Institute for International Research

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Monday, January 21, 2008

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1:30-5:00 pm
PM Workshop: Vaccine Formulation & Stability Strategies
Dr. Ian C. Boulton, Former Development Scientist, Formulation & Stability, SANOFI-PASTEUR, President and Chief Scientific Officer, THE IMAGO GROUP

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Tuesday, January 22, 2008

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9:15 am
Relating Protein-Osmolyte Interactions to Protein Stability
David Wayne Bolen, PhD, Professor of Biochemistry & Molecular Biology, UNIVERSITY OF TEXAS MEDICAL BRANCH

1:45 pm
Track A: Formulation Track
Case Study: Formulation for Lyophilized Proteins: Fast Dynamics as an Indicator of Protein Stability in Glass
Marcus T. Cicerone, Polymers Division, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

2:30 pm
Track B: Forced Degradation/Analytical Track
Case Study: Detection and Quantitation of Oxidation in Monoclonal Antibodies
Jianming Mo, PhD, PFIZER

3:00 pm
Track A: Formulation Track
Case Studies: Explore the Potential for Determining Leachables Using HPLC Multi-Detection Systems
James F. Castner, PhD, Senior Principal Research Scientist, BRISTOL MYERS SQUIBB- MEDICAL IMAGING

4:15 pm
Track B: Forced Degradation/Analytical Track
Case Study: Laboratory Models for Induction of Protein Degradation/Aggregation: Evaluating Processing Steps in Manufacturing
Don Eisenhauer, PhD, Research Investigator, ABBOTT LABORATORIES

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Wednesday, January 23, 2008

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9:00 am
Case Study: Formulation and Forced Degradation Considerations in Vial and Dual Chamber Cartridge and/or Syringe
Susan W.H. Martin, PhD, Principal Scientist, PFIZER, PHARMACEUTICAL, R&D-GLOBAL BIOLOGICS

3:15 pm
Track B: Forced Degradation/Analytical Track
Case Studies: Deamidation in Protein Drug Formulations
Elizabeth M. Topp, PhD, Professor, Department of Pharmaceutical Chemistry, THE UNIVERSITY OF KANSAS

3:45 pm
Panel Discussion: Orthogonal Methods and Characterization Technologies To Characterize Degradants and Aggregates
Dingjiang Liu, PhD, Principal Scientist, Department of Protein Formulation, Amgen