image: Barbara Brenner, a legal expert in medical law and human rights, will deliver a talk titled "Regulatory Restrictions vs. Human Rights, the Hippocratic Oath, and the Freedom of Therapy – The Legal Aspect of Phage Therapy" at Targeting Phage Therapy on June 20-21, 2024
Credit: Targeting Phage Therapy
The 7th World Conference on Targeting Phage Therapy 2024 is set to take place on June 20-21 at the Corinthia Palace in Malta, welcoming over 150 attendees from 30 countries and featuring more than 32 communications. This annual event showcases the latest advancements in phage research and therapy, emphasizing how these developments could revolutionize healthcare practices globally.
The Ethical Considerations and Regulatory Landscape of Phage Therapy will be highlighted
Targeting Phage Therapy 2024 will include a dedicated session on the ethical and regulatory aspects of phage therapy, particularly in Europe. Barbara Brenner, a legal expert in medical law and human rights, will deliver a talk titled "Regulatory Restrictions vs. Human Rights, the Hippocratic Oath, and the Freedom of Therapy – The Legal Aspect of Phage Therapy". Her presentation will focus on balancing regulatory frameworks with the urgent need for accessible, life-saving treatments.
Phage therapy faces significant regulatory and ethical challenges, and Brenner will address several critical points:
- Regulatory Frameworks and Human Rights: Brenner will provide an overview of EU and German legal and regulatory frameworks, highlighting the tension between the right to safe drugs and the right to life-saving treatment in emergencies, especially concerning antimicrobial-resistant (AMR) infections and non-GMP phages.
- Ethical and Legal Questions: The session will explore whether it is ethical to deny life-saving treatments for safety reasons and whether regulatory bodies like the FDA and EMA can be held liable for prohibiting non-GMP phages if GMP phages are unavailable or unaffordable. Additionally, Brenner will discuss the validity of scientific evidence derived from anecdotal sources versus the necessity of randomized controlled trials (RCTs) and whether these trials need to be redesigned. The legal status of phage therapy as "experimental" and the potential liability of clinicians who refuse phage therapy when it could save a patient will also be examined.
- Combatting Antimicrobial Resistance (AMR): The presentation will include the One Health approach, integrating human, animal, and environmental health practices. Brenner will highlight Georgia's successful model, advocating for the promotion of phages as primary interventions, reserving chemical antibiotics for situations where phages are ineffective.
Speakers Lineup
- Robert T. Schooley, University of California, San Diego, USA
Clinical Trials in Phage Therapeutics: Looking Under the Hood
- Ekaterina Chernevskaya, Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, Russia
Adaptive Phage Therapy in the Intensive Care Unit: From Science to Patients
- Jean-Paul Pirnay, Queen Astrid Military Hospital, Belgium
Magistral Phage Preparations: Is This the Model for Everyone?
- Barbara Brenner, Kanzlei BRENNER, Germany
Regulatory restrictions vs. Human Rights, the Hippocratic oath and the Freedom of therapy– The legal aspect of phage therapy
- Nannan Wu, Shanghai Public Health Clinical Center, Fudan University, China
Phage Therapy: A Glimpse into Clinical Studies Involving Over 150 Cases
- Graham F. Hatfull, University of Pittsburgh, USA
Mycobacteriophages and Their Therapeutic Potential
- Antonia P. Sagona, University of Warwick, United Kingdom
Genetic Engineering of Phages to Target Intracellular Bloodstream E.coli Infections
- Paul Turner, Yale University, USA
Leveraging Evolutionary Trade-Offs in Development of Phage Therapy
- Pieter-Jan Ceyssens, Sciensano, Belgium
Quality control of phage Active Pharmaceutical Ingredients (APIs) in Belgium
- Wolfgang Weninger, Medical University of Vienna, Austria
The Phageome in Normal and Inflamed Human Skin
- Sabrina Green, KU Leuven, Belgium
Making Antibiotics Great Again: Phage resistance in vivo correlates to resensitivity to antibiotics in pan-resistant Pseudomonas aeruginosa
- Rodrigo Ibarra Chávez, University of Copenhagen, Denmark
Phage Satellites, a Diversity of Extradimensional Symbionts and Pathways to Phage Therapy
- Domenico Frezza, University of Roma Tor Vergata, Italy
Towards efficient phage therapies: investigation of phage / bacteria equilibrium with metagenome of dark matter in natural samples
- Besarion Lasareishvili, Eliava Institute of Bacteriophage, Microbiology and Virology, Georgia
Modern Concepts of Phage Therapy: An Immunologist’s Vision
- Kilian Vogele, Invitris, Germany
Cell-Free Production of Personalized Therapeutic Phages Targeting Multidrug-Resistant Bacteria
- Frederic Bertels, Max Planck Institute for Evolutionary Biology, Germany
Improving Phages through Experimental Evolution
- Eugene V Koonin, National Institutes of Health, USA
Evolution and megataxonomy of viruses: the place of phages in the virosphere
- Federica Briani, University of Milan, Italy
Addressing Phage Resistance to Enhance the Robustness of Phage Therapy for Pseudomonas aeruginosa Infections in People with Cystic Fibrosis
- Jumpei Fujiki, University of California San Diego, USA
Phage therapy: Targeting intestinal bacterial microbiota for the treatment of liver disease
Targeting Phage Therapy 2024 Supporters: Cellexus, Precision Phage, Jafral.
Contributing Partner: PHAGE Therapy, Applications, and Research Journal.
Media Partner: Bacteriophage.news.
For more information, registration details, list of attendees and the program, please visit: www.phagetherapy-site.com.