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 Staff / Welcome and Introduction from the Chairs
7:40 pm - 9:30 pm
Keynote Session: Translation of In Silico , In Vitro and In Vivo ADME Data Through Mechanistic Understanding and Modelling and Simulation
Discussion Leader: John Harrelson (Pacific University, United States)
7:40 pm - 7:55 pm
Opening Remarks
7:55 pm - 8:00 pm
Introduction by Discussion Leader
8:00 pm - 9:00 pm
K Sandy Pang (University of Toronto, Canada)
"Improving Our Understanding of ADME Processes with Pharmacokinetic Modeling: Forging Forward with Easily Incorporated Modules for The Intestine and Liver"
9:00 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
The Power of Computational ADME in Drug Discovery and Development
Discussion Leader: Prashant Desai (Genentech, United States)
9:00 am - 9:30 am
Giulia Caron (University of Torino, Italy)
"Finding the Relevant Conformations to Discover New Beyond Rule of 5 (bRo5) Drugs"
9:30 am - 9:45 am
Discussion
9:45 am - 10:15 am
Susanne Winiwarter (AstraZeneca, Sweden)
"Possibilities and Pitfalls of In Silico ADME Model Use in Drug Discovery – Examples from Experience"
10:15 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
Maria Posada (Eli Lilly and Company, United States)
"Early Mechanistic Pharmacokinetics and Dose Predictions to Aid Drug Design"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
Christopher Keefer (Pfizer, United States)
"Early Dose Predictions – How Early is too Early?"
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 Hour™
The GRC Power Hour™ is designed to address diversity and inclusion in the scientific workplace by providing a safe environment for informal and meaningful conversations amongst colleagues of all career stages. The program supports the professional growth of all members of our communities, including ethnicity, race and/or gender identity by providing an open forum for discussion and mentoring.
Organizers: Netz Arroyo (Johns Hopkins University School of Medicine, United States) and Armina Abbasi (Amgen Inc., United States)
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Expanding ADME Capabilities Through New Laboratory Techniques
Discussion Leader: Bernard Murray (Gilead Sciences, United States)
7:30 pm - 7:55 pm
Graeme Young (GSK R&D, United Kingdom)
"Accelerator Mass Spectrometry - from Niche to Routine in Human ADME ….and Future Possibilities"
7:55 pm - 8:10 pm
Discussion
8:10 pm - 8:35 pm
Hongbing Wang (University of Maryland School of Pharmacy, United States)
"3D Cell Culture Models for Metabolism and Drug-induced Liver Injury"
8:35 pm - 8:50 pm
Discussion
8:50 pm - 9:15 pm
Dylan Ross (PNNL, United States)
"Ion Mobility-Mass Spectrometry: The Next Big Dimension in Metabolite Identification"
9:15 pm - 9:30 pm
Discussion
Tuesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Mechanistic ADME: Metabolism, Biotransformation, Transport, and IVIVE
Discussion Leader: Klarissa Jackson (University of North Carolina at Chapel Hill, United States)
9:00 am - 9:30 am
Matthew Cerny (Pfizer, Inc., United States)
"Use of Mechanistic Assays to Design Out Cytochrome P450 Time-Dependent Inactivation"
9:30 am - 9:45 am
Discussion
9:45 am - 10:15 am
Ana Vergara (Merck, United States)
"Use of Alternative Cosubstrates UDP-Glucose and UDP-Xylose by UDP-glycosyltransferases in the Metabolism of Polycyclic Aromatic Hydrocarbons"
10:15 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
Jacqueline Tiley (University of North Carolina at Chapel Hill, United States)
"Quantification of Placental Transport Proteins in Extracellular Vesicles; Opportunities and Challenges"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
Bhagwat Prasad (Washington State University, United States)
"Scaling Tissue-Specific Drug Metabolism Using Proteomics-Informed Modeling"
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
Clinical Approaches and Investigations Expanding Our Translational ADME Understanding
Discussion Leader: Mary Paine (Washington State University, United States)
7:30 pm - 7:55 pm
Janne Backman (University of Helsinki, Finland)
"Studying Complex Drug-Drug Interactions Using Clinical Cocktails and Biomarkers"
7:55 pm - 8:10 pm
Discussion
8:10 pm - 8:35 pm
Stephani Stancil (Children’s Mercy Kansas City, United States)
"Developing Pharmacodynamic Biomarkers to Leverage Pharmacokinetics and Improve Adolescent Mental Health"
8:35 pm - 8:50 pm
Discussion
8:50 pm - 9:15 pm
Nathan Cherrington (University of Arizona, United States)
"Piggybacking ADME Mechanisms for Adverse Drug Reactions to Diagnose Patients with NASH"
9:15 pm - 9:30 pm
Discussion
Wednesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Advances in Mechanistic Modelling and Simulation of ADME Properties and PKPD Relationships
Discussion Leader: Yuching Yang (U.S. Food and Drug Administration, United States)
9:00 am - 9:30 am
Nina Isoherranen (University of Washington, United States)
"Autocrine, Paracrine and Endocrine Signaling in Regulating Tissue Concentrations in Progressive Disease"
9:30 am - 9:45 am
Discussion
9:45 am - 10:15 am
Kate Gill (Certara UK, United Kingdom)
"Predicting Drug-Biologic Interactions Using Physiologically Based Pharmacokinetic Models - Current Status and Future Advances"
10:15 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
Xiling Jiang (FDA, United States)
"Clinical Pharmacology Considerations for Therapeutic Protein-Drug Interaction"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
Lara Clemens (Simulations Plus Inc., United States)
"Mechanistic Modeling of Inflammatory Contributions to Biologics-Induced Liver Injury Using Tocilizumab as an Exemplar Compound"
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
Early-Career Investigator Presentations
Discussion Leader: Swati Nagar (Temple University, United States)
7:30 pm - 7:45 pm
Lianne Stevens (LUMC & TNO, The Netherlands)
"Ex Vivo Multi-Organ Perfusion; Demonstrator Study Showing Absorption, Metabolism and Excretion of Midazolam"
7:45 pm - 7:50 pm
Discussion
7:50 pm - 8:05 pm
Eva Streekstra (Radboudumc & TNO, The Netherlands)
"Intestinal Tissue Organoids To Study Drug Transport And Metabolism From Infants To Adults"
8:05 pm - 8:10 pm
Discussion
8:10 pm - 8:25 pm
Rachel Parise (Temple University , United States)
"MALDI Mass Spectrometry Imaging of Verapamil in Rat Liver Tissue Sections"
8:25 pm - 8:30 pm
Discussion
8:30 pm - 8:45 pm
Aiden Nguyen (Pacific University School of Pharmacy, United States)
"In-vitro and In-vivo Assessment of CYP2A-Mediated Interactions Between Nicotine and the CannabisTerpene Limonene"
8:45 pm - 8:50 pm
Discussion
8:50 pm - 9:05 pm
Jinghan Liu (University of Michigan, United States)
"Human Cytochrome P450 3A7 Binding Four Copies of Its Native Substrate Dehydroepiandrosterone 3-Sulfate"
9:05 pm - 9:10 pm
Discussion
9:10 pm - 9:25 pm
Sean Edwards (University of Liverpool, UK, United Kingdom)
"In Silico Modelling of Transmucosal Drug Delivery Informed by In Vitro Approaches"
9:25 pm - 9:30 pm
Discussion
Thursday
7:30 am - 8:30 am
Breakfast
8:30 am - 9:00 am
Business Meeting
Nominations for the Next Vice Chair(s); Complete the GRC Evaluation Forms; Discuss Future Dates and Venue; Election of the Next Vice Chair(s)
9:00 am - 12:30 pm
Mechanistic Drug Discovery and Development Problem Solving Beyond Small and Large Molecules
Discussion Leader: Anshul Gupta (Generation Bio, United States)
9:00 am - 9:30 am
Carina Cantrill (F. Hoffman La Roche, Switzerland)
"DMPK Optimization of Targeted Protein Degraders; Challenges, Strategies and Lessons Learned"
9:30 am - 9:45 am
Discussion
9:45 am - 10:15 am
Prathap Nagaraja Shastri (Johnson and Johnson, United States)
"Advancements in Translational PK/PD and Clinical Pharmacology Considerations for CAR-Ts"
10:15 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:30 am
Nancy Chen (Takeda Development Center Americas, Inc. (TDCA), United States)
"Peeling the Onion: from AAV Injection to Therapeutic Transgene Protein Production"
11:30 am - 11:45 am
Discussion
11:45 am - 12:15 pm
Jimit Raghav (Speaker, United States)
"Preclinical Considerations for Targeted Non-Viral Vector Based Gene Therapy"
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
Regulatory and DDI Clinical Problem Solving
Discussion Leader: Aleksandra Galetin (University of Manchester, United Kingdom)
7:30 pm - 7:55 pm
Carolina Säll (Novo Nordisk, Denmark)
"Predicting Peptide Drug-Drug Interactions During Drug Development - Current Challenges and Future Opportunities"
7:55 pm - 8:10 pm
Discussion
8:10 pm - 8:35 pm
Xinning Yang (Silver Spring, Maryland, United States)
"Utility of Endogenous Biomarkers and Pharmacogenetics in Drug Interaction Assessments Involving CYPs and Transporters"
8:35 pm - 8:50 pm
Discussion
8:50 pm - 9:15 pm
Karen Rowland-Yeo (Certara UK Ltd, United Kingdom)
"PBPK Modelling of Disease Effects in Special Populations: Case Studies"
9:15 pm - 9:30 pm
Discussion
Friday
7:30 am - 8:30 am
Breakfast
9:00 am
Departure