Clinical trials in phage therapy: generating evidence to enable regulatory approval and clinical use

Event Description

Explore the clinical, scientific, and regulatory dimensions of bacteriophage therapy in this two-day workshop. Gain practical insights into clinical trial design, regulatory approval pathways, patient selection, and implementation challenges, while engaging directly with leading clinicians, researchers, and regulatory experts to advance phage therapy towards clinical practice.

Intended audience

This course is aimed at infectious disease specialists, clinicians, clinical microbiologists, biomedical researchers, regulatory professionals, policymakers, clinical trial coordinators, and study managers involved in antimicrobial therapy, translational research, and therapeutic development. It is also particularly relevant to biotechnology and early-stage pharmaceutical professionals working in phage therapy, as well as early- to mid-career professionals seeking practical clinical and regulatory insights in this rapidly evolving field.

Objectives

By the end of the workshop, participants will be able to:

• Describe the current clinical landscape of bacteriophage therapy, including major ongoing and upcoming clinical trials in Europe and internationally.
• Compare key regulatory frameworks, requirements, and evidentiary standards for phage-based products across the EMA, FDA, and national authorities.
• Apply fundamental principles of clinical trial design, including patient selection, endpoint determination, and methodological considerations specific to phage therapy.
• Critically appraise clinical and cohort study evidence on the safety, efficacy, and potential futility of phage therapy in complex and persistent bacterial infections.
• Identify key ethical, manufacturing, and phage susceptibility testing considerations relevant to clinical research.
• Apply basic principles of pharmacokinetics/pharmacodynamics (PK/PD), dosing strategies, safety monitoring, and adverse event management.
• Identify strategies to improve patient selection, data collection, and data sharing, fostering multicentre collaboration and clinical progress.
• Recognise the key challenges and practical requirements for translating phage therapy research into clinical practice.

Course coordinator

Novella Cesta, Italy

Organisers

ESCMID and ESGNTA

Accreditation

ESCMID office will apply for EACCME accreditation. 
Each participant can only receive the number of credits according to actual participation in the event and upon completion of the feedback survey.

Certification

Course organisers will monitor attendance. Participants are required to attend at least 70% of live sessions to be eligible to receive a certificate.

Course Venue

Italian National Institute of Health (Istituto Superiore di Sanità)
Aula Pocchiari
Viale Regina Elena, 299, 00161 Roma RM, Italy

Accommodation

Accommodation is not included in the registration.

Registration details

Registration fees include full access to the course, coffee breaks and lunches described in the programme. Travel costs and accommodation are not included with either fee.

Do not miss the opportunity to update your knowledge with an extensive network of experts in the field, and register now!
 

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