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Key Sessions

Michelle Trucksis

Feedback from Seres Therapeutics, Inc. - Lessons Learnt from Microbiome Therapeutics in Clinical Development

Seres Therapeutics, Inc.

Scott Michonski

Designing Scale Up and Manufacturing Processes for Microbiome Therapeutics

Vedanta Biosciences, Inc.

Mar 15
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08:50 - 09:00 10 mins
Chairperson's Opening Remarks
09:00 - 09:30 30 mins
Microbiome Therapeutics Europe
Notes from the Underground -The Dirt on Clinical Development of a Soil Bacteria
  • Larry Weiss - Chief Medical Officer, AOBiome
more
09:30 - 10:00 30 mins
Microbiome Therapeutics Europe
Feedback from Seres Therapeutics, Inc. - Lessons Learnt from Microbiome Therapeutics in Clinical Development
  • Michelle Trucksis - Executive Vice-President and Chief Medical Officer, Seres Therapeutics, Inc.
more
10:00 - 10:30 30 mins
Microbiome Therapeutics Europe
Clinical Development of Microbiome Therapeutics for Cardio-Metabolic Disorders
  • Luc Sterkman - CEO, Caelus Health B.V.
more

The presentation will address the challenges in the design and evaluation of clinical trials of microbiome therapeutics. Main points to be covered include:

  • Study design – key objectives in T2DM and Metabolic Syndrome
  • Study preparation – choice of formulation and challenges in manufacturing
  • Study conduct in subjects with Metabolic Syndrome
  • Evaluation of results – data mining – value of metagenomics
10:30 - 11:00 30 mins
Microbiome Therapeutics Europe
Morning Coffee and Networking
11:00 - 11:30 30 mins
Microbiome Therapeutics Europe
Business, Regulatory, and Clinical Strategies to Develop New Microbiome-Directed Therapeutics
  • Ken Blount - Head of External Research, Rebiotix, Inc.
more

Research and business around the microbiome continues to rapidly expand. There are currently many institutions and companies looking at various ways to utilize bugs as drugs. More science and quality parameters are being developed to create, manufacture and commercialize these new and unique medicines to treat various diseases of the microbiome Microbiota Restoration Therapy (MRT) is one example of a new and novel way to provide bugs as drugs utilizing Science and Quality.

11:30 - 12:00 30 mins
Microbiome Therapeutics Europe
Designing Scale Up and Manufacturing Processes for Microbiome Therapeutics
  • Scott Michonski - Manager of Process Development, Vedanta Biosciences, Inc.
more

Live Biotherapeutic Products (LBPs) have great potential to treat diseases related to the dysbiosis of the gut microbiota. Designing scale up processes for LBPs presents its own unique challenges. This presentation will discuss the considerations necessary when performing process development, scale up, and manufacturing for multiple anaerobic microbial cultures for a rationally designed CGMP LBP.

12:00 - 13:00 60 mins
Microbiome Therapeutics Europe
Lunch and Networking
13:00 - 13:30 30 mins
Microbiome Therapeutics Europe
Formulation Technologies to Ensure Consistent Stable Product Production
  • Sejal Ranmal - Director of Formulation, Intract Pharma Limited
more
13:30 - 14:00 30 mins
Microbiome Therapeutics Europe
Regulation of Fecal Microbiota Transfer Products – The German Perspective
  • Maria Vehreschild - Clinical Microbiome Research Group and Clinical Trials Unit II Infectious Diseases, University Hospital Cologne
more

German authorities classify fecal microbiota transfer (FMT) products as drugs to be manufactured in a GMP facility, regulated under the German Medicines Act. The University Hospital Cologne is creating a GMP-certified national stool bank to assure supply with high quality FMT products for the purpose of clinical care and clinical trials.

14:00 - 14:30 30 mins
Microbiome Therapeutics Europe
Spotlight Presentation: CMO Perspective: Optimising Anaerobic Manufacturing for Large Scale Production of Microbiome Therapeutics
more
  • Evaluating CMO’s with capability to manufacture microbiome therapeutics
  • Scale up strategies for anaerobic microbial organisms for phase III production volumes
  • Anaerobic culturing methods
  • Downstream purification processes
  • Developing testing methods to ensure GMP quality control, product stability and potency

If you are interested in giving this presentation please contact perri.lucatello@knect365.com

14:30 - 15:00 30 mins
Microbiome Therapeutics Europe
Commercialisation Strategies for Microbiome Therapeutics
  • Jonathan Gilbert - Global Commercial Lead Microbiome GI Health, Nestlé Health Science
more
15:00 - 15:30 30 mins
Microbiome Therapeutics Europe
Afternoon Coffee
15:30 - 16:00 30 mins
Microbiome Therapeutics Europe
Near Extinction of a Keystone Commensal in the Infant Gut Microbiome
  • David Kyle - Chairman and CSO, Evolve Biosystems Inc.
more

Human milk has been the sole source of nutrition for infants for millions of years, and is rich in specific oligosaccharides (HMOs).  The natural infant gut microbiome is dominated by a single species of Bifidobacteria that is exceptionally competitive at consuming HMOs.  Through the unintended consequences of formula feeding, antibiotic use, and C-Section deliveries, a keystone commensal in this natural microbiome has been lost in the developed world.  We have rescued the natural microbiome from the present dysbiosis through an early remodeling that returns the colonic microenvironment to its natural state.

16:00 - 16:30 30 mins
Microbiome Therapeutics Europe
Panel Discussion: Funding and Investment Opportunities for Microbiome Therapeutics
more
  • What is the outlook for microbiome therapeutics?
  • Evaluating new projects and upcoming investments in microbiome therapeutics: What do you look for investment?
  • Expectations of partnerships/ financing of biotechs and pharma in this space – What stage of product development / idea development is required for investment?
  • Realistic expectations for early exploratory studies compared to phase II studies
16:30 - 16:35 5 mins
End of Conference Day 2