Model Based Drug Development
Loews Philadelphia Hotel
1200 Market Street
Philadelphia, PA

Schedule of Presentations:

Monday, January 12, 2009
08:00:00 (Workshop) : Registration Opens / Breakfast and Coffee
10:30:00 WORKSHOP : Networking and Refreshment Break
12:15:00 WORKSHOP : Lunch for Workshop Attendees
12:15:00 Registration for Main Conference
13:15:00 Chairperson's Introduction and Brief Topic Overview David Moskowitz
13:30:00 KEYNOTE PRESENTATION : The Use of Decision Analytic Paradigms to Reduce Uncertainty in Drug Development Anis Khan, Rajesh Krishna
14:15:00 KEYNOTE PRESENTATION ON PHARMACOMETRICS : Beyond PK/PD Modeling: The Use of Pharmacometrics to Increase Quantitative Decision Making, Reduce Speculation, and Increase FDA Approval Rates Jeffrey S Barrett
15:00:00 Networking & Refreshment Break
15:30:00 FAILING EARLY WITH BIOMARKERS CAN WE STEP TWICE INTO THE SAME RIVER? : Using Genomic Modeling and Translational Informatics in Pre-Clinical Research to Establish Better Biomarkers and Make the GO/ NO GO Decision Earlier and with more Accuracy Sandor Szalma
16:30:00 CASE STUDY- MIXED EFFECTS MODELING : Utilizing Mixed Effects Modeling to Integrate Complex Information from Multiple Endpoints into Easy to Interpret Quantitative Measurements for Dose Prediction and Drug Interaction Rick Fang
17:15:00 Day One Concludes
Tuesday, January 13, 2009
08:00:00 Breakfast and Coffee
09:00:00 Chairman's Recap of Day One David Moskowitz
09:15:00 CASE STUDY-IN SILICO AND IN VITRO MODELING : Defining a New Platform for Drug Discovery and Jay Wu
10:00:00 CASE STUDY- IN VITRO/IN VIVO CORRELATION MODELING : Use of Non-Linear Fixed Effects Modeling to succesfully develop an IVIVC, supporting optimal dissolution specification setting for launch An Vermeulen
10:45:00 Networking & Refreshment Break
11:15:00 CASE STUDY- IN VITRO TOXICITY MODELING : Drug-Induced Liver Toxicity Study: Evaluating Hepatotoxicity Using Cell Based Imaging Assays Lei Guo
12:00:00 Lunch
13:15:00 MODELING TO OPTIMIZE TRIAL DESIGN : Clinical Trial Simulation: An Integration tool to design a POC anti-infective agent trial Hui Holly Kimko
14:00:00 IN SILICO MODELING : Using Innovative Modeling and Simulation Strategies in the Development of Therapeutic Monocolonal Antibodies Chee Ng
14:45:00 PANEL DISCUSSION ON PROTEOMICS : The Future of Small Molecules: Will Proteomics Supplant Small Molecules as the Platform for Drug Development?
15:45:00 Conference Concludes
3D Tissue Models
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