1. CBER Overview of Laboratory of Molecular Virology Indira Hewlett, Ph.D Laboratory Chief

2. CBER CBER-OBRR DIVISION OF EMERGING& TRANSFUSION TRANSMITTED DISEASES Director Hira L. Nakhasi, Ph.D. Deputy Director Paul A. Mied, Ph.D. Product Testing staff Robin M. Biswas, M.D. Laboratory of Bacterial, Parasitic, &Unconventional agents David Asher, M.D. Laboratory of Molecular Virology Indira K. Hewlett, Ph.D. Laboratory of Hepatitis & Related Emerging Agents Gerardo Kaplan, Ph.D.

3. CBER LMV - History l Created during CBER reorganization of 1992 l Responsible for all HIV tests based on synthetic peptides, rDNA and molecular probes l Acquired responsibility for all HIV and HTLV products in 1999 l WNV, Vaccinia virus and software added since 2001

4. CBER Laboratory of Molecular Virology Indira Hewlett, Chief Hewlett Lab Lee, S Wood, O Tang, S Srinivasan, K (Counter- terrorism Dayton Lab Zhang, M Khan, Q Dhawan Lab Devadas, K ORISE Rios Lab Daniel, S Grinev, A Regulatory Product Akolkar, P Geyer, S Hu, J Software Gubernot, D Sanchez, B

5. CBER LMV mission- Regulatory l Review and license applications for a) in vitro tests (donor screening and diagnostic) for HIV, HTLV and other retroviruses in blood, plasma and other body fluids e.g. oral fluid b) WNV donor screening assays since 2003 c) consult reviews for Smallpox submissions d) software and instrument reviews for DETTD

6. CBER LMV mission- Regulatory (con’t ) l Conventional Ab, Ag and NAT assays, rapid tests for diagnosis, patient monitoring, genotyping, drug resistance, and home use l Perform inspections of test kit manufacturing facilities l Develop guidelines, review criteria and standards for validation of tests l Develop policies related to their use through interagency/industry and BPAC discussions

7. CBER LMV mission: Research l Perform research on HIV-1, HIV-2, HTLV, WNV and Vaccinia l Conduct laboratory investigations of disease transmission and pathogenesis l Develop and evaluate new technologies and methods to ensure blood safety from transmission of HIV, WNV and Vaccinia l Develop laboratory standards/panels for standardization and lot release of HIV and WNV assays

8. CBER Research programs Hewlett: HIV diagnosis and pathogenesis -Genetic diversity, diagnostic significance and pathogenesis of HIV variants -Reference reagents for HIV NAT assays Srinivasan: Vaccinia virus as a model for Smallpox -Viremia in vaccinated individuals -Molecular basis for myocarditis

9. CBER

10. CBER Summary l LMV has maintained product responsibility for HIV tests for over a decade l New product responsibilities including WNV, Vaccinia, software/instruments l LMV has maintained and initiated new research programs to support its regulatory function