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