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.
Day One: Monday, June 29
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.
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.
Concurrent Short Courses 3 & 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.
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.
Day Two: Tuesday, June 30
Concurrent Symposia 1 & 2
Symposium 1 - Specific Populations: Inclusive Drug Development for Mothers, Infants, and Children
Synopsis: Pharmacotherapy in lactating mothers and their 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.
Symposium 2 - Conquering Low Clearance: Unleashing Next-Gen In vitro Tools and Strategies
Synopsis: 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.
Concurrent Symposia 3 & 4
Symposium 3 - DILI Prediction: Models, Mechanisms, and Mitigation Strategies
Synopsis: 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.
Symposium 4 - Advanced Antibody-based Therapeutics: Beyond Vanilla IgG DMPK
Synopsis: 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.
Concurrent Symposia 5 & 6
Symposium 5 - Novel ADME assays for antibody-based therapeutics and how to validate and use them
Synopsis: 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.
Symposium 6 - Driving Drug Development with Transporters: New Tools, New Targets, and New Modalities
Synopsis: 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.
Day Three: Wednesday, July 1
Plenary Session 1
Bridging Bench and Bytes: AI/ML for ADMET Insights
Synopsis: 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.
Debate Session
“This house believes that the biggest breakthroughs in DMPK will come from serendipitous discoveries driven by curiosity, not from an AI driven model”
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.
Plenary Session 2
The Rise of Human Microphysiological Systems for drug efficacy and PK
Synopsis: 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.
Day Four: Thursday, July 2
Plenary Session 3
Unlocking the Future: ADME/DMPK of New Therapeutic Modalities
Synopsis: 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.
Plenary Session 4
Drug Discovery and Development Talescrophysiological Systems for drug efficacy and PK
Synopsis: 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.