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.
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
Overview Microdose /Microtrace studies
Graeme Young, Accelerator 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, SwitzerlandMicrotracer applications beyond guideline required hADME
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
Target-Mediated Drug Disposition In Vitro
Yuki Noguchi, Chugai, JapanIn Vitro Assessment of Brain Uptake
Claire Simonneau, Roche, SwitzerlandBioanalysis in Target 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
Current experimental tools for transporters abundance and differences in expression in special populations
Zubida Al-Majdoub, University of Manchester, United KingdomAge dependent differences in transporters for the optimization of pediatric therapy
Saskia de Wildt, Radboud University, NetherlandsChanges in transporter activity in liver disease with case examples
Sibylle Neuhoff, Certrara, UK and Uganda
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; Farzaneh Salem, GSK, UK
PKPD modelling for protein degraders
Andreas Reichel, Bayer, GermanyTranslational strategies for multi-specific antibodies (t-cell engagers) in oncology/ immunology
Felix Stader, Certara, Switzerland
17:00 - 17:45
Focus Group Networking Event
17:45 - 18:00
Opening Remarks
18:00 - 19:00
Keynote
Hans Clevers, Utrecht University, Netherlands
19:00 - 21:00
Opening Welcome Reception / Meet the Exhibitors
07:15 - 17:45
Day Two: Tuesday, June 30
Registration Open
08:30 - 09:30
Plenary Lecture 1
Specific populations with a focus on 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, University of Liverpool, Gulu 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; Jane Kenny, Genentech, USA
Clearance 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, USANavigating cytochrome P450 identification for low clearance compounds: steer clear of human liver microsomes and recombinant enzymes
Tashinga Bapiro, AstraZeneca, UK
12:00 - 13:30
Lunch/Exhibits/Poster Viewing
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: Why do seemingly safe drugs turn on the liver?
Heiko Schadt, Novartis, SwitzerlandAssessment of efficacy, ADME, toxicity of ASO and siRNA drugs using human microphysiological systems
Xiabo Zhong, University of Connecticut, USA
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
Animal models and scaling to human. Co-administration of IVIG. Importance assessing DMPK properties of engineered/complex biologics
Kenta Haraya, Chugai, JapanImpact of complex format on non-specific CL
Stefan Weise, Roche, GermanyRenal catabolism of certain complex antibody formats
Hanine Rafidi, Genentech, USA
15:30 - 16:00
Break, Posters, Exhibitors
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; Terje Andersen, University of Oslo, Norway
Uptake and FcRn recycling assays
Mark Bryniarski, Amgen, USAValidation and use of in vitro assays for non-specific CL
Thomas Kraft, Roche, Germany
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, USANew targets for transporters - Transporters in lysosomes
Bhagwat Prasad, University of Cincinnati, USADefining the Placenta Transporter Proteome in Clinical Specimens
Jacqueline Tiley, University of North Carolina, USAApplication of endogenous biomarkers and liquid biopsy to characterise transporter expression in the disease
Aleksandra Galetin, University of Manchester, UK
18:00 - 19:30
Poster Viewing Hours
07:15 - 17:45
Day Three: Wednesday, July 1
Registration Open
08:30 - 09:30
Plenary Lecture 2
AI / Model informed drug development
Piet van der Graaf, Certara, UK
09:30 - 10:00
Break, Posters, Exhibitors
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
12:00 - 14:00
Lunch/Exhibits/Poster Viewing
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
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
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, UKNeurotoxicity screening using a dynamic brain organoid model with African genetics
Chrisna Gouws, North-West University, South AfricaOrganoid models for cystic fibrosis treatment optimization, directly from organoids to patients
Jeffrey Beekman, Utrecht University, Netherlands
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 - 10:00
Break, Posters, Exhibitors
10:00 - 12:00
2026 Awards Program
12:00 - 13:00
Lunch/Exhibits/Poster Viewing
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
Biotransformation of Peptides and Proteins. Case Study with an FGF21 Analogue
Joergen Olsen, Novo Nordisk, DenmarkBeyond the Liver: Peptide–siRNA Conjugates Tackling Extrahepatic Delivery and DMPK Hurdles
Marie Ahlqvist, Astra Zeneca, Sweden
15:00 - 15:30
Refreshment Break
15:30 - 17:00
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
Zosurabalpin (Antibiotic with novel MoA)
Caterina Bissantz, Roche, SwitzerlandLead-to-Candidate ADME Optimization - Case Studies
Amit Kalgutkar, Pfizer, USANerandomilast
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, France