Applied Clinical Trials
A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.
Director
Ivor Pritchard* (240) 453-6900
NIH Institutes, Center, and Divisions
Deputy Director and Director, Office of International Activities
Melody Lin (240) 453-8126
Associate Director, Regulatory Affairs
Michael Carome (240) 453-8237
Director, Division of Compliance Oversight
Kristina Borror (240) 453-8132
Director, Division of Education and Development
Shirley Hicks (240) 453-8227
Director,Division of Policy and Assurances
Irene Stith-Coleman (240) 453-8138
Commissioner
Andrew von Eschenbach (301) 827-3310
Chief of Staff
Susan Winckler (301) 827-3310
Deputy Commissioner for Operations and Chief Operating Officer
John Dyer (301) 827-3310
Deputy Commissioner and Chief Medical Officer
Janet Woodcock (301) 827-3310
Deputy Commissioner for Policy, Planning, and Preparedness
Randall Lutter (301) 827-3370
Deputy Commissioner for International and Special Programs
Murray Lumpkin (301) 827-5709
Chief Counsel
Gerald Masoudi (301) 827-1137
Assistant Commissioner for External Relations
Theresa Toigo* (301) 827-6251
Department of Health and Human Services: Food and Drug Administration
Assistant Commissioner for Planning
Malcolm Bertoni* (301) 827-5292
Assistant Commissioner for Policy
Jeffrey Shuren (301) 827-3360
Assistant Commissioner for Counterterrorism and Emerging Threats
Boris Lushniak (301) 827-4067
Assistant Commisioner for Integrity and Accountability
William McConagha (301) 827-4067
Assistant Commissioner for International Programs
Melinda Plaisier (301) 827-4480
Director, Office of Pediatric Therapeutics
Dianne Murphy (301) 827-1996
Director, Office of Combination Products
Joanne Less* (301) 427-1934
Associate Commissioner for Management
Kathleen Heuer (301) 255-6762
Director, Office of Crisis Management
Ellen Morrison (301) 827-5660
Director, Office of Critical Path Programs
Rachel Behrman (301) 827-5660
Director, National Center for Toxicological Research
William Slikker (301) 827-5660
Associate Commissioner for Science and Health Coordination
Norris Alderson (301) 827-3340
Assistant Commissioner for Women's Health
Kathleen Uhl (301) 827-0350
Director, Office of Orphan Products Development
Timothy Cote (301) 827-3666
Director, Office of Special Health Issues
Theresa Toigo (301) 827-4460
GoodClinicalPracticeProgram
Special Assistant to the Director
Patricia Beers Block (301) 827-3340
Expert Consumer Safety Officer
Carolyn Hommel (301) 827-3340
Senior Advisor for Clinical Science
David Lepay (301) 827-3340
Biophysicist
Jean Toth-Allen (301) 827-3340
Associate Commissioner for Regulatory Affairs
Margaret Glavin (301) 827-3101
Deputy Commissioner for Compliance Policy
David Horowitz (301) 827-3101
Deputy Commissioner for Field Operations
Diana Kolaitis (718) 662-5416
Senior Advisor for Clinical Science
Lori Love (301) 827-3684
Director
Daniel Schultz (240) 276-3939
Deputy Director
Linda Kahan (240) 276-3939
Director, Office of Device Evaluation
Donna Bea Tillman (240) 276-3993
Director, Office of Compliance
Timothy Ulatowski (301) 276-0100
Director, Division of Bioresearch Monitoring
Michael Marcarelli (301) 276-0125
Director, Office of In Vitro Diagnostic Device Evaluation and Safety
Steven Gutman (240) 276-0375
Director, Office of Surveillance and Biometrics
Susan Gardner (240) 276-0125
Director
Janet Woodcock* (301) 594-5400
Deputy Director
Douglas Throckmorton (301) 594-5400
Associate Director for Safety Policy and Communications
Paul Seligman (301) 594-0104
Associate Director for Medical Informatics
Randy Levin (301) 827-7784
Associate Director for Analysis and Strategic Initiatives
Theresa Mullin (301) 594-5400
Associate Director for International Programs
Justina Molzon (301) 594-5400
Associate Director for Regulatory Policy
Jane Axelrad (301) 594-5400
Director, Office of Executive Programs
Deborah Henderson (301) 594-6779
Director, Office of Management
Russell Abbott (301) 594-6741
Director, Office of Training and Communication
Nancy Smith (301) 827-1651
Director, Office of Information Technology
James Shugars (301) 827-6240
Director, Office of Counterterrorism and Emergency Coordination
Rosemary Roberts (301) 796-2210
Director
ShaAvhree Buckman (301) 796-2600
Director, Office of Clinical Pharmacology and Biopharmaceutics
Lawrence Lesko (301) 796-2450
Director, Office of Biostatistics
Robert O'Neill (301) 796-1700
Director
Deborah Autor (301) 827-8910
Deputy Director
Joe Famulare (301) 827-8910
Director, Division of Scientific Investigations
Gary Della'Zanna (240) 276-8817
Deputy Director
Joseph Salewski (240) 276-8817
Chief, Good Clinical Practices Branch I
Constance Lewin (240) 276-8829
Chief, Good Clinical Practices Branch II
Leslie Ball (240) 276-8840
Chief, GLP/Bioequivalence Investigations Branch
C.T. Viswanathan (240) 276-8853
Director
Robert Temple (301) 796-2270
Deputy Director
Rachel Behrman* (301) 796-2270
Director, Division of Drug Marketing, Advertising, and Communications
Thomas Abrams (301) 796-1200
Director
John Jenkins (301) 796-0700
Deputy Director
Sandra Kweder (301) 796-0700
Director, Office of Drug Evaluation I
Robert Temple* (301) 796-2270
Director, Office of Drug Evaluation II
Curtis Rosebraugh* (301) 796-2310
Director, Office of Drug Evaluation III
Julie Beitz (301) 796-2100
Director, Office of Antimicrobial Products
Edward M. Cox (301) 796-1300
Director, Office of Oncology Products
Richard Pazdur (301) 796-2340
Director, Office of Nonprescription Products
Charles Ganley (301) 796-2060
Director
Helen Winkle (301) 796-2400
Deputy Director
Keith Webber (301) 796-2400
Director, Office of New Drug Quality Assessment
Moheb Nasr (301) 796-1900
Director, Office of Generic Drugs
Gary Buehler (240) 276-9310
Director, Office of Testing and Research
Vincent Vilker (301) 796-0200
Director, Office of Biotechnology Products
Steven Kozlowski (301) 796-2390
Director
Gerald Dal Pan (301) 796-2380
Director
Jesse Goodman (301) 827-0372
Deputy Director
Karen Midthun (301) 827-0376
Associate Director for Research
Kathryn Carbone (301) 827-0377
Associate Director for Policy
Diane Maloney (301) 827-0372
Associate Director for Quality Assurance
Sheryl Lard-Whiteford (301) 827-0379
Associate Director for Review Management
Robert Yetter (301) 827-0373
Senior Advisor for International Affairs
Joan W. Blair (301) 827-0639
Senior Policy Advisor for Chemistry and Manufacturing Controls
Christopher Joneckis (301) 435-5681
Director, Office of Biostatistics and Epidemiology
Steven Anderson* (301) 827-3034
Director, Office of Communication, Training, and Manufacturers Assistance
Lorrie McNeill (301) 827-2000
Director, Office of Management
Joseph Biviano (301) 827-1320
Director, Office of Information Technology
Ginger Leo (301) 827-1368
Director, Office of Blood Research and Review
Jay Epstein (301) 827-3518
Director, Office of Vaccines Research and Review
Norman Baylor (301) 827-0655
Director, Office of Cellular, Tissue, and Gene Therapies
Celia Witten (301) 827-6536
Director, Office of Compliance and Biologics Quality
Mary Anne Malarkey (301) 827-6190
Director, Division of Inspections and Surveillance
Gilliam Conley (301) 827-6221
Chief, Bioresearch Monitoring Branch
Patricia Holobaugh (301) 827-6221
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.