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FDA Workshop on Emerging Tick-Borne Diseases and Blood Safety


April 6, 2017

Ruth Kirschstein Auditorium, Natcher Building, NIH Campus
Bethesda, Maryland


Center for Biologics Evaluation and Research, FDA
American Association of Blood Banks
America's Blood Centers
National Heart, Lung, and Blood Institute, NIH
U.S. Department of Defense
U.S. Department of Health and Human Services

Morning Session

8:00 AMRegistration
8:30 AMWelcome Address
Peter W. Marks, MD, PhD - FDA
8:40 AMAnnouncements, Objectives, and FDA Perspective on Emerging Tick-Borne Diseases
David A. Leiby, PhD - FDA
8:55 AM Plenary Presentation on Tick-Borne Diseases
Peter J. Krause, MD – Yale University
Session 1: Biology, Epidemiology and Clinical Burden of HGA
9:30 AMAnaplasma phagocytophilum, etiologic agent of human granulocytic anaplasmosis
Cara Cherry, DVM, MPH - CDC
9:55 AM Clinical Aspects of HGA
J. Stephen Dumler, MD - USUHS
10:20 AM Coffee Break – Sponsored by AABB
Session 2: Biology, Epidemiology and Clinic Burden of Other Emerging Tick-Borne Agents
10:50 AM Other Emerging Tick-Borne Agents
Sam R. Telford III, PhD – Tufts University
11:20 AM State's Perspective on Burgeoning Tick-borne Diseases
Alfred DeMaria, Jr., MD – Massachusetts Department of Health
11:50 AM Round Table Discussion I
Morning speakers; Bryan R. Spencer, MPH – American Red Cross; and Hira L. Nakhasi, PhD - FDA
12:20 PMLunch

Afternoon Session

Session 3: Transfusion Transmission
1:20 PM Transmission Risks Posed by Emergent Agents
David A. Leiby, PhD - FDA
1:45 PM Incidence of Transfusion Transmission (HGA and Other Agents)
Susan L. Stramer, PhD – American Red Cross
2:10 PM Coffee Break – Sponsored by America's Blood Centers
Session 4: Mitigation Efforts
2:40 PM Mitigation Strategies
Lou Katz, MD – America's Blood Centers
3:10 PM Conceptual Framework for Test Development
Raymond P. Goodrich, PhD – Colorado State University
3:40 PM Risk Based Decision Making: The ABO Approach
Judie Leach Bennet, LLM – Canadian Blood Services
4:10 PM Roundtable Discussion II
Afternoon speakers; CAPT Roland L. Fahie - DoD; Roger Y. Dodd, PhD – American Red Cross; and Jay S. Epstein, MD - FDA
5:00 PMSummary & Wrap-up
David A. Leiby, PhD - FDA
5:15 PMAdjourn