Wednesday Afternoon, October 21 |
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| 12:00 |
Registration |
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| 1:00 |
SHORT COURSE |
Garrett Fitzmaurice (Harvard) |
6:00 |
MIXER |
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Thursday Morning, October 22 |
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8:00 |
Continental Breakfast and Registration |
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| WELCOME AND KEYNOTE LECTURE |
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| 8:30 | Welcome and Introduction |
Donald Bennett (Biogen) Mathis Thoms (Harvard) |
| Keynote Presentation |
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| 8:45 | FDA's Critical Path Initiative: Opportunities and Challenges | ShaAvhree Buckman (FDA) |
PHARMACOLOGY/SAFETY/TOXICOLOGY/PK |
Chair: Keith Soper (Merck) |
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| Invited Presentation |
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| 9:30 | Should we Assess Tumorigenicity with the Peto or Poly-k Test? | Ralph L. Kodell (U. Arkansas Med. Sciences) |
10:15 |
Break |
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| Contributed Presentations |
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| 10:30 | Characterization of Gene Expression Profiles from Drug-Induced Liver Injury | C. Chang (FDA) |
| 11:00 | Variable Triage Using Non-Negative Matrix Factorization | J. Xia (NISS) |
| 11:30 | A Latent Pharmacokinetic Time Profile to Model Dose-Response Survival Data | T. Jacobs (UCB) |
12:00 |
Lunch and Poster Session |
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Thursday Afternoon, October 22 |
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| CHEMISTRY, MANUFACTURING & CONTROLS (CMC) |
Chairs: Charles Tan (Merck) Jinglin Zhong(FDA) |
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| Invited Presentations |
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| 1:00 | Multivariate Predictive Distributions: A Risk-Based Strategy for ICH Q8 Design Space Development |
John Peterson (GSK) |
| Contributed Presentations |
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| 1:45 | Prediction-based Design Space as a general concept for drug development ... and role for statisticians |
B. Boulanger (UCB) |
| 2:15 | Improved Protocol and Data Analysis for Accelerated Shelf-Life Estimation of Solid Dosage Forms |
A. Carella (Pfizer) |
2:45 |
Break |
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| DISCOVERY/EARLY DEVELOPMENT/-OMICS | Chair: Fred Immermann (Wyeth) |
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| Invited Presentation |
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| 3:00 | Dynamic Analyses of Neural Signals | Emery N. Brown (Harvard-MIT) |
| Contributed Presentations |
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| 3:45 | Portable Linear Prediction Rules for Classification and Prediction with an Application to Toxicogenomics |
N. Raghavan (J&J) |
| 4:15 | Detecting Drug Levels in the Brain using EEG Data | P. Brain (Pfizer) |
| 4:45 | Dose-Response Assay Equivalence with Replicate Data |
S. Novick (GSK) |
5:15 |
Group Photograph |
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| 5:45 |
Poster Session & Refreshment |
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Conference Dinner |
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| 7:00 | Welcome by Department Chair |
Victor DeGruttola (Dept. of Biostatistics, HSPH) |
| Invited Dinner Presentation |
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| 7:10 |
Megatrends for the Statistics Profession | Steve Ruberg (Lilly) |
| 8:00 | Dinner at Elements Cafe |
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Friday Morning, October 23 |
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8:00 |
Continental Breakfast |
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| DISCOVERY/EARLY DEVELOPMENT/-OMICS |
Chair: Fred Immermann |
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| Invited Presentation |
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| 8:30 | The Importance of Simple Tests in High-Throughput Biology | Keith Baggerly (MD Anderson Cancer Center) |
| Contributed Presentations |
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| 9:15 | An Integrated 'Omics' Approach to Biomarker Discovery in Translational Medicine Research | J. Kasturi (J&J) |
| 9:45 | Data Analysis Approaches for Modern Cell Biology Techniques |
A. Handzel (Merck) |
10:15 |
Break |
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| CHEMISTRY, MANUFACTURING & CONTROLS (CMC) |
Chairs: Charles Tan (Merck) Jinglin Zhong (FDA) |
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| Invited Presentation |
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| 10:30 | Quality Considerations in the Establishment of Specifications for Pharmaceuticals |
Dennis Sandell (Siegfried), Terry Tougas(Boehringer) |
| Contributed Presentation |
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| 11:15 | The Mean versus Individual Measurements: A Key to Developing a Risk Based Quality System |
T. Schofield (GSK) |
11:45 |
Lunch |
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Friday Afternoon, October 23 |
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| CHEMISTRY, MANUFACTURING & CONTROLS (CMC) |
Chairs: Charles Tan (Merck) Jinglin Zhong (FDA) |
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| Contributed Presentations |
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| 1:00 | Evaluations of Parallelism Test Methods Using ROC Analysis |
H. Yang (MedImmune) |
| 1:30 | Using a Tolerance Interval Approach to set Quality Specification and Sampling Acceptance Plan of Delivery Dose Uniformity | Y. Tsong (FDA) |
PHARMACOLOGY/SAFETY/TOXICOLOGY/PK |
Chair: Keith Soper |
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| Invited Presentation |
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| 2:00 | Kidney Toxicity Biomarker Qualification: A Journey Along the Critical Path | Dan Holder (Merck) |
| Contributed Presentation |
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| 2:45 | Statistical Aspects of Allometric Scaling in Pharmaceutical Research | L. Bijnens (J&J) |
3:15 |
Break |
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| Contributed Presentation |
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| 3:30 | Experimental Design for Pop-PK Modeling |
X. Hou (Merck) |
OTHER/METHODOLOGY |
Chair: Bill Pikounis (Johnson & JOhnson) |
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| Contributed Presentations |
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| 4:00 | Expected Design Space: A Bayesian Perspective based on Modeling, Prediction, and Multi-Criteria Decision Method | P. Lebrun (Ulg, Belgium) |
| 4:30 | Meta-Analysis and Combining Information in fMRI |
M. Vangel (MGH) |
| 5:00 | Conference Wrap-Up |
James Colaianne (Johnson & Johnson) |