It is a great pleasure to welcome Prof. Robert Schooley, from University of California, San Diego (USA) as a key note speaker during Targeting Phage Therapy 2024, this June in Malta.Dr. Schooley will highlight the pivotal moment that phage therapy research finds itself in. With Phase 2 studies transitioning to Phase 3 trials, he stresses the critical need for a unified approach in integrating translational research components into clinical trials to ensure their success and meaningfulness.
Dr. Schooley critiques the current trend in trial design, which often aims narrowly at achieving clinical endpoints for regulatory approval, yet lacks the depth to provide insights or guidance should the trial not meet its objectives.
He references the instructive case of one study, which, despite its failure, offered valuable lessons due to its comprehensive assessment approach. This study revealed significant insights post hoc, such as issues with microbiology, phage-phage antagonism, and dilution effects, which were not addressed upfront. These revelations underscore the necessity of including detailed evaluations in clinical trials to verify that phages reach the infection site in effective quantities and intervals, to monitor the development of resistance during the study, and to assess the impact of phage-specific antibodies on treatment efficacy.
Dr. Schooley’s message is a call to action for the phage therapy research community to adopt a more thorough and insightful approach in clinical trials. This includes the implementation of substudies to document key aspects of phage therapy application and the development of consensus protocols for evaluating phage-specific immunity, pharmacokinetics/pharmacodynamics (PK/PD) relationships, and phage resistance mechanisms. Such measures are vital for understanding why certain therapeutic interventions succeed or fail, enabling researchers to refine and improve treatment strategies.
In advocating for this approach, Dr. Schooley highlights a fundamental challenge: the repetition of past mistakes due to a lack of comprehensive analysis and learning from failed trials. Without addressing this issue, the field risks stagnation, unable to leverage cumulative experience to accelerate progress. His passionate plea underscores the importance of not just aiming for short-term successes in phage therapy research but also building a robust and insightful framework that enhances the field’s overall efficacy and resilience.