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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
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Jump to Day Two
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Jump to Day Four
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8:00 AM - 7:00 PM

Day One: Sunday, October 11

Registration Open

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

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

  • 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: Thomas Kraft, Roche, Germany; 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, Vividion, USA

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

  • GST metabolism
    Drake Russell, Vividion, USA

  • GI Metabolism
    Eimear O'Mahoney, University of Washington, USA

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

4:00 - 5:00 PM

Focus Group Meetings

6:00 - 6:15 PM

Opening Remarks

6:15 - 7:15 PM

Keynote Session

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

  • Gemma Dickinson, Eli Lilly, USA

  • Nathan Cherrington, University of Arizona, USA

  • Aurora Authement, University of Washington, USA

7:15 - 9:15 PM

Opening Welcome Reception

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, Posters, Exhibitors

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

  • Consider a computational biology talk by an academic
    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

12:00 - 3:00 PM

Lunch/Exhibits/Poster Viewing

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, 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, 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

  • Drug-drug interactions with thiopurine drugs: new assays and insights
    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

6:30 - 7:30 PM

New Investigators Event

7:30 - 8:30 PM

Poster Viewing Hours

7:00 - 5:00 PM

Day Three: Tuesday, October 13

Registration Open

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, Posters, Exhibitors

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

  • Case study: BIIB080, an investigational antisense oligonucleotide therapy targeting tau
    Kumar Kandadi, Biogen, USA

  • Mechanistic PBPK modeling of brain penetration for novel modalities (biologics)
    Shenjia Wu, SUNY Buffalo, USA

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

  • 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/Exhibits/Poster Viewing

2:30 - 3:45 PM

ISSX Awards

4:00 - 5:15 PM

Poster Awards

7:00 AM - 5:00 PM

Day Four: Wednesday, October 14

Registration Open

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, Posters, Exhibitors

10:00 AM - 12:00 PM

Concurrent Symposia 7 & 8

Session 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

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

Session 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/Exhibits/Poster Viewing

2:30 - 4:30 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

  • Using quantitative clinical pharmacology approaches to achieve mechanistic understanding of drug disposition and drive drug development
    Aleksandra Galetin, University of Manchester, UK

  • Virtual twin-PBPK modelling in obesity using endogenous biomarker data
    Maria Posada, Eli Lilly and Company, USA