Sunday
2:00 pm - 9:00 pm
Arrival and Check-in
6:00 pm - 7:00 pm
Dinner
7:30 pm - 7:40 pm
Introductory Comments by GRC Site Staff / Welcome from the GRC Chair
7:40 pm - 9:30 pm
Keynote Session: Modeling Complex Biological Systems
The opening keynote presentations address network approaches to modeling the evolution and development of complex biological systems. Understanding how nonclinical results translate to human starts with understanding how complex systems develop and evolve across scales of complexity.
Discussion Leader: James Stevens (Paradox Found Consulting, USA / Leiden University, The Netherlands)
7:40 pm - 7:50 pm
Opening Remarks
7:50 pm - 8:25 pm
Gunter Wagner (Yale University, USA)
"Network Biology and the Evolution of Complex Biological Systems"
8:25 pm - 8:40 pm
Discussion
8:40 pm - 9:15 pm
Patrick Cahan (Johns Hopkins University, USA)
"Gene Regulatory Networks and Computational Approaches to Stem Cell Differentiation"
9:15 pm - 9:30 pm
Discussion
Monday
7:30 am - 8:30 am
Breakfast
8:30 am - 9:00 am
Group Photo
9:00 am - 12:30 pm
Quantitative and Systems Toxicology
The session topics introduce quantitative approaches to modeling complex biological systems. Topics are linked to areas covered later in the meeting including cell signaling, liver metabolism and toxicity and immunity/inflamation.
Discussion Leader: Donald Mager (University at Buffalo, State University of New York, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
Nicolas Le Novere (Babraham Institute, United Kingdom)
"Computational Systems Models of Cell Signaling Networks"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
Jason Papin (University of Virginia, USA)
"Reconciling Rat and Human Liver Genome Scale Metabolic Networks"
10:20 am - 10:35 am
Discussion
10:35 am - 11:05 am
Coffee Break
11:05 am - 11:35 am
Douglas Lauffenburger (Massachusetts Institute of Technology, USA)
"Computational Modeling of Inflammation and Immunity"
11:35 am - 11:50 am
Discussion
11:50 am - 12:05 pm
Mohan Rao (AbbVie, USA)
"Computational Prediction of Off-Target Interactions for Small Molecules"
12:05 pm - 12:10 pm
Discussion
12:10 pm - 12:25 pm
Peter Bloomingdale (University at Buffalo, USA)
"Systems Pharmacology Modeling of Intracellular Signaling in Peripheral Neurons: Investigation of Dexanabinol for the Prevention of Chemotherapy-Induced Peripheral Neuropathy"
12:25 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Application of Systems Models in Drug Safety Assessment
The session continues the focus on computational modeling but shifts toward application of quantitative systems models in addressing safety issues during drug candidate selection and development.
Discussion Leader: Yvonne Dragan (Takeda, USA)
7:30 pm - 7:45 pm
Panuwat Trairatphisan (Universitätsklinikum Aachen, Germany)
"Logic Modelling and Causal Reasoning Approaches to Study Molecular Mechanisms of Compound-Induced Toxicity"
7:45 pm - 7:50 pm
Discussion
7:50 pm - 8:20 pm
Blanca Rodriguez (University of Oxford, United Kingdom)
"Computational Modeling of Cardiac Adverse Events"
8:20 pm - 8:35 pm
Discussion
8:35 pm - 9:05 pm
Cynthia Afshari (Amgen Inc., USA)
"Integrative Biology Provides a Model for Evolving Drug Safety Assessment"
9:05 pm - 9:20 pm
Discussion
9:20 pm - 9:30 pm
General Discussion: Quantitative Modeling and Drug Safety: Opportunities and Challenges
Tuesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Microphysiological Systems - Engineering Human Biology
Presentations will highlight recent advances in tissue engineering for key organ systems important in drug safety evaluation including liver, gut and vascular models.
Discussion Leader: Brian Berridge (National Toxicology Program, National Institutes of Environmental Health Sciences, NIH, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
D. Lansing Taylor (Drug Discovery Institute, University of Pittsburgh, USA)
"Functional Coupling of Liver Microphysiological Systems"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
Christopher Hughes (University of California, Irvine, USA)
"Tissue Engineering of Functional Vascular Networks"
10:20 am - 10:35 am
Discussion
10:35 am - 11:05 am
Coffee Break
11:05 am - 11:35 am
Sarah Blutt (Baylor College of Medicine, USA)
"Gastrointestinal Microphysiological Systems: Opportunities and Challenges"
11:35 am - 11:50 am
Discussion
11:50 am - 12:05 pm
Seyoum Ayehunie (MatTek Corporation, USA)
"Use of In Vitro Human Intestinal Microtissues as Relevant Models for Drug Safety Studies in the Gut"
12:05 pm - 12:10 pm
Discussion
12:10 pm - 12:25 pm
Johanna Chuchuy (Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Germany)
"Retina-on-a-Chip: Merging Organoid and Organ-on-a-Chip Technology for Complex Multi-Layer Tissue Models"
12:25 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Stem Cells in Health and Disease
Stem cell approaches are transforming our understanding of disease progression and patient responses to therapeutic intervention. This session will focus on the role of stem cells in cancer and cardiovascular disease.
Discussion Leader: Donna Mendrick (U.S. Food and Drug Administration, USA)
7:30 pm - 7:45 pm
Molly Morgan (University of Wisconsin-Madison, USA)
"Microenvironmental Regulation of Hormone Signaling in the Organotypic Breast"
7:45 pm - 7:50 pm
Discussion
7:50 pm - 8:20 pm
Jorge Nieva (University of Southern California, USA)
"Host Factors in Drug Toxicity"
8:20 pm - 8:35 pm
Discussion
8:35 pm - 9:05 pm
Joseph Wu (Stanford Cardiovascular Institute, Stanford University School of Medicine, USA)
"Cardiomyocytes in Microphysiological Systems: Application for Safety and Efficacy"
9:05 pm - 9:20 pm
Discussion
9:20 pm - 9:30 pm
General Discussion: Improving Drug Safety Testing with Microphysiological Systems
Wednesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Challenges and Opportunities for Immunomodulator Development
The therapeutic potential of immune modulators is transforming approaches to cancer and autoimmune disease. The session topic focus on the latest developments in therapeutic modulation of immune function.
Discussion Leader: Helen Haggerty (Bristol-Myers Squibb, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
Laura Johnson (GlaxoSmithKline, USA)
"Engineering T-Cells for Immunotherapy in Cancer"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
Jeffrey Ravetch (Rockefeller University, USA)
"Impact of the Fc in Efficacy and Safety of Immunomodulatory Agents and Translation Across Species"
10:20 am - 10:35 am
Discussion
10:35 am - 11:05 am
Coffee Break
11:05 am - 11:35 am
Karen Price (Bristol Myers Squibb, USA)
"Balancing Safety and Activity of CTLA4-Targeted Therapy with Second Generation Antibodies in a Non-Human Primate Model"
11:35 am - 11:50 am
Discussion
11:50 am - 12:05 pm
Stephanie Dauth (Fraunhofer IME, Germany)
"Evidence of Combinational Therapy with Biological and Non-Biological Immune-Modulatory Drugs: Need for Clinical Studies Beyond Licensing"
12:05 pm - 12:10 pm
Discussion
12:10 pm - 12:25 pm
Zoltan Maliga (Laboratory of Systems Pharmacology, Harvard Medical School, USA)
"Deep Immunophenotyping of Sporadic and Anti-Cancer Drug-Associated Skin Toxicity"
12:25 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 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
Patient Safety and Immunomodulators in Clinical Development
In this session, the focus on immune modulation shifts to understanding the opportunities and challenges in identifying and managing safety during clinical trials for novel immune modulators.
Discussion Leader: Anja Stauber (Eli Lilly and Company , USA)
7:30 pm - 8:00 pm
Agne Taraseviciute (University of Washington / Seattle Children's Hospital / Seattle Children's Research Institute, USA)
"Nonhuman Primate Models for CAR-T Cell Therapy"
8:00 pm - 8:15 pm
Discussion
8:15 pm - 8:55 pm
Amy Rosenberg (U.S. Food and Drug Administration, USA)
"Understanding and Monitoring Adverse Event in Clinical Trials of Novel Immune Modulators"
8:55 pm - 9:10 pm
Discussion
9:10 pm - 9:30 pm
General Discussion: Immune Modulator and Safety: The Road Ahead
Thursday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Pharmacovigilance and Adverse Event Monitoring
The pharmacovigilance session covers post-marketing adverse event detection, monitoring and management including use of big data and machine learning and approaches.
Discussion Leader: Lori Minasian (National Cancer Institute, NIH, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
Robert Ball (U.S. Food and Drug Administration, USA)
"Data Mining and Pharmacovigilance in Regulatory Practice"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
Nicholas Tatonetti (Columbia University, USA)
"Data Science and Mapping Health Care Outcomes"
10:20 am - 10:35 am
Discussion
10:35 am - 11:05 am
Coffee Break
11:05 am - 11:35 am
David Hong (University of Texas MD Anderson Cancer Center, USA)
"Monitoring Adverse Events in Treatment of Cancer"
11:35 am - 11:50 am
Discussion
11:50 am - 12:05 pm
Aimee Deaton (Amgen, USA)
"Rationalizing Secondary Pharmacology Screening Using Human Genetic and Pharmacological Evidence"
12:05 pm - 12:10 pm
Discussion
12:10 pm - 12:25 pm
Yun Hao (Columbia University, USA)
"An Integrative Model for Predicting the Toxicity of Target Proteins to Human Tissues"
12:25 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Keynote Session: Therapeutic Opportunities and Safety Issues in Immune Modulation
The closing keynote will focus on how basic research on the immune system translate from the bench to the bedside in oncology as well as the challenges and opportunities represented by our emerging understanding of safety and immune modulation.
Discussion Leader: Myrtle Davis (Bristol-Myers Squibb, USA)
7:30 pm - 7:40 pm
Introduction by Discussion Leader
7:40 pm - 8:40 pm
Alan Korman (Bristol-Myers Squibb, USA)
"Modulating the Immune Systems for Therapeutic Benefit"
8:40 pm - 9:00 pm
Discussion
9:00 pm - 9:20 pm
General Discussion: Improving Drug Safety from Models to Patients
9:20 pm - 9:30 pm
Closing Remarks
Friday
7:30 am - 8:30 am
Breakfast
9:00 am
Departure