8:00am | Morning Registration & Networking

8:15 am Chairs Opening Comments

REGULATORY CONSIDERATIONS & CHALLENGES

8:25 am Equip and De-Risk Your Microbiome Drug Development for the European Market – Regulatory Science and a ‘Development-by- Design’ Approach

  • Celine Druart Pharmabiotic Research Institute, Microbiome Project Manager

Synopsis

  • Overview of the current European regulatory framework surrounding microbiome drug development
  • Microbiome drug products are Biologics – applying the Development-by-Design mindset and the added value of tools such as the TPP; QTPP and Risk Analysis
  • Potential future evolution of the European regulatory framework; ongoing revision of the Blood, Tissues & Cells legislation

8:55 am Regulatory Considerations for Microbiome Based Therapeutics

Synopsis

  • Investigational New Drug Applications (INDs)
  • Additional Chemistry, Manufacturing and Controls (CMC) considerations for INDs with:
  1. Fecal Microbiota Transplantation (FMT)
  2. Live Biotherapeutic Products (LBPs)
  • COVID testing for FMT donors

9:25 am Data Directed Discovery of Microbiome Derived Therapeutics

  • Lutz Kraus Head of Data-Mining and Artifical Intelligence, Microba

Synopsis

  • Presenting how big data in combination with machine learning can be applied for the rational discovery of microbiome-derived therapeutics
  • Applying this novel approach to IBD which has helped identify new biological leads which have shown to supress key inflammatory pathways
  • Developing new therapeutic leads for other indications, including metabolic diseases, GI conditions and psychiatric disorders

9:55 am Taking the Microbiome Beyond the gut – Realizing the Full Potential of Microbiome Therapies Through Targeted Systemic Effects

Synopsis

  • After landmark successes in C. diff, the rapidly maturing microbiome field is poised to deliver meaningful clinical data across a wider range of systemic diseases
  • Principles for target- and mechanism-driven LBP discovery & development
  • Successful drug development is about more than just great research – CMC, IP, Clinical & Regulatory considerations

10:25am | Morning Refreshments and Speed Networking

MICROBIOME BASED BIOMARKERS & DRUG RESPONSE

10:45 am Discover how Biomarkers are Developing & Validating Therapeutic Targets

Synopsis

  • Biomarker; causality versus association in clinical sciences
  • Case report; Bif105 reduce pectic ulcers
  • Determining mode of action of live therapeutics

11:15 am Using Precision Microbiome Profiling to Develop a Biomarker for Immune Checkpoint Inhibitor Response and a Potent Therapeutic Consortium

Synopsis

  • Microbiotica’s metagenomic platform in combination with a new microbiome in Melanoma has enabled identification of a microbiome signature of response to Immune Checkpoint Inhibitor consistent across four independent studies
  • MB097 is a precision-medicine Live bacterial Therapeutic derived from a microbiome signature
  • Human primary immune cell assays and syngeneic models have validated
  • MB097 is being scaled up for First-in-human trials to start in 2022

11:45 am Embrace the New: How Rethinking the Microbiome Can Advance Therapeutics and Improve the Patient Experience

Synopsis

  • What we are doing to shift the paradigm in the microbiome space?
  • The grand trifecta: PK, PD, and Ecology
  • Biomarker development with an LBP
  • Target engagement and what that means

12:15 pm Leveraging Strain-level Metagenomics in Developing Microbiome Therapeutics

12:45 | Lunch & Extensive Networking Opportunities

STREAM C: MANUFACTURING MILESTONES & ADVICE

1:45 pm Development of Microbiome Drug Products

2:15 pm Co-Cultivation is a Powerful Approach to Produce a Robust Functionally Designed Synthetic Consortium as a Live Biotherapeutic Product (LBP)

Synopsis

  • PharmaBiome have developed a co-culturing technology for the production of microbial consortia based on bottom-up functional design principles
  • Co-cultured consortia have improved stability and robustness properties compared to single strain cultures
  • Co-culturing strains increases the overall yield

2:45 pm Do’s and Don’ts’s of LBP lyophilization

Synopsis

  • Challenges in LBP lyo manufacturing
  • Lyophilization scale up challenges
  • Importance of controlled drying process

3:15 pm A Novel Therapeutic Approach for the Elimination of Harmful Bacteria From the Microbiome

Synopsis

  • Learn the development of Eligobiotics(r): a new class of phage-derived antimicrobials with unparalleled specificity
  • EB003: an Eligobiotic(r) for the treatment of Shiga toxin-producing E.coli
  • Eligobiotics(r) as novel Gene Therapy products allowing precise intervention on the microbiome

STREAM D: DISEASE SPECIFIC CASE STUDIES

1:45 pm Drug Development in the Skin Microbiome for the Treatment of Pruritus Associated with Atopic Dermatitis

Synopsis

  • Pre-Clinical Development and Immune Regulation
  • Mechanisms of Action – Live vs. Dead
  • Additional Targets

2:15 pm ECOSPOR III data

Synopsis

To highlight:

  • The efficacy and safety of SER-109 in patients with recurrent CDI
  • Efficacy of SER-109 versus placebo in patients with risk factors for recurrence
  • The time to recurrence and the importance of rapid microbiome recovery
  • Quality of life in patients receiving SER-109 compared to placebo
  • Inactivation of potential pathogens in donor stool via the manufacturing process

2:45 pm A Case Study Story Exploring the Pathway to Drug Development Surrounding IBD

3:15 pm Analyzing the Progress of the Oncology Landscape to Enable & Amplify Future Development in This Field

3:45pm | Afternoon Break, Refreshments & Networking

4:05 pm Delve Into Manufacturing and Controls of LBPs: Meeting GMP and Regulator guidelines

Synopsis

  • Definition of LBPs by regulators ( FDA/EDQM)
  • Applicable Guidelines and Pharmacopea monographs for Mfg and Controls
  • Application : CQAs and QTPPs

4:35 pm Low-Temperature Drying & Microencapsulation of Microbiomes

Synopsis

Discover the:

  • Advancements of Electrostatic Spray Drying PolarDry
  • Low-temperature drying in nitrogen for thermal and oxidative sensitive products
  • Microencapsulation of API and actives to eliminate degradation or denaturalization
  • A continuous process for time and energy saving; and a full production line for your choice of scale

INVESTMENT AND COMMERCIALISATION

4:45 pm Building Investor Confidence in Microbiome Drug Development; how to Promote And Restore Confidence

Synopsis

  • Numerous challenges from bench to bedside but overall industry progress
  • Selecting therapeutically-relevant indications beyond C. difficile
  • The impact of recent clinical setbacks – Lessons learned on how and when to enter clinic with microbiome therapeutics

5:15 pm Medicen Initiative

Synopsis

Uncover the benefits of a unity community:

  • Regrouping pharmaceutical companies, start-ups and academics in the microbiome field. Actively collecting and understanding the current, in silico, in vitro and in vivo tools available today and recommend their best potential use
  • Explaining the initiative’s aims also, on the basis of use cases in the pharmaceutical industry
  • Explore the elaborate decision trees on what triggers microbiome studies today and also what is missing to be able to generate more systematic microbiome data on future drug products

4:05 pm A Deep Dive Into the Potential of Microbiome Therapeutics in Cardiometabolic And Related Disorders

Synopsis

Learn about:

  • FMT as unique discovery tool and potential intervention
  • The value of Microbiome Therapeutics in Diabetes, NAFLD/NASH and Cancer-related cachexia

4:35 pm BGY-1601, Vaginal tablet: a “Universal” First-Line Monotherapy of Acute Vaginitis Symptoms

Synopsis

Learn how this applies to:

  • Women’s Health
  • Live Biotherapeutic Products
  • Bacterial Vaginosis (BV) and Vulvovaginal Candidiasis (VVC)

4:45 pm Inflammation, Iron And the gut Microbiome; Challenges for Mitigating the Effects of Inflammatory Bowel Disease Using LBPs

Synopsis

  • Learn how Ferryx has identified a safe and effective strain of Streptococcus thermophilus (FX856)
  • This is able to survive and thrive during periods of active inflammation and has demonstrated anti-inflammatory properties making it an ideal candidate for an LBP to ameliorate symptoms of IBD

5:35 pm MRM Health’s Preclinical Optimized Consortia Programs in Metabolic Disease and CNS Disorders

Synopsis

  • Partnered programs with IFF in Type 2 Diabetes and NASH
  • Preclinical program in Parkinson’s Disease

6:00 pm Chair’s Closing Comments

6:10 pm End of Conference