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  1. Immunology Devices Panel

Roster of the Immunology Devices Panel

Purpose: The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including oncology, immunology, and allergy and makes appropriate recommendations to the Commissioner of Food and Drugs.

Applying for Membership on FDA Advisory Committees

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

Current Number of Vacancies: 0

Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

Tracy G. Lively, Ph.D.
Expertise: Tumor Markers
Term: 06/30/2022 – 02/28/2026
Deputy Associate Director
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute/National Institutes of Health
9606 Medical Center Drive, MSC 9730
Rockville, MD 20892

Designated Federal Officer
James Swink
Center for Devices and Radiological Health
Office of Management
10903 New Hampshire Avenue
WO Bldg. 66 Rm 5211
Silver Spring, Maryland 20993
Office: (301) 796-6313
Fax: (301) 847-8505

Bernice L. Coleman, Ph.D., ACNP*
Expertise: Heart Transplantation
Term: 09/13/2022 – 02/28/2025
Assistant Professor, Biomedical Sciences and Medicine
Cedars Sinai Medical Center
8700 Beverly Blvd.
North Tower, Plaza Level, Room 2606
Los Angeles, CA 90048

Donald A. Berry, Ph.D.
Expertise: Biostatistics
Term: 06/30/2022 – 02/28/2026
Department of Biostatistics
The University of Texas M.D. Anderson Cancer Center
1515 Holcombe Blvd.
Houston, TX 77030

Stephen F. Badylak, D.V.M., Ph.D., M.D.
Expertise: Tissue Engineering/Regenerative Medicine
Term: 06/30/2022 – 02/28/2026
Deputy Director
McGowan Institute for Regenerative Medicine
University of Pittsburgh
450 Technology Drive, Suite 300
Pittsburgh, PA 15219

Andrew N. Hoofnagle, M.D., Ph.D.
Expertise: Clinical Pathology
Term: 08/30/2022 – 02/28/2025
Professor and Head, Division of Chemistry
Department of Laboratory Medicine and Pathology
Campus Box 357110
University of Washington Medical Center
Seattle, WA 98195

Amy S. McKee, Ph.D.
Expertise: Immunology
Term: 08/30/2022 – 02/28/2025
Assistant Professor
University of Colorado, Anshutz Medical Campus
12700 E. 19th Avenue, Mailstop B164
Aurora, CO 80045

K. Michael Pollard, Ph.D.
Expertise: Toxicology, Immunology
Term: 06/30/2022 – 02/28/2025
Associate Professor
Department of Molecular Medicine
Scripps Research Institute
10550 N. Torrey Pines Rd., IMM208A
La Jolla, CA 92037

Emily C. Somers, Ph.D., ScM
Expertise: Epidemiology; Rheumatology
Term: 08/30/2022 – 02/28/2025
School of Medicine & Public Health
Department of Internal Medicine
University of Michigan
1800 Plymouth Road B14-G236
Ann Arbor, MI 48109

Noah Lermer, Ph.D. ** 
Expertise: Immunoassays
Term: 06/13/2023 – 02/28/2027
Director, Regulatory Affairs 
Abbott Laboratories
Diagnostics Division
100 Abbott Park Road
Abbott Park, IL 60064

* Consumer Representative
** Industry Representative

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