Review of Site Visit Report Laboratory of Molecular Virology DETTD/OBRR/CBER March 18, 2005 Hira L. Nakhasi, Ph.D. Director, DETTD

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Review of Site Visit ReportLaboratory of
Molecular VirologyDETTD/OBRR/CBERMarch 18,
2005 Hira L. Nakhasi, Ph.D.Director, DETTD
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Immediate Office of the Director Hira Nakhasi,
Ph.D. (Director)Paul Mied, Ph.D. (Deputy
Director)Elliot Cowan, Ph.D., Assoc. Dir.
Regulatory AffairsCharles Lucey, M.D. MPH, JD
(Assoc. Dir. Medical Affairs)Carloyn Feemester
(CS0)
Division of Emerging and Transfusion Transmitted
Diseases
Laboratory of Molecular Virology Indira Hewlett,
Ph.D. (Chief) HTLV, HIV, WNV Molecular
Virology Immuno-pathogenesis Gene Regulation
Laboratory of Hepatitis and Related Emerging
Agents Gerardo Kaplan, Ph.D. (Chief) HBV, HCV,
HAV Hepatitis Viral Regulation Hepatitis Viral
Pathogenesis
Laboratory of Bacterial, Parasitic, and
Unconventional Agents David Asher, M.D.
(Chief) TSE, Leishmania, Malaria TSE
Pathogenesis, Detection Parasitic Pathogenesis
Detection
Product Testing Staff Robin Biswas, M.D.
(Head) Lot release testing of Serological and
Nucleic acid based kits HIV, HTLV, Hepatitis B,C
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Division of Emerging and Transfusion Transmitted
Diseases (DETTD) Mission

• Plans and conducts basic and applied research
• development, manufacture , pathogenesis and
  testing
• of blood borne Viral (HIV , HTLV, hepatitis,
  WNV), Parasitic (Leishmania, Malaria, Chagas) ,
  Bacterial , potential BT agents (Plague, Anthrax,
  Hemorrhagic viruses) and Transmissible Spongiform
  Encephalopathy agents or prions.
• Ensures the safety of Nations blood supply
• by reviewing, evaluating and recommending
  actions
• BLAs, PMAs, INDs, IDEs, 510(k)s for blood
  screening and diagnostic testing for above
  mentioned agents.
• Develops and revises FDA Guidance for users of
  blood screening and diagnostic products.

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Division of Emerging and Transfusion Transmitted
Diseases (DETTD) Mission

• Performs lot-release testing for approval of
  investigational tests and of licensed products.
• Develops reference materials for lot-release
  testing.
• Performs inspections of manufacturers of licensed
  products, manufacturing facilities.
• Provides expert scientific and technical advice
  to other Agency and Government components.
• Presents issues related to the safety and
  efficacy of blood donor screening testing at the
  Blood Product Advisory Committee and TSE Advisory
  Committee meetings

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Personnel and Budget FY 04

• Total Staff 58
• Senior Investigators 11
• Biologists 14
• Staff Fellows 7
• Staff Scientists 5
• Regulatory Scientists 13
• Administrative Staff 2
• Post-doctoral Fellows 6
• Budget (FY 2004) 400,000
• Published 41 original articles and book chapters

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Regulatory ActivitiesFY 04

• Regulatory submissions
• IND/IDE (original) IND/IDE (amendments) BLA
  (original application) BLS (supplement) PMA PMA
  supplement 510(k) (original) PMA/BLA Annual
  Reports
• Total 374
• Tested and released 1052 lots and performed 8
  inspections and 2 laboratory investigations

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Research Priorities

• I. Pathogenesis of Blood borne Viral, Bacterial
  and Parasitic agents
• A. Pathogenesis of HIV, drug resistant HIV,
  genetic variants of HIV, HIV tat, HTLV, WNV
• B. HHV and other herpes infections in AIDS
• C. Pathogenesis of Malaria, Leishmania and Chagas
  diseases
• D. Pathogenesis of hemorrhagic viruses and
  bacterial agents used as bioterrorism agents
• E. Pathogenesis of HCV, HBV,HAV and other related
  Hepatitis viruses
• F. Pathogenesis of TSE (prion) and bacterial
  agents

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Research Priorities continued..

• II. Blood Donor Screening Test Development
• A. Development of new technologies for detection
  of retroviruses in blood and body fluids
  including microarray, PERT and related methods.
• B. Identification and characterization of new
  HIV-1 and -2 variants Impact on diagnostics,
  drug therapy and vaccine development
• C. Development of lot release panels and
  standards for blood borne agents (e.g. HIV, WNV,
  HCV, HBV)
• D. Development of pathogen chip using microarray
  DNA technology for screening of blood borne
  parasitic, bacterial, viral and bioterrorism
  agents (e.g. Hemorrhagic viruses, smallpox
  anthrax, Tularemia, and plague).
• E. Development of detection and validation
  methods for TSE agents
• F. Develop and optimize PCR based, rapid and
  reliable methods to detect bacterial agents in
  blood

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Critical Path Initiatives

1. Standards for West Nile virus testing
2. Smallpox and blood safety
3. HIV surveillance in Cameroon
4. Relative sensitivity of HBsAg tests and HBV NAT
5. Development of oligonucleotide based microarray
   detection multiplex system for viral, bacterial
   and parasitic blood borne pathogens
6. Development of proof of concept for new vaccine
   strategies for parasitic and viral agents

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Counter Terrorism Initiatives

• Develop laboratory expertise in new technologies
• Utilize this expertise for evaluation of related
  submissions from industry
• Transfer technology for industry development
• Lot-release testing
• Understand the molecular mechanisms of
  pathogenesis of BT agents in blood

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Thank You