Digital Day One
All Times in EST
9:00 am Chair’s Opening Remarks
Clarifying the Road to Regulatory Approval for the Development of Bacteriophages
9:05 am Discussing the FDA Scientific & Regulatory Considerations for Bacteriophage Therapies
Synopsis
- Regulatory Considerations for Bacteriophage Therapy
9:25 am Developing Phage-Based Therapeutics for Unmet Medical Needs: The BiomX Experience
Synopsis
- What is known: how phage therapeutics fit into existing regulatory frameworks
- What is new: manufacturing challenges for pathogenic producer cell lines and product safety
- What regulatory approaches remain to be determined: e.g. novel clinical trial approaches, long term safety, product evolution to keep in front of phage resistance
9:45 am WHO Perspective on Phage Therapies
Synopsis
- WHO sets global public health priorities as detailed in the Bacteria Priority Pathogen List (WHO BPPL)
- Who analyses annually the antibacterial clinical and preclinical pipeline to review how global priorities are addressed by products under development and what are the unmet medical needs
- Phage therapies are reviewed within the annual WHO Pipeline analysis in a section dedicated to non-traditional approaches
10:05 am Speaker Q&A
10:20 am Virtual Speed Networking
Synopsis
This session is the ideal opportunity to take advantage of informal networking time and understand who is also prioritizing and overcoming challenges within the various sectors of the bacteriophage world
10:40 am Morning Break & Networking
Establishing a Holistic Understanding of Antibiotic vs. Antimicrobial Resistance Around the World
11:00 am Phage Banks as Essential Tools for Rapidly and Cost-Effectively Addressing the Antimicrobial Resistance Crisis in the Developing World
Synopsis
- Discussion of the worldwide epidemic differences between industrialized and developing nations by analyzing the reasons of the prolonged
pandemic in developing countries - Benefits of distributing antibiotic alternatives locally in Africa and Asia to better prepare them to respond to AMR deaths
- Establishing the critical mechanism through which developing countries can quickly and economically respond to AMR outbreaks by setting up operational phage banks in Africa and Asia
11:20 am Bacteriophages from Hospital Wastewater Against Clinical Bacterial Isolates in the Philippines
Synopsis
- Learning how bacteria are isolated from clinical samples to determine the next course of action
- Discussion into why hospital wastewater is served as the source for bacteriophage isolation
- Deep dive into the method of identification for both bacteria and bacteriophages in the Philippines
11:40 am Phages for All: How to Build an Infrastructure for Phage Therapy in Resource-Limited Settings
Synopsis
- In-country partnerships and collaborations are key to setting up sustainable infrastructure for a new drug modality
- Cost is the main challenge and must be considered during product development
- Emerging markets are an incredible opportunity for antimicrobials such as phage
12:00 pm Speaker Q&A
12:30 pm Lunch & Networking
Understanding the Best Use of Phage Cocktails in Therapeutics to Treat Infectious Disease & Minimize Risk of Resistance
1:30 pm Phage Cocktails More Effectively Constrain Enterococcus Growth
Synopsis
- Enterococcus becomes abundant after antibiotic treatment
- Building repositories of lytic phage with known host ranges and entry mechanisms is an important first step for using phage therapeutically
- Experimental co-evolution of bacteria and their lytic phage to quickly identify how they interact
1:50 pm Session Information TBC
2:10 pm Speaker Q&A
2:30 pm Virtual Speed Networking
Synopsis
This session is the ideal opportunity to take advantage of informal networking time, and understand who is also prioritising and overcoming challenges within the various sectors of the bacteriophage world
3:00 pm Afternoon Break & Networking
Factors Affecting Anticipated Efficacy in Clinical Trials & eIND Cases – an ESGNTA Session
3:20 pm Clinical Phage Microbiology: The Art of Matching
Synopsis
- Uncovering one of the keys to successful phage therapy by using the ‘right’ phage for therapy due to their high specificity and unpredictable
behavior - Matching phages to bacteria for therapy requiring several methods in multiple conditions in an attempt to model the situation within the patient
- Deep dive into the various cases that require unique modeling, e.g. biofilm, inhalation, and implants infections
3:40 pm Antibody Mediated Neutralization of Phages for Treatment of a Pulmonary Infection
Synopsis
- Successful treatment of patients with phage for non-tuberculosis mycobacterial infections
- Challenges in the treatment of patients with phage for non-tuberculosis mycobacterial infections
- How phage neutralizing antibodies can impact phage therapy
4:00 pm Single Center or Single Phage Preparations Experience We Can Learn from eIND Cases on Efficacy
Synopsis
- Deep dive into the single center and companionate use of phages currently used worldwide for a holistic understanding
- Learning the outcomes of the unique centers for successful cases of therapy
- In order to better delineate factors that will predict successful therapy and clinical studies from such cases series related to the use of single phages or patient’s selection in such centers a discussion on: 2 such case studies
4:20 pm Therapeutic Phage Monitoring of the Human Host Immune Response
Synopsis
- Understanding the interaction between phage and bacteria associated with complex human host responses to both bacteria and phage that
directly influence the inflammatory syndrome - Discussing phage amplification in target bacterial populations that change over time and development of acquired immune clearance
influencing phage kinetics and dose adjustments may be necessary in response to diagnostic data - The human host immune response may vary as a function of phage and bacterial kinetics or be independent of them and significant beneficial immunomodulation may occur which can be detected through immune profile transcriptomics