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

9:10 am Discussing the FDA Scientific & Regulatory Considerations for Bacteriophage Therapies

  • Cara Fiore Senior Regulatory Reviewer, Microbiologist Division of Vaccines and Related Products Applications (DVRPA), Office of Vaccines Research and Review (OVRR), Center For Biologics Evaluation and Research (CBER) , US Food and Drug Administration (FDA)


  • Regulatory Considerations for Bacteriophage Therapy
  • FDA grants INDs for phage- based therapy for resistant infections

9:30 am A Corporation Perspective on Developing Bacteriophage Therapies in 3 Questions: What Do We Know, What is New, What Remains to be Determined?

  • Edward Burd Senior Vice President Regulatory Affairs , BiomX


  • 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

9:50 am WHO Perspective on Phage Therapies

  • Valeria Gigante Team Lead - One Health Research Priority-Setting & Synergy, World Health Organization


  • 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

10:10 am Speaker Q&A

10:30 am Virtual Speed Networking


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

11:00 am Morning Break & Networking

Establishing a Holistic Understanding of Antibiotic vs. Antimicrobial Resistance Around the World

11:20 am Phage Banks as Essential Tools for Rapidly and Cost-Effectively Addressing the Antimicrobial Resistance Crisis in the Developing World

  • Tobi Nagel Founder & President , Phages for Global Health


  • 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

11:40 am Bacteriophages from Hospital Wastewater Against Clinical Bacterial Isolates in the Philippines

  • Ursela P. Guce Bigol Supervising Science Research Specialist , Department of Science and Technology – Industrial Technology Development Institute


  • 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

12:00 pm Phages for All: How to Build an Infrastructure for Phage Therapy in Resource-Limited Settings

  • Minmin Yen Chief Executive Officer & Co-Founder  , PhagePro


  • 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

12:20 pm Speaker Q&A

12:50 pm Lunch & Networking

Understanding the Best Use of Phage Cocktails in Therapeutics to Treat Infectious Disease & Minimize Risk of Resistance

1:50 pm Phage Cocktails More Effectively Constrain Enterococcus Growth

  • Katrine Whiteson Associate Professor & Co-Director, Department of Molecular Biology & Biochemistry UCI Microbiome Center


  • 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

2:10 pm Speaker Q&A

2:30 pm Virtual Speed Networking


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

  • Ronen Hazan Associated professor, Institute of Biomedical and Oral Research (IBOR) of the Hebrew University, Jerusalem Israel and the Israeli Phage Therapy Center.


  • Uncovering one of the keys to successful phage therapy by using the ‘right’ phage for therapy due to their high specificity and unpredictable
  • 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


  • 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 Phage Experience: What We Can Learn from eIND Cases About Efficacy

  • Saima Aslam Professor - Division of Infectious Diseases & Global Public Health, iPATH
  • Ran Nir Paz Professor & Senior Physician, Hadassah-Hebrew University Medical Center


  • 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

  • Ameneh Khatami Senior Lecturer and Clinical Academic, University of Sydney and Sydney Children’s Hospitals Network


  • 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

4:40 pm Speaker Q&A

5:00 pm Chair’s Closing Remarks