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Meeting Program

Theme: Back to the Future: DMPK Foundations and New Concepts

The 27th North American ISSX Meeting, Back to the Future: DMPK Foundations and New Concepts, will examine how core DMPK principles continue to inform—and evolve alongside—emerging scientific approaches in drug discovery and development.

The scientific program spans artificial intelligence and machine learning in ADME research, advances in drug–drug interaction assessment, mechanistic and systems pharmacology modeling, and real-world case studies highlighting unexpected biotransformations. Additional sessions explore innovative strategies for treating neurodegenerative diseases, pharmacogenetic drivers of drug toxicity, long-acting medicines, structure-based ADME, and the evolving landscape of obesity therapeutics.

Complementing the symposia, in-depth short courses will address microphysiological systems, in vitro–in vivo extrapolation, DMPK characterization of biologics, and emerging insights into extrahepatic metabolism, offering attendees both foundational knowledge and forward-looking perspectives on the future of DMPK.

Jump to Day One: Sunday, October 11
Jump to Day Two: Monday, October 12
Jump to Day Three: Tuesday, October 13
Jump to Day Four: Wednesday, October 14

Schedule at a Glance

Time Sunday, October 11 Monday, October 12 Tuesday, October 13 Wednesday, October 14
Morning Short Courses 1 & 2 Plenary Speaker & Concurrent Symposia Plenary Session & Concurrent Symposia Plenary Speaker & Concurrent Symposia
Midday Lunch for Short Course Attendees Lunch, Posters, Exhibits & Thought Leadership Presentations Lunch, Posters, Exhibits & Thought Leadership Presentations Lunch, Posters, & Exhibits
Afternoon Short Courses 3 & 4 Concurrent Symposia & Roundtable Discussion ISSX Awards & Poster Awards Symposia
Evening Opening Remarks, Keynote Lecture & Opening Welcome Reception Poster Viewing Hours Offsite Networking Reception n/a

8:00 AM - 7:00 PM

Day One: Sunday, October 11

Registration

9:00 AM - 12:00 PM

Concurrent Short Courses 1 and 2

Short Course 1: Opportunities for microphysiological systems in ADME research

Microphysiological systems have been in the spotlight for their potential to replace in vivo models and/or as more comprehensive alternatives for conventional in vitro models. The emphasis on the development of NAMs by the FDA further enhanced the relevance of further exploration of these systems.

Chair: Salman Khetani, University of Illinois Chicago, USA

  • Key characteristics of MPS for adoption by industry
    Salman Khetani, University of Illinois Chicago, USA

  • The do’s and don'ts of MPS use in industrial practice
    David Stresser, Abbvie, USA

  • Complex In Vitro Models: State of Readiness for Safety and Disposition in Pharma
    Jessica Klein, Genentech, USA

  • Choosing your MPS: Simplicity vs. Complexity
    Nancy Allbritton, University of Washington, USA

Short Course 2: The A to Z of IVIVE for ADME processes

This short course provides an overview on the concepts of the in vitro to in vivo extrapolation for ADME processes and discuss advancements in the predictive tool kit that can enable efficient drug design and development.

Chair: Manthena Varma, Pfizer, USA; Ron Aoyama, Kardigan Bio, USA

  • In vitro-in vivo extrapolation of hepatic clearance across different mechanisms
    Heather Eng, Pfizer, USA

  • State-of-the-art on tissue partitioning and volume of distribution predictions
    Viera Lukacova, SimulationsPlus, USA

  • Building a predictive scaling strategy for hepatobiliary transport clearance
    Xiaomin Liang, Gilead, USA

  • Leveraging novel tools for absorption predictions: Translating complex interplay of solubility/permeability/active transport/metabolism
    Paresh Chothe, AstraZeneca, USA

12:00 - 1:00 PM

Lunch for Morning and Afternoon Short Course Attendees

  • Included in Short Course registration cost.

1:00 - 4:00 PM

Concurrent Short Courses 3 and 4

Short Course 3: Bioanalytical Focus Group: (pre)clinical DMPK characterization of therapeutic antibodies

This short course provides an overview of strategies to characterize the drug metabolism and pharmacokinetics (DMPK) properties of therapeutic antibodies in preclinical development. The course emphasizes the integration of in vitro and in vivo methodologies to achieve a comprehensive understanding of antibody DMPK behavior.

Co-Chairs: Matt Albertolle, Neurocrine Biosciences, USA; Long Yuan, Biogen, USA

  • Assessing Non-Specific Clearance and Subcutaneous Dosing of Biologics in vitro
    Mark Bryniarski, Amgen, USA

  • Biotransformation of Therapeutic Antibodies and Conjugates
    Wenying Jian, Johnson & Johnson, USA

  • Designing and Implementing In Vivo Preclinical Animal Studies for Biologics
    Douglas Leipold, Genentech, USA

  • Discovery Bioanalysis for Biologics and ADC Therapeutics Using LC-MS
    Jifa Zhang, Merck, USA

Short Course 4: Biotransformation Focus Group: Beyond the liver - exploring the frontiers of extrahepatic metabolism in drug disposition

This short course will delve into the roles of extrahepatic metabolism in drug disposition. Experts from academia and industry will highlight cutting-edge research on intestinal, brain and microbiome metabolism, as well as case studies from drug development pipelines.

Co-Chairs: Karin Otte, Merck, USA; Drake Russell, Neurocrine, USA

  • Overview of extrahepatic metabolism
    Bhagwat Prasad, Cincinnati Children's Hospital, USA

  • Beyond the Liver: Contributions of Glutathione S-Transferases to Xenobiotic Metabolism
    Drake Russell, Neurocrine, USA

  • Elucidating Intestinal Metabolism with Human Enteroid Monolayers: A New Approach Methodology
    Eimear O'Mahony, University of Washington, USA

  • Industrial perspective on how to deal with extrahepatic metabolism
    Matt Cerny, Pfizer, USA

4:00 - 6:00 PM

Focus Group Meetings

4:00 – 4:45 pm: Biotransformation Mechanisms and Pathways and Transporters
5:00 – 5:45 pm: Modeling and Simulation and Bioanalysis in ADME Science

6:00 - 6:15 PM

Opening Remarks

6:15 - 7:15 PM

Keynote Session

A Dialogue about the Future of Technology and its Impact on Academia and the Pharmaceutical Industry

  • Gemma Dickinson, Eli Lilly and Company, USA

  • Nathan Cherrington, University of Arizona, USA

  • Aurora Authement, University of Washington, USA

7:15 - 9:15 PM

Opening Reception

Kick off the meeting by connecting with colleagues, exhibitors, sponsors, and fellow attendees at the Opening Reception. Enjoy refreshments, explore the exhibit hall, and get a first look at the poster presentations while catching up with old friends and making new connections.

7:00 AM - 5:00 PM

Day Two: Monday, October 12

Registration Open

8:30 - 9:30 AM

Plenary Speaker 1

Unanticipated and novel metabolic reactions and their implications in drug discovery and development

  • Cyrus Khojasteh, Genentech, USA

9:30 - 10:00 AM

Break

Take a break to connect with colleagues, visit with exhibitors and sponsors, explore the posters, and attend the Thought Leader Presentation featuring the latest insights from our sponsors.

9:40 – 9:55 AM: Thought Leadership Presentation, Presented by WuXi AppTec
Visualizing Maternal and Fetal Distribution Using Quantitative Whole-Body Autoradiography, Leah Lake

10:00 AM - 12:00 PM

Concurrent Symposia 1 & 2

Symposium 1:Revolutionizing ADME research: Can artificial intelligence and machine learning lead the way?

This session will explore the opportunities and the limitations of AI/ML tools in optimization of molecules in drug discovery and development.

Co-Chairs: Marjoleen Nijsen, Abbvie, USA; Marcel Hop, Genentech, USA

  • The future of generative drug discovery
    Sean Ekins, Collaborations Pharmaceuticals, USA

  • The impact of computational ADME models, including MPO tools, in drug discovery
    Yanran Wang, Genentech, USA

  • AbbVie’s AI/ML strategy as integrated discovery tool in the screening funnel for ADME/PK with a focus on small molecules and BRo5 molecules
    Edward Price, AbbVie, USA

  • Computational Drug Discovery on a Budget:  What Can We Accomplish Using Open Source and AI?
    Eric Walters, Rosalind Franklin University of Medicine and Science, USA

Symposium 2: Latest advances in assessment of drug-drug interactions

DDI risk assessments from preclinical to clinical stages in drug development. To disseminate the latest knowledge, new evaluation systems, and quantitative approaches for DDI risk assessments.

Co-Chairs: Chie Emoto, Chugai Pharmaceutical, Japan; Jaydeep Yadav, Merck, USA

  • Assessment of small molecule drugs as a victim of DDI
    Elaine Tseng, Pfizer

  • Quantitative prediction of transporter DDI using human liver chimeric mice evaluations
    Taiji Miyake, Chugai, Japan

  • PBPK model credibility assessment
    Karen Yeo, Certara, United Kingdom

  • Prediction of ADC payload mediated DDI: different modeling approaches or Prediction of cytokine mediated P450 suppression by PBPK modeling
    Yuan Chen, Genentech, USA

12:00 - 3:00 PM

Lunch Break: Exhibits, Poster Presentations, and Thought Leadership Presentations

Grab lunch and take some time to connect with colleagues, visit with exhibitors and sponsors, explore the poster presentations, and attend Thought Leader Presentations featuring the latest insights from our sponsors.

12:00 - 12:45 PM: A1-A6 Finalist Presentations

12:45 - 1:30 PM: A7-A13 Finalist Presentations

Poster Session 1 (P1 - P50):

  • 1:30 - 2:15 PM Odd Poster Presentations

  • 2:15 - 3:00 PM Even Poster Presentations

Thought Leader Presentations

  • 1:30 - 1:45 PM: Presented by Pharmaron
    Streamlining ADC Bioanalysis: Workflow for the Simultaneous Quantitation of Free Payload, Intact ADC, and Total Antibody Using a Single-Sample, Thomas Kralj, PhD

  • 1:50 - 2:05 PM: Presented by Discovery Life Sciences
    Do We Know Enough About Human Hepatocyte Lots for ADME?, Erik Willems

  • 2:10 - 2:25 PM: Presented by ATCC
    Advancing Human-Relevant Drug Discovery Through the Integration of Primary Cells, Patient-Derived Organoids, and Microphysiological Systems, Abhay Andar, PhD & Carolina Lucchesi, PhD

3:00 - 5:00 PM

Concurrent Symposia 3 & 4

Symposium 3: Mechanistic modeling: from in vitro to systems pharmacology

The session will cover the basic concepts of membrane permeability and partitioning, from small molecules to modalities such as PROTACs and bispecific antibodies, ending with a talk on systems modeling. The importance of modeling membranes for absorption and distribution across drug modalities will be discussed.

Co-Chairs: Swati Nagar, Temple University, USA; Maria Posada, Eli Lilly and Company, USA

  • Modeling membrane partitioning and permeability of drugs to predict intracellular concentrations
    Ken Korzekwa, Temple University, USA

  • Tools to predict oral absorption of PROTACs
    Priyanka Kulkarni, Takeda, USA

  • In vitro models to inform the profile of bispecific antibodies and their clinical studies
    Fei Hua, Eli Lilly and Company, USA

  • Mechanistic PK/PD modeling to evaluate efficacy of antibacterial combinations
    Gauri Rao, University of Southern California, USA

Symposium 4: Unanticipated and unique biotransformations - case studies

The session will discuss various case studies and examples of unique metabolic reactions in drug metabolism, including ways to characterize them, implications for drug development as well as ways to address them so as to improve drug properties.

Co-Chairs: Upendra Argikar, Gates Medical Research Institute, USA; Swati Nagar, Temple University, USA

  • Beyond Oxidation: Thiol Drug Methylation and its Potential for Drug–Drug Interactions
    Rheem Totah, University of Washington, USA

  • Metabolism of novel anti-tuberculosis drugs
    Jennifer Dumouchel, Gates Medical Research Institute, USA

  • Cannabidiol-induced liver injury with and without valproate in MPS
    Klarissa Jackson, University of North Carolina, USA

  • Unanticipated Metabolite Disposition: Mechanistic ADME Case Studies
    Jason Boer, Incyte, USA

5:15 - 6:15 PM

Roundtable Discussion

Capitalizing on external ADME capabilities in drug discovery and development

  • Paresh Chothe, AstraZeneca, USA

  • Amelia Deitchman, University of California San Francisco, USA

  • Barry Jones, Pharmaron, UK

6:30 - 7:15PM

New Investigators Event

6:30 - 7:30 PM

20th Annual Hepatocyte Research Association Meeting:
From Isolation to Innovation: The Hepatocyte Journey

6:30 - 8:00 PM

  • ISSX Connect: Meet the Focus Groups and New Investigators

    The relaxed, come-and-go format of this networking event allows attendees to engage directly with leaders from ISSX Focus Groups and New Investigators to learn more about ongoing activities and priorities. This session is intended to help new members, students, and non-members discover the networks within ISSX, ask questions, and identify concrete opportunities to get involved.

  • Poster Viewing Hours

7:00 - 5:00 PM

Day Three: Tuesday, October 13

Registration Open

7:15 - 8:15 AM

Industry-Sponsored Symposia Breakfast

  • WuXi AppTec: Navigating Peptide Biotransformation Challenges with Advanced LC-HRMS and TidesID, Improving Oral Peptide Absorption: From Permeation Enhancer Screening to In Vivo PK, Pen Li, PhD, Jianping Sun

  • BioIVT: In Vitro Tools for Exploring Tissue Metabolism of Peptides - a GLP-1 Agonist Case Study Combining Biotransformation and Proteomics, Joanna Barbara, PhD

8:30 - 9:30 AM

Plenary Session

Current and Future Perspectives on NAMs

  • Lorna Ewart, Emulate, United Kingdom

  • Namandje Bumpus, Charles River, USA

9:30 - 10:00 AM

Break

Take a break to connect with colleagues, visit with exhibitors and sponsors, explore the posters, and attend the Thought Leader Presentation featuring the latest insights from our sponsors.

9:40 – 9:55 AM: Thought Leadership Presentation, Presented by Axiom
Decoding Drug-Induced Liver Injury Through Multimodal Human Hepatic Profiling, Will Van Treuren, PhD

10:00 AM - 12:00 PM

Concurrent Symposia 5 & 6

Symposium 5: Breaking barriers: Innovative strategies to treat Alzheimer’s and other neurodegenerative diseases by conquering the blood-brain barrier

This session will explore the opportunities and challenges posed by new modalities (brain shuittled antibodies, oligonucleotides, etc.) for the treatment of neurodegenerative diseases, highlighting the need for new experimental tools as well as enhanced modeling and simulation.

Co-Chairs: Marcel Hop, Genentech, USA; Marjoleen Nijsen, Abbvie, USA

  • From preclinical models to patients: Challenges in CNS delivery using receptor-mediated transport platforms
    Shyeilla Dhuria, Denali, USA

  • Mechanistic PBPK modeling of brain penetration for novel modalities, specifically biologics
    Shengjia Wu, SUNY Buffalo, USA

  • Case study: The role of translational DMPK/PD in the Development of Trontinemab: A novel BrainshuttleTM Aβ antibody
    Niels Janssen, Roche, Switzerland

Symposium 6: Pharmacogenetic and clinical factors influencing drug toxicity

This session will explore how genetic variability and clinical factors contribute to adverse drug reactions, with a focus on pharmacogenetic markers and drug-gene interactions. Speakers from academia and industry will present case studies and emerging data on toxicity linked to key metabolic pathways and transporters.

Chair: Ute Schwarz, Western University, Canada

  • DPYD and fluoropyrimidine-associated toxicity
    Steven Offer, University of Iowa, USA

  • OATP1B1 and statin-induced myotoxicity considering ethnic variation
    Richard Kim, Western University, Canada

  • Pharmacogenetic testing and data interpretation: hits and misses affecting drug toxicity
    Andrea Gaedigk, UMKC, USA

  • The Significance of Clinical Immunogenicity in the Development of Biological Therapeutics
    Shalini Gupta, Amgen, USA

12:00 - 2:30 PM

Lunch Break: Exhibits, Poster Presentations, and Thought Leadership Presentations

Grab lunch and take some time to connect with colleagues, visit with exhibitors and sponsors, explore the poster presentations, and attend Thought Leader Presentations featuring the latest insights from our sponsors.

Poster Session 2 (P51 - P120):

  • 12:30 - 1:30: Odd Poster Presentations

  • 1:30 - 2:30: Even Poster Presentations

Thought Leader Presentations

  • 12:30 - 12:45 PM: Presented by BioIVT

  • 12:50 - 1:05 PM: Presented by Frontage Laboratories, Inc.
    A Practical DMPK Framework for Oligonucleotide Therapeutics, Hani Zaher, PhD

  • 1:10 - 1:25 PM: Presented by Charles River
    Bridging Bioanalytical Platforms for ADC Pharmacokinetics: Comparative Evaluation of LC-MS/MS and Ligand-Binding Assays for Total Antibody and Total ADC Quantification, Abdul Basit Shaikh

  • 1:30 - 1:45 PM: Presented by WuXi AppTec
    Physicochemical Property-Guided Formulation Screening to Optimize the Preclinical Pharmacokinetic Profiles of PROTAC Degraders, Quanli Feng

2:30 - 3:45 PM

Poster Awards

This session features rapid-fire presentations from our top 13 poster finalists (A1–A13). Following the presentations, the top three pre-doctoral and post-doctoral presenters will be recognized with awards.

3:45 - 5:15 PM

ISSX Awards

6:00 - 8:00 PM

Offsite Networking Reception

7:00 AM - 5:00 PM

Day Four: Wednesday, October 14

Registration Open

7:15 - 8:15 AM

Industry-Sponsored Symposia Breakfast

  • Discovery Life Sciences: Accelerated CYP Inhibition and Reactivity Profiling to Generate Public ADMET Datasets of Unprecedented Scale, Lauren Orr, PhD

  • SCIEX

8:30 - 9:30 AM

Plenary Speaker 2

An update on transporters and drug-drug interactions: where are we today, and where are we going?

  • Kathy Giacomini, UCSF, USA

9:30 - 10:00 AM

Break

Take a break to connect with colleagues, visit with exhibitors and sponsors, explore the posters, and attend the Thought Leader Presentation featuring the latest insights from our sponsors.

9:40 – 9:55 AM: Thought Leadership Presentation, Presented by CN Bio
Beyond DDI prediction: Uncovering gut and liver mechanisms with interconnected human organ models, Joseph Broomfield, PhD

10:00 AM - 12:00 PM

Concurrent Symposia 7 & 8

Symposium 7: Discovery and development of long acting medicines

This session will focus on the advances in long acting injectables and other delivery routes, including technical advances as well as the implications for optimization of ADME properties and PK/PD to ensure a duration of action of one month or more

Co-Chairs: Xingrong Liu, Gilead Sciences, USA; Upendra Argikar, Gates Medical Research Institute, USA

  • Progress and challenges in development of long acting medicines
    Andrew Owen, University of Liverpool, United Kingdom

  • Discovery and development of subcutaneous macrocyclic peptides that inhibit PD-L1
    Matt Soars, Bristol Myers Squibb, USA

  • Discovery and development of GS-3242, a long-acting integrase inhibitor for the treatment of HIV-1
    Murali Subramanian, Gilead, USA

  • Patient centric implantable LAIs
    Rene Holm, University of Southern Denmark, Denmark

Symposium 8: Enabling drug discovery with structure-based and structure-activity ADME

This session will cover the emerging understanding of the molecular mechanisms and structure activity of DMEs and drug transporters. Previously unknown protein-ligand interactions and chemical attributes in the context of small molecule ADME or designing molecules will be the focus.

Chair: Manthena Varma, Pfizer, USA

  • Decoding the structural activity of renal drug transporters
    Sanjay Nigam, UCSD, USA

  • PK optimization of targeted protein degraders - SAR of ADME properties
    Laurie Volak, Volak PharmaKinetic Solutions, USA

  • Decoding the selective chemical modulation of CYP3A4
    Taosheng Chen, St. Jude, USA

  • Learnings from cryo-EM structures of OATP1B1 and its complexes with substrates and inhibitors
    Min Woo Sung, Pfizer, USA

12:00 - 2:30 PM

Lunch Break: Exhibits, Poster Presentations, and Thought Leadership Presentations

Grab lunch and take some time to connect with colleagues, visit with exhibitors and sponsors, explore the poster presentations, and attend Thought Leader Presentations featuring the latest insights from our sponsors.

Poster Session 3 (P121 - P190):

  • 12:30 - 1:30: Odd Poster Presentations

  • 1:30 - 2:30: Even Poster Presentations

Thought Leader Presentations

  • 12:30 - 12:45 PM: Presented by ThermoFisherScientific
    Advancing New Approach Methodologies (NAMs): Building Reliable Human PSC-Derived Models for Translational Drug Discovery and Safety Assessment, Kevin Pridham

  • 12:50 - 1:05 PM: Presented by Axiom
    From Chemical Reactivity to Cellular Toxicity: Mechanistic Insights from Multimodal Profiling, Chengpeng Wang, PhD

  • 1:10 - 1:25 PM: Presented by LabCorp
    From Microdose to Major Metabolites: Where AMS Fits in the Modern DMPK Toolbox, Rebecca L Hansen, PhD

2:30 - 4:15 PM

Symposia 9

Symposium 9: Past failures, current successes and future opportunities in the treatment of obesity: M & S, DDI and beyond

This session will explore the evolving landscape of obesity treatment, highlighting how modelling and simulation, drug-drug interaction (DDI) assessments, and translational strategies are shaping therapeutic innovation.

Chair: Maria Posada, Eli Lilly and Company, USA; Aleksandra Galetin, University of Manchester, UK

  • Virtual twin-PBPK modelling in obesity using endogenous biomarker data
    Aleksandra Galetin, University of Manchester, UK

  • Disposition landscape of danuglipron and its chemotypes: Preclinical to clinical perspectives in obesity management
    Ernesto Callegari, Pfizer, USA

  • Using quantitative clinical pharmacology approaches to achieve mechanistic understanding of drug disposition and drive drug development
    Maria Posada, Eli Lilly and Company, USA

4:15 - 4:30 PM

Closing Session