Process Analytical Technologies Subcommittee of the

Advisory Committee for Pharmaceutical Science

February 25-26, 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

Nancy Chamberlin, Pharm.D.

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


Joseph Bloom, Ph.D. 10/31/03

Assistant Professor

Pharmaceutical Department

University of Puerto Rico

School of Pharmacy

Medical Science Campus

4th Floor, Office 416

P.O. Box 365067

Rio Piedras, Puerto Rico 00935-5067


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

Chemistry Department

University of Washington

Room 141 CHL, Box 351700

Seattle, WA 98195-1700


Robert A. Lodder, Ph.D.

Associate Professor,

Pharmaceutical Sciences

University of Kentucky

College of Pharmacy

A-123, Astec

907 Rose Street

Lexington, KY 40506-0286

Government Participant

William F. Koch, Ph.D.

Deputy Director, Chemical Science

and Technology Laboratory

National Institute of Standards and


100 Bureau Drive, 227/A311, Stop 8300

Gaithersburg, MD 20899-8300


Process Analytical Technologies Subcommittee of the

Advisory Committee for Pharmaceutical Science

Other 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


Purdue University

1336 Robert E. Heine Pharmacy Bldg

West Lafayette, IN 47907-13306


Thomas J. Hale


2053 N Howe Street

Chicago, IL 60614


G.K. Raju, Ph.D.

Executive Director, MIT/PHARMI

MIT Program on the Pharmaceutical


Room 56-653,

Massachusetts Institute of Technology,

77 Massachusetts Avenue,

Cambridge, MA 02139

Industry Guests/Participants

Leon Shargel, Ph.D., R.Ph.

Vice President, Biopharmaceutics

Eon Labs Manufacturing Inc.

227-15 N. Conduit Avenue

Laurelton, NY 11413


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


68, Milton Road


Hertfordshire SG 12 OQD

United Kingdom


Rick E. Cooley

Engineering Consultant

Eli Lilly and Company

Measurement Techology Group

Corporate Center

Indianapolis, IN 46285


Jerome (Jerry) 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


Process Analytical Technologies Subcommittee of the

Advisory Committee for Pharmaceutical Science

Industry Guests/Participants (cont.)

Judy Wong, M.S.

Senior Engineer

Pharmaceutical Process Development

Schering Plough Research Institute

2000 Galloping Hill Road, K-2-1, F31A

Pharmaceutical Development

Kenilworth, NJ 07033


Steve Hammond


Process Analytical Support Group

Global Manufacturing Services

Pfizer Ltd., IPC 597

Ramsgate Road


Kent CT13 9NJ

United Kingdom


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


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