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


Gloria L. Anderson, Ph.D. 10/31/02

Consumer Representative

Fuller E. Callaway Professor of


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.


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


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


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


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.


Office of New Drug Chemistry, HFD-800


Joseph Famulare


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.


Division of Pharmaceutical Analysis

Office of Testing and Research, HFD-920


Michael C. Olson


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