious Diseases Grants or Cooperative Agreements NIH-Wide Funding Opportunity Announcements Global Health is one of five focus areas of the NIH Director NIAID Funding Opportunity Announcements and Requests for Applications 2009 RFA NIAID Partnerships with Public-Private Partnerships (Reissuance of 2006 Solicitation) 2008 RFA Novel Interventions and Tools for malaria, NTDs and their vectors Neglected Infectious Diseases may be included as potential BioDefense threats and/or emerging infectious diseases

5 Resources for Researchers Product Development Pathway Basic Research Preclinical Development Clinical Evaluation Hypothesis Development and Testing Discovery IDE- and IND- Enabling Activities Research Tools and Technologies Trials Funding opportunities Research tools and technologies Preclinical and clinical services to facilitate product development

6 Preclinical Services to Support Product Development Product Development Pathway Basic Research Preclinical Development Clinical Evaluation Hypothesis Development and Testing Discovery IDE- and IND- Enabling Activities Research Tools and Technologies Trials In vitro testing In vivo testing Lead identification and development Chemistry and manufacturing Synthesis and Optimization Preclinical development, planning, and evaluation

7 Clinical Services to Support Product Development Product Development Pathway Basic Research Preclinical Development Clinical Evaluation Hypothesis Development and Testing Discovery IDE- and IND- Enabling Activities Research Tools and Technologies Trials Clinical trials Support for clinical programs

8 Integration of Resources for Researchers Malaria Research & Reference Reagent Resource Center Schistosomiasis Research Reagent Resource Center Biodefense and Emerging Infec1ous Diseases Research Resources Program World Reference Center for Arboviruses Filariasis Research Resource Center Shiga Toxin- Producing E. coli Center Respiratory Pathogens Reference Laboratory Support New Animal Models for Post Genomics (TB & IA) Animal Models of Human Viral Infec1on for Evalua1on of Experimental Therapeu1cs Leprosy/Armadillo Support and Maintenance In Vitro and Animal Models for EID and Biodefense Past Network on An1microbial Resistance in S. aureus (NARSA) Services for Preclinical Development of Therapeu1c Agents Animal Models for Preven1on and Treatment of Hepa11s B & C In Vitro An1viral Screening Program TB Vaccine Tes1ng and Research Materials Microbiology and Infec1ous Diseases Biological Resource Repository In Vitro Assessment for An1microbial Ac1vity Animal Models of Infec1ous Diseases Vaccine and Other Biologics Development Services (Under Development) Therapeu1c and Interven1onal Product Development Services (Under Development) Present

9 What Can the Resources Provide? Expertise/capability Data to support/address: Research/knowledge gaps New/continued funding Go/no-go decisions Investigational New Drug (IND) Applications Lifting of FDA clinical hold

10 Examples of Resources and Services for Malaria and NTDs Reagents and Organisms through Resource Centers - MR4 (malaria), FR3 (filariasis), SR3 (Schistosomiasis) Assays - NIH Molecular libraries for in vitro and in vivo screening and screening resources Animal models - Disease, drug & vaccine testing models

11 Products Supported by NIAID for Malaria and NTDs: Selected Examples Candidate Therapeutics - AQ13 (Tulane U.), antimalarial currently in Phase II clinical trial - Tafenoquine (GSK/WRAIR) antimalarial for pediatric indication - K777, Chagas drug (UCSF/DNDi). IND application by Oxadiazoles for Schistosomiasis (Rush U./NIH) - Bacterial crystal proteins as macrofilaricide (UCSD) Candidate Vaccines 3 candidate malaria vaccines from preclinical to clinical development (EBA 175 RII NG, Ad35.CS01 and EP1300) Candidate vaccines for Schistosomiasis, Amebiasis and Leishmaniasis

12 Preclinical Services Application and Approval Process Program Officer and Requestor explore request informally Branch/Office Review* Program Officer invites Requestor with promising concept to submit formal request for approval Senior Leadership Review* Studies/protocols are carried out under existing contracts *Based on standard criteria

13 Making Information Available

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16 Summary Global Health is considered an NIH priority NIAID supports research and development for malaria and NTDs NIAID resources can facilitate, accelerate and enable Product Development Researchers can access these resources Talk to your Program Officer!

17 Backup Slides

18 Accessibility is Service Dependent Available through application Investigators in academia, not-for-profit organizations, industry, and government National/International NIH funding not required

19 Requirements for Users Requirements may include: Incurring shipping and handling charges Acknowledging the contribution of NIAID contract support in publications, presentations, and other communications Providing citations for manuscripts, abstracts and presentations related to work supported by preclinical services