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Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
November 4 and 5, 2002
Issue: To review current developments in WNV transmission in the US and to explore strategies to address issues related to the development of donor screening tests and the utility of virus inactivation methods.
Monday, November 4, 2002
8:00 a.m. - Welcome and overview of Workshop goals- Jesse Goodman (CBER)
8:05 a.m. - Historical perspective of donor screening testing - John Finlayson (CBER/OBRR)
I. WNV biology and epidemiology
(Chair- Hira Nakhasi and Jesse Goodman, FDA)
8:15 a.m. - WNV biology - Margo Brinton, (Georgia State Univ. Atlanta)
8:35 a.m. - Current status of the WNV disease and transmission cases in the US and risk from other Japanese Encephalitis family of flaviviruses - Lyle Petersen (CDC)
8: 55 a.m. - Questions
II. Methodologies for detection of WNV and flexibility for WNV NAT cross reaction with Japanese Encephalitis family of flaviviruses
(Chair- Robert S. Lanciotti, CDC and Maria Rios, FDA)
Serology and Nucleic acid based assays
9:10 a.m.
- Detection of Human Antibodies to WNV with a Recombinant Antigen Microsphere Immunofluoresence Assay - Susan J. Wong (NY State Dept. Health)
- Serological and Molecular Amplification Assays for the Detection of WNV infection - Robert S. Lanciotti (CDC)
- Utilizing Nucleic Acid Amplification Technologies in Arboviral Testing Programs: Practical Experiences from the Maryland Public Health Laboratory - Robert A. Myers (Maryland DHMH Laboratories)
10:15 a.m. - Break
10:30 a.m.
- New York Sate Encephalitis Initiative - Cinnia Haung (New York State Dept. Health)
- Detection Issues in Testing Tissues from West Nile virus - Laura D. Kramer (New York State Dept. Health)
- Controls, Panels, and a Sensitive and Specific Real-Time RT-PCR Assay for West Nile virus - Mark Manak (Boston Biomedica, Inc.)
11:35 a.m. - General discussion
12:05 p.m. - Lunch
III. Human cells, tissues, and cellular and tissue-based product (HCT/P) and organ donor transmission issues
(Laura St. Martin, HRSA and Carolyn Wilson, FDA)
1:05 p.m.
- Overview of the Organ Procurement and Transplantation Network - Bill Hobson, HRSA
- Organ Donor Screening/Donor Acceptance in Extra-Renal Transplantation - Richard B. Freeman, M.D., (Tufts University School of Medicine)
- Donor Acceptance in Renal Transplantation/Viral Disease Transmission in Transplant Recipients - James Burdick, MD (Johns Hopkins School of Medicine)
- Marrow Donation/Transplantation Issues - Dennis Confer, M.D., (National Marrow Donor Program)
- Viral Disease Transmission Issues in Pancreatic Islet Cell Transplantation - David Harlan, M.D., NIAID
- HCT/P Transmission Issues, Melissa Greenwald, OCGT
2:25 p.m. - Discussion
IV. Industry perspectives on the development of WNV tests for donor screening
(Chair- Indira Hewlett and Robin Biswas)
2:55 p.m.
- Update on National Genetics Institute WNV screening assays - Andrew Conrad
- West Nile virus Transcription Mediated Amplification (TMA) Assay - Cristina Giachetti- GenProbe
3:25 p.m. - Break
3:40 p.m.
- No Denial about West Nile: Update on Roche's West Nile Virus Program - James Gallarda
- Real-time nucleic acid sequence-based amplification for West Nile virus detection - Lynell M. Grosso- BioMuriex
- Target Enrichment Strategy- Proposal for Improvement of Sensitivity and Specificity of RT-PCR Based WNV Blood Assays - Martin Munzer- Cygene
- Production of Materials in Support of WNV Assay Development - Bruce Phelps - Chiron
- An Update on Abbott Laboratories' Strategy for WNV Serological testing - George Dawson - Abbott Laboratories
- Feasibility of an Improved Immuno-Assay for West Nile virus - Charles Tackney - Ortho Clinical diagnostics
4:50 p.m. - General Discussion (current scientific issues and opportunities for collaboration)
5:50 p.m. - Recess (until 8:00 a.m., November 5, 2002)
Tuesday, November 5, 2002
V - Pathogen inactivation targeted at WNV
(Chair- Mahmood Farshid, FDA and Luiz Barbosa, NIH)
Viral Inactivation Methods in Blood Components
8.00 a.m.
- Overview of different methodologies - Steve Wagner (ARC)
Industry Representatives:
- Cerus - Larry Corash
- Vitex- Bernadette Alford
- Gambro- Ray Goodrich
Viral clearance methods in plasma and plasma-derived products
- Role of Model Viruses in Current Inactivation Studies - Dominique Pifat, Bayer Corporation
- Robustness data from model viruses - Albrecht Groner, Aventis Behring GmbH
- Equality of Model viruses and current data for WNV - Thomas Kreil, Baxter Bioscience
9:45 a.m. - General Discussion
10:15 a.m. - Break
VI. Proposed studies on prevalence in donors
(Chair - Mary Chamberland, CDC and Liana Harvath-NHLBI, NIH)
10:30 a.m.
"The NIH Collaborative Donor Prevalence Linked Study"
Steve Kleinman - University of British Columbia, B.C., Canada
Mike Busch- University of California at San Francisco (UCSF), S.F. CA
Susan Stramer - ARC
11:00 a.m. - General Discussion
VII. Regulatory issues
(Chair - Paul Mied, FDA)
11:35 a.m.
- Considerations in developing assays for testing donors for West Nile Virus -
Robin Biswas (FDA)
- Guidance for Industry: Recommendations for the assessment of donor suitability and blood and blood product safety in cases of known or suspected West Nile virus infection - Martin Ruta (FDA)
11:55 a.m. - Discussions
12:15 p.m. - Lunch
VIII. Implementation issues: blood and tissue organizations
(Chair- Alan Williams and Melissa Greenwald, FDA)
1:15 p.m.
- Steve Kleinman - AABB
- Susan Stramer - ARC
- Celso Bianco - ABC
- Michael Kanaley - PPTA
- Martin Mozes - AOPO
- Jackie Malling - EBAA
- Mark Damario - ASRM
2:25 p.m. - Discussion
3:00 p.m. - Break
3:15 p.m. - Panel Discussion
Panelists: Jesse Goodman (FDA), Hira Nakhasi (FDA), Liana Harvath (NIH), Mahmood Farshid (FDA), Darin Weber (OCTGT), Bill Hobson (HRSA), Glen Freiberg (AdvaMed), Robert S. Lanciotti (CDC), Lou Katz (Blood Banking Organizations), Mike Busch, Steve Wagner, Thomas Kreil (PPTA)
4:15 p.m. - Concluding Summary - Edward Tabor, FDA
4:30 p.m. - Adjournment
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