JSM 2011 Online Program
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Activity Details
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| 293 | Tue, 8/2/2011, 8:30 AM - 10:20 AM | CC-D236 | |
| Topics in Nonclinical Biostatistics for Biologics — Topic Contributed Papers | |||
| Biopharmaceutical Section | |||
| Organizer(s): Bert Gunter, Genentech Inc., Priya Kulkarni, Genentech Inc. | |||
| Chair(s): Priya Kulkarni, Genentech Inc. | |||
| 8:35 AM | Parallelism for a Sigmoid Curve in Assay Development — Jason Liao, Teva Branded Pharmaceutical Products R&D, Inc. | ||
| 8:55 AM | Regression to the Rescue: The Use of Statistical DOE to Derive a Novel Manufacturing Control Strategy for Ensuring the Quality of an Antibody-Drug Conjugate — Lisa J. Bernstein, Genentech Inc. ; Daniel A. Coleman, Genentech Inc. | ||
| 9:15 AM | Statistical Considerations for Defining Cut Points and Titers in Anti-Drug Antibody (ADA) Assays — Ken Goldberg, Johnson & Johnson Pharmaceutical R&D, LLC ; Sheng Dai, Johnson & Johnson Pharmaceutical R&D, LLC ; Allen Schantz, Johnson & Johnson Pharmaceutical R&D, LLC | ||
| 9:35 AM | Statistical Issues in Estimating, Tracking, and Comparing Complex Nonlinear Parameters Determined When Developing and Manufacturing Biologics — Patrick J. Gaffney, ImClone Systems ; Anthony Lonardo, ImClone Systems | ||
| Discussant: Bill Pikounis, Johnson & Johnson Pharmaceutical R&D, LLC | |||
| 10:15 AM | Floor Discussion | ||
2011 JSM Online Program Home
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