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Thursday, February 7, 2008
8:30 am – 12:00 pm
Lessons Learned from Experience
8:00 am
Welcome/Introductions
Douglas M. Fast, Ph.D.
Pfizer, Inc.
8:45 am
Incurred Sample Repeat Analysis: Regulatory Perspective
Jacqueline O’Shaughnessy, Ph.D.
U.S. Food and Drug Administration
9:15 am
Incurred Sample Reanalysis – Is it Insurance for a Weak Assay?
Jo Marie Smolec, Ph.D.
Intertek-ALTA Immunochemistry
9:45 am
Incurred Sample Reanlysis for Chromatographic Assays-Popular Approaches to Date
Steve Lowes, Ph.D.
Advion Biosciences
10:45 am
Did Incurred Samples Reanalyis Raise Confidence in Bioanalytical Results?
Surendra Bansal, Ph.D.
Hoffmann-LaRoche, Inc.
11:15 am
Incurred Sample Reanalysis-European Bioanalysis Forum's Perspective and Experience
Philip Timmerman
European Bioanalysis Forum
11:45 am
Panel Discussion
1:00 pm
Presentation of Survey Results
Russell S. Weiner, Ph.D.
Bristol-Myers Squibb Company
1:30 pm – 5:00 pm
Concurrent Breakout Sessions
1:30 pm – 2:30 pm
Breakout Session I: Large Molecules
1:30 pm
Incurred Sample Analysis for Macromolecular Therapeutics:Case Studies Discussion
Binodh DeSilva, Ph.D.
Amgen, Inc.
1:30 pm - 2:30 pm
Breakout Session I - Small Molecules
When and How to Demonstrate Assay Reproducibility
Moderator
Douglas M. Fast, Ph.D.
Pfizer, Inc.
1:30 pm
Repeat Analysis and Statistics - An Example
Min Chang, Ph.D.
Abbott Laboratories, Inc.
2:00 pm
How and When to Establish Incurred Sample Reproducibility for Clinical Samples
John Smeraglia, M.Sc.
Pfizer, Inc.
2:30 pm - 4:00 pm
Breakout Session II: Large Molecules
2:30 pm
Incurred Sample Analysis:Practical Aspects of the Process
Marie Rock
Midwest BioResearch
3:30 pm
Incurred Sample Analysis: Practical Aspects of the Process (Continued)
Marie Rock
Midwest BioResearch LLC
2:30 pm - 4:00 pm
Breakout Session II: Small Molecules
How to Select Samples for Reanalysis
Daniel Tang, Ph.D.
Shanghai ChemPartner Co., LTD.
2:30 pm
An Example of Sample Selection Process for Incurred Sample Reanalysis to Ensure Assay Reproducibility:
Pros and Cons
Qin Ji, Ph.D.
Covance Laboratories
3:30 pm
Issues and Paradigms in Selecting Incurred Samples for Reanalysis
Saleh Hussain, Ph.D.
Anapharm-a Pharmanet Company
4:00 pm - 5:00 pm
Breakout Sesson III: Large Molecules
Acceptance Criteria and Potential Outcomes
Moderator
Steve Keller, Ph.D.
PDL BioPharma, Inc.
4:00 pm
Statistical Recommendations in the Evaluation of Incurred Sample Reproducibility
Viswanath Devanarayan, Ph.D.
Abbott Laboratories
4:30 pm
Outcomes and Consequences of Incurred Sample Reproducibility Assessment
Mario Rocci, Ph.D.
Prevalere Life Sciences, Inc.
4:00 pm – 5:00 pm
Breakout Session III: Small Molecules
Acceptance Criteria for Incurred Sample Reanalysis and How Should Reanalysis Results be Reported
Anthony J. DeStefano, Ph.D.
Procter and Gamble
Friday, February 8, 2008
8:30 am – 9:30 am
Concurrent Breakout Sessions (Continued)
8:30 am – 9:30 am
Breakout Session IV: Large Molecules
Documentation
Marian Kelley
Centorcor R&D, Inc.
8:30 am – 9:30 am
Breakout Session IV: Small Molecules
Impact on Study if Reproducibility Fails, Follow-up and Investigation
Ajai Chaudhary, Ph.D.
Eli Lilly and Company
10:30 am
Reports from Breakout Sessions
11:15 am
Panel Discussion
12:00 pm
Adjournment
Closing Remarks
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