
Conference: EACPT 2025 CONGRESS
Date: June 28 - July 1, 2025
Location: Helsinki, Finland
Booth: 3
Get an exclusive preview of DIDB’s ConMed Navigator
Built on regulatory agency-recommended classifications and powered by DIDB data, ConMed Navigator is scheduled to launch in Fall 2025. Sign up for a sneak preview exclusive to EACPT 2025 attendees and learn about how CoMed Navigator helps scientists to quickly identify concomitant medications and more:
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- Search a comprehensive list of drug characteristics, anchored to marker studies, to assess potential DDI risk and inform clinical development strategies for your NME
- Improve drug labeling and provide clinical context with specific examples of concomitant medications related to your target patient population
Where to hear Certara insights and Expertise
Session B1: Preclinical data informing clinical pharmacology
Session Chairs: Mikko Koskinen (Orion Corporation) and Piet van der Graaf (Certara)
Presenter: Piet van der Graaf, Professor of Systems Pharmacology, University of Leiden, The Netherlands
Senior VP and Head of QSP, Certara
Session B5: Addressing unmet needs
Session Chairs: Timo Myöhänen (University of Helsinki) and Caridad Pontes (Universitat Autónoma de Barcelona)
Presenter: Piet van der Graaf, Professor of Systems Pharmacology, University of Leiden, The Netherlands
Senior VP and Head of QSP, Certara
Poster presentation
Authors: Diane-Charlotte Imbs, Amandine Manon, Dennis Heller, William Copalu
As radioligand therapies (RLTs) gain traction in oncology, regulatory guidance on clinical pharmacology remains limited. This poster outlines practical, experience-based recommendations to define a robust clinical pharmacology strategy for RLTs. Drawing on FDA/EMA interactions, we propose integrating ADME characterization, DDI assessments, QTc risk evaluation, special population analyses, immunogenicity considerations, and dose optimization, ideally within First-in-Human (FIH) studies. These insights aim to support sponsors navigating evolving expectations and preparing for later-phase development.
Get an exclusive preview of DIDB’s ConMed Navigator
Sign up for a sneak preview exclusive to EACPT 2025 attendees and learn about how CoMed Navigator helps scientists to quickly identify concomitant medications and more
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