Food and Drug Administration
Center for Drug Evaluation and Research
Process Analytical Technologies Subcommittee of the
Advisory Committee for Pharmaceutical Science
June 12, 13, 2002
Acting Chair
Thomas Layloff, Ph.D.
Principle Program Associate
Center for Pharmaceutical Management
Management Sciences for Health
5 Thomas Court
Granite City, IL 62040-0286
Executive Secretary, Acting
Kathleen Reedy, RDH, MS
Advisors and Consultants Staff
Center for Drug Evaluation and Research
Food and Drug Administration (HFD-21)
5600 Fishers Lane
Rockville, MD 20857
(301) 827-7001 Fax: (301) 827-6776
Members
Gloria L. Anderson, Ph.D. 10/31/02
Consumer Representative
Fuller E. Callaway Professor of
Chemistry
Morris Brown College
643 Martin Luther King Jr. Drive, NW
Atlanta, GA 30314-4140
Judy P. Boehlert, Ph.D. 10/31/02
President, Boehlert Associates, Inc.
102 Oak Avenue
Park Ridge, NJ 07656-1325
Arthur H. Kibbe, Ph.D. 10/31/04
Professor and Chairman
Dept of Pharmaceutical Sciences
Nesbitt School of Pharmacy
Wilkes University
170 S. Franklin St.
Wilkes-Barre, PA 18766
SGE Consultants
Melvin V. Koch, Ph.D., Director, CPAC
University of Washington
Room 141 CHL, Box 351700
Seattle, WA 98195-1700
Robert A. Lodder, Ph.D., Associate Professor
University of Kentucky College of Pharmacy
A-123, Astec, 907 Rose Street
Lexington, KY 40506-0286
G.K. Raju, Ph.D.
Executive Director, MIT/PHARMI
MIT Program on the Pharmaceutical Industry
Massachusetts Institute of Technology,
77 Massachusetts Avenue,
Cambridge, MA 02139
Guests/Speakers Participants
Eva M. Sevick-Muraca, Ph.D.
Professor
Dept. of Chemical Engineering
Texas A&M University
337 Zachry Engineering Center
College Station, TX 77843-3122
Leon Lachman, Ph.D., President
Lachman Consulting
1600 Stewart Avenue
Westbury, NY 11590
Kenneth R. Morris, Ph.D.
Associate Department Head
Department of Industrial and Physical Pharmacy
Purdue University
1336 Robert E. Heine Pharmacy Bldg
West Lafayette, IN 47907-13306
Howard Mark, Ph.D
Mark Electronics
21 Terrace Street
Suffern, NY 10901
Emil Walter Ciurczak, Ph.D.
77 Park Road
Golden’s Bridge, NY 10526
Industry Guests/Participants
Efraim Shek, Ph.D.
Divisional Vice President,
Pharmaceutical and Analytical Research
and Development
Abbott Laboratories
Dept. 04R-1, Building NCA4-4
1401 Sheridan Road
North Chicago, IL
Ronald W. Miller, Ph.D.
Associate Director of Pharmaceutical Technology & Development
Bristol-Myers Squibb
One Squibb Drive
Building 107, Second floor
New Brunswick, NJ 08903-0191
David Richard Rudd, Ph.D.
Analytical Manager
GlaxoSmithKline Research and Development
Building 5, Park Road
Ware, Hertfordshire SG12 0DP
United Kingdom
Rick E. Cooley
Engineering Consultant
Eli Lilly and Company
Measurement Techology Group
Corporate Center
Indianapolis, IN 46285
Jerome Workman, Jr., M.A., Ph.D., FAIC, CChem, FRSC
Senior Research Fellow
Analytical Science & Technology
Kimberly-Clark Corp.
2100 Winchester Road
Neenah, WI 54956
Jozef H. M. T. Timmermans, Ph.D.
Manager, Pharmaceutical Technical
Operations
Merck and Company, Inc.
Sumneytown Pike
Mailstop: WP762M-1
West Point, PA 19486
Robert S. Chisholm
International Technology Manager
AstraZeneca International
Alderley House
Alderley Park
Macclesfield
Cheshire SK10 4TF
United Kingdom
Colin Walters
Senior Engineer
Pharmaceutical Process Development
Schering Plough Research Institute
2000 Galloping Hill Road, K-2-1, F31A
Pharmaceutical Development
Kenilworth, NJ 07033
Doug Dean, Ph.D.
Global Pharmaceutical Sector Team
PricewaterhouseCoopers Consulting
St. Jakobs-Strasse 25
Ch-4002 Basel
Switzerland
John G. Shabushnig, Ph.D.
Business Unit Director,
Center for Advanced Sterile Technology
Pharmacia Corporation
7171 Portage Road
Kalamazoo, MI 49001
John C. James, Ph.D.
Executive Director
Analytical Research and Development
Teva Pharmaceuticals USA
1090 Horsham Road
PO Box 1090
North Wales, PA 19454-1090
FDA Participants
Helen N. Winkle
Acting Director
Office of Pharmaceutical Science, HFD-003
Ajaz S. Hussain, Ph.D.
Deputy Director,
Office of Pharmaceutical Science, HFD-003
Yuan-yuan Chiu, Ph.D.
Director
Office of New Drug Chemistry, HFD-800
Joseph Famulare
Director
Division of Manufacturing and Product Quality
Office of Compliance, HFD-320
Douglas I. Ellsworth
District Director, NJ District
Office of Regulatory Affairs, Central Region, HFR-CE300
Moheb M. Nasr, Ph.D.
Director
Division of Pharmaceutical Analysis
Office of Testing and Research, HFD-920
Michael C. Olson
Director
Division of Field Science
Office of Regional Operations
Office of Regulatory Affairs, HFC-140
Frank O. Holcombe Jr., Ph.D.
Associate Director for Chemistry
Office of Generic Drugs, HFD-600