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SESSION OUTLINES

Session 1: Novel Drug Modalities & Emerging Therapeutics
Session chairs:

• SPS: Mia Lundblad
• DMDG: Kevin Brady

Scope:
Speakers are invited to give insights to the field of PK, PD, QSP, as well as clinical pharmacology and translational sciences with focus on novel and emerging drug modalities, such as novel biologics formats, conditionally activated antibodies, cell and gene therapies, and nucleic acid therapeutics. These new modalities have rapidly advanced and are already reaching dosing in patients. However, deeper or alternative pharmacokinetic and pharmacodynamic paradigms need to be applied and there are translation challenges with regards to predicting doses, exposures and effect/activity. To understand and develop new approaches and models in this context is not only important from an efficacy point of view but also from a safety perspective. This session aims to address these challenges and advancements, providing insight into the nonclinical and clinical strategies employed with these emerging therapies.

Confirmed speakers:

• Lingling Zhang, Wuxi: Radiolabeling Strategies and ADME Insights for Oligonucleotide Therapeutics
• Lene Alifrangis, Novo Nordisk: Prediction of liver target engagement for GalNAc-conjugated siRNA using a semi-mechanistic PKPD model
• Robert Nelson, BioAgilytix: Interpreting Immunogenicity Data to Support AAV Gene Therapy Development: A Bioanalytical and Translational Perspective
• Joseph Ciccolini, La Timone University Hospital of Marseille, France: Antibody Drug Conjugates in Oncology: why “Magic Bullet” does not mean “Magic Pharmacology”

Please contact Kevin Brady (kbnbeconsulting@gmail.com)  and Mia Lundblad (mslu@novonordisk.com)  for further details.

Session 2: Targeted Covalent Inhibitors
Session chairs:

• DMDG: Andreas Reichel
• GMP: Priscilla Brun

Scope:
This session explores the unique challenges and strategies in developing Targeted Covalent Inhibitors. While TCIs are small molecules, their reactive warheads require specialized approaches for optimization. We will discuss specific screening methodologies to balance warhead reactivity with target selectivity, tailored ADME optimization strategies, and the distinct PK/PD characterization needed to account for irreversible binding kinetics. The session aims to share recent experiences in TCI development, highlighting how traditional small molecule approaches must be adapted for this promising modality. Join us to exchange insights on assay design, risk assessment for off-target reactivity, and preclinical evaluation strategies specific to covalent inhibitors.

Speakers to be confirmed.

Please contact Andreas Reichel (andreas.reichel@bayer.com) and Priscilla Brun (priscilla.brun@sanofi.com) for further details.

The Debate
Session chairs:

• Stephen Madden & Steve Hood

Scope:
A recurring theme and unique feature of the DMDG organisations. The legendary DMDG debate returns for another round. There will be someone proposing for and someone proposing against, and we have the audience. Let the battle(s) begin...

Topic for debate to be announced.

Session 3: Advanced Modelling & AI Technologies
Session chairs:

• DMDG: James Yates
• GMP: Frederic Dayan

Scope:
Modelling approaches, such as AI/ML and Quantitative Systems Pharmacology, are having an increasing and evolving role in drug discovery and drug development. These novel approaches also hold the promise of enabling a new generation of highly personalized therapeutic drug monitoring, driven by patient-specific modelling and data-driven decision support.
Once QSP was in the realm of target validation, now it is being used to design and analyse clinical trials. AI/ML methods have progressed from classical pattern-recognition and predictive modelling to the use of Large Language Models capable of extracting knowledge from the literature and even assisting in the automatic generation of model code. In this session we will explore applications of these varied mathematical modelling approaches, understand where they are having the most impact and unveil the challenges that lie ahead. We invite speakers to submit abstracts and to share their experiences of these emerging techniques.

Confirmed speakers:

• Benjamin Maurel, Inserm: Latent Neural-ODEs for model-informed precision dosing
• Jure Fabjan, ESQ Labs: Federated Machine Learning for Predictive Pharmacokinetics: From Organ-on-Chip to Clinical Data
• Paul-Emeric Saunier, Biotrial: Enhancing Dose-Effect Characterization in Clinical Trials Using Foundation Model-Derived EEG Biomarkers

Please contact james.x.yates@gsk.com and f.dayan@exactcure.com for further details.

Session 4: Unraveling PK properties with advanced in vitro models and bioanalytical methods
Session chairs:

• SPS: Patrik Lundquist
• GMP: Florence Gattacceca

Scope:
Novel drug modalities and reduction of animal use imply to develop relevant in vitro models to unravel PK properties and predict PK in humans. Specific bioanalytical methods are also required for a robust PK evaluation. Speakers are invited to present groundbreaking biological or bioanalytical methods which allowed to shed light on specific PK properties of novel drug modalities and/or to replace animal experiments in the prediction of PK in human. Empowerment of experimental tools with machine learning could also be included in the session, which aims at highlighting the evolution of experimental tools along the evolution of therapeutic modalities and ethical constraints.

Confirmed speakers:

• Johanna Paris, Sanofi: Uncharted territory: Innovative bioanalysis for challenging PK scenarios
• Emily Rayner, TNO: The development and application of advanced ex vivo intestinal tissue-based models to predict the oral absorption and intestinal metabolism of drugs, including bRo5 compounds
• Volker Lauschke, Karolina Institutet: Important material considerations for pharmacokinetic and toxicological analyses in organotypic and microphysiological culture models

Please contact florence.gattacceca@univ-amu.fr and patrik.lundquist@uu.se for further details.

Student/Early Career (EC) session:
Session chairs and Student/EC abstract review panel members:

• Hannah Spencer hspencer-94@hotmail.com and Lerryn Hilton lerryn.hilton@pharmaron-uk.com covering student & EC applications, respectively (DMDG)
• Isabelle Alakiki isabellealakiki@hotmail.com and Raphael Saporta raphael.saporta1@servier.com covering student & EC applications, respectively (GMP)
• Thomas Dorlo thomas.dorlo@uu.se  covering student & EC applications (SPS)

Scope:
This session will highlight the work of students and/or early careers scientists (within the first 5 years of DMPK or a related discipline role) and feature short presentations selected by all three contributing societies and shorter (c.5 minutes) poster blitz style presentations summarising posters from students/ early career scientists to a welcoming audience. Any questions or additional discussions related to the shorter poster blitz style presentations are encouraged at the subsequent poster viewing sessions and during coffee breaks throughout the conference.

Session 5: Emerging Pathways in Drug Metabolism
Session chairs:

• DMDG: Maria Chatzopoulou
• GMP: Fiona Plait

Scope:
Drug metabolism and biotransformation are evolving beyond traditional paradigms, introducing new challenges for drug discovery and development. This session will spotlight the growing importance of non-CYP pathways and extrahepatic metabolism, which complicate clearance prediction and safety assessment. Contributions from these routes are common in new modalities and often lead to clearance underprediction due to poor in vitro–in vivo extrapolation (IVIVE) and limited scaling strategies. The microbiome is also increasingly recognized as a key driver of variability and unexpected metabolic profiles. These trends add complexity to the translatability of in vitro systems and hindering accurate prediction of circulating metabolites and reinforcing the need to reshape ADME strategies. By integrating mechanistic insights with innovative tools and predictive models, this session aims to provide a forward-looking view of modern drug metabolism science.
Speakers are invited to share their insights, case studies, emerging methodologies and integrated approaches that advance our understanding of these complex drug metabolism pathways.
Topics in scope:

• Non-CYP IVIVE
• Non-CYP reaction phenotyping
• Extrahepatic modelling
• Microbiome in drug metabolism
• Biotransformation routes for new modalities
• Translatability of in vitro systems

Confirmed speakers:

• Alan Krick, Sanofi: Leveraging Biotherapeutic Biotransformation Insights to Drive PK Quality and Decision Making
• Patrick Lundquist, Uppsala University: Advanced in vitro models for the assessment of intestinal metabolism and permeability
• Sanna-Mari Aatsinki, Admescope: Optimizing In Vitro Systems for Reliable Prediction of UGT-Mediated Drug–Drug Interactions

Please contact Maria Chatzopoulou (maria.chatzopoulou@ucb.com) and Fiona Plait (fiona.plait@simulations-plus.com) for further details.

Session 6: Translational Science & Drug Discovery: Enabling end-to-end inclusive research
Session chairs:

• DMDG: Amaka Ezuruike
• GMP: Jeremy Perrier

Scope:
The process of drug development has evolved over the years with an increasing focus on enabling science-driven research that addresses population heterogeneity throughout the R&D life cycle, thereby significantly reducing the risk of late-stage clinical trial failures. Translational science now drives end-to-end inclusive drug development research through the integration of tools such as advanced human in vitro systems (e.g., organoids), model-informed drug development (MIDD) approaches (e.g., PBPK, QSP, POPPK/PD, digital twin or virtual patient models for precision dosing and AI), and real-world evidence. By leveraging these quantitative translational frameworks, a safer and faster drug development process, more representative of all patient groups can be achieved. In spite of this, drug development is still considered lengthy, arduous, and expensive.
The format of the session will be four brief talks of 15 minutes each. The first speaker will give an overview of the session. The other speakers will demonstrate using case study examples of how one or more of these translational approaches have been directly applied to projects. This will be followed by a panel discussion of about 30 minutes involving all the speakers and moderated by the co-chairs, during which we are hoping to stimulate discussions around what we are doing well and what changes are still needed to maximize R&D success while ensuring patient benefit.

Confirmed speakers:

• Karen Rowland Yeo, Certara UK: MOXIDECTIN: From bench to bedtime
• Murat Cirit, Javelin Biotech: A Multi-Tissue Chip Platform for Predictive Assessment of Human Pharmacokinetic Parameters and Profiles of IV Drugs
• Sheila Annie Peters, Boehringer Ingelheim: Utility of PBPK models to identify mechanisms limiting oral bioavailability
• Thierry Lavé, Independent Consultant: Integrating heterogeneity in research and early development. A proactive strategy

Please contact Amaka Ezuruike (udoamaka.ezuruike@certara.com) or Jeremy Perrier (Jeremy.perrier@loreal.com) for further details.

Candle light speaker:
Session chairs:

• Suzanne Iverson
• Rasmus Jansson-Löfmark

Speaker: to be announced

Scope:
The Candlelight Keynote Lecture is a cherished tradition of the Swedish Pharmaceutical Society (SPS) —born from a moment of serendipity. Several Rosenön symposia ago, a severe snowstorm cut the power to the venue. To keep the meeting alive, participants moved to the cafeteria, lit candles, and continued the lecture by candlelight. From that memorable evening, the “Candlelight Lecture” was established.
Each year, a leading figure in pharmacokinetics (PK) and drug metabolism is invited to share career highlights in an intimate, "unplugged" format. Now, please sit back and enjoy this year’s speaker.

Session 7: Mind the Gap: From Early Discovery Insights to Development Decisions for Transporter Predictions
Why Transporter Predictions Break Down - hidden gaps and emerging tools.
Session chairs:

• SPS: Anna Nordmark
• DMDG: Claire Purdy

Scope:
Transporter inhibition and transporter substrate understanding remains one of the most challenging areas in translational science, where disconnects between early discovery and development-stage data and predictions to the clinical situations often lead to uncertainty. Despite sophisticated in vitro systems and mechanistic models, gaps persist in accurately forecasting transporter-mediated drug-drug interactions and tissue-specific drug disposition. We want to explore why these gaps occur, building on Session 6 and how we can bridge them through innovative science and technology, leading us into Session 8.
We want to highlight transporter inhibition and transporter substrate interactions as a case studies for prediction failures - examining limitations in current in vitro/in vivo extrapolation, mechanistic models, and computational approaches. Contributions that showcase emerging solutions such as NAMs (New Approach Methodologies), organ-on-chip systems, multi-omics integration prediction tools as well as clinical data are encouraged. Case studies illustrating the leap from discovery screens to development decisions and actual clinical data —whether successful or cautionary—are particularly welcome.
We invite abstract submissions which address:

• Mechanistic gaps in transporter inhibition predictions or transporter substrate interactions between discovery and development phases
• In vitro/in vivo disconnects and strategies to improve extrapolation
• NAMs and advanced experimental or predictive platforms for transporter studies
• Case studies where transporter inhibition or substrate interactions identified in discovery impacted development decisions and clinical studies

Confirmed speakers:

• Alex Williams, Cyprotex: Predicting the potential for OCT1-mediated drug-drug interactions with fenoterol
• Mailys De Sousa Mendes, Certara: Expression-Dependent IC50 shift: Stirring the Unstirred Water Layer
• Daan van Valkengoed, Leiden Academic Center for Drug Research, Leiden University: In vitro-in vivo extrapolation of P-glycoprotein activity: computational insights into the potential and limitations of current approaches for central nervous system drug discovery

If you are working on closing these gaps—through novel models, experimental innovation, or cross-disciplinary integration—we want to hear from you! Please contact Anna Nordmark (anna@nordmarkclinpharm.se) and Claire Purdy for further details.

Session 8: Clinical Pharmacology and DMPK Applications and Case Studies — Translating Clinical Data into Decisions
Session chairs:

• DMDG: Graeme Scarfe
• SPS: Angelica Quartino

Scope:
We invite submissions of abstracts to present on case studies where clinical pharmacology, DMPK, and model informed drug development (MIDD) leveraged clinical data to inform drug development and regulatory decisions. This session will highlight how clinical evidence, thoughtful study designs, and quantitative approaches supported DMPK/PD characterization e.g., SAD/MAD, food effect, human ADME, drug–drug interactions, special populations (renal/hepatic impairment, pediatrics, elderly), immunogenicity/target mediated disposition for biologics, dose selection/justification, formulation or delivery changes, bioequivalence/biosimilarity, and lifecycle/label optimization. This session is open to all therapeutic areas and modalities — from first in human through late stage and post approval. Priority is given to scientific novelty, including innovative clinical designs, creative sampling schemes, inventive DDI, human ADME or special population strategies, translational and back translational PK/PD, and impactful quantitative approaches that integrate clinical DMPK/PD data to guide dose and drug development.

Confirmed speakers:

• Daniel Bending, Eli Lilly and Company Limited: Accelerating ADC Development Through Clinical and Preclinical Utility Index Modelling: A Folate Receptor Alpha-ADC Case Study
• Edna Choo, Genentech: Unraveling the mysteries of drug disposition – from discovery to NDA
• Helena Edlund, AstraZeneca: Translating ANGPTL3 lowering into dose selection and outcome expectations for AZD1705 via integrated model-informed drug development
• Adam Robinson-Miller, Quotient Sciences: 15 years of variation in human ADME study designs

Please contact Graeme Scarfe (graeme.scarfe@nxera.life) and Angelica Quartino (angelica.quartino1@astrazeneca.com) for further details.

Sessions 9: Free Communications
Session chairs:

• DMDG: Claire Henson
• GMP: Alicja Puszkiel

Scope:
This is an open session for any hot topics or informative case studies that may not fit into the themes of any other session but that are too good to miss out from. We foster a broad selection of engaging topics that inspire and benefit the community. It is also an opportunity for Early Career Scientists to use this session to share data and gain experience at presenting in front of a friendly audience.

Confirmed speakers:

• Steve Hood, GSK: The ADME Package for the Bepirovirsen File: What’s in the box?
• Susana Proença, ESQ Labs: EsqIVIVE, An R Package for Standardized In Vitro-In Vivo Extrapolation within the OSP ecosystem
• Tamás Szalai, Charles River Laboratories: In Vitro DDI Assessment of Advanced Modalities

Please contact Claire Henson (claire.henson@pharmaron-uk.com) and Alicja Puszkiel (alicja.puszkiel@aphp.fr) for further details.