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
Discussion Leader: J. Steven Leeder (Children's Mercy Hospital, USA)
7:40 pm - 7:55 pm
Opening Remarks
7:55 pm - 8:55 pm
Chris Goldring (MRC Centre for Drug Safety Science, University of Liverpool, United Kingdom)
"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
Discussion Leader: Bruno Stieger (University Hospital Zurich, Switzerland)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
Katherine Elvira (University of Victoria, Canada)
"The Role of Microfluidic/Microphysiologic Systems for Studying Drug Transport"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
Nicolas Tournier (CEA, France)
"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
Manthena Varma (Pfizer, USA)
"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
Miro Eigenmann (Roche, Switzerland)
"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
3:00 pm - 4:00 pm
The GRC Power Hourâ„¢
The GRC Power Hourâ„¢ is designed to address challenges women face in science and issues of diversity and inclusion. The program supports the professional growth of all members of our communities by providing an open forum for discussion and mentoring.
Organizers: Katherine Elvira (University of Victoria, Canada) and Sara Humphreys (Amgen, USA)
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
Discussion Leader: Natalie Hosea (Global DMPK, Takeda California, USA)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 8:00 pm
Sara Humphreys (Amgen, USA)
"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
Andy Zhu (Takeda Pharmaceuticals, USA)
"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
Tristan Maurer (Pfizer, USA)
"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
Discussion Leader: Mary Paine (Washington State University, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
Elaine Tseng (Pfizer Inc, USA)
"Optimizing In Vitro Tools for Successful Translation of Time-Dependent Inhibitors"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
John Harrelson (Pacific University, USA)
"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
Jash Unadkat (University of Washington, USA)
"Cannabinoid-Drug Interactions: Getting into the Weeds"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
Janne Backman (University of Helsinki, Finland)
"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
Discussion Leader: Yurong Lai (Gilead Sciences, USA)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 8:00 pm
Kenta Yoshida (Genentech Research and Early Development, USA)
"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
Kara Pearson (Merck & Co., Inc., USA)
"Translational Mechanistic Safety Biomarkers in Drug Development"
8:40 pm - 8:50 pm
Discussion
8:50 pm - 9:15 pm
James Monroe (Merck, USA)
"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
Discussion Leader: Alison Harrill (National Institute of Environmental Health Sciences, NIH, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
Stephen Ferguson (National Institute of Environmental Health Sciences, NIH, USA)
"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
Zackary Kenz (DILIsym Services, USA)
"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
Jean-Charles Gautier (Sanofi, France)
"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
Yuanyuan Zhang (Wake Forest School of Medicine, USA)
"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
Discussion Leader: Patrick Murphy (Academic Consultant, USA)
7:30 pm - 7:45 pm
Sumit Bansal (University of Washington, USA)
"The Potential of Cannabinoids to Precipitate Drug Interactions"
7:45 pm - 7:50 pm
Discussion
7:50 pm - 8:05 pm
Olive Njuma (Vanderbilt University School of Medicine, USA)
"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
John Rodgers (Washington State University, USA)
"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
Surabhi Talele (University of Minnesota, Twin Cities, USA)
"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
Rakshit Tanna (Washington State University, USA)
"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
Andrea Treyer (Uppsala University, Sweden)
"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
Discussion Leader: Eric Williams (Molecular Templates, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:35 am
David Nettleton (Novartis Institutes for BioMedical Research, USA)
"Improving Peptide Exposure"
9:35 am - 9:50 am
Discussion
9:50 am - 10:20 am
Richard Lehner (University of Alberta, Canada)
"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
Michael Mohutsky (Eli Lilly and Company, USA)
"What a Difference a Species Makes: Enzymatic Hydrolysis"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
Jerome Schentag (University at Buffalo, USA)
"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
Discussion Leader: Jane Kenny (Genentech, USA)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 8:00 pm
Ryan Takahashi (Genentech, USA)
"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
Filipe Lopes (F. Hoffmann-La Roche, Switzerland)
"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
Namandje Bumpus (Johns Hopkins University School of Medicine, USA)
"Drug Activation via Phosphorylation"
9:15 pm - 9:30 pm
Discussion
Friday
7:30 am - 8:30 am
Breakfast
9:00 am
Departure