Vaccines, Blood & Biologics

Public Workshop: Application of Advances in Nucleic Acid and Protein Based Detection Agenda

FDA Workshop: Application of Advances in Nucleic Acid and Protein Based Detection Methods for Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations

Main Auditorium
Natcher Conference Center
Building 45
National Institutes of Health
Bethesda, MD 20892

April 10-11, 2013

Workshop Chair:
Sanjai Kumar, Ph.D., CBER, FDA
Workshop Co-Chairs:
Indira Hewlett, Ph.D., CBER, FDA
Robert Duncan, Ph.D., CBER FDA

Center for Biologics Evaluation and Research, FDA
Advanced Medical Technology Association (AdvaMed)
America’s Blood Centers
National Heart, Lung and Blood Institute, NIH
Office of the Assistant Secretary for Health, HHS

April 10, 2013

7: 00 a.m. Registration

8:00 a.m. Welcoming Remarks:
Peter Marks, M.D., Ph.D., CBER, FDA

8:10 a.m. Introduction: Donation testing and transfusion safety
Jay S. Epstein, M.D., CBER, FDA

Session I. Blood Safety from Infectious Agents: Present and the Future
Chair: Louis M. Katz, M.D., America’s Blood Centers

8:25 a.m. Emerging Infectious Diseases: Global hot-spots and risk to blood safety
Nathan Wolfe, M.A., D.Sc., Stanford University, Metabiota

8:55 a.m. FDA’s approach to maintain blood safety from infectious agents in an ever changing landscape
Hira L. Nakhasi, Ph.D., CBER, FDA

9:15 a.m. Advances in pathogen testing technology and transfusion safety
Susan L. Stramer, Ph.D., American Red Cross

9:45 a.m. BREAK

Session II. Advances in Blood-borne Pathogen Detection
Chair: Charles Chiu, M.D., Ph.D., University of California, San Francisco

10:00 a.m. Molecular approaches for pathogen discovery
Thomas Briese, Ph.D., Columbia University

10:30 a.m. Microarrays and next generation sequencing for blood-borne pathogen detection, diagnostics and discovery
Charles Chiu, M.D., Ph.D., University of California, San Francisco

11:00 a.m. Protein arrays for surveillance, monitoring and implications for donor screening
Philip Felgner, Ph.D., University of California, Irvine

11:30 a.m. Implementation of nucleic acid tests for infectious disease testing of donors: CBER’s experience
Indira Hewlett, Ph.D. CBER, FDA

11:45 a.m. Panel Discussion: Sessions I and II
Chair: Charles Chiu, M.D., Ph.D.
Panelists: Louis M. Katz, M.D; Nathan Wolfe, M.A., D.Sc.; Hira L. Nakhasi, Ph.D.; Susan L. Stramer, Ph.D.; Thomas Briese, Ph.D.; Philip Felgner, Ph.D.; Indira Hewlett, Ph.D.

1:15 p.m. LUNCH

Session III. Molecular DNA-based Typing of Blood Cell Antigens
Chair: Connie M. Westhoff, Ph.D., New York Blood Center

2:30 p.m. An overview of blood cell antigen typing and blood group genotyping by BioArray
Connie M. Westhoff, Ph.D., New York Blood Center

3:00 p.m. Current approaches for HLA testing
M. Sue Leffell, Ph.D., Johns Hopkins University School of Medicine

3:30 p.m. Genomics-based approach for HLA and red cell antigen typing
Christian Gabriel, M.D., Red Cross Transfusion Service of Upper Austria

4:00 p.m. PCR-, hybridization- and flow cytometry-based blood group genotyping
Gorka Ochoa, M.D., Ph.D., Progenika, Inc.

4:15 p.m. Blood group genotyping with Life Technologies OpenArray® Real-Time System
Gregory Denomme, Ph.D., BloodCenter of Wisconsin

4:30 p.m. BREAK

4:45 p.m. Panel Discussion
Chair: Connie M. Westhoff, Ph.D.
Panelists: M. Sue Leffell, Ph.D.; Christian Gabriel, M.D.; Gorka Ochoa, M.D., Ph.D.; Gregory Denomme, Ph.D.; Bill Flegel, M.D., NIH Clinical Center


April 11, 2013

7:00 a.m. Registration

Session IV. Highly Multiplexed Technologies for Blood Donor Screening
Chair: Andrew Kasarskis, Ph.D., Mount Sinai School of Medicine

8:00 a.m. Simultaneous, quantitative detection of all category A viral pathogens and inflammatory response profiling in a single tube requiring no enzymatic reactions
Pejman Naraghi-Arani, Ph.D., Lawrence Livermore National Laboratory

8:30 a.m. Evolving sequence-based approaches for pathogen detection
Andrew Kasarskis, Ph.D., Mount Sinai School of Medicine

9:00 am. TessArae resequencing platform
Clark Tibbetts, Ph.D., TessArae LLC

9:15 a.m. Life Technologies OpenArray Platform for pathogen detection
Elena Grigorenko, Ph.D., Diatherix Laboratories, Inc.

9:30 a.m. Antigen and antibody-based tests
Raya D. Zerger, MT(ASCP)SBB, Beckman Coulter, Inc.

9:45 a.m. Transcription-mediated amplification testing
Jeffrey M. Linnen, Ph.D., Hologic Gen-Probe

10:00 a.m. BREAK

Session V. Bioinformatics, Data Analysis and Management
Chair: Tom Slezak, Lawrence Livermore National Laboratory

10:15 a.m. Tools for pathogen discovery and identification using next generation sequencing data analysis
Matthew Meyerson, M.D., Ph.D., Dana-Farber Cancer Institute, Harvard Medical School

10:45 a.m. Bioinformatics for microarray data analysis
Kevin McLoughlin, M.S., Lawrence Livermore National Laboratory

11:15 a.m. Data analysis for red cell and HLA genotyping
Sukanta Banerjee, Ph.D., BioArray Solutions, Immucor

11:30 a.m. Bioinformatics and data analysis for blood centers
Edward P. Notari, M.P.H., American Red Cross

11:45 a.m. Panel Discussion: Sessions IV and V
Chair: Tom Slezak
Panelists: Pejman Naraghi-Arani, Ph.D.; Andrew Kasarskis, Ph.D.; Clark Tibbetts, Ph.D.; Elena Grigorenko, Ph.D.; Raya D. Zerger, MT(ASCP)SBB; Jeffrey M. Linnen, Ph.D.; Vahan Simonyan, Ph.D., CBER, FDA; Matthew Meyerson, M.D., Ph.D.; Kevin McLoughlin, Ph.D., Sukanta Banerjee, Ph.D.; Edward P. Notari, M.P.H.

1:00 p.m. LUNCH

Session VI. Perspectives in Developing Multiplex Devices for Donor Screening
Chair: Michael Busch, M.D., Ph.D., Blood Systems Research

2:00 p.m. Blood center perspective in developing multiplex devices for donor screening
Michael Busch, M.D., Ph.D., Blood Systems Research Institute

2:20 p.m. Analytical studies and clinical trial design: CDRH perspective
John Peyton Hobson, Ph.D., CDRH, FDA

2:35 p.m. Multiplex donor testing for blood donors: Looking ahead, development and system constraints
Peter Scott, M.B.A., AdvaMed, Immucor

2:50 p.m. Advances in pathogen testing technology and transfusion safety and multiplexed donor testing: Implications for donor and blood product management
Susan L. Stramer, Ph.D., American Red Cross, Biomedical Services

3:10 p.m. BREAK

3:30 p.m. Panel Discussion
Chair: Michael Busch, M.D., Ph.D.
Panelists: John Peyton Hobson, Ph.D.; Peter Scott, M.B.A.; Susan L. Stramer, Ph.D.; Paul A. Mied, Ph.D., CBER, FDA; Ginette Michaud, M.D., CBER, FDA; Melissa Greenwald, M.D., CBER, FDA

Session VII. Conclusion and Future Steps
Chair: Sanjai Kumar, Ph.D., CBER, FDA

4:05 p.m. Summary of sessions:
Charles Chiu, M.D., Ph.D.; Connie M. Westhoff, Ph.D.; Tom Slezak; Michael Busch, M.D., Ph.D.

4:30 p.m. Recommendations by the expert panel on the next steps and how to promote the development of multiplex platforms for blood donor screening and red cell antigen typing
Chair: Sanjai Kumar, Ph.D.
Panelists: Jay S. Epstein, M.D.; Ginette Michaud, M.D.; Hira L. Nakhasi, Ph.D.; Uwe Scherf, Ph.D., CDRH, FDA; Matthew Kuehnert, M.D., CDC; Louis M Katz, M.D.; Michael Busch, M.D., Ph.D.; Susan L. Stramer, Ph.D.; Charles Chiu, M.D., Ph.D.; Tom Slezak; Connie M. Westhoff, Ph.D.; Harvey Alter, M.D., NIH; Simone Glynn, M.D., NHLBI; James Berger, M.S., OASH, HHS; Peter Scott, M.B.A.

5:55 p.m. Closing Remarks:
Hira L. Nakhasi, Ph.D.


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