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 AMPlenary 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 AMClinical Aspects of HGA
J. Stephen Dumler, MD - USUHS
10:20 AMCoffee Break– Sponsored by AABB

Session 2: Biology, Epidemiology and Clinic Burden of Other Emerging Tick-Borne Agents

10:50 AMOther Emerging Tick-Borne Agents
Sam R. Telford III, PhD – Tufts University
11:20 AMState's Perspective on Burgeoning Tick-borne Diseases
Alfred DeMaria, Jr., MD – Massachusetts Department of Health
11:50 AMRound 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 PMTransmission Risks Posed by Emergent Agents
David A. Leiby, PhD - FDA
1:45 PMIncidence of Transfusion Transmission (HGA and Other Agents)
Susan L. Stramer, PhD – American Red Cross
2:10 PMCoffee Break– Sponsored by America's Blood Centers

Session 4: Mitigation Efforts

2:40 PMMitigation Strategies
Lou Katz, MD – America's Blood Centers
3:10 PMConceptual Framework for Test Development
Raymond P. Goodrich, PhD – Colorado State University
3:40 PMRisk Based Decision Making: The ABO Approach
Judie Leach Bennet, LLM – Canadian Blood Services
4:10 PMRoundtable 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