1. SARS Research Resources at NIAID Linda C. Lambert, Ph.D. Program Officer Influenza, SARS, and Related Viral Respiratory Diseases NIAID/NIH/DHHS

2. Advancing the Science of SARS Diagnostic Tests u Sharing information and resources -An important, often rate-limiting step in basic and translational research is the identification, procurement, and distribution of state-of-the-art reagents and technology. u Addressing the need -The NIAID has established a series of repositories that serve as worldwide resources to facilitate research and product development for infectious diseases. u Building resources for SARS -Examples of NIAID repositories -Current infrastructure for SARS Other SARS research resources - Other SARS research resources

3. Advancing Science NIAID Repositories u History 1961: NIAID Viral Reagent Program  Vision: produce, test and globally distribute reagents as viral reference standards that were not readily available from other sources.  Goal: individual laboratories could test their working reagents against these standards  Model: enteroviruses  Viruses, antigens, seed materials, antisera  Contracts with Industry, Non-profit research organizations, academia  WHO standard human and animal interferons and control serum  influenza, rhinovirus, RSV  www.bratonbiotech.com www.bratonbiotech.com  Project Officer: Teri Greenfield, Virology Branch, NIAID

4. Advancing Science NIAID Repositories u AIDS Reagent Program --1988: 62 Reagents from 20 contributors - 2003: 4,300 Reagents - 139,000 vials shipped worldwide -www.aidsreagent.org www.aidsreagent.org u In Stock -Proteins / Peptides -Cell lines -Recombinant DNA clones -Antibodies-Viruses u Recipients Academia (54%)International Community (26%) U.S. Govt. (11%)Industry (9%)

5. Advancing Science NIAID Repositories u AIDS Reagent Program -Donations and contract-generated resources u Web-based system -Registration forms -Recombinant DNA clones -Antibodies-Viruses -Community Feedback and needs u International training courses u Dr. Opendra K. Sharma, Project Officer, DAIDS/NIAID

6. Advancing Science NIAID Repositories u “Elements of a Request” –Name, contact information, reagent and intended use –Certification of compliance with applicable safety standards –Certification of use –“MTA” elements »Human use, animal use –Cost: Free! --except for shipping –Reporting agreement –Signature of Requestor and Organization Officer –Biographical Sketch, Research Experience, Relevant Publications

7. Advancing Science NIAID Repositories u NIAID Biodefense and Emerging Infectious Diseases Research Resources Program –Fall 2003 start date –Identify, acquire, and produce or expand and clone organisms and reagents –Pathogens—can include SARS –genetically manipulated cell lines –DNA libraries –DNA clones –body fluids, cells, and tissues

8. Advancing Science NIAID Repositories u NIAID Biodefense and Emerging Infectious Diseases Research Resources Program –Proteins and synthetic peptides –Monoclonal and polyclonal antibodies –Antiviral drugs and therapeutics –Chemicals –Immunomodulators, vaccines, adjuvants –Diagnostic tools and kits for detection and measurement

9. Advancing Science NIAID Repositories u NIAID Biodefense and Emerging Infectious Diseases Research Resources Program –BSL 3 capability (not BSL 4) –GMP produced materials –In compliance with all Federal and State regulations –Web-based system –Dr. Ken Cremer, Project Officer, DMID/NIAID

10. Advancing the Science of SARS Diagnostic Tests u NIAID Biodefense and Emerging Infectious Diseases Research Resources Program –Opportunity to develop SARS reagents »SARS Chips »T-cell epitope peptides of the SARS virus (in progress) u SARS Diagnostics: Meeting Scientific Challenges –Infrastructure in place respond to a prioritized list of needed reagents for SARS diagnostic development –Capacity to receive, aliquot, test, store and distribute clinical materials –Capacity develop or procure SARS research materials –International and Interagency collaborations and coordination

11. Advancing the Science of SARS Diagnostic Tests u Points to consider –Use of donated reagents for commercial purposes »AIDS Reagent Program: Donors are asked to apply any restrictions on the commercial use of their reagents u Use of reagent without an agreement from the donor u Recipient agrees to negotiate “in good faith” and share $ with donor/donor’s institution u Recipient must sign an agreement with donor prior to receiving reagent u Recipient must not use or incorporate the reagent for commercial purposes –Renewable versus non renewable resources »Prioritization of use of limited materials? u Approvals? u International and interagency collaboration?

12. Advancing the Science of SARS NIAID Research Resources u Antiviral screening contracts –In vitro assays –Animal model development »In vivo assays u Research and Development Contracts –Immunoassays: ELISAs, “neuts” –Basic and mechanistic studies