Drug Safety Strategies to De-Risk Compounds
World Trade Center Boston
200 Seaport Boulevard
Boston, MA 02210
Drug Safety Strategies to De-Risk Compounds  
Drug Discovery

Schedule of Presentations:

Wednesday, August 5, 2009
07:30:00 Registration and Coffee
08:10:00 Conference Chair Opening Remarks Vivek Kadambi
08:15:00 Improving Hepatotoxicity Models
08:15:00 Non-Clinical Findings Predicting for Human Liver Injury (Including Idiosyncratic) Carl L. Alden
08:40:00 Novel Approaches for Drug Development Using Mice with Humanized Livers Katsutoshi Yoshizato
09:05:00 Engineering Microscale Liver Models for Drug Development Salman R. Khetani
09:30:00 Imaging Techniques for Assessing Toxicity in Primary Human Hepatocytes Eric Tien
09:35:00 Conference Keynote
09:55:00 William B. Mattes, Ph.D. Skirting Drug Safety Potholes in the Critical Path to POC William B. Mattes
10:20:00 Networking Refreshment Break in Exhibit & Poster Hall
10:25:00 Biomarker Development Strategies
11:00:00 Leveraging Resources to Advance Drug Development: A Consortium Model for Biomarkers Research Shawnmarie Mayrand-Chung
11:25:00 Regulatory Perspective on Qualification & Implementation of PET & Radiolabeled Imaging Biomarkers in Multicenter Clinical Trials George Q. Mills
11:30:00 Strategic Discussion Group
11:50:00 What Is Needed From Biomarkers for Preclinical and Clinical Testing? Wendy Sanhai, George Q. Mills, William B. Mattes
12:30:00 Networking Luncheon in Exhibit & Poster Hall
12:35:00 Improving Models of Cardiovascular Toxicity
14:00:00 Pure Murine Embryonic Stem Cell-derived Cardiomyocytes: A Predictive Tool for the Assessment of Cardiotoxicity Heribert Bohlen
14:35:00 QTempo: A More Sensitive, Accurate Alternative to the hERG Assay Utilizing Pluripotent Stem Cell-derived Beating Cardiomyocytes Yasuyuki Asai
15:10:00 Therapeutic Benefit Versus Cardiovascular Toxicity with Anticancer Therapy Vivek Kadambi
15:45:00 Networking Refreshment Break in Exhibit & Poster Hall
15:55:00 Emerging Technologies and Models to Improve Predictivity from Preclinical to Clinical
16:30:00 Application of Omic Technologies to Identify Biomarkers of Toxicity Donna L. Mendrick
16:55:00 Human Proximal Tubule Cell Monolayers: A New Approach to Understand Renal Drug-drug Interactions Colin D A Brown
17:10:00 POINT: Animal models have limitations in predicting human safety
17:15:00 COUNTERPOINT: Animal models are useful today in predicting human safety
17:20:00 Are Animal Models of Disease Predictive of Human Drug Safety? Alain Stricker-Krongrad, Vivek Kadambi, Lauren E. Black, Tim MacLachlan, Jim Murray
18:00:00 Attendee Networking Dinner
Thursday, August 6, 2009
08:45:00 Conference Chair Opening Remarks Eric A Blomme
08:50:00 Case Studies of Translational Approaches from Preclinical Models to Man
08:55:00 Leveraging Clinical Hepatoxicity Information to Better Understand Mechanisms for Early Drug Discovery Jeremy Jenkins
09:30:00 Drug-Induced Delay in Cardiac Conduction - An Elixir Pharmaceuticals Case Study to Identify Mechanism and De-Risk Backups Rory Curtis, Michael R. Gralinski
10:10:00 Networking Refreshment Break
10:40:00 Safety Assessment of Proarrhythmic Potential of Cardiac Drugs Lin Wu
11:10:00 Three Case Studies of Strategic Use of Novel Technologies in Toxicology to De-risk Compounds Eric A Blomme
11:40:00 An in vitro and in vivo Evaluation of the Off-Target Profile of the CETP Inhibitor, Torcetrapib Michael J. Forest
12:10:00 Networking Luncheon with Attendee/Speaker Chat Sessions
12:15:00 Drug-Induced Mitochondrial Dysfunction Yvonne Will
12:20:00 Progress in the Development of Human Models of ADMET via Humanized Mice or Human Based Systems Colin D A Brown
12:50:00 Applying "Omics' Technologies to Identify Toxicity Biomarkers Donna L. Mendrick
12:50:00 Predicting for Human Cardiovascular Toxicity Vivek Kadambi, Lin Wu
13:00:00 Imaging for Hepatotoxicity Eric Tien
13:10:00 How Can Systems Biology Help in De-risking Molecules? David Cook
13:30:00 A 28-Day Mechanistic Safety Study in Rhesus Monkeys on Hepatitis C Virus Protease Inhibitor BILN 2061: A Case Study of Lessons Learned from One Compound's Attrition Due to Toxicity that Aided Decisions on Follow-up Compound Selections James H. Stoltz
13:50:00 in silico Methods in Drug Safety Josef Scheiber
14:00:00 Preclinical Studies to Support Selection of First-in-Human Dose of XOMA 052, A Novel Monoclonal Antibody Targeting IL-1 beta Kathleen Meyer
14:05:00 Making Better Decisions on Compound Selection and De-Selection from Preclinical Safety Data: Systems Biology, Computational and in silico Approaches
14:30:00 Early Risk Identification Using Novel Multidimensional Data Mining Technology Mohammad Afshar
15:00:00 Networking Refreshment Break
15:30:00 Developing Computational Biology in Toxicology: Predictions, Data and Culture Sherri Matis-Mitchell
16:00:00 A Systems Biology Approach to Identifying Biomarkers for Efficacy and Toxicity of Drugs Keith O. Elliston
16:30:00 Close of Conference
18:15:00 Announcements
18:20:00 End of the drug discovery and development week
3D Tissue Models
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