USP Annual Scientific Meeting

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

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

(Revised 5/09/2008)

Track Descriptions

Preliminary Program/ Subject to Change

Tuesday, September 23, 2008
1:00 p.m. – 5:00 p.m. Pre-Registration and Information
1:00 p.m. – 4:30 p.m. Pre–conference Session: Resolution 3 – Emerging Science and Technologies that are Changing the Industry, Regulation, and Healthcare Practice

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. – 9:30 a.m. Opening General Session
8:00 a.m. – 8:30 a.m. State of the USP
Roger L. Williams, M.D., Chief Executive Officer, USP
Darrell R. Abernethy, M.D., Ph.D., Chief Science Officer, USP
8:30 a.m. – 9:15 a.m. Keynote Speaker
Kenneth D. Mandl, M.D., MPH (Confirmed)
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;
9:15 a.m. – 9:30 a.m. Annual Scientific Meeting Overview and Housekeeping Announcements
9:30 a.m. – 10:00 a.m. Morning Break
10:00 a.m. – 12:30 p.m.

Session I

Track I: Quality of Manufactured Medicines –Impurities
  • Drug Product Degradation Specifications – Industry and FDA Perspectives
Speaker: Mark Argentine, Ph.D., Eli Lilly
Speaker: Abi D'sa, Ph.D, Food and Drug Administration
Track II: Quality of Manufactured Medicines–General Notices and Process Topics
  • Revised General Notices – Special Topics
Speaker: Todd L. Cecil, Ph.D., Vice President, Compendial Science
Speaker: Neil Schwarzwalder, Chair, USP General Notices Project Team and Member, USP Residual Solvents Project Team
Track III: Quality of Manufactured Medicines–General Chapters and Performance Testing–Microbiology Topics (One Day Offering)
  • Harmonized Microbial Limit Tests
  • Revised Sterility Tests
  • Mycoplasma Testing
Speaker: Radhakrishna S. Tirumalai, Ph.D., Senior Scientist, USP
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
Speaker: Donald Singer, Member, USP Microbiology and Sterility Assurance Expert Committee
Track IV: Quality of Manufactured Medicines–Drug Products
  • <1090> Assessment of Drug Product Performance--Bioavailability, Bioequivalence, and Dissolution
  • <1096> Drug Product Selection
  • Biopharmaceutics Drug Disposition Classification
Speaker: Leon Shargel, Ph.D., Member, USP Biopharmaceutics Expert Committee
Speaker: Thomas Foster, Pharm. D., Chair, USP Biopharmaceutics Expert Committee
Panelists: Nancy Jo Braden, M.D., The Phoenix Health Plan Community Connection, Karl Matuszewski, Pharm. D., University HealthSystem Consortium, and Gordon Johnston, R. Ph., GPhA
Track V: Quality of Food Ingredients (One Day Offering)
  • Inherent Impurities (Contamination)
  • Intentional Impurities (Adulteration)
  • Compendial Perspective
Speaker: Alan Rulis, Ph.D., Center for Chemical Regulations and Food Safety, Exponent
Speaker: Roger A. Clemens, Dr.Ph., MPH, Member
DS: Non–Botanicals Expert Committee, Member, USP
Food Ingredients Expert Committee, and Member, USP
Speaker: Grady W. Chism, Ph.D., Member, USP Food Ingredients
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
  • Heparin Contamination
  • Diethylene Glycol in Glycerin
  • Adulteration of Pet Food with Melamine
Speaker: William F. Koch, Ph.D., Chief Reference Materials Officer, USP and Ali Al–Hakim, Ph.D., Food and Drug Administration
Speakers: Darrell R. Abernethy, M.D., Ph.D., Chief Science Officer, USP and Abi D'sa, Ph.D, Food and Drug Administration
Speaker: Roy L. M. Dobson, Ph.D., Procter & Gamble
Track II: Quality of Manufactured Medicines–General Notices and Process Topics
  • Equivalent or Better Concept
Speaker: Walter Hauck, Ph.D., Senior Scientific Fellow, USP
Speaker: Industry Speaker: To be announced...
Track III: Quality of Manufactured Medicines–General Chapters and Performance Testing–Microbiology Topics (One Day Offering)
  • Environmental Monitoring
  • Sterility Assurance
Speaker: Radhakrishna S. Tirumalai, Ph.D., Senior Scientist, USP
Speaker: Anthony Cundell, Ph.D., Member, USP Microbiology and Sterility Assurance Expert Committee
Speaker: James Agalloco, Member, USP Microbiology and Sterility Assurance Expert Committee
Speaker: David Hussong, Member, USP Microbiology and Sterility
Track IV: Quality of Manufactured Medicines–Drug Products
Harmonization of Bioequivalence Requirements
  • Administration Simplification Approaches
  • Science and Technical Topics
Speaker: Paul Fackler, Ph.D., Teva Pharmaceuticals
Speaker: Salomon Stavchansky, Ph.D., Chair, USP International Health Expert Committee
Panelist: Craig Simon, Ph.D., Health Canada
Track V: Quality of Food Ingredients (One Day Offering)
  • Biotechnological Foods/Food Ingredients (Innovation)
  • Functional Foods/Food Ingredients (Claims)
  • Compendial Perspective
Speaker: Martina Newell–McGloughlin, D.Sc., Director University of California Systemwide Biotechnology Research and Education Program, Co–Director NIH Training Program in Biomolecular Technology, Co–Director NSF CREATE IGERT, and Adjunct Professor, Plant Pathology, UC Davis
Speaker: Fereidoon Shaidi, Ph.D., Memorial University
Speaker: Joseph F. Borzelleca, Ph.D., Medical College of Virginia Department of Pharmacology and Toxicology
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. – 9:30 a.m. Interactive General Session—<231> Heavy Metals
  • Speakers – To be announced
9:30 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
  • FDA Perspectives
  • IHC, Q3C, and VICH Residual Solvents (What and How)
Speaker: To be announced, Food and Drug Administration
Speaker: Art Faulkner, Ph.D, Pfizer
Speaker: Sue Schniepp, Independent Consultant
Track II: Quality of Manufactured Medicines–General Notices and Process Topics
  • Monograph Redesign
Speaker A: Todd Cecil, Ph.D., Vice President, Compendial Sciences, USP
Speaker B: Judy Boehlert, Ph.D., Chair, USP MD–GRE Expert Committee
Track III: Quality of Manufactured Medicines – General Chapters and Performance Testing- Packaging Topics (One Day Offering)
  • Glass Containers – Approach, Current State, Future
  • Plastic Materials and Plastic Containers
  • Elastomers – Recent Changed in <381>
Speaker: Michael Eakins, Ph.D., Vice Chair, USP Packaging and Storage Expert Committee
Speaker: Dwain Sparks, Ph.D., Member, USP Packaging and Storage Expert Committee
Speaker: Steven Nail, Ph.D., Chair, USP, Parenteral Products: Industrial Expert Committee
Track IV: Quality of Manufactured Medicines–Drug Products
  • Drug Product General Chapters by Route of Administration and <1151>
  • Drug Product PVT with Reference Materials by Route of Administration
Speaker: David Long, Ph.D., Chair, USP PDF Expert Committee
Speaker: Erika Stippler, Ph.D., Director, Dosage Form Performance Laboratory, USP
Speaker: Walter Hauck, Ph.D., Senior Scientific Fellow, USP
Track V: Quality of Food Ingredients — No session offered
Track VI: Quality of Dietary Supplements (One Day Offering)
  • Detection of Intentional Adulterants in Traditional Medicines
  • Phytoequivalence and Flexible Monograph Approach for Botanical Preparations
Speaker: Hwee–Ling Koh, Ph.D., National University of Singapore, Department of Pharmacy, Faculty of Science
Speaker: Werner Busse, Ph.D., Dr. Willmar Schwabe Pharmaceuticals
Special Topic: Quality of Veterinary Drugs (One Day Offering)
  • Performance Testing of Veterinary Dosage Forms
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
  • Genotoxic Impurities
Speaker: Peter Kasper, Ph.D., BfArM, Bonn, Germany
Speaker: Timothy J. McGovern, Ph.D., SciLucent, LLC
Track II: Quality of Manufactured Medicines–General Notices and Process Topics
  • Public Notice and Comment—New Approaches
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
Track III: Quality of Manufactured Medicines – General Chapters and Performance Testing- Packaging Topics (One Day Offering)
  • What Quality by Design (QbD) Means to Drug Packaging Materials
  • <1079> Update Good Shipping and Storage Practices
  • Application of Authentication and Track and Trace Technologies to Packaging
Speaker: To be announced, Food and Drug Administration
Speaker: Mary Foster, Member, Packaging and Storage Expert Committee
Speaker: Michael Eakins, Ph.D., Vice Chair, USP Packaging and Storage Expert Committee
Track IV: Quality of Manufactured Medicines–Drug Products
  • Quality of Design (QbD)
  • Dissolution – Short and Long–term Opportunities
  • Comparator Pharmaceutical Product Reference Material
Speaker: Arzu Selen, Ph.D., Food and Drug Administration
Speaker: Erika Stippler, Ph.D., Director, Dosage Form Performance Laboratory, USP
Speaker: James Polli, Ph.D., Member, USP Biopharmaceutics Expert Committee
Track V: Quality of Food Ingredients — No session offered

Quality of Dietary Supplements (One Day Track)
  • Role of Quality Standards on Dietary Supplements cGMP Implementation
  • New Approaches to Standard Setting via Performance–based Procedures
Speaker: Gabriel Giancaspro, Ph.D., Director, Dietary Supplements, USP
Speaker: Joseph Betz, Ph.D., Office of Dietary Supplements, National Institutes of Health
Special Topic: Quality of Veterinary Drugs (One Day Offering)
  • Raw Material Testing
Speaker: Brian Carlin, Ph.D., FMC BioPolymer
Speaker: Michael E. Oehlsen, Ph.D., Center for Veterinary Medicine

    2:00 p.m.–5:00 p.m.
    Special Topic:
    Drug Safety and Efficacy in Global Markets

Speaker A:    Denis D. Broun, M.D., UNAIDS (Joint United Nations Programme on HIV/AIDS)

Speaker B:    Anthony F. Boni, Office of Health, Infectious Diseases and Nutrition, USAID

Speaker C:    Maurice N.G. Dukes, M.D., Meyler's Side Effects of Drugs

Speaker D:    Andreas Seiter, M.D., World Bank
"Access to Quality Medicines in Low–Income Countries"

Speaker E:    Vince Suneja, U.S. Department of Commerce
"The Impact of the Globalization of the Pharmaceutical Industry on the Quality of Medicines"

Speaker F:    Zhong–Yuan Yang, Guagzhou Municipal Institute for Drug Control "Measures for Improving Drug Quality in China"

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

Track I: Closing Session –
  • Track Sessions—Next Steps
    • Impurities
    • General Notices
    • General Chapters
    • Drug Products
    • Food Ingredients and Dietary Supplements
    • Veterinary Medicine
  • Future Directions
    • Board of Trustees Strategic Plan
    • Workplan of the 2010–2015 Council of Experts
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