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 Microbiologist, FDA Office of Vaccines Research & Review

Synopsis

  • Regulatory Considerations for Bacteriophage Therapy
  • FDA green lights study of phage-based drug for resistant infections

9:30 am Developing Phage-Based Therapeutics for Unmet Medical Needs: The BiomX Experience

  • Edward Burd Senior Vice President Regulatory Affairs , BiomX

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

9:50 am Speaker Q&A

10:10 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

  • Tobi Nagel Founder & President , Phages for Global Health

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

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

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

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

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

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

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

  • Pierre Kyme Senior Director Business Development, Armata Pharmaceuticals

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

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

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

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

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

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

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

4:40 pm Speaker Q&A

5:00 pm Chair’s Closing Remarks