Conferences
DMDG-GMP-SPS Joint Meeting 2026
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5-7 October 2026
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Diplomat Hotel Prague, Evropská 15, 160 41 Praha 6, CZ
Following on from the highly successful Joint Scientific Meeting in Amsterdam in 2022, the DMDG, Groupe de Metabolisme et Pharmacokinetique (GMP) and Swedish Pharmaceutical Society (SPS) have announced that they will again be collaborating on a joint meeting in 2026.
The meeting will take place at the Diplomat Hotel in the beautiful city of Prague between 5th and 7th October 2026.
The Scientific Organising Committee has prepared a draft agenda featuring Early Careers, Candlelight Lecture, and Debate sessions, alongside topics reflecting current areas of strong scientific interest across ADME, DMPK, and PK/PD modelling.
Featured Presentation
Bridging the Gap: Establishing Predictive In Vitro Models for the In Vivo Metabolism of GalNAc-Conjugated siRNAs
GalNAc-conjugated siRNAs have emerged as a promising class of therapeutics with potential across various disease areas. Assessing metabolic stability and biotransformation plays a critical role in the development of these therapies, necessitating the selection of suitable in vitro models. However, many existing in vitro systems fail to accurately predict in vivo metabolic behavior.
Our objective was to systematically identify the optimal models and conditions to simulate in vivo metabolism. We selected Inclisiran, a representative GalNAc-conjugated siRNA, as the model compound. We conducted a thorough comparison of in vitro metabolism across various matrices—including serum, plasma, plated hepatocytes, liver homogenate, S9 fractions, tritosomes, lysosomes, and cytosol—to reflect Inclisiran’s trajectory from injection to the RNA-induced silencing complex (RISC) in hepatocytes.
Our findings demonstrate that rat serum and heparinized plasma closely mirror the in vivo metabolism of Inclisiran by blood nucleases. Furthermore, we optimized several effective hepatic systems to accurately simulate intracellular liver metabolism. To ensure translational relevance, ongoing research focuses on validating these models across different species, particularly human systems. Comparative analyses between human and animal models will help refine species-specific metabolic predictions and reduce discrepancies in drug development.
This research offers valuable insights into the metabolic pathways of Inclisiran, establishing a critical foundation for selecting appropriate in vitro systems. Ultimately, these validated models will facilitate the design and screening of future oligonucleotide therapeutics, thereby advancing the field of RNA-based drug development.
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A specific LC-MS/MS method for the reliable determination of 1-O-acyl glucuronide in phosphate buffer
This study addresses the challenges in accurately quantifying 1-O-acyl glucuronides (1-O-AGs) in stability assays, which are crucial for assessing the potential risk of idiosyncratic drug toxicity (IDT). Acyl glucuronides (AGs), formed via phase II metabolism of carboxylic acid-containing drugs, are chemically unstable and undergo hydrolysis or intramolecular rearrangement, generating reactive isomers that may covalently bind to proteins and contribute to IDT. The potassium phosphate buffer (KPB) system is widely used to evaluate AG stability, with the half-life in KPB serving as a key predictor of IDT risk. However, the migration of 1-O-AGs produces multiple isomers, complicating chromatographic separation and detection.
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High-Throughput In Vitro Permeation Enhancer Screening in Caco-2 Cells: Accelerating Oral Peptide Therapeutics Development
The development of oral peptide therapeutics has gained significant attention in the pharmaceutical industry. However, one of the key challenges limiting peptide oral bioavailability is the poor permeability. To overcome this challenge, permeation enhancers (PEs) have emerged as a critical strategy in enhancing peptide delivery. Rodents have been commonly used for screening PEs for peptide therapeutics. To minimize animal testing and better align with FDA’s 3Rs (Replacement, Reduction, Refinement) principles, we developed a pre-screening strategy utilizing Caco-2 cells.
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In Vitro Metabolite Characterization of an Anti-TFR1 Antibody-siRNA Conjugate in Mouse Serum Through Total Oligonucleotide Analysis Following Proteinase K Digestion
Antibody–oligonucleotide conjugates (AOCs) represent a transformative therapeutic modality for targeted extra-hepatic delivery of oligonucleotide therapeutics, yet their efficacy fundamentally depends on maintaining molecular integrity in systemic circulation prior to reaching the target tissue. In vitro serum stability assessment therefore constitutes a critical component of AOC characterization.
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Tritium (3H) Radiolabeling Synthesis and Quantitative Whole-Body Autoradiography (QWBA) Study of a Novel ADC
ADC-001 is a novel HER2-targeting ADC candidate with novel antibody. Following tritium (3H) radiolabeling, the conjugate was administrated to tumor bearing mice (BALB/c nude mouse), and quantitative whole-body autoradiography (QWBA) was employed to comprehensively characterize the tissue distribution and tumor uptake of ADC-001 in vivo.
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Voluntary Intake as a Welfare-Friendly Gavage Alternative for Preclinical PK in Bama Mini Pigs
This study systematically evaluated the feasibility of voluntary free-feeding as a substitute for oral gavage in PK studies using the Bama miniature pig model. The voluntary feeding method met bioequivalence criteria under fed conditions and exhibited PK profiles consistent with gavage under fasted conditions, with variability remaining within an acceptable range. Importantly, this approach substantially reduces animal stress and procedural interference while simplifying the experimental workflow.
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Micro-Volume DLS for Accurate Sizing and Aggregation Risk Assessment of Preclinical Biologics
In this study, five representative biologic modalities—siRNA, monoclonal antibody (mAb), bispecific antibody (BsAb), double-stranded DNA (dsDNA), and antibody–drug conjugate (ADC)—were employed as model compounds. We systematically compared the consistency of size measurements between high-volume (1 mL) and low-volume (0.04 mL) cuvettes, and evaluated the applicability of dynamic light scattering (DLS) for size characterization and aggregation risk discrimination. The aim is to provide a low-consumption, high-sensitivity, and sample-recoverable analytical solution for preclinical quality control.
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A specific LC-MS/MS method for the reliable determination of 1-O-acyl glucuronide in phosphate buffer
Take control compound Acyl-β-D-glucuronide of Ibuprofen (a commercially available drug) as an example, a highly specific LC-MS/MS method was developed using an ACQUITY UPLC Protein BEH C4 column with a gradient elution of water and acetonitrile (both containing 0.1% formic acid) and detection via a Sciex Triple Quad 6500+ mass spectrometer.
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Magnetic Solid-Phase Extraction Coupled with LC-MS/MS for the Determination of GalNAc-Conjugated Oligonucleotides in Biological Matrices
This work established a magnetic solid-phase extraction (mSPE) pretreatment method for GalNAc-siRNA. It inherits the high selectivity of SPE while delivering the convenience and rapidity of magnetic separation, eliminating tedious wash and centrifugation steps. The magnetic core enables quick aggregation and dispersion under an external magnetic field, facilitating transfer, washing and elution. Combined with self-developed protein denaturant and high-capacity weak anion exchange (WAX) magnetic beads, mSPE efficiently recovers oligonucleotides and mitigates matrix effect and interference.
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A Novel Peptide Nucleic Acid Hybridization-Based Method for Sensitive and Selective Determination of siRNA
siRNA technology is widely used in gene function research and nucleic acid drug development. However, conventional bioanalytical methods all have critical limitations. ELISA and q-PCR offer high sensitivity but cannot distinguish intact siRNA from its metabolites, whereas LC‑MS/MS provides structural specificity but suffers from labor-intensive sample preparation and relatively lower sensitivity. To overcome these limitations, we developed a nucleic acid hybridization-based pretreatment method using heterologous peptide nucleic acid (PNA) probes, which enables precise separation and enrichment of target nucleic acids from complex samples.
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