CONFERENCE DAY ONE
TUESDAY, MARCH 26

8.00 Registration & Morning Coffee

8.50 Chairperson Opening Remarks

Leveraging Lessons Learned from Existing & Emerging Therapeutics to Accelerate Development of Phage Therapy

Introduction and Purpose:
As phage therapy re-emerges, it is poised to become a mainstream option in an era where antibiotics will only be prescribed appropriately and when necessary. This theme will pinpoint key differences between existing antibacterial and other biologic product development pathways, as well as explore translational elements that can be harnessed from these therapeutics to accelerate development of phage therapy.

9.00

A Few New Spokes, Not a Whole New Wheel: Harnessing Industry Knowledge & Best Practices to Facilitate Phage Development Programs

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Susan Lehman
Principal Scientist
AmpliPhi Biosciences

Mobilizing Industry and Government Guidance on Regulation to Move Phage Therapy Towards the Market Place

Introduction and Purpose:
Increasing momentum of phage therapy has resulted in increased governmental attention. Given the active engagement of US regulators in phage therapy in recent years, significant progress has been made in understanding what the regulatory pathway may be for these products. However, uncertainty in regulation remains. The next theme will provide an opportunity to discuss regulatory considerations for phage as both a standalone and adjunctive therapy.

9.30

Regulatory Considerations for Bacteriophage Therapy

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Scott Stibitz
Chief, Laboratory of Mucosal Pathogens & Cellular Immunology
FDA

10.00

Clinical Regulatory Review for Bacteriophage Therapy

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Rebecca Reindel
Medical Officer
FDA

10.30 Speed Networking & Morning Refreshments

11.30

It’s All About the Regs: Treating Patients and Getting to the Market

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Carrie-Lynn Langlais Furr
VP, Regulatory Affairs & Project Management
AmpliPhi Biosciences

Natural, Synthetic & CRISPR-Engineered Phages - Reviewing the Scope of the Phage Therapy Product Landscape

Introduction and Purpose:
Novel bacteriophages are constantly being discovered in both human and environmental samples. However, it remains unclear in which disease settings different phage approaches hold most promise. The purpose of this theme is to showcase the diversity of bacteriophage products that are in the pipeline and how different products might be more suitable in specific disease settings.

12.00

Native and Synthetically Engineered Phage Cocktail for Treating Chronic Diseases

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Assaf Oron
Chief Business Officer
BiomX

12.30

13.00

Engineered Phage: Expanding the Scope of Phage Product Potential

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Challenges and Lessons of Product Development Using an Example from Aquaculture

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Jeffrey Wager
Co-Founder, Chairman & CEO
EnBiotix

Jaroslaw Dastych
CEO
Proteon Pharmaceuticals

13.30 Lunch & Networking

14.30

CRISPR-Enhanced Bacteriophage (crPhage™) Improves Efficacy In Vitro and In Vivo over Wild-Type Phage

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Dave Ousterout
Co-Founder & CTO
Locus Biosciences

15.00

Delivery of Therapeutic Genetic Circuits by Engineered Phage Capsids

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Xavier Duportet
Co-Founder & CEO
Eligo Bioscience

Exploring Phage-Based Approaches in Various Disease Settings

Introduction and Purpose:
An in-depth understanding of the lytic and lysogenic life cycles of bacteriophages has led to the harnessing of phagebased products beyond wild-type and engineered phages themselves. This theme will explore how phage lysins are moving through product development pipelines with great success.

15.30

16.00

Using Phage Lysins to Control Infections by Gram-Positive and Gram-Negative Pathogens

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Platforms for Fast Purification of Food & Clinical Grade Bacteriophages

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Vincent Fischetti
Professor
Rockefeller University

Ales Strancar
CEO
BIA Separations

16.20 Afternoon Refreshments & Networking

Mastermind Session: Establishing Gold Standards for Phage Therapy Clinical Trials in Specific Disease Settings

Introduction and Purpose:
This session will facilitate in-depth discussion amongst participants in an informal setting. After splitting into groups, participants will have the opportunity to discuss the clinical considerations needed for well-designed clinical trials that demonstrate the safety and efficacy of phage therapy in specific disease settings. Notes from this session will be shared with attendees after the meeting.

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17.30 Chairperson Closing Remarks

17.40 Close of Conference Day One