Saturday
2:00 pm - 5:00 pm
Arrival and Check-in
3:30 pm - 3:45 pm
Introductory Comments by GRC Site Staff / Welcome from the GRS Chair
3:45 pm - 4:30 pm
Advancing Microphysiological Systems
Discussion Leader: Natalie Holman (Roivant Sciences, Inc., USA)
3:45 pm - 4:00 pm
Marko Groeger (University Hospital Jena, Germany)
"A Microphysiological Model of the Human Liver"
4:00 pm - 4:05 pm
Discussion
4:05 pm - 4:20 pm
Julia Rogal (Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Germany)
"WAT-on-a-Chip: Microphysiological Systems Integrating White Adipose Tissue"
4:20 pm - 4:25 pm
Discussion
4:25 pm - 4:30 pm
General Discussion
4:30 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Translational Safety and Precision Medicine
Discussion Leaders: Shraddha Thakkar (National Center for Toxicological Research, U.S. Food and Drug Administration, USA) and Alison Harrill (National Institute of Environmental Health Sciences, NIH, USA)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 8:00 pm
Vishal Vaidya (Pfizer, USA)
"Vignettes in Translational Biomarker Science"
8:00 pm - 8:05 pm
Discussion
8:05 pm - 8:20 pm
Darshan Mehta (National Center for Toxicological Research, U.S. Food and Drug Administration, USA)
"Mining Pharmacogenomic Information from Drug Labeling Using FDALabel Database for Advancing Precision Medicine"
8:20 pm - 8:25 pm
Discussion
8:25 pm - 8:40 pm
Kai Zhang (University of Kentucky, USA)
"Developing Precise Immunomodulatory Therapeutics for Fetal Alcohol Spectrum Disorders"
8:40 pm - 8:45 pm
Discussion
8:45 pm - 9:00 pm
Marije Niemeijer (Leiden Academic Centre for Drug Research (LACDR), Leiden University, The Netherlands)
"High Throughput Transcriptomics of Primary Human Hepatocyte Inter-Individual Variance in Adaptive Stress Response Activation"
9:00 pm - 9:05 pm
Discussion
9:05 pm - 9:20 pm
Lauren Lewis (Texas A&M University, USA)
"Inter-Individual Variability in Epigenetic and Genotoxic Responses to 1,3-Butadiene in a Population-Based Collaborative Cross Model"
9:20 pm - 9:25 pm
Discussion
9:25 pm - 9:30 pm
General Discussion
Sunday
7:30 am - 8:30 am
Breakfast
9:00 am - 11:00 am
Patient-Focused Drug Safety / Mentorship Component: Career Development Panel
Discussion Leader: Nicolas Le Novere (Babraham Institute, United Kingdom)
9:00 am - 9:20 am
Kyle Hawkins (Vanderbilt University, USA)
"Optimization of Neuronal Differentiation Protocols with Nonlinear Model Predictive Control and Secretome-Based Moving Horizon Estimation"
9:20 am - 9:25 am
Discussion
9:25 am - 9:40 am
Christina Battista (DILIsym Services, Inc. / UNC Eshelman School of Pharmacy, USA)
"Direct Activation of CD8+ T Cells Lays Groundwork for Mathematical Representation of Idiosyncratic Drug-Induced Liver Injury (iDILI)"
9:40 am - 9:45 am
Discussion
9:45 am - 10:00 am
Arun Tailor (University of Liverpool, United Kingdom)
"Amoxicillin-Peptide Adducts Activate T-Cells from DILI Patients in a HLA DRB1*15:01-DQB1*06:02 Risk Haplotype Restricted Manner"
10:00 am - 10:05 am
Discussion
10:05 am - 11:00 am
Panel Discussion
Challenges Facing Early Career Professionals in Drug Development and Safety
Alison Harrill (National Institute of Environmental Health Sciences, NIH, USA)
Shraddha Thakkar (National Center for Toxicological Research, U.S. Food and Drug Administration, USA)
Vishal Vaidya (Pfizer, USA)
Jeff Willy (Eli Lilly and Company, USA)
11:00 am - 12:30 pm
Poster Session
Coffee will be served in the poster area from 11:00 am - 11:30 am
12:30 pm - 1:30 pm
Lunch
1:30 pm - 2:30 pm
Systems Pharmacology and Toxicology
Discussion Leader: Julia Tobacyk (University of Arkansas for Medical Sciences, USA)
1:30 pm - 1:45 pm
Peter Bloomingdale (University at Buffalo, USA)
"Systems Pharmacology Modeling of Intracellular Signaling in Peripheral Neurons: Identification of Dexanabinol for the Prevention of Chemotherapy-Induced Peripheral Neuropathy"
1:45 pm - 1:50 pm
Discussion
1:50 pm - 2:05 pm
Traci Clymer (George Washington University, USA)
"Computational Redesign of Organophosphate Flame Retardants and Pesticides for Improved Safety and Efficacy"
2:05 pm - 2:10 pm
Discussion
2:10 pm - 2:25 pm
Cristian Trovato (University of Oxford, United Kingdom)
"In Silico Trials in Human Ventricular and Purkinje Cell Models Predict Safety and Efficacy of 10 Anti-Arrhythmic Drugs"
2:25 pm - 2:30 pm
Discussion
2:30 pm - 3:00 pm
Evaluation Period
Fill in GRS Evaluation Forms
3:00 pm
Seminar Concludes