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: Translational Models for Drug-Induced Liver Injury
7:40 pm - 7:55 pm
Opening Remarks
7:55 pm - 8:55 pm
"Translational Models for Drug-Induced Liver Injury"
8:55 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
New Models for Predicting Human Pharmacokinetics
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
"The Role of Microfluidic/Microphysiologic Systems for Studying Drug Transport"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
"PET Imaging for In Vivo Determination of Pharmacokinetic Parameters"
10:20 am - 10:35 am
Discussion
10:35 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
"The Extended Clearance Concept: Identification of Clinically Relevant Drug Transporters and DDI Risks in Early Drug Development"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
"Developing Improved Pharmacokinetic Models for Therapeutic Antibodies"
12:15 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
Predicting Human PK, PK/PD and Efficacious Dose
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 8:00 pm
"What We Know and Don't Know About PK/PD Relationships for Therapeutic siRNA"
8:00 pm - 8:10 pm
Discussion
8:10 pm - 8:35 pm
"Human Pharmacokinetic and Dose Predictions in Immunology and Immuno-Oncology: Considerations and Case Studies"
8:35 pm - 8:50 pm
Discussion
8:50 pm - 9:15 pm
"Leveraging Mechanistic Models to Inform Drug Design and Early Clinical Development"
9:15 pm - 9:30 pm
Discussion
Tuesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Translational Approaches to Untangle Xenobiotic-Drug Interaction Mechanisms and Improve Pharmacotherapy
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
"Optimizing In Vitro Tools for Successful Translation of Time-Dependent Inhibitors"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
"Variety Is the Spice of Life: Pre-Clinical Approaches to Evaluate Mechanisms of Cinnamaldehyde-Drug Interactions"
10:20 am - 10:35 am
Discussion
10:35 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
"Cannabinoid-Drug Interactions: Getting into the Weeds"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
"Clinical Approaches to Untangle Complex Drug-Drug Interaction Mechanisms"
12:15 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
Translational Biomarkers for Transporter Function and Toxicity
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 8:00 pm
"Overview of Transporter DDI Biomarkers: Where We Are and Where We Are Going"
8:00 pm - 8:15 pm
Discussion
8:15 pm - 8:40 pm
"Translational Mechanistic Safety Biomarkers in Drug Development"
8:40 pm - 8:50 pm
Discussion
8:50 pm - 9:15 pm
"Safety Assessment of Acyl Glucuronides: Approach the Problems that Drive Toxicity"
9:15 pm - 9:30 pm
Discussion
Wednesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Predictive Models for Liver and Kidney Toxicity
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
"High Throughput Transcriptomics in Metabolically Competent Hepatic Spheroid Models for Chemical Screening and Prioritization at the NTP"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
"Utilization of Direct CD8+ T Cell Activation Mathematical Model Groundwork in Preliminary Amodiaquine-Based iDILI Model"
10:20 am - 10:35 am
Discussion
10:35 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
"Urinary miRNA Biomarkers of Kidney Toxicity and Their Site Specificity Within the Renal Nephron: A HESI Consortium Effort"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
"In Vitro 3D Renal Organoids Generated from Human Urine-Derived Stem Cells for Nephrotoxicity Testing"
12:15 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
Young Investigator Presentations
7:30 pm - 7:45 pm
"The Potential of Cannabinoids to Precipitate Drug Interactions"
7:45 pm - 7:50 pm
Discussion
7:50 pm - 8:05 pm
"The Abundant DNA Adduct N7-Methyl Deoxyguanosine Contributes to Miscoding During Replication by Human DNA Polymerase?"
8:05 pm - 8:10 pm
Discussion
8:10 pm - 8:25 pm
"Exploring Beyond the Steady State: Kinetic Evaluations of In Vitro CYP and AO Inhibition"
8:25 pm - 8:30 pm
Discussion
8:30 pm - 8:45 pm
"CNS Delivery of VX-970: A Selective ATR Inhibitor for Radiosensitization in GBM"
8:45 pm - 8:50 pm
Discussion
8:50 pm - 9:05 pm
"Assessing Transporter-Mediated Goldenseal-Drug Interactions in Healthy Volunteers Using a Transporter Cocktail"
9:05 pm - 9:10 pm
Discussion
9:10 pm - 9:25 pm
"Impact of Intracellular Concentrations on Metabolic Drug-Drug Interaction Studies"
9:25 pm - 9:30 pm
Discussion
Thursday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Understanding Hydrolases for Clinical Outcomes
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
"Improving Peptide Exposure"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
"Carboxylesterases and Arylacetamide Deacetylase: Drug Metabolizing Enzymes Moonlighting as Lipid Hydrolases. Or Is It Vice Versa ?"
10:20 am - 10:35 am
Discussion
10:35 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
"What a Difference a Species Makes: Enzymatic Hydrolysis"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
"Oral and Intracellular Delivery of Macromolecules: Two Targets for the Price of One"
12:15 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
The Importance of Understanding Metabolite Profiles
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 8:00 pm
"Adventures in Biotransformation: Metabolites and the Enzymes and Mechanisms that Form Them"
8:00 pm - 8:10 pm
Discussion
8:10 pm - 8:35 pm
"Metabolites and Their Relevance for Human Safety: From In Vitro to In Vivo "
8:35 pm - 8:50 pm
Discussion
8:50 pm - 9:15 pm
"Drug Activation via Phosphorylation"
9:15 pm - 9:30 pm
Discussion
Friday
7:30 am - 8:30 am
Breakfast
9:00 am
Departure