Conference Day Two, 1st February, 2024
8:00 am Morning Refreshments & Networking
8:49 am
COMPILING OUR REGULATORY UNDERSTANDINGS TO ADDRESS NOVEL QUESTIONS FACING THE ADVANCING MICROBIOME FIELD
8:50 am Chair’s Opening Remarks
9:00 am A 2023 Landscape Review and Future Outlooks of Microbiome Therapeutics
Synopsis
- Outlining key leaders in the space and overall highlights of the year, including regulatory developments
- Exploring the progression of the preclinical and clinical landscapes within drug development
- Giving an analysis of the trial landscape, comparing this past year to the last 10 years and exploring future outlooks for 2024
9:30 am Commercial Manufacture of Microbial Therapeutics at Sacco System: From Microliters to Tons
Synopsis
- Sacco System at a glance: comprehensive services in the development and GMP production of Live Biotherapeutics for all applications
- Exploring our process for biotherapeutics – from strain intake to production
- Sharing the lastest work in developing and producing facultative and strict anaerobe at scales ranging from the lab to 20,000L scale
10:00 am Regulatory Science for Accelerated Market Access
Synopsis
- Developing global microbiome reference reagents
- Outlining novel regulatory science
- Exploring regulatory bottlenecks
10:30 am Panel Discussion: Consolidating Feedback from Agencies’ Interactions to Strengthen our Regulatory Understanding
Synopsis
- Sharing interactions across EMA, FDA and APAC regulators
- Outlining elements of internal regulatory frameworks
- Giving perspectives on how organisations can get the most out of their interactions with regulators
11:00 am Morning Break & Networking
11:29 am
TRANSLATIONAL TRACK
11:30 am European Regulatory Developments: Uncovering the New SoHo Regulation & Outlining the Revision of the General Pharmaceutical Legislation
Synopsis
- Recognizing microbiome samples as a source of innovative treatments and recent regulatory developments are helping to clarify the regulatory pathway to market authorization
- Human microbiome samples will be included in the scope of the new European SoHO regulation, which is expected to come into force in 2026
- Outlining that the published first draft of the upcoming new EU general pharmaceutical legislation will specify the interplay between the SoHO and Pharma regulations, including the definition of “SoHO-derived medicinal products other than ATMPs
12:00 pm MH002, an Optimized Consortia Therapeutic for Inflammatory Bowel Diseases, Combines Clinical Efficacy with an Excellent Safety Profile in a Phase 2a Study in Ulcerative Colitis
Synopsis
- MH002, a 6-strain consortia therapeutic designed, optimized and manufactured through MRM Health’s CORAL® technology, is the most advanced live biotherapeutic in clinical development for Ulcerative Colitis and Pouchitis
- Receive first-time insight in the integrated data from a placebo-controlled randomized phase 2a study of MH002 in Ulcerative Colitis patients, combining clinical efficacy and safety profile
12:30 pm Lunch Break & Networking
1:30 pm Uncovering Phase Three Clinical Data Results for MBK-01 in Primary & Recurrent C.Diff Infection
Synopsis
- Sharing clinical data from most advanced product
- Exploring regulatory challenges
- Navigating early pricing and reimbursement considerations
2:00 pm Challenges in Clinical Trial Execution for Live Biotherapeutics
Synopsis
- Introducing B244, a topical live biotherapeutic for the treatment of inflammatory skin disease
- Outlining challenges associated with first-in-class drugs, especially live biotherapeutics
- Improving trial design increased yield efficacy and illuminates a path towards additional indications for B244
11:14 am
ENABLING TECHNOLOGIES TRACK
11:30 am Advancing Co-Cultivation Capabilities with Novel Technologies
Synopsis
- Navigating current co-cultivation technology
- Exploring opportunities in manufacturing
- Outlining impact areas
12:00 pm Applying Microbiome Intervention Strategies at SNIPR Biome: Precision Bacterial Killing & In Situ Production of Therapeutic Molecules
Synopsis
- Revealing clinical results from phase 1 study on orally dosed, engineered CRISPR-armed phages designed for precision killing of E. coli
- Outlining preclinical insights from using live bacteria for in situ production of therapeutic molecules to treat cardiometabolic disease
12:30 pm Lunch Break and Networking
1:30 pm Assessing the Differential Profile of Breast Intratumoural Bacteria in Treatment Responders and Non-responders Using In-silico Approaches
Synopsis
- Investigating the unsterile tumour microenvironment
- Uncovering the intratumour bacteria that appear to determine response and alter the TME
- Applying the BioCorteX Carbon Mirror platform is altered to run in-silico simulations.
2:00 pm Deep Genomic Characterization of the Gut Microbiome: A Novel Space for Biomarker Discovery
Synopsis
- Profiling taxonomic and functional characterization of prevalent human gut commensals
- Improving the resolution of the microbiome as a biomarker and its associations with human health
- Biomarker specialist combining microbiome and host genetics for diagnosis and prognosis of complex diseases
2:30 pm Afternoon Break & Networking
3:00 pm Microbiome Therapeutic Innovations: Past, Present & Beyond
Synopsis
- Discussing how the discovery of the microbiome and its role in human health has revolutionized our understanding of disease and led to the development of new therapeutic approaches.
- Highlighting the most promising microbiome therapeutics in development, such as fecal microbiota transplants, engineered probiotics, and bacteriophages, and discuss their potential to treat a wide range of diseases, including cancer, inflammatory bowel disease, and mental health disorders.
- Imagining how microbiome therapeutics could be used to transform healthcare in the future, including personalized medicine approaches tailored to each individual’s microbiome, and the development of new preventative strategies to promote health and well-being