CONFERENCE DAY TWO LIVE
7:50 am Morning Coffee
8:50 am Chair’s Opening Remarks
Spotlighting the Latest Clinical Updates & Where to Go Next for Sustainable Commercialization of Bacteriophages
9:00 am Executing Definitive Pivotal Trials for Bacteriophages to Prove Clinical Efficacy
Synopsis
- Spearheading randomized clinical trials of bacteriophages to meet regulatory standards
- How to move beyond compassionate use of bacteriophages to obtain robust clinical evidence
- Navigating the ethical considerations in placebo-controlled trials to demonstrate bacteriophage superiority over antibiotics
New Data!
9:30 am Fireside Chat: How Can Bacteriophage Therapies be Sustainable in the Market?
Synopsis
- What indications should be prioritized to bring the first phage therapies to market
- How to ensure companies will sell bacteriophage therapy after receiving approval
- Understanding that route for smaller businesses who are working in the bacteriophage space
10:30 am Morning Networking Break
Supercharging the Global Distribution of Stable Bacteriophages with Effective Business Models to Deliver Therapy to Patient in Need
11:30 am Developing GMP Manufacture of Bacteriophages to Align with Regulatory Guidance
Synopsis
- Diving into the manufacture guidelines required by regulations
- How to ensure that host-related impurities are removed from the phage therapy by specific quality assays
- Understanding the regulatory pathways from FDA, Healthcare Canada, MHRA and EMA
New Company!
12:00 pm Phage Manufacturing to Different Scale
Synopsis
- Upstream and downstream processing
- Critical Process Parameters
12:10 pm Exploring Personalized vs Off-the-shelf Phage Therapies as Most Effective Therapies to Achieve Market Approval
Synopsis
- Utilizing personalized phage therapies that are tailored for specific disease indications
- How to choose an individualized or off-the-shelf phage therapy based on disease indication
- Developing a broad range phage cocktail as a rapid response to infection
New Company!
12:30 pm Networking Lunch
Developing Personalized & Off-the-shelf Bacteriophage Therapies for a Wide Range of Indications
1:30 pm Roundtable Discussion: Optimizing CMC to Develop High Purity, Stable & GMP Bacteriophages for Cost-Effective & Safe Use in Patient Treatment Regiments
Synopsis
- How to prepare for large scale production of GMP-compliant bacteriophages to deliver an approved product to the market
- How to implement analytical assays of bacteriophages maintain quality and consistency across batches
- How to adapt upstream and downstream manufacture of bacteriophages from laboratory to large scale production with high titers and purity
2:00 pm Engineered Phage Tail-Like Bacteriocins as Human Therapeutics
Synopsis
- Phage tail-like bacteriocins can be retargeted by engineering receptor binding proteins
- These structures have in vivo bactericidal activity and can be used for treatment of infectious disease or microbiome manipulation
- Methodologies can be interchanged with phages
New Company!
2:30 pm Developing Engineered Lysin Proteins to Combat Antibiotic-Resistant Bacteria
Synopsis
- Using DNA shuffling technology for recombinant assembly of high dimensional libraries of engineered lysins
- Integrating high-throughput production and screening of lysins active against gramnegative bacteria
- Maintaing activity of lysins under physiological conditions
New Company!