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Drug Metabolism
Gordon Research Conference

Exploring Advances in Quantitative Predictions of Drug Metabolism, Transport, Safety and Pharmacokinetics

Dates

July 9-14, 2017

Location

Holderness School
Holderness, NH Site Information

Organizers

Chair:
Donavon J. McConn

Vice Chair:
Swati Nagar

Application Deadline

The application deadline for this meeting was June 11, 2017. You may still submit an application, which may be considered by the conference chair if there is still room available.

Meeting Description

There has been an extraordinary evolution in the knowledge and tools related to drug metabolism, transport, and modeling and simulation over the past 2 decades. Industry, academic and regulatory scientists with interests in drug metabolism, transporters, pharmacokinetics and related disciplines will gather at the 47th Drug Metabolism Gordon Research Conference to learn about and discuss how these advances currently translate into clinical predictivity. Young investigators, including postdoctoral fellows and graduate students, will interact with academic and industry leaders in an informal setting. The collegial nature and the opportunity to learn, discuss unpublished research, share new ideas, and establish collaborations, have made this venue a favorite in the drug metabolism community.

The 2017 conference will focus on integrating the new discoveries, technologies and techniques into optimal clinical predictions from a DMPK perspective. Sessions will include advances in metabolic and transporter predictions (and their relationship to Pharmacokinetics and Safety), extrahepatic P450s, non-P450 mechanisms, antibodies and antibody-drug conjugates (ADC), PBPK and other predictive tools and challenging traditional metabolism and transporter mechanisms. Each presentation will include unpublished data and expert opinions to stimulate audience discussion. Attendees are encouraged to submit posters. The Wednesday evening program features oral presentations selected from the submitted posters by young investigators.

With scientific sessions in the mornings and evenings, the afternoons are set aside for attendees to enjoy the many outdoor recreational activities in the New Hampshire area. Afternoon "traditions" of this conference include an Academia vs. Industry softball game (Tuesday; no experience necessary!), and hiking and kayaking/canoeing outings in the White Mountains. The registration fee includes all meals and housing on the Holderness School campus. We hope that you will join us for an outstanding meeting focused on the advances in drug metabolism science as they relate to clinical predictivity.

Contributors

Meeting Program

Sunday
2:00 pm - 9:00 pmArrival and Check-in
6:00 pmDinner
7:30 pm - 7:40 pmWelcome / Introductory Comments by GRC Site Staff
7:40 pm - 9:30 pmKeynote Session: Quantitative Extrapolations of Transporters and Drug Metabolizing Enzymes
Discussion Leader: Donavon McConn (Takeda California, USA)
7:40 pm - 7:55 pmOpening Remarks
7:55 pm - 8:55 pmJoseph Polli (GlaxoSmithKline, Inc., USA)
"A Quantification Identity Crisis for DMPK and ADME-Exploring Advances in Quantitative Predictions of Drug Metabolism, Transport, Safety and Pharmacokinetics"
8:55 pm - 9:30 pmDiscussion
Monday
7:30 am - 8:30 amBreakfast
8:30 amGroup Photo
9:00 am - 12:30 pmQuantitative Predictions for Non-P450 Mechanisms
Discussion Leader: Tom Leyh (The Albert Einstein College of Medicine, USA)
9:00 am - 9:05 amIntroduction by Discussion Leader
9:05 am - 9:30 amHansruedi Glatt (German Institute of Human Nutrition, Germany)
"Role of Sulfotransferases in Metabolic Activation"
9:30 am - 9:45 amDiscussion
9:45 am - 10:15 amWen Xie (University of Pittsburgh, USA)
"Sulfotransferases in Liver Disease"
10:15 am - 10:30 amDiscussion
10:30 am - 11:00 amCoffee Break
11:00 am - 11:30 amS. Joshua Swamidass (Washington University in St. Louis, USA)
"Modeling the In Vivo Balance Between Phase I and Phase II Metabolism"
11:30 am - 11:45 amDiscussion
11:45 am - 12:15 pmBarry Potter (University of Oxford, United Kingdom)
"Sulfatase Inhibitors: From Concept to Clinic and Beyond"
12:15 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmAntibody/ADC Biophysics Considerations in Predicting Human Disposition
Discussion Leader: Brooke Rock (Amgen, USA)
7:30 pm - 7:35 pmIntroduction by Discussion Leader
7:35 pm - 7:55 pmJun Wu (Amgen, USA)
"Binding Affinity of LM to FcRn and Its Importance in Disposition of Large Molecules"
7:55 pm - 8:10 pmDiscussion
8:10 pm - 8:35 pmMengmeng Wang (Pfizer, USA)
"Understanding Localization of Biotherapeutics at Whole body, Tissue and Cellular Level in Preclinical Development"
8:35 pm - 8:50 pmDiscussion
8:50 pm - 9:15 pmDenise O'Hara (Pfizer, USA)
"Physiologically-Relevant Kd Measurements to Inform PK-PD Modeling"
9:15 pm - 9:30 pmDiscussion
Tuesday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmSafety Considerations in Clinical Drug Metabolism and Transport
Discussion Leader: Maciej Zamek-Gliszczynski (GlaxoSmithKline, USA)
9:00 am - 9:05 amIntroduction by Discussion Leader
9:05 am - 9:30 amKunal Taskar (GlaxoSmithKline, United Kingdom)
"Pharmacokinetics, Efficacy and Safety in Drug-Drug Interactions: Do They Go Hand in Hand?"
9:30 am - 9:45 amDiscussion
9:45 am - 10:15 amXiaoyan Chu (Merck & Co., Inc., USA)
"Understanding Complex Perpetrator DDIs Involving Hepatic/Gut Transporters and Their Interplay with CYP3A Enzymes: From In Vitro to Mechanistic Clinical Evaluations"
10:15 am - 10:30 amDiscussion
10:30 am - 11:00 amCoffee Break
11:00 am - 11:30 amAdrian Ray (Gilead Sciences, Inc., USA)
"Thiamine Transporters: Emerging Mechanisms of Drug Toxicity and Disposition"
11:30 am - 11:45 amDiscussion
11:45 am - 12:15 pmMary Paine (Washington State University, USA)
"Identification of Natural Products as Precipitants of Clinical Drug Interactions: Challenges and Opportunities"
12:15 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmChallenging Michaelis-Menten Drug Metabolism and Transport Kinetics
Discussion Leader: Christopher Kemper (Pharma Navigators, LLC, USA)
7:30 pm - 7:35 pmIntroduction by Discussion Leader
7:35 pm - 7:55 pmKenneth Korzekwa (Temple University, USA)
"Using Numerical Approaches to Model Complex CYP Kinetics"
7:55 pm - 8:10 pmDiscussion
8:10 pm - 8:35 pmRory Remmel (University of Minnesota, USA)
"Atypical Kinetics of UDP-Glucuronosyltransferases: The Problem of Determining Accurate In Vitro Clearances"
8:35 pm - 8:50 pmDiscussion
8:50 pm - 9:15 pmJoanne Wang (University of Washington, USA)
"Atypical Kinetics in Drug Transporters: Theoretical and Practical Considerations"
9:15 pm - 9:30 pmDiscussion
Wednesday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmQuantitative Understanding of Fraction Metabolized: Newer Challenges in Scaling and Predictivity
Discussion Leader: Griff Humphreys (Bristol-Myers Squibb, USA)
9:00 am - 9:05 amIntroduction by Discussion Leader
9:05 am - 9:35 amPhilip Potter (St. Jude Children's Research Hospital, USA)
"Evaluating In Vivo Esterase-Mediated Drug Metabolism: Should Be Easy, but Why Do We Fail?"
9:35 am - 9:50 amDiscussion
9:50 am - 10:15 amYurong Lai (Gilead Sciences, USA)
"The Combination of Bottom-Up and Top-Down Modelling Approaches to Predict In Vivo Hepatic Uptake Clearance and Tissue Partitioning"
10:15 am - 10:30 amDiscussion
10:30 am - 11:00 amCoffee Break
11:00 am - 11:30 amBhagwat Prasad (University of Washington, USA)
"Role of Quantitative Proteomics Data to Predict Fraction Metabolized by Non-CYP Enzymes"
11:30 am - 11:45 amDiscussion
11:45 am - 12:15 pmBirk Poller (Novartis Pharma AG, Switzerland)
"ECM-Based IVIVE Method for the Prediction of Human Clearance and Relative Elimination Pathway Contributions"
12:15 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:00 pm - 7:30 pmBusiness 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 pmYoung Investigator Presentations
Six poster abstracts from trainees will be highlighted with short oral presentations.
Discussion Leader: Patrick Murphy (Academic Consultant, USA)
7:30 pm - 7:45 pmTheresa Aliwarga (University of Washington, USA)
"Formation and Distribution of Cis- and Trans-Epoxyeicosatrienoic Acids in Patients with Cardiovascular Disease"
7:45 pm - 7:50 pmDiscussion
7:50 pm - 8:05 pmLaura Drbohlav (University of Kansas, USA)
"Treatment of Hepatocellular Carcinoma HepG2 Cells with β-Naphthoflavone Simultaneously Increased Intracellular and Exosomal Expression of CYP1A1"
8:05 pm - 8:10 pmDiscussion
8:10 pm - 8:25 pmGassiot Matthieu (Institut de Recherche en Cancérologie de Montpellier (IRCM), U1194, INSERM, France)
"Identification of Molecular Determinants Involved in the Transport and Metabolism of Kinase Inhibitors in Prostate Cancer Cells"
8:25 pm - 8:30 pmDiscussion
8:30 pm - 8:45 pmLuc Rougee (Eli Lilly and Company, USA)
"Time-Dependent Inhibition of Cytochrome P450 3A4 by Itraconazole and Metabolites"
8:45 pm - 8:50 pmDiscussion
8:50 pm - 9:05 pmKimberly Holt (Temple University School of Pharmacy, USA)
"Comparison of Different Tissue:Plasma Water Partition Coefficient Models and Their Ability to Predict the Steady-State Volume of Distribution and the Concentration-Time Profiles in Humans"
9:05 pm - 9:10 pmDiscussion
9:10 pm - 9:25 pmDeepak Kumar Bhatt (University of Washington, USA)
"Genetic Variation, Age, and Gender Are Associated with Human Liver UGT2B17 Protein Abundance and Activity"
9:25 pm - 9:30 pmDiscussion
Thursday
7:30 am - 8:30 amBreakfast
9:00 am - 12:30 pmEmerging Technologies in Predicting Extrahepatic Metabolism and Toxicity
Discussion Leader: Rheem Totah (University of Washington, USA)
9:00 am - 9:05 amIntroduction by Discussion Leader
9:05 am - 9:30 amMurat Cirit (Massachusetts Institute of Technology, USA)
"Translational Applications of the Human Physiome on a Chip"
9:30 am - 9:45 amDiscussion
9:45 am - 10:15 amKelsey Retting (Organovo, USA)
"A Three-Dimensional Bioprinted Model of the Renal Proximal Tubule for Evaluation of Drug-Induced Nephrotoxicity"
10:15 am - 10:30 amDiscussion
10:30 am - 11:00 amCoffee Break
11:00 am - 11:30 amKevin Healy (University of California, Berkeley, USA)
"Microphysiological Organ Systems for Drug Discovery, Disease Modeling, Personalized Medicine"
11:30 am - 11:45 amDiscussion
11:45 am - 12:15 pmElizabeth Gillam (University of Queensland, Australia)
"Ancestral Sequence Reconstruction of P450s: the 'Retro' Approach to Understanding Drug Metabolism"
12:15 pm - 12:30 pmDiscussion
12:30 pmLunch
1:30 pm - 4:00 pmFree Time
4:00 pm - 6:00 pmPoster Session
6:00 pmDinner
7:30 pm - 9:30 pmAdvances and Challenges in Predicting Human PK Profiles
Discussion Leader: Natalie Hosea (Global DMPK, Takeda California, USA)
7:30 pm - 7:35 pmIntroduction by Discussion Leader
7:35 pm - 8:00 pmNeil Parrott (Roche, Switzerland)
"Physiologically-Based Pharmacokinetic (PBPK) Modeling Predictions for Entry into Human (EIH) Studies: An Analysis of Small Molecule Development Candidates at Hoffmann-LaRoche, 2003-2015"
8:00 pm - 8:10 pmDiscussion
8:10 pm - 8:35 pmJ. Cory Kalvass (AbbVie, USA)
"Assessment of Dose, Intrinsic Pharmacokinetics, and Efficacious Steady-State Concentration of 368 Oral Drugs"
8:35 pm - 8:45 pmDiscussion
8:45 pm - 9:10 pmTristan Maurer (Pfizer, USA)
"Early PK Predictions to Enable Rational and Efficient Drug Design"
9:10 pm - 9:20 pmDiscussion
9:20 pm - 9:30 pmClosing Remarks
Friday
7:30 am - 8:30 amBreakfast
9:00 amDeparture
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