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Drug Safety
Gordon Research Conference

Improving Drug Safety: From Innovation in the Lab to Application in the Clinic

Dates

June 26 - July 1, 2016

Location

Stonehill College
Easton, MA

Organizers

Chair:
Thomas Schroeter

Vice Chair:
James L. Stevens

Meeting Description

The Drug Safety Gordon Research Conference is a leading venue for discussing contemporary approaches to drug safety assessment and to translate innovation in the lab to clinical drug safety research. Building on the momentum of a very successful inaugural meeting, for the 2016 Conference, experts and thought leaders from academia, industry and regulatory agencies will discuss the latest development and application of innovative methodologies for pharmaceutical risk assessment. The meeting sessions are organized to parallel the flow of knowledge in drug discovery and development beginning with computational models and systems biological approaches to drug safety assessment, through microphysiological systems and on to the pivotal transition to clinical development before addressing post marketing concerns. The conference will also feature a session on drug safety of biologics, a timely and important topic for which classical drug safety tools often don't suffice. For the first time, a Gordon Research Seminar on Drug Safety will be held in conjunction with the conference and will provide young researchers and early-career scientists the opportunity to present and discuss their current research with their peers. Networking and the free exchange of ideas is an important part to the success of the conference. Participants will have the opportunity to present their cutting-edge work in poster format during session breaks in a relaxed setting that stimulates open dialogues which often carry on into the social activities during the afternoon sessions and at the bar at the end of the day. A committee will select some posters for short oral presentations that will be featured during late-breaking sessions, allowing those participants to share their work with leading experts in their field and to receive feedback from an audience of experts.

Related Meeting

This GRC was held in conjunction with the "Drug Safety" Gordon Research Seminar (GRS). Refer to the associated GRS program page for more information.

Contributors

Final Meeting Program

Sunday
2:00 pm - 9:00 pmArrival and Check-in
6:00 pmDinner
7:30 pm - 7:40 pmWelcome / Introductory Comments by GRC Site Staff
7:40 pm - 9:30 pmKeynote Session: Network Pharmacology and Toxicology
Discussion Leader: David Watson (Eli Lilly and Company, USA)
7:40 pm - 7:45 pmIntroduction by Discussion Leader
7:45 pm - 8:45 pmRavi Iyengar (Icahn Sinai School of Medicine at Mount Sinai, USA)
"Systems Approaches for Understanding Drug Toxicity"
8:45 pm - 9:30 pmDiscussion
Monday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmComputational Toxicology and Systems Biology
Discussion Leader: Jeffrey Sutherland (Sano Informed Prescribing, USA)
9:00 am - 9:05 amIntroduction by Discussion Leader
9:05 am - 9:45 amWeida 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 amDiscussion
10:05 am - 10:30 amCoffee Break
10:30 am - 11:10 amRichard Judson (U.S. Environmental Protection Agency, USA)
"Using Computational Toxicology to Enable Risk-Based Chemical Safety Decision Making"
11:10 am - 11:30 amDiscussion
11:30 am - 11:50 amSelected 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 pmDiscussion
12:00 pm - 12:20 pmSelected 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 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmStem Cells and Tissue Engineering – Advances, Opportunities, Limitations
Discussion Leader: Myrtle Davis (National Cancer Institute, NIH, USA)
7:30 pm - 7:35 pmIntroduction by Discussion Leader
7:35 pm - 8:15 pmJoseph Wu (Stanford Cardiovascular Institute, Stanford University School of Medicine, USA)
"IPSCs for Precision Medicine and Drug Discovery"
8:15 pm - 8:25 pmDiscussion
8:25 pm - 9:05 pmSelected 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 pmDiscussion
9:15 pm - 9:25 pmSelected from Poster Abstracts: Ilka Maschmeyer (TissUse, Germany)
"Mulit-Organ-Chip Developments: Towards a Paradigm Shift in Drug Development"
9:25 pm - 9:30 pmDiscussion
Tuesday
7:30 am - 8:30 amBreakfast
8:30 amGroup Photo
9:00 am - 12:30 pmApplications 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 amIntroduction by Discussion Leader
9:05 am - 9:45 amAnthony Bahinski (GlaxoSmithKline, USA)
"Human Organs-on-Chips"
9:45 am - 10:05 amDiscussion
10:05 am - 10:30 amCoffee Break
10:30 am - 11:10 amJonathan Himmelfarb (University of Washington, USA)
"Human Kidney on a Chip: A Microphysiological System Useful for Nephrotoxicity Assessment"
11:10 am - 11:30 amDiscussion
11:30 am - 12:10 pmJohn Wikswo (Vanderbilt University, USA)
"Modular Architectures and Control Strategies for Coupled Microphysiological Systems"
12:10 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmDrug Safety of Large Molecules: Translational Safety
Discussion Leader: Joy Cavagnaro (Access BIO, LC, USA)
7:30 pm - 7:35 pmIntroduction by Discussion Leader
7:35 pm - 8:15 pmShawn 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 pmDiscussion
8:25 pm - 9:05 pmHelen Haggerty (Bristol-Myers Squibb, USA)
"Targeting CD28 Post TeGenero: Translating Preclinical Safety to the Clinic"
9:05 pm - 9:15 pmDiscussion
9:15 pm - 9:25 pmSelected 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 pmDiscussion
Wednesday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmModeling Clinical Drug Toxicity
Discussion Leader: Vikram Sinha (Merck & Co., Inc, USA)
9:00 am - 9:05 amIntroduction by Discussion Leader
9:05 am - 9:45 amDonald Mager (University at Buffalo, State University of New York, USA)
"Toxicodynamic Modeling of Anticancer Drug Adverse Effects"
9:45 am - 10:05 amDiscussion
10:05 am - 10:30 amCoffee Break
10:30 am - 11:10 amPaul 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 amDiscussion
11:30 am - 12:10 pmThomas 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 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:00 pm - 7:30 pmBusiness 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 pmTranslational Safety and Patient Tailoring
Discussion Leader: Donna Mendrick (U.S. Food and Drug Administration, USA)
7:30 pm - 7:35 pmIntroduction by Discussion Leader
7:35 pm - 8:15 pmElizabeth Phillips (Vanderbilt University, USA)
"Translational Drug Safety: Predicting and Preventing Severe Immunologically Mediated Drug Reactions"
8:15 pm - 8:35 pmDiscussion
8:35 pm - 9:15 pmDavid 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 pmDiscussion
Thursday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmPharmacovigilance and Leveraging Big Data to Detect Safety Signals
Discussion Leader: Michael von Forstner (Acino Pharma AG, Switzerland)
9:00 am - 9:05 amIntroduction by Discussion Leader
9:05 am - 9:45 amAndrew Bate (Pfizer, United Kingdom)
"Pharmacovigilance's New Frontier - Innovating to Ensure Operational Value of Big Data"
9:45 am - 10:05 amDiscussion
10:05 am - 10:30 amCoffee Break
10:30 am - 11:10 amOlaf 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 amDiscussion
11:30 am - 11:50 amSelected from Poster Abstracts: Tal Lorberbaum (Columbia University, USA)
"Big Data + Small Experiments: Discovery and Validation of Drug-Drug Interactions"
11:50 am - 12:00 pmDiscussion
12:00 pm - 12:20 pmSelected 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 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmKeynote Session: Pharmacogenomics in Drug Safety Assessment
Discussion Leader: Cindy Afshari (Amgen Inc., USA)
7:30 pm - 7:35 pmIntroduction by Discussion Leader
7:35 pm - 8:35 pmSir Munir Pirmohamed (University of Liverpool, United Kingdom)
"ADR Pharmacogenomics: From Discovery to Implementation"
8:35 pm - 9:20 pmDiscussion
9:20 pm - 9:30 pmClosing Remarks
Friday
7:30 am - 8:30 amBreakfast
9:00 amDeparture
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