Sunday |
2:00 pm - 9:00 pm | Arrival and Check-in |
6:00 pm | Dinner |
7:30 pm - 7:40 pm | Welcome / Introductory Comments by GRC Site Staff |
7:40 pm - 9:30 pm | Keynote Session: Network Pharmacology and Toxicology |
| Discussion Leader: David Watson (Eli Lilly and Company, USA) |
7:40 pm - 7:45 pm | Introduction by Discussion Leader |
7:45 pm - 8:45 pm | Ravi Iyengar (Icahn Sinai School of Medicine at Mount Sinai, USA) "Systems Approaches for Understanding Drug Toxicity" |
8:45 pm - 9:30 pm | Discussion |
Monday |
7:30 am - 8:30 am | Breakfast |
9:00 am - 12:30 pm | Computational Toxicology and Systems Biology |
| Discussion Leader: Jeffrey Sutherland (Sano Informed Prescribing, USA) |
9:00 am - 9:05 am | Introduction by Discussion Leader |
9:05 am - 9:45 am | Weida Tong (National Center for Toxicological Research, Food and Drug Administration, USA) "Of Text and Gene: Analysis of Big Data in Toxicogenomics with Text Mining Methods" |
9:45 am - 10:05 am | Discussion |
10:05 am - 10:30 am | Coffee Break |
10:30 am - 11:10 am | Richard Judson (U.S. Environmental Protection Agency, USA) "Using Computational Toxicology to Enable Risk-Based Chemical Safety Decision Making" |
11:10 am - 11:30 am | Discussion |
11:30 am - 11:50 am | Selected from Poster Abstracts: Kenichi Shimada (Harvard Medical School, USA) "Systematic Analysis of Open TG-GATEs Reveal Mechanistic Insights in Multiple DILI Pathologies" |
11:50 am - 12:00 pm | Discussion |
12:00 pm - 12:20 pm | Selected from Poster Abstracts: Nicole Muszynski (Vanderbilt University, USA) "Rapid Threat Assessment: Bridging the Gap Between Multi-Omic Network Analysis and Biological Mechanism of Action of Drugs and Toxins" |
12:20 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:30 pm - 9:30 pm | Stem Cells and Tissue Engineering – Advances, Opportunities, Limitations |
| Discussion Leader: Myrtle Davis (National Cancer Institute, NIH, USA) |
7:30 pm - 7:35 pm | Introduction by Discussion Leader |
7:35 pm - 8:15 pm | Joseph Wu (Stanford Cardiovascular Institute, Stanford University School of Medicine, USA) "IPSCs for Precision Medicine and Drug Discovery" |
8:15 pm - 8:25 pm | Discussion |
8:25 pm - 9:05 pm | Selected from Poster Abstracts: Ksenia Blinova (Food and Drug Administration, USA) "In Vitro Clinical Trial with Personalized iPS-Cardiomyocytes Compared to Actual Clinical Trial Results of 2 QT Prolonging Drugs" |
9:05 pm - 9:15 pm | Discussion |
9:15 pm - 9:25 pm | Selected from Poster Abstracts: Ilka Maschmeyer (TissUse, Germany) "Mulit-Organ-Chip Developments: Towards a Paradigm Shift in Drug Development" |
9:25 pm - 9:30 pm | Discussion |
Tuesday |
7:30 am - 8:30 am | Breakfast |
8:30 am | Group Photo |
9:00 am - 12:30 pm | Applications of Microphysiologic Systems to Drug Safety Assessment |
| Discussion Leader: Rachelle Prantil-Baun (Wyss Institute for Biologically Inspired Engineering, Harvard University, USA) |
9:00 am - 9:05 am | Introduction by Discussion Leader |
9:05 am - 9:45 am | Anthony Bahinski (GlaxoSmithKline, USA) "Human Organs-on-Chips" |
9:45 am - 10:05 am | Discussion |
10:05 am - 10:30 am | Coffee Break |
10:30 am - 11:10 am | Jonathan Himmelfarb (University of Washington, USA) "Human Kidney on a Chip: A Microphysiological System Useful for Nephrotoxicity Assessment" |
11:10 am - 11:30 am | Discussion |
11:30 am - 12:10 pm | John Wikswo (Vanderbilt University, USA) "Modular Architectures and Control Strategies for Coupled Microphysiological Systems" |
12:10 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:30 pm - 9:30 pm | Drug Safety of Large Molecules: Translational Safety |
| Discussion Leader: Joy Cavagnaro (Access BIO, LC, USA) |
7:30 pm - 7:35 pm | Introduction by Discussion Leader |
7:35 pm - 8:15 pm | Shawn Heidel (Covance, Inc., USA) "Preclinical Safety of Biologics Requires a Case-by-Case Approach to Maximize Translation to the Clinic" |
8:15 pm - 8:25 pm | Discussion |
8:25 pm - 9:05 pm | Helen Haggerty (Bristol-Myers Squibb, USA) "Targeting CD28 Post TeGenero: Translating Preclinical Safety to the Clinic" |
9:05 pm - 9:15 pm | Discussion |
9:15 pm - 9:25 pm | Selected from Poster Abstracts: Marie-Clare St. Rose (Pfizer Inc., USA) "Human and Cynomolgus Monkey Cytokine Release Assays with Blood Outgrowth Endothelial Cells May Improve Preclinical Hazard Prediction" |
9:25 pm - 9:30 pm | Discussion |
Wednesday |
7:30 am - 8:30 am | Breakfast |
9:00 am - 12:30 pm | Modeling Clinical Drug Toxicity |
| Discussion Leader: Vikram Sinha (Merck & Co., Inc, USA) |
9:00 am - 9:05 am | Introduction by Discussion Leader |
9:05 am - 9:45 am | Donald Mager (University at Buffalo, State University of New York, USA) "Toxicodynamic Modeling of Anticancer Drug Adverse Effects" |
9:45 am - 10:05 am | Discussion |
10:05 am - 10:30 am | Coffee Break |
10:30 am - 11:10 am | Paul Watkins (UNC School of Pharmacy Institute for Drug Safety Sciences, USA) "Modeling Idiosyncratic Hepatotoxicity: Progress and Challenges of DILIsim Initiative" |
11:10 am - 11:30 am | Discussion |
11:30 am - 12:10 pm | Thomas Eissing (Bayer Technology Services GmbH, Germany) "Physiologically-Based
and Mechanistic Modeling to Integrate and Translate Knowledge to Assess the
Efficacy and Safety of Drugs" |
12:10 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:00 pm - 7:30 pm | Business Meeting |
| Nominations for the Next Vice Chair; Fill in Conference Evaluation Forms; Discuss Future Site and Scheduling Preferences; Election of the Next Vice Chair |
7:30 pm - 9:30 pm | Translational Safety and Patient Tailoring |
| Discussion Leader: Donna Mendrick (U.S. Food and Drug Administration, USA) |
7:30 pm - 7:35 pm | Introduction by Discussion Leader |
7:35 pm - 8:15 pm | Elizabeth Phillips (Vanderbilt University, USA) "Translational Drug Safety: Predicting and Preventing Severe Immunologically Mediated Drug Reactions" |
8:15 pm - 8:35 pm | Discussion |
8:35 pm - 9:15 pm | David Strauss (U.S. Food and Drug Administration, USA) "Novel Clinical Biomarkers, Induced Pluripotent Stem Cells and Clinical Trials in a Dish for Cardiac Toxicity of New Drugs" |
9:15 pm - 9:30 pm | Discussion |
Thursday |
7:30 am - 8:30 am | Breakfast |
9:00 am - 12:30 pm | Pharmacovigilance and Leveraging Big Data to Detect Safety Signals |
| Discussion Leader: Michael von Forstner (Acino Pharma AG, Switzerland) |
9:00 am - 9:05 am | Introduction by Discussion Leader |
9:05 am - 9:45 am | Andrew Bate (Pfizer, United Kingdom) "Pharmacovigilance's New Frontier - Innovating to Ensure Operational Value of Big Data" |
9:45 am - 10:05 am | Discussion |
10:05 am - 10:30 am | Coffee Break |
10:30 am - 11:10 am | Olaf Klungel (Utrecht University, The Netherlands) "Value of Observational Research on Post-Licensing Drug Safety and Effectiveness: Importance of Robust Pharmacoepidemiologic Methods" |
11:10 am - 11:30 am | Discussion |
11:30 am - 11:50 am | Selected from Poster Abstracts: Tal Lorberbaum (Columbia University, USA) "Big Data + Small Experiments: Discovery
and Validation of Drug-Drug Interactions" |
11:50 am - 12:00 pm | Discussion |
12:00 pm - 12:20 pm | Selected from Poster Abstracts: Jeff Macdonald (University of North Carolina, USA) "Real-Time Bioenergetic and Fluxomic Datasets for Safe Dose Determination and Drug Safety Discovery" |
12:20 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:30 pm - 9:30 pm | Keynote Session: Pharmacogenomics in Drug Safety Assessment |
| Discussion Leader: Cindy Afshari (Amgen Inc., USA) |
7:30 pm - 7:35 pm | Introduction by Discussion Leader |
7:35 pm - 8:35 pm | Sir Munir Pirmohamed (University of Liverpool, United Kingdom) "ADR Pharmacogenomics: From Discovery to Implementation" |
8:35 pm - 9:20 pm | Discussion |
9:20 pm - 9:30 pm | Closing Remarks |
Friday |
7:30 am - 8:30 am | Breakfast |
9:00 am | Departure |