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USP Annual Scientific Meeting Agenda

Quality of Manufactured Medicines, Quality of Food Ingredients and Dietary Supplements

September 23–26, 2008
Westin Crown Center • Kansas City, Missouri


Track Descriptions

Preliminary Program/ Subject to Change

Tuesday, September 23, 2008
1:00 p.m. Welcome and Introductory Remarks
  • Opening and Procedural Matters
  • Advisory Panel Deliverables and Future Meetings
1:15 p.m. Advisory Panelist Presentations (20-minute presentations)
2:30 p.m. Advisory Panelists Presentations, Continued
3:30 p.m. Interactive Discussion
  • Roger L. Williams, M.D., Chief Executive Officer, USP

Wednesday, September 24, 2008
7:00 a.m. – 5:00 p.m. Registration and Information
7:00 a.m. – 8:00 a.m. Continental Breakfast
8:00 a.m. – 9:45 a.m. Opening General Session
8:00 a.m. – 8:30 a.m. USP Update   (3.3MB)
Roger L. Williams, M.D., Chief Executive Officer, USP
Board Strategic Reports  (2.7MB)
Duane M. Kirking, Pharm.D., Ph.D., USP Board of Trustees
8:30 a.m. – 9:30 a.m. Welcome to Kansas City
John Doull, M.D., Ph.D., Professor Emeritus, University of Kansas Medical Center

Keynote Address:
Tectonic Shifts in the Health Information Economy: Implications for Evidence-based Medicine  (4.4MB)
Kenneth D. Mandl, M.D., MPH  (12KB)
Associate Professor, Harvard Medical School;
Faculty, Children's Hospital Informatics Program at the Harvard-MIT Division of Health Sciences and Technology;
Co–Director, PHIConnect, a CDC Center of Excellence in Public Health Informatics;
Affiliated Faculty, Harvard–MIT Division of Health, Sciences & Technology;
Faculty, MIT Center for Biomedical Informatics;
Faculty, Division of Emergency Medicine, Children's Hospital Boston;
9:30 a.m. – 9:45 a.m. Annual Scientific Meeting Overview  (1.5MB)
Darrell R. Abernethy, M.D., Ph.D., Chief Science Officer, USP  (75KB)
Housekeeping Announcements
10:00 a.m. – 12:30 p.m.

Session I

Track I: Quality of Manufactured Medicines –Impurities
Degradation Products and Impurities in API and Drug Products Speaker: Mark Argentine, Ph.D., Eli Lilly  (15KB)
Speaker: Abi D'sa, Ph.D, Food and Drug Administration  (12KB)
Track II: Quality of Manufactured Medicines–General Notices and Process Topics Speaker: Todd L. Cecil, Ph.D., USP  (12KB)
Speaker: Neil Schwarzwalder, Chair, USP General Notices Project Team and Member, USP Residual Solvents Project Team  (11KB)
Track III: Quality of Manufactured Medicines–General Chapters and Performance Testing–Microbiology Topics (One Day Offering)
Microbiology – Overview of Current Initiatives Speaker: Radhakrishna S. Tirumalai, Ph.D., USP  (12KB)
Speaker: Scott Sutton, Ph.D., Member, USP Microbiology and Sterility Assurance Expert Committee
Speaker: James Akers, Ph.D., Chair, USP Microbiology and Sterility Assurance Expert Committee  (18KB)
Speaker: Donald Singer, Member, USP Microbiology and Sterility Assurance Expert Committee  (12KB)
Track IV: Quality of Manufactured Medicines–Drug Products Speaker: Leon Shargel, Ph.D., Member, USP Biopharmaceutics Expert Committee  (13KB)
Speaker: Thomas Foster, Pharm. D., Chair, USP Biopharmaceutics Expert Committee  (13KB)
Panelists: Nancy Jo Braden, M.D., USP Information: Therapeutic Decision Making Expert Committee, Karl Matuszewski, Pharm. D., University Health System Consortium, Gordon Johnston, R. Ph., USP Council of the Convention, and Philip Mayer, Ph.D., Wyeth Research
Track V: Quality of Food Ingredients (One Day Offering) Speaker: Alan Rulis, Ph.D., Center for Chemical Regulations and Food Safety, Exponent  (12KB)
Speaker: Roger A. Clemens, DRPH, MPH, Member DS: Non–Botanicals Expert Committee, Member, USP Food Ingredients Expert Committee, and Member, USP Food Ingredients Expert Committee  (12KB)
Speaker: Grady W. Chism, Ph.D., Member, USP Food Ingredients Expert Committee   (11KB)
Track VI: Quality of Dietary Supplements — No session offered
12:30 p.m. – 2:00 p.m. Lunch
2:00 p.m. – 4:30 p.m.

Session II

Track I: Quality of Manufactured Medicines–Impurities
Anticipating the Unknown – Finding Adulteration or Contamination of Marketed Products Speaker: Roy L. M. Dobson, Ph.D., Procter & Gamble  (11KB)
Speaker: William F. Koch, Ph.D., Chief Reference Materials Officer, USP and Ali Al–Hakim, Ph.D., Food and Drug Administration  (12KB)
Speakers: Robert H. Lafaver, M.S., USP and Abi D'sa, Ph.D, Food and Drug Administration  (12KB)
Track II: Quality of Manufactured Medicines–General Notices and Process Topics Speaker: Walter Hauck, Ph.D., USP  (11KB)
Speaker: Timothy Schofield, M.S., Merck & Co., Inc.  (14KB)
Track III: Quality of Manufactured Medicines–General Chapters and Performance Testing–Microbiology Topics (One Day Offering) Microbiology – A Look to the Future Speaker: Radhakrishna S. Tirumalai, Ph.D., USP  (12KB)
Speaker: Anthony Cundell, Ph.D., Member, USP Microbiology and Sterility Assurance Expert Committee  (11KB)
Speaker: James Agalloco, Member, USP Microbiology and Sterility Assurance Expert Committee  (15KB)
Speaker: David Hussong, Member, USP Microbiology and Sterility  (13KB)
Track IV: Quality of Manufactured Medicines–Drug Products
Harmonization of BE Requirements Speaker: Paul Fackler, Ph.D., Teva Pharmaceuticals  (11KB)
Speaker: Salomon Stavchansky, Ph.D., Chair, USP International Health Expert Committee
Panelist: Craig Simon, Ph.D., Health Canada  (11KB)
Track V: Quality of Food Ingredients (One Day Offering) Speaker: Martina Newell–McGloughlin, D.Sc., Director University of California Systemwide Biotechnology Research and Education Program, UC Davis  (12KB)
Speaker: Fereidoon Shahidi, Ph.D., Memorial University  (12KB)
Speaker: Joseph F. , Ph.D., Medical College of Virginia Department of Pharmacology and Toxicology  (12KB)
Track VI: Quality of Dietary Supplements — No session offered
5:30 p.m. – 7:30 p.m. Networking Reception and Fellowship Posters

Thursday, September 25, 2008
7:00 a.m. – 5:00 p.m. Registration and Information
7:00 a.m. – 8:00 a.m. Continental Breakfast
8:00 a.m. – 9:45 a.m. Interactive General Session—<231> Heavy Metals
9:00 a.m. Interactive Panel Discussion
9:45 a.m. – 10:00 a.m. Break (All)
10:00 a.m. – 12:30 p.m.

Session III

Track I: Quality of Manufactured Medicines–Impurities
Residual Solvents Speaker: Larry Ouderkirk, Food and Drug Administration
Speaker: Sue Schniepp, Independent Consultant  (12KB)
Track II: Quality of Manufactured Medicines–General Notices and Process Topics Speaker A: Todd Cecil, Ph.D., USP  (12KB)
Speaker B: Judy Boehlert, Ph.D., Chair, USP Monograph Development–Gastrointestinal, Renal, and Endocrine Expert Committee  (12KB)
Track III: Quality of Manufactured Medicines – General Chapters and Performance Testing- Packaging Topics (One Day Offering)
Packaging Materials – Current and Future Directions Speaker: Michael Eakins, Ph.D., Vice Chair, USP Packaging and Storage Expert Committee  (12KB)
Speaker: David E. Albert, Ph.D., M.S., NAMSA  (14KB)
Speaker: Steven Nail, Ph.D., Chair, USP, Parenteral Products: Industrial Expert Committee  (12KB)
Track IV: Quality of Manufactured Medicines–Drug Products Speaker: David Long, Ph.D., Chair, USP Pharmaceutical Dosage Forms Expert Committee  (11KB)
Speaker: Erika Stippler, Ph.D., USP  (12KB)
Speaker: Walter Hauck, Ph.D., USP  (11KB)
Track V: Quality of Food Ingredients — No session offered
Track VI: Quality of Dietary Supplements (One Day Offering) Speaker: Hwee–Ling Koh, Ph.D., National University of Singapore, Department of Pharmacy, Faculty of Science  (11KB)
Speaker: Werner Busse, Ph.D., Dr. Willmar Schwabe Pharmaceuticals  (12KB)
Speaker: Brad W.C. Lau, Ph.D., Macau Institute for Applied Research in Medicine and Health, Macua University of Science & Technology  (12KB)
Special Topic: Quality of Veterinary Drugs (One Day Offering)
Performance Testing of Veterinary Dosage Forms Speaker: Todd Foster, Ph.D., Pfizer  (11KB)
Speaker: Rafaat Fahmy, Ph.D., Center for Veterinary Medicine, Food and Drug Administration  (12KB)
12:30 p.m. – 2:00 p.m. Lunch
2:00 p.m. – 4:30 p.m.

Session IV

Track I: Quality of Manufactured Medicines–Impurities Speaker: Peter Kasper, Ph.D., BfArM  (11KB)
Speaker: Timothy J. McGovern, Ph.D., SciLucent, LLC  (11KB)
Speaker: Mark D. Argentine, Ph.D., Eli Lilly  (15KB)
Track II: Quality of Manufactured Medicines–General Notices and Process Topics Speaker: Susan S. de Mars, Chief Legal Office, USP and Angela Long, Vice President, Volunteer and Organizational Affairs, USP 
Speaker: Joseph Garber, Chair of Compendial Process Improvement Project Team  (12KB)
Track III: Quality of Manufactured Medicines – General Chapters and Performance Testing- Packaging Topics (One Day Offering)
Packaging Issues in Light of ObD and Globalization Speaker: Mary Foster, Member, Packaging and Storage Expert Committee
Speaker: Michael Eakins, Ph.D., Vice Chair, USP Packaging and Storage Expert Committee  (12KB)
Track IV: Quality of Manufactured Medicines–Drug Products Speaker: Arzu Selen, Ph.D., Food and Drug Administration  (15KB)
Speaker: Erika Stippler, Ph.D., USP  (12KB)
Speaker: James Polli, Ph.D., Member, USP Biopharmaceutics Expert Committee  (11KB)
Track V: Quality of Food Ingredients — No session offered
Track VI: Quality of Dietary Supplements (One Day Track) Speaker: Gabriel Giancaspro, Ph.D., USP  (101KB)
Speaker: Joseph Betz, Ph.D., Office of Dietary Supplements, National Institutes of Health  (12KB)
Special Topic: Quality of Veterinary Drugs (One Day Offering) Speaker: Brian Carlin, Ph.D., FMC BioPolymer
Speaker: Michael E. Oehlsen, Ph.D., Center for Veterinary Medicine  (11KB)

Friday, September 26, 2008
7:30 a.m. – 12:00 Noon Registration and Information
7:30 a.m. – 8:30 a.m. Continental Breakfast
8:30 a.m. – 10:00 a.m.

Session V

Closing Session
10:00 a.m. – 10:30 a.m. Break
10:30 a.m. – 12 noon Closing Session, continued
12 noon 2008 Annual Scientific Meeting Adjourns