Dr. Classen is a clinician scientist specialized in internal medicine and infectious diseases at the University Hospital Cologne, Germany. She works at the Department I for Internal Medicine, Division of Infectious Diseases, and the Institute for Medical Microbiology, Immunology and Hygiene, where she leads the interdisciplinary research group “Translational Bacteriophage Research.” She is also one of the coordinators of a newly developed consensus guideline on personalized phage therapy.

In this talk, Dr. Classen will present the consensus-based guideline designed to support the safe and standardized clinical implementation of personalized phage therapy. Phages represent a promising option for personalized treatment of difficult-to-treat bacterial infections. However, their clinical use remains challenging due to the lack of harmonized principles, infrastructure, and practical guidance covering the full translational pathway, including phage selection, preparation, clinical administration, monitoring, and documentation.

To address these challenges, a multidisciplinary international consortium developed a comprehensive guideline within the methodological framework of the Association of the Scientific Medical Societies of Germany. The guideline was created through collaboration between 20 German professional societies, 18 international experts, German patient advocacy groups, and regulatory authorities. It provides more than 60 practice-oriented recommendations addressing key aspects of clinical phage therapy, from infrastructure and quality control to treatment procedures and future research priorities.

By offering clear and actionable guidance, this consensus initiative aims to facilitate the safe, transparent, and standardized integration of personalized phage therapy into clinical practice.

Key Scientific Highlights

• Development of the first comprehensive consensus guideline for clinical implementation of personalized phage therapy in Germany and beyond
• Over 60 evidence-informed recommendations covering infrastructure, phage preparation, quality control, clinical administration, and documentation
• International multi-stakeholder collaboration involving professional societies, experts, regulators, and patient representatives
• Identification of key research priorities to advance clinical phage therapy in the coming years
• A framework to support regulatory alignment and safe translation of phage therapy into routine clinical care