Advisory Committees

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Roster

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. More info (Posted 2/27/2007)

Current Number of Vacancies = 3
Note, one or more vacancies may be in the nomination process or a final appointment may have been made.


Designated Federal Officer
Yvette Waples, Pharm.D.
Division of Advisory Committee and Consultant Management
Office of Executive Programs
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Phone: (301) 796-9001
Fax: (301) 847-8533

Jessie L-S Au, Ph.D.
Expertise: Biochemistry
Term: 07/01/2013– 10/31/2016
Chief Scientific Officer
Optimum Therapeutics LLC
9363 Towne Center Drive #110
San Diego, California 92121

*Rose Marie Caballero, M.S.N., R.N.
Expertise: Consumer Representative
Term: 12/05/2011 – 10/31/2015
Director Associate Degree Nursing Program
Career Point College
4522 Fredericksburg Rd Ste A-18
San Antonio, Texas 78201

James C. Cloyd, Pharm.D.
Expertise: Clinical Pharmacology & Orphan Drug Research
Term: 11/01/2013-10/31/2017
Director, Center for Orphan Drug Research
Professor, Department of Experimental and Clinical Pharmacology
University of Minnesota, McGuire Translational Research Facility
2001 6th Street, SE
Minneapolis, Minnesota 55455

**Jack A. Cook, Ph.D.
Expertise: Clinical Pharmacology
Term: 04/04/2012 – 10/31/2015
Clinical Pharmacology
Specialty Care Business Unit
Pfizer, Inc.
445 Eastern Point Road
Groton, Connecticut 06340

David A. Flockhart, Ph.D.
Expertise: Pharmacology/Pharmacogenetics/Drug Metabolism
Term: 12/30/2014 – 10/31/2018
Director, Indiana Institute for Personalized Medicine
Professor of Medicine, Genetics and Pharmacology
Division of Clinical Pharmacology
Indiana University School of Medicine
950 W. Walnut Street
Indianapolis, Indiana 46202

**Edwin L. Hemwall, Ph.D.
Expertise: Non-prescription Drug Development
Term: 04/04/2012 – 10/31/2015
Global R&D Franchise Leader
Merck Consumer Care
One Merck Drive
P.O. Box 100
Whitehouse Station, New Jersey 08889-0100

**Peter K. Honig, M.D., M.P.H.
Expertise: Clinical Pharmacology and Drug Development
Term: 04/04/2012 – 10/31/2015
Head, Global Regulatory Affairs
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
P.O. Box 15437
Wilmington, Delaware, 19850-5437

**James J. Keirns, Ph.D.
Expertise: Clinical Pharmacology and Translational Science
Term: 04/04/2012 – 10/31/2015
Vice President
Chief Clinical Pharmacology Scientist
Global Clinical Pharmacology & Exploratory Development
Astellas Pharma Global Development, Inc.
1 Astellas Way, N2.296
Northbrook, IL, 60062

Donald E. Mager, Pharm.D., Ph.D.
Expertise: Pharmacokinetics/Pharmacodynamics
Modeling/ Pharmacometrics/ Immuno-pharmacology
Term: 12/30/2014 – 10/31/2018
Associate Professor of Pharmaceutical Sciences
University of Buffalo, SUNY
Department of Pharmaceutical Sciences
School of Pharmacy and Pharmaceutical Sciences
431 Kapoor Hall
Buffalo, New York 14214

Marilyn E. Morris, Ph.D.
Expertise: Pharmaceutics/Pharmacokinetics/Pharmacodynamics
Term: 11/01/2013 - 10/31/2017
Professor, Department of Pharmaceutical Sciences School of Pharmacy
University at Buffalo
527 Hochstetter Hall
Amherst, New York 14260

Kathleen A. Neville, M.D., M.S.
Expertise: Clinical Pharmacology and Pediatric Hematology/Oncology
Term: 11/01/2013 - 10/31/2017
Associate Professor of Pediatrics
University of Missouri
Director, Experimental Therapeutics in Pediatric Oncology Program
Children's Mercy Hospitals and Clinics
2401 Gillham Road, Kansas City, Missouri 64108

Anne S. Robinson, Ph.D.
Expertise: Chemical Engineering
Term: 11/01/2013 - 10/31/2017
Department of Chemical and Biomolecular Engineering Catherine and Henry Boh Professor of Engineering
Tulane University
300 Boggs Laboratory
New Orleans, Louisiana 70118-5674

Elizabeth M. Topp, Ph.D.
Expertise: Chemical Engineering/Pharmaceutics
Term: 12/5/2011 – 10/31/2015
Head, Dept. of Industrial and Physical Pharmacy
College of Pharmacy, Nursing, and Health Sciences
Purdue University, RHPH
575 Stadium Mall Drive
West Lafayette, Indiana 47907

Scott A. Waldman, M.D., Ph.D.
Expertise: Pharmacology
Term: 12/30/2014 – 10/31/2018
Chairman and Professor
Departments of Pharmacology and Experimental Therapeutics and Medicine
Thomas Jefferson University
132 South 10th Street, 1170 Main
Philadelphia, Pennsylvania 19107

* Consumer Representative
** Industry Representative (non voting)


Page Last Updated: 01/23/2015
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