Meeting Program
Theme: From Benchside Research to Bedside Reality: DMPK's Next Chapter
The 16th European ISSX Meeting will explore how advances in DMPK are transforming benchside research into bedside reality, shaping the next chapter of drug discovery and development.
The scientific program spans innovative experimental systems, AI/ML, model-informed drug development, specific populations, and the ADME challenges of emerging therapeutic modalities, complemented by Drug Discovery and Development Tales that reveal the real-world decisions, setbacks, and breakthroughs behind successful medicines.
A dedicated debate will challenge the community to reflect on whether the future of DMPK will be driven primarily by data-centric AI approaches or by curiosity-driven scientific discovery.
Thank You to Our Meeting Sponsors!
Schedule at a Glance
| Time | Monday, June 29 | Tuesday, June 30 | Wednesday, July 1 | Thursday, July 2 |
|---|---|---|---|---|
| Morning | Short Courses 1 & 2 | Plenary Lecture & Concurrent Symposia | Plenary Lecture & Plenary Session | Plenary Lecture |
| Midday | Lunch for Short Course Attendees | Posters, Exhibits & Thought Leadership Presentations | Posters, Exhibits & Thought Leadership Presentations | Awards Program |
| Afternoon | Short Courses 3 & 4 | Concurrent Symposia | ISSX Debate Session & Plenary Session | Posters, Exhibits & Thought Leadership Presentations |
| Evening | ISSX Connect Networking, Opening Remarks, Keynote Lecture & Opening Reception | Poster Viewing Hours | Networking Reception at Kunstmuseum Basel | Closing Scientific Sessions |
08:00 - 19:00
Day One: Monday, June 29
Registration Open
09:00 - 12:30
Concurrent Short Courses 1 and 2
Short Course 1: From ancient atoms to precision medicines: The benefits of microdose/microtrace studies for pharmaceutical development
A special workshop will cover the latest in radiotrace technology and innovative clinical designs for drug development. Attendees will learn how radiotrace advancements can accelerate drug development. The event highlights new applications and challenges for large molecule therapeutics. The critical role of biotransformation will be discussed in detail, specifically how radiotrace technology can elucidate metabolic pathways. Biomarker assessment’s role in optimizing therapeutic outcomes will be discussed as well. The workshop aims to provide actionable insights for improving drug development efficiency and effectiveness.
Co-Chairs: Markus Walles, Novartis, Switzerland; Carley Heck, Pfizer, USA
A brief history of Accelerator Mass Spectrometry: development, applications and alternative technologies
Graeme Young, Accelerated Medical Solutions, UKAccelerator Mass Spectrometry for the Support of Microtracer Studies: Insights to technology, applications and strategies in state-of-the-art drug development
Stefan Blech, Boehringer Ingelheim, GermanyAdvanced Bioanalysis Techniques: Radiolabeling and Accelerator Mass Spectrometry for Therapeutic Biologics
Frederic Lozach, Novartis, SwitzerlandApplications of cAMS beyond DMPK: Focus on Biomarker studies, distribution studies etc.
Wouter Vaes, Peregrion, Netherlands
Short Course 2: Preclinical 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. Course will be complementary to the short course for the San Francisco Meeting.
Co-Chairs: Thomas Kraft, Roche, Germany; Jun Qu, University at Buffalo, USA
Practical Approaches for Evaluating and Predicting Target-Mediated Drug Disposition (TMDD) of Antibodies: From In Vitro Assays to Nonlinear PK Prediction
Yuki Noguchi, Chugai, JapanIn Vitro Assessment of Brain Uptake
Claire Simonneau, Roche, SwitzerlandIn vivo DMPK and biodistribution studies for therapeutic antibodies
Michael Otteneder, Roche, SwitzerlandLC-MS-based analysis of antibody biotherapeutics, targets and biomarkers in tissues
Jun Qu, University at Buffalo, USA
12:30 - 13:30
Lunch for Morning and Afternoon Short Course Attendees
Included in Short Course registration cost.
13:30 - 17:00
Concurrent Short Courses 3 and 4
Short Course 3: Navigating drug transporter variability across specific populations: From mechanisms to clinical implications
This short course will cover current experimental tools for assessing transporter abundance and sources of variability in drug transporter expression across specific populations. Presenters will discuss how these data inform in vitro to in vivo extrapolation (IVIVE) and physiologically-based pharmacokinetic (PBPK) modelling, to better predict drug disposition and DDI risk in specific populations (e.g., children). The session will demonstrate how integrating experimental and modelling strategies is crucial for improving our understanding of drug therapy in these groups.
Co-Chairs: Carina Cantrill, Roche, Switzerland; Roos Masereeuw, Utrecht University, Netherlands
From measurement to meaning: Assessing transporter abundance differences across special populations
Zubida Al-Majdoub, University of Manchester, United KingdomDevelopmental drug transporter expression and function: implications for paediatric pharmacotherapy
Pieter Annaert, KU Leuven, BelgiumChanges in transporter activity in liver disease with case examples
Sibylle Neuhoff, Certara UK Ltd., United KingdomPBPK Applications for Assessing Transporter Mediated PK and DDI changes in Specific and Disease Populations
Kunal Taskar, GSK, United Kingdom
Short Course 4: Model-informed drug discovery and development for challenging modalities
Computational approaches enable in silico investigation of drug concentrations and effects that can support decision making throughout drug discovery and development. The mechanisms that drive the PK/PD, and the level of detail at which these mechanisms are understood and can be modelled quantitatively, vary across modalities, leading some modalities to be more challenging during discovery and development. This short course will introduce attendees to the key considerations and data requirements for PBPK and PK/PD modelling for challenging modalities.
Co-Chairs: Daniel Scotcher, The University of Manchester, UK; Eva Huehn, Roche, Switzerland
PKPD modelling for protein degraders
Andreas Reichel, Bayer, GermanyTranslational strategies for multi-specific antibodies (t-cell engagers) in oncology/ immunology
Felix Stader, Certara, SwitzerlandModelling Of Oligonucleotides And SiRNA Therapeutics
Farzaneh Salem, GSK, UKMechanistic modelling in regulatory decision process
Mary Malamatari, MHRA, UK
17:00 - 17:45
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!
17:45 - 18:00
Opening Remarks
18:00 - 19:00
Keynote: Human organoids model disease in 3D and in 2D
Hans Clevers, Utrecht University, Netherlands
19:00 - 21:00
Opening Reception / Meet the Exhibitors
07:00 - 18:00
07:30 - 08:15
Day Two: Tuesday, June 30
Registration Open
Industry-Sponsored Symposia Breakfast: WuXi AppTec
Optimizing PK Strategies for Brain-Targeting Drugs Using Humanized Animal Models
Furong Jiao, PhD
08:30 - 09:30
Plenary Lecture 1
Can We Predict Dosages in Specific Populations: Insights from Obesity and Pediatrics
Catherijne Knibbe, Leiden University, Netherlands
09:30 - 10:00
Break, Posters, Exhibitors
10:00 - 12:00
Concurrent Symposia 1 & 2
Symposium 1: Specific Populations: Inclusive Drug Development for Mothers, Infants, and Children
Pharmacotherapy in lactating mothers and infants represents a significant clinical and drug development challenge. This vulnerable population is often excluded from clinical trials, leading to a critical gap in knowledge regarding drug safety, disposition, and appropriate dosing. This session will provide a comprehensive overview of the state-of-the-art methodologies being employed to bridge this gap and ensure safer medicine use for mothers and children.
Co-Chairs: Saskia de Wildt, Radboud University, Netherlands; Aleksandra Galetin, University of Manchester, UK
Clinical lactation studies
Catriona Waitt, Infectious Diseases Institute, Makerere University, UgandaPredicting the impact of CYP genotypes and enzyme ontogenies on infant exposures of venlafaxine and its active metabolite in lactation
Karen Rowland Yeo, Simcyp, UKSafety assessment of infant systemic exposure through human milk - a contribution from the ConcePTION project
Pieter Annaert, KU Leuven, BelgiumModel informed drug development in pediatric/neonates
Michael Gertz, Roche, Switzerland
Symposium 2: Conquering Low Clearance: Unleashing Next-Gen In vitro Tools and Strategies
Approximately 30% of discovery compounds now fall into the low-clearance category and accurately predicting their disposition is a significant and persistent challenge. With the emergence of novel long-term culture systems, a deeper appreciation for the rate-limiting role of transporters, and the maturation of integrative modeling platforms tools, the approaches for accurately measuring in vitro and predicting low CL in the clinic are evloving, here we discuss the latest data and best practices.
Co-Chairs: Volker Lauschke, Karolinska Institute, Sweden; Kenichi Umehara, Roche, Switzerland
Navigating cytochrome P450 identification: steer clear of human liver microsomes and recombinant enzymes
Tashinga Bapiro, AstraZeneca, UKIn vitro tools to determine low clearance: Spheroids and beyond
Carl Petersson, Merck, GermanyClearance prediction and estimation of fraction metabolized (fm) using HepatoPac
Kenichi Umehara, Roche, SwitzerlandUtilizing all in one system for measuring hepatic influx, egress, and metabolism based on extended clearance concept and summary of low CL prediction with 3 novel plated human hepatocyte models
Cory Kalvass, AbbVie, USANew Investigator: Influence of Intra- and Extracellular Free Drug Concentrations in the Human Colon on Local and Systemic Drug Exposure
Rebekkah Hammar, Uppsala University, Sweden
12:00 - 13:30
Exhibits, Poster Presentations, and Thought Leadership Presentation
Attendees are invited to enjoy lunch on their own, visit exhibitors, explore the posters, and participate in the following activities:
12:15 - 12:30: Thought Leader Presentation, Presented by Evotec
Challenges in the design and implementation of DMPK workflows for diverse modalities, Phil Butler12:30 - 13:15: Poster Award Finalist Presentations, A1 - A13
12:00 - 13:30
ISSX New Investigators Resume Review
Hosted by CAPKR - New investigators are invited to participate in the ISSX Resume Review Session, featuring a dedicated 15-minute one-on-one review with an experienced professional who will provide personalized resume feedback and career guidance. Appointments will be assigned on a first-come, first-served basis. Advanced registration is required.
13:30 - 15:30
Concurrent Symposia 3 & 4
Symposium 3: DILI Prediction: Models, Mechanisms, and Mitigation Strategies
Predicting Drug-Induced Liver Injury remains a critical hurdle, demanding a deeper understanding of its complex mechanisms. This session will address the persistent challenge of predicting Drug-Induced Liver Injury (DILI). Presentations will cover novel strategies to de-risk drug candidates, advanced cellular models, risk assessment for covalent inhibitors, immune mediated DILI and species-specific metabolic pathways. The goal is to provide a contemporary view on integrated in vitro and in silico approaches for profiling drug candidates in terms of DILI liabilities and underlying mechanisms.
Co-Chairs: Amit Kalgutkar, Pfizer, USA; Pieter Annaert, KU Leuven, Belgium
The DILI Enigma: When Drug Liabilities Converge into Liver Injury
Heiko Schadt, Novartis, SwitzerlandAn Autologous iPSC-Derived Multicellular Liver Platform for De-Risking Immune-Mediated DILI
Estelle Berreur, Roche, SwitzerlandNew methodologies to assess DILI risk for covalent inhibitor drug candidates
Sara Amberntsson, Astrazeneca, SwedenAssessment of Efficacy and Hepatotoxicity of Antisense Oligonucleotide Drugs Using Human Liver Microphysiological Systems
Xiao-bo Zhong, University of Connecticut, USANew Investigator: Toward improved prediction of drug-induced cholestasis: a mechanism-based hepatic tri-culture approach
Caro Mertens, KU Leuven, Belgium
Symposium 4: Advanced Antibody-based Therapeutics: Beyond Vanilla IgG DMPK
This session explores the DMPK and ADME challenges of complex biologics, moving beyond standard IgG antibodies. It will cover how advanced formats, like Fc-fusions or multispecifics, impact key parameters such as nonspecific clearance, TMDD, renal catabolism, and biotransformation. The discussion will highlight critical learnings and provide key considerations to inform the design of next-generation antibody therapeutics.
Co-Chairs: Thomas Kraft, Roche, Germany; Kenta Haraya, Chugai, Japan
FcRn‑Driven Translation: Predicting Human PK of Fc‑Engineered Antibodies from Preclinical Data
Kenta Haraya, Chugai, JapanBeyond Molecular Weight: How Shape, Flexibility, and Receptor Affinity Govern Kidney Filtration of Biologics
Hanine Rafidi, Genentech, USAStructure-PK Relationship: Spatial Geometry of Complex Antibody Formats Controls Non-Specific Clearance
Stefan Weise, Roche, GermanyFcRn – a bifunctional receptor with therapeutic applications
Jan Terje Andersen and Sopisa Benjakul, UiO, Institute of Clinical Medicine, Norway
15:30 - 16:00
Break, Posters, Exhibitors
Attendees are invited to take a refreshment break, visit exhibitors, explore posters, and attend the following session:
15:35 – 15:50: Thought Leadership Presentation, Presented by BioIVT
Beyond CYP: In Vitro Tools for Exploring Tissue Metabolism – a GLP-1 Peptide Drug Case Study, Joanna E. Barbara, PhD
16:00 - 18:00
Concurrent Symposia 5 & 6
Symposium 5: Novel ADME assays for antibody-based therapeutics and how to validate and use them
This session will focus on novel in vitro ADME assays designed for antibody-based therapeutics, with an emphasis on their practical use and validation. Experts will present on key topics including in vitro assays for FcRn recycling, the assessment of non-specific uptake and clearance, and the in vitro evaluation of target-mediated drug disposition (TMDD). A concluding roundtable discussion will allow participants to compare different approaches to FcRn recycling assays, providing a holistic view of best practices in the field.
Co-Chairs: Claire Simonneau, Roche, Switzerland; Jan Terje Andersen, University of Oslo, Norway
Applications & Considerations of Cellular Assays for Understanding the Elimination of Fc-Bearing Therapeutics
Mark Bryniarski, Amgen, USAA versatile technology platform tailored to dissect mechanism-of-action, de-risk development and predict PK and PD properties of FcRn-binding molecules
Torleif Gjoelberg, Authera, NorwayValidation and use of in vitro assays for non-specific CL
Thomas Kraft, Roche, GermanyRoundtable Discussion: Binding, Retention, or Recycling? Navigating FcRn Assays for PK Assessment
Tilman Schlothauer, Jan Terje Andersen, Claire Simmonneau, Stefan Weise, Kip Conner, Max Brinkhaus
Symposium 6: Driving Drug Development with Transporters: New Tools, New Targets, and New Modalities
The session aims to cover a range of emerging themes related to drug transporters, including new tools for characterization of transporter activity in vitro and in vivo, new subcellular targets and role of transporters for new therapeutic modalities.
Co-Chairs: Aleksandra Galetin, The University of Manchester, UK; Marie-Emilie Willemin, Johnson & Johnson, Belgium
Transporters and new therapeutic modalities
Raymond Evers, Johnson & Johnson, USARole of Lysosomal Transporters and Enzymes in Drug Metabolism and Disposition
Bhagwat Prasad, University of Cincinnati, USADefining the Placenta Transporter Proteome in Clinical Specimens
Jacqueline Tiley, University of North Carolina, USANew Investigator: Metabolomics-based identification of circulating breast cancer resistance protein biomarker candidates
Kreetta Hämäläinen, University of Helsinki, FinlandAlterations in transporters in disease: Insights from endogenous biomarkers and liquid biopsy
Aleksandra Galetin, University of Manchester, UK
18:00 - 19:30
Poster Viewing Hours
07:00 - 18:30
Day Three: Wednesday, July 1
Registration
07:30 - 08:15
Industry-Sponsored Symposia Breakfast: Altis Biosystems
Expanding the DMPK Toolbox: Characterization of RepliGut® Planar for Current and Emerging Therapeutic Modalities
Benjamin Scruggs, PhD
08:30 - 09:30
Plenary Lecture 2
Model-informed drug design, discovery and development (MID4): combining mechanistic platforms with AI
Piet van der Graaf, Certara, UK
09:30 - 10:00
Break, Posters, Exhibitors
Attendees are invited to take a refreshment break, visit exhibitors, explore posters, and attend the following session:
09:40 – 9:55: Thought Leadership Presentation, Presented by WuXi AppTec
Mastering siRNA Plasma Protein Binding: Overcoming Artifacts in Ultrafiltration and EMSA for Robust ADME, Jie Wang, PhD
10:00 - 12:00
Plenary Session 1: Bridging Bench and Bytes: AI/ML for ADMET Insights
AI/ML and computational tools continue to shape how we approach ADMET science with data being our most valuable asset. This session will introduce how AI/ML is changing lab automation for data generation along with ML models for in vitro and in vivo prediction and how these are applied in drug discovery teams to guide design and lead compound selection.
Co-Chairs: Prashant Desai, Genentech, USA; Fabio Brocatelli, Altos Labs, USA
Machine learning for Pharmacokinetics optimization and property balancing in drug design
Raquel Rodriguez, Novartis, SwitzerlandIntelligent Bioanalysis - iBA
Andreas Luippold, Boehringer Ingelheim, GermanyTransforming Animal Study Toxicology Reports into Structured, Harmonized Data Using Large Language Models
Tatyana Doktorova, Roche, SwitzerlandFrom Limited Sampling to Digital Twins: AI-Enabled Precision Dosing in Routine Care
Jean Baptiste Woillard, University of Limoges, France
12:00 - 14:00
Exhibits, Poster Presentations, and Thought Leadership Presentations
Attendees are invited to enjoy lunch on their own, visit exhibitors, explore the posters, and participate in the following activities:
12:00 - 13:30: Poster Session 1 Presentations, P1-P100:
12:00 - 12:45: Odd Posters Presentations
12:45 - 13:30: Even Posters Presentations
12:15 - 12:30: Thought Leader Presentation, Presented by Charles River
Advancing In Vitro Drug Metabolism Assays: Toward Flexible, Fit‑for‑Purpose Design, Zsolt Fekete
14:00 - 16:30
ISSX Debate Session
Motion: This house believes that major innovations in ADME Sciences will be driven by human intuition and curiosity, and not AI
Moderator: Steve Hood, GSK, UK
The motion will be proposed by Fabio Broccatelli (Altos Labs, USA) and seconded by Amit Kalgutkar (Pfizer, USA)
The motion will be opposed by Carina Cantrill (Roche, Switzerland) and further opposed by Piet van der Graaf (Certara UK/ Leiden University, Netherlands)
16:30 - 17:00
Break, Posters, Exhibitors
Attendees are invited to take a refreshment break, visit exhibitors, explore posters, and attend the following session:
16:35 – 16:50: Thought Leadership Presentation, Presented by Pharmaron
Accelerator Mass Spectrometry in Drug Development: Clinical Applications and Technological Advances, Adrian Pereira
17:00 - 18:30
Plenary Session 2: The Rise of Human Microphysiological Systems for drug efficacy and PK
Traditionally, rodent models have been used for ADME-T studies, but their predictive capacity is limited and often show mild or late-onset phenotypes. Ethical concerns and advances in animal-free innovations drive a shift away from animal use. Advanced 3D organoids and organ-on-a-chip systems now offer human-relevant platforms that bridge rapid 2D screening and in vivo studies, improving mechanistic insight and accelerating therapeutic development.
Co-Chairs: Roos Masereeuw, Utrecht University, Netherlands; Rose Hayeshi, North-West University, South Africa
Immunocompetent chip models for drug screenings
Henriette Lanz, Mimetas, NetherlandsA primary human Gut/Liver microphysiological system to estimate human oral bioavailability
Yassen Abbas, CN Bio, UKBridging the Nasal Route to the Brain: Advanced Microphysiological Platforms for Drug Delivery and Pharmacokinetics
Chrisna Gouws, North-West University, South AfricaOrganoid models for cystic fibrosis treatment optimization, directly from organoids to patients
Jeffrey Beekman, Utrecht University, Netherlands
19:00 - 21:00
Networking Reception
Don’t miss the Networking Reception at the historic Kunstmuseum Basel! Join colleagues and friends for an evening of conversation, connection, and celebration at one of Switzerland’s most renowned art museums.
This event is included in your meeting registration
07:30 - 18:00
Day Four: Thursday, July 2
Registration Open
08:30 - 09:30
Plenary Lecture 3
Clinical Pharmacology Considerations of Biologics
Don Mager, SUNY Buffalo, USA
09:30 - 9:45
Break, Posters, Exhibitors
Attendees are invited to take a refreshment break, visit exhibitors, and explore posters.
9:45 - 12:00
2026 Awards Program
ISSX Lifetime Contributions to ADME Research Award
Malcolm Rowland, PhD, The University of Manchester, UK (Emeritus)
Best Poster Awards
Authors of posters A1-A13 will present rapid fire presentations of their research
ISSX European New Investigator Award
Thomas E. Kraft, PhD, Roche, Germany
From Solute Carriers to Complex Biologics: A Structural Journey through the Evolving Frontier of ADME
ISSX European Scientific Achievement Award
Aleksandra Galetin, PhD, The University of Manchester, UK
From Questions to Applications: Translating Complex PK into Real‑World Impact
12:00 - 13:00
Exhibits and Poster Presentations
Attendees are invited to enjoy lunch on their own, visit exhibitors, explore the posters, and participate in the following activities:
12:00 - 12:45: Poster Session 2 Presentations, P101 - P146
13:00 - 15:00
Plenary Session 3: Unlocking the Future: ADME/DMPK of New Therapeutic Modalities
This session explores DMPK challenges in cutting-edge therapies, including targeted covalent inhibitors (TCIs) peptides/radioligand therapies and siRNA conjugates. It covers biotransformation challenges and highlights unique issues and solutions for TCIs, peptides/oligos as biologically active molecules. Attendees will gain insights into pharmacokinetic hurdles and strategies for siRNA-based treatments targeting the heart. Emerging radioligand therapies and their critical DMPK considerations are also covered.
Co-Chairs: Markus Walles, Novartis, Switzerland; Marie Ahlqvist, AstraZeneca, Sweden
The Covalent Conundrum: Unique DMPK Aspects of Targeted Covalent Inhibitors
Shuai Wang, Genentech, USAWhat are PK features that make a RLT successful?
Daniela Baldoni, Novartis, SwitzerlandDMPK Challenges for targeting oligonucleotides (peptide and antibody conjugates) to extrahepatic tissues like heart and kidneys
Marie Ahlqvist, Astra Zeneca, SwedenBiotransformation of Peptides and Proteins. Case Study with an FGF21 Analogue
Joergen Olsen, Novo Nordisk, Denmark
15:00 - 15:30
Break, Posters, Exhibitors
Attendees are invited to take a refreshment break, visit exhibitors, and explore posters.
15:30 - 17:30
Plenary Session 4: Drug Discovery and Development Tales
This session will feature experienced scientists who will share their stories of drug discovery and development. Speakers will reveal the pivotal moments, unexpected challenges, and crucial decisions that shaped a project's fate. The focus will be on the unseen narratives—the near-misses, the unexpected data, and the moments of scientific intuition that ultimately led to success or informed a critical "no-go" decision.
Co-Chairs: Amit Kalgutkar, Pfizer, USA; Simone Schadt, Roche, Switzerland
The ADME Package for the Bepirovirsen File: What’s in the box?
Steve Hood, GSK, UKLead-to-Candidate ADME Optimization - Case Studies
Amit Kalgutkar, Pfizer, USAMetabolic Chiral Inversion Of Nerandomilast Occurs Via Microbial Sulfoxide Reduction And CYP450 Oxidation
Mitch Taub, Boehringer Ingelheim, USAEvaluation of in vitro biotransformations of balinatunfib (SAR441566) and its metabolite M8 in a human intestinal microbiota model
Cyril Borie, Sanofi, FranceZosurabalpin: Overcoming Nonclinical and Clinical Challenges for a New Antibiotic
Caterina Bissantz and Carina Cantrill, Roche, Switzerland