JUNE 3 - 5, 2020 • VIRTUAL EVENT | EDT TIMEZONE · Drug Discovery, Microbiome Research Takeda GUT BRAIN AXIS With multiple preclinical and clinical studies demonstrating gut-brain

Designing microbiome-modulating therapeutics for the treatment of neurological, cancer, metabolic and gastro-intestinal indications

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Associate Event Partners:

Senior Event Partners:

Event Partner:

Gut-Brain Axis Immuno-oncology Gastro-Intestinal Metabolic Manufacturing Commercial Partnerships

• Discoverthelatestpreclinicaldataandmodelsfromtranslationalmicrobiomestudies

• Evaluateunpublished2019/2020biomarkerandmetabolomicdatafromphase1,2and3clinicaltrials

• Understandthekeymetabolitesandmechanismsofactiondescribingthemicrobiome’sroleinextra-intestinal&intestinalindications

• Assessthemodalityspectrumofmicrobiome-modulatingtherapeuticsfromFMTtoSmallMoleculetophage

• Formingstrategicpartnershipswithbigpharma

• SecuringfundingfromVCs

• ImprovingLBPmanufacturingqualitycontrolusingPCRandFlowCytometry

JUNE3-5,2020•VIRTUALEVENT|EDTTIMEZONE

Runningsimultaneouslywith:

Jessica Schneider Director Takeda

Diwakar Davar Associate Professor UniversityofPittsburgh

Emeran Mayer Professor UCLA

Assaf Oron CBO BiomX

Johan Van Hylckama Vlieg CSO Kaleido

Sudha Biddinger Associate Professor HarvardMedicalSchool

Isabelle de CremouxCEO Seventure

www.microbiomeconnecthuman-usa.com•+44(0)2036962920•[email protected]

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WELCOMEThe gut microbiome is becoming an increasingly important druggabletarget for pharma

companies through a rangeofmodalities from FMT to small molecule and even phage. 2020lookssettobeapivotalyear for the microbiome industry with a handful of companies (including

Seres, Rebiotix and Finch Therapeutics) set to release ground-breaking phase3clinicaldata.

We’re a step away from marketapproval, but there’s still so much to learn…

Major advances in shotgun metagenomicsequencing and computationalbiology allow us to

see what’s going on at a strain specific and metabolomic level of detail. Elucidating the keymetabolitesandmechanismsofaction in bothextra-intestinal and intestinalindications is a

key objective in 2020/2021 and is a cornerstone of discussion at this year’s MicrobiomeConnect:NorthAmerica with leadingacademics and biotechcompanies presentingpreclinicalandclinicaldatafrom2019/2020.

WELCOME

WHAT’SNEWATMICROBIOMECONNECT:HUMAN?

1. 2019/2020 preclinical mechanistic and metabolomic data from Matt Henn (Seres), Imke Mulder (4DPharma), Assaf Oron (BiomX) & Sudha Biddinger (HarvardMedicalSchool).

2. The latest translational clinical trial data from Ellen Li (StonyBrookUniversity), Jason Norman(Vedanta) & Michael Zasloff (Enterin).

3. Improving QC for cGMP scaling of LBP manufacturing for phase 2 and 3 clinical trials with DanCouto (Vedanta).

4. Forming successful strategic partnerships with pharma with Jessica Schneider (Takeda).

5. Gut microbiota manipulation using a range of modalities including FMT, bacterial consortia, singlestrain, phage and small molecules for treatment of extra-intestinal and intestinal conditions.

Join over key opinion leaders and expert speakers across three dedicated days to examine the latest preclinical and clinical data in extra-intestinal and intestinal indications. This is your opportunity to find out how others plan on translating gut-microbiome research into therapeutics that have the power to treat Oncological, Neurological, Gastro-Intestinal & Metabolic diseases.

WE’REGOINGDIGITAL!Kisaco Research is committed to providing attendees across all of our events with the best possible experience, it’s for this reason we’ve decided to go digital and embrace the amazing new technology that enables us to deliver a virtual event. Here’s what we think are the biggest benefits of going digital, and how you can make best use of your event experience:

TOP 10 BENEFITS OF VIRTUAL EVENTS

TailorYourAgenda– with sessions spanning across multiple days, design your own agenda based on who you want to hear from and what will be most useful to your business.

ImprovedAudienceVisibility– you can see exactly who is registered to attend the event and when they’re online – make that valuable connection in real-time!

On-DemandContent– missed a session or couldn’t tune in that day? That’s fine, sessions will be available to listen to for 2 months post event. That also means you can listen to your favourite speaker multiple times.

HighQualitySpeakers– this doesn’t change, whether we run a live event or a virtual one, we recruit industry leading, insightful speakers to inspire.

MoreNetworkingOpportunities– do you sometimes miss the one person you were hoping to meet at live events? With virtual events you can instant message them, reserve a time in their diary, and email them.

GetMoreInvolved– virtual events offer many more interactive opportunities than live events; participate in live polls, live Q&A and live panel discussions – helping you build your personal brand and your business connections.

SaveTime&Money– tune into an event from the comfort of your own home, no need to travel overseas, spend time away from loved ones and spend your company’s money! This makes networking and knowledge sharing much more cost efficient.w

IncreasedContent– we can run more sessions at one time without the constraints of venue capacities, meaning we can provide you with more valuable content in one go.

BusinessDevelopmentOpportunities– for those looking to partner on the virtual events, there’s lots of session formats that will place you at the centre of the conversations you need to have, including but not limited to; topic specific roundtables, keynote panels, ask the expert chat rooms and more. Talk to our team to find out more [email protected].

Insights– using analytics, we can help you benchmark, to stay ahead of industry trends. We can also share audience insights on job titles, seniority and geography, so you know your networking with the right connections t to match your business needs.

For more information visit www.microbiomeconnecthuman-usa.com

www.microbiomeconnecthuman-usa.com • +44 (0) 203 696 2920 • [email protected]

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Jessica Schneider Director, Gastroenterology Drug Discovery, Microbiome Research Takeda

Matt Henn CSO Seres

Julius Goepp CEO ScaledMicrobiomics

Christopher Missling CEO Anavex

Johan Van Hylckama Vlieg CSO Kaleido

Giulio Pasinetti Professor IcahnSchoolofMedicine

Bret Wallace Director Symberix

Torsten Madsen CMO AxialBiotherapeutics

Greg Perry CFO FinchTherapeutics

Chris Weidenmaier Associate Director - Host Cell Biology FinchTherapeutics

Imke Mulder Research Director 4DPharma

Frank Middleton Associate Professor UpstateMedicalSchool

Assaf Oron CBO BiomX

Isabelle de Cremoux CEOSeventure


Denise Kelly Venture Partner Seventure

SPEAKERS

SPEAKERS

Xue Liang Senior Scientist Merck

Diwakar Davar Assistant Professor UniversityofPittsburgh,SchoolofMedicine

Ben Bradley Head of Partnerships & Licensing CHAINBiotech

Ellen Li Professor StonyBrookUniversity

Nicole McKnight COO Amabiotics


Morten Isaksen CEO Bio-Me

Gregory Lambert CEO Targedys


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SPEAKERS

SPEAKERS

Serguei Fetissov Professor RouenUniversity

Jack Egelund Madsen Chief Business Officer ClinicalMicrobiomics

Nikole Kimes Founder & CSO SioltaTherapeutics

Dan Couto COO Vedanta

Lucy Yanckello PhD Student UniversityofKentucky

Heidi Hau Director, Technology Expansion Rebiotix

Glennda Smithson Director, Translational Biomarker Research Takeda

Matthew Steele Regulatory Information Specialist FDA

Anna Williamson Senior Director Oncology Business & Head of UK Business Development Roche/Genetech

Romain Dailiere CEO Everimmune

John Aunins CTO Seres

Mingyang Song Associate Professor HarvardT.HChanSchoolofPublicHealth

Raja Dhir Co-Founder & Co-CEO SeedInc

Fyza Shaikh Postdoctoral Fellow TheJohnsHopkinsHospital

Mike Romanos CEO Microbiota

Gerard Honig Associate Director, Research Innovation Crohn’s&ColitisFoundation

Bharat Dixit VP, Biopharmaceutical Development & Manufacturing ClearBTherapeutics

This event is a unique gathering of individuals from academia and industry who are collaborating to advance microbiome science. Kisaco has gone out of their way to include speakers and perspectives not found elsewhere. I look forward to attending again.”

KCMICROBIOMECOMMUNICATIONSGROUP


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WHYATTEND


John Aunins CTO Seres

Anna Williamson Senior Director Oncology Business & Head of UK Business Development Roche/Genentech

Dan Couto COO Vedanta

Mike Romanos CEO Microbiotica


Chris Weidenmaier Associate Director - Host Cell Biology FinchTherapeutics

Fyza Shaikh Postdoctoral Fellow TheJohnsHopkinsHospital

Frank Middleton Associate Professor UpstateMedicalSchool

Jessica Schneider Director, Gastroenterology Drug Discovery, Microbiome Research Takeda

GUT BRAIN AXISWith multiple preclinical and clinical studies demonstrating gut-brain mechanisms of action, Enterin share new phase 2a data in Parkinson’s disease and Emeran Mayer, professor at UCLA unpicks the techniques that companies and academics are implementing to translate data into therapeutics.

COMMERCIAL PARTNERSHIPS Funding and commercial partnerships are a crucial success factor for biotechs looking to progress through later stage clinical trials. Anna Williamson of Roche/Genentech, Jessica Schneider of Takeda and Rodolphe Clerval of Enterome share details and take-homes from their successful industry partnerships.

IMMUNO-ONCOLOGYThere’s a race to find the best PD-1 inhibitor combination therapy. How will the microbiome fare vs oncolytic viruses and radiotherapy options and what’re leading companies doing to develop different modalities? Hear the latest clinical updates from Roche, Enterome and Microbiotica.

MANUFACTURINGWe can make them in the lab, but can we do it at scale? Dan Couto, COO at Vedanta expands on how they’re manufacturing LBPs at scale for phase 3 trials and John Aunins, CTO at Sers describes how they’re optimising manufacturing processes and utilising the latest QC analysis techniques to ensure bio-comparable product. METABOLIC

Obesity alone effects 40% of US adults with an estimated medical cost of over $150 bn. Leverage the latest clinical data describing the molecular mechanism of TMAO in metabolic syndrome from Sudha Biddinger’s of Harvard Children’s Hospital and the use of fibre to modulate the PERK pathway.

GASTRO-INTESTINALIt’s a pivotal year for GI indications with Seres, Rebiotix and Finch Therapeutics set to release ground-breaking phase 3 clinical data in Q1 2020. Dissect the latest unpublished mechanistic and metabolomic data and implement their clinical practices in your own drug development pipelines.

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AUDIENCE

BigFood&ingredientscompanies

ATTENDINGCOMPANIES

35%

30%

10%

20%

5% Academics

Pharma

Sequencing,metabolomics,metagenomics,CDMO,CRO&Bioinformatics

Biotechs


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INVESTMENT&STRATEGICPARTNERSHIPS

8:50 Welcome Note

9:00 Keynote Presentation: Gut instincts: The steps a microbiome company needs to take to guarantee VC funding• Understand how microbiome investment is set to change in 2021 in light of COVID-19 and Rebiotix’s positive phase 3 clinical results.• Asses what makes a successful microbiome company and delve into the reasons Seventure invested in Enterome, MaaT Pharma, Targedys, LNC

and Vedanta and what they’re looking for in terms of (pre)clinical data for future investment in microbiome companies.

Isabelle de Cremoux – CEO – Seventure

9:30 Microbiome Investment: Interactive Panel Discussion Our panellists assess what pharma and VCs look for when investing in biotechs from a data and business point of view, so that you can:

• Analyse how strategic partnership deals between biotech companies and Pharma are structured.• Understand the data you need to attract investment and how this differs in preclinical vs clinical data.• Discover how your company can secure funding for pre-clinical and phase 1/2 clinical trials.

Jessica Schneider – Director, Gastroenterology Drug Discovery, Microbiome Research – Takeda

Greg Perry - CFO- FinchTherapeutics

Gerard Honig – Associate Director, Research and Innovation – Crohn’sandColitisFoundation

10:00 Comfort Break

MICROBIOMEINONCOLOGY

10:10 Round Table Session: Defining clinical endpoints in microbiome/oncology clinical studies.

10:40 Immune check point inhibitor combination therapies: where does the microbiome stand?With big pharma investing in a verity of immune checkpoint inhibitor combination therapies (oncolytic viruses, combinations of checkpoint inhibitors, microbiome-based therapies) where does the microbiome stand vs other combo therapy types and what does the microbiome industry need to do to ‘win’ this battle vs other combo therapy types?

Assaf Oron – CBO – BiomX

Mike Romanos – CEO – Microbiota

Imke Mulder – Research Director – 4DPharma

Morten Isaksen - CEO - Bio-Me

DAY1 June 3 | 8:50 AM – 1:05 PM (EDT Timezone)

AGENDA



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AGENDA

11:15 Modulating the gut microbiota through FMT to influence the efficacy of PD-1 checkpoint inhibitor therapy• Discover how the composition of the intestinal microbiome effect PD-1 checkpoint inhibition therapy. Is it causal or a correlation?• Learn how to modulate the gut microbiome using FMT to improve response to Pd-1 checkpoint inhibition therapy from• What is the mechanistic understanding of the gut microbiome’s role in checkpoint inhibition and how does it differ in responders vs nonresponders?• Understand the future clinical study plans to improve mechanism of action.

Diwakar Davar – Assistant Professor -UniversityofPittsburgh

11:40 Comfort Break

11:50 From Lab Bench to Bedside: Positioning microbiome analysis for clinical utility• PMP is a rapid, detailed, accurate and high throughput microbiome profiling tool that makes that fulfills the requirements for microbiome-based

Precision Medicine in a clinical setting.• Learn about preliminary results of using PMP to distinguish between UC and CD in children with IBD.• Application of PMP in cancer treatment in general and ImmuneOncology specifically.

Morten Isaksen - CEO - Bio-Me

12:15 Developing live biotherapeutics for immuno-oncology: Latest preclinical data and mechanisms of action• 4D pharma present their preclinical data demonstrating the ability of LBPs to offer a novel approach to immuno-oncology in monotherapy and

combination settings through strong immunostimulatory profiles.• Assess the selected LBP candidates that inhibit tumour growth across multiple preclinical models and how these could be applied clinically in the future.• Learn how 4D pharma were able to characterise the bioactive molecules involved in molecular mechanisms of action and develop drugs to target

immuno-oncology.

Imke Mulder – Research Director -4DPharma

12:40 Utilising Diversigen’s bioinformatic platform for microbiome analysis:• Understand how Rebiotix and Prescient are implementing bioinformatic analysis in their clinical analysis and how you can apply their approaches

to your pipeline• Discover the potential of bioinformatics in antibiotic resistance, viral pathogenesis and skin microbiome research.

13:05 Close of Content

13:10 Open Networking and Pre-arranged Meetings commence Platform will remain open for meetings until 5:00pm. Please note: The platform will remain open for this allotted period to allow you to plan meetings in and around your schedule.

17:00 Close of Conference Day 1



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INVESTMENT&STRATEGICPARTNERSHIPS

8:50 Welcome Note

9:00 Developing FMT for treating Autism Spectrum Disorder• Understand the clinical study data describing the impact of microbiota transfer therapy via FMT on gut microbiota composition• and GI and ASD symptoms. This includes improved GI symptoms, behavioural improvements and increased microbiota diversity.• Discover the molecular mechanisms linking the gut microbiota to abnormal metabolites and behaviour through the latest preclinical and phase 1 data.• Review how biomarkers were measured in the clinical study and how can these biomarkers be used to evaluate and improve treatment efficacy?

Chris Weidenmaier - Associate Director - Host Cell Biology –FinchTherapeutics

9:25 The Oral Microbiome Opportunity and Identifying the Biomarkers for Early Stage Parkinson’s Disease• Using shotgun metatranscriptomics and metagenomics to map taxa of healthy vs early stage Parkinson’s patients revealed 40 distinct taxa with

altered abundance, including clusters of specific Lactobacilli.• The approach also revealed shifts in functional transcriptional networks of oral bacteria and the human host.• This approach thus facilitates identification of biomarkers that may help improve the accuracy of Parkinson’s diagnosis, and indicate potential

therapeutic opportunities.• Current work is expanding the human studies and using in vitro and in vivo mouse models to investigate the possible manipulation of the

microbiome to improve Parkinson’s related symptoms.

Frank Middleton – Associate Professor – UpstateMedicalUniversity

9:50 Comfort break

10:00 Round Table Session: Using NGS to determine causality and identify drug targets in microbiome-based therapeutics.

10:35 A mechanistic understanding of RBX2600 in recurrent Clostridioides difficile infections• Understand the current mechanistic understanding of RBX2600 in recurrent Clostridioides difficile infections• Latest phase 2a/b clinical data covering mechanism of action and metabolomic impact of the RBX2600 in recurrent C. difficile infection.• Phase 2a/b clinical trial design and lessons learned from the studies so far

Heidi Hau – Director, Technology Expansion – Rebiotix

11:00 Comfort Break


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REGULATORYCHALLENGES

11:10 On the edge of market approval: FDA Q&A session:With Rebiotix’s positive initial phase 3 clinical results, this is the perfect opportunity to ask the FDA direct questions regarding the future of microbiome-based therapies and the route to market approval:

• With multiple modalities being used to modulate the gut microbiota, what biomarkers do you needed to be measured to determine PK and PD?

• How do we measure the safety and efficacy of microbiome modulating drugs?• What will be required from the FDA in terms of standardisation of these measurement methods?

How will Rebiotix’s positive phase 3 results impact this?

Matt Steele – Regulatory Information Specialist – FDA

NEUROLOGICALDISEASES

11:40 A clinician’s perspective: Applying our knowledge of the Gut-Brain-Axis in Parkinson’s patients • Understand the role of the gut microbiota in neurological disorders and the application of dietary

changes to prevent disease progression. • Discover the microbiome derived metabolites involved in Parkinson’s and the key biomarker’s measured.

Ali Keshavarzian - Professor, Department of Internal Medicine, Division of Digestive Diseases and Nutrition, RushMedicalCollege

MANUFACTURING

12:05 Panel: Breaking down the major challenges of manufacturing defined consortia of LBPs including process development optimization, meeting cGMP manufacturing requirements and quality control practices.• Understand how our speakers are controlling the costs of goods for LBPs in phase 1 and 2.• Assess the latest methods to avoid pathogen presence in final LBP product.• In-house or CDMO? With manufacturing not being a core competency of microbiome companies,

what are the implications of both business models and which is best for your company?• How can you implement better analytics for quality control (including PCR and flow cytometry) to

replace classical approaches like microscopy and CFU count?

John Aunins – CTO – Seres

Dan Couto – COO – Vedanta

Bharat Dixit – VP, Biopharmaceutical Development & Manufacturing – ClearBTherapeutics

Adrien Nivoliez - CEO -Biose

12:40 Linking gut-microbiota biomarkers with improved clinical response in Alzheimer’s patients treated with ANAVEX2-73• Discover the correlations between the gut microbiota and response to the drug in Alzheimer’s patients.• Assess the mechanism of action of the drug from 2020 phase 2b/3 clinical data from 450

Alzheimer’s patients.• Analyze the genomic biomarkers used in the study to determine efficacy and apply to your own

discovery pipeline.• Understand how and why the high levels of two specific microbial families improve ANAVEX2-73

response in Alzheimer’s patients.

Christopher Missling – CEO – Anavex

13:05 Close of Content

13:10 Open Networking and Pre-arranged Meetings commence Platform will remain open for meetings until 5:00pm. Please note: The platform will remain open for this allotted period to allow you to plan meetings in and around your schedule.

17:00 Close of Conference Day 2


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DAY3 June 5 | On Demand Content Only

An Emerging Paradigm of Microbiome-Targeting Precision Medicines: The GUSome as a Case Study

• Introduce the role of enteric bacterial beta-glucuronidases (GUS) in triggering lower GI toxicities associated with prescription medications

• Demonstrate that GUS-targeting, small-molecule drugs can prevent these medication-induced lower GI injuries, such as chemotherapy induced diarrhoea

• Reveal the inter-individual variability among the ~300 GUS orthologs that make up the “GUSome” in the human gut microbiome

• Discuss the GUSome as a case study on the unique challenges of developing microbiome-targeting drugs• Demonstrate the utility of a stool-based functional assay to assess patient-relevant GUSome function• Disclose how the assay can be developed as a companion diagnostic to potentially identify patients who are

responsive to GUSome targeted drugs

Bret Wallace – Director – Symberix

Linking fiber intake with survival post colorectal cancer diagnosis

• Assessing whether post-diagnosis fiber intake correlates with improved survival rates in a 1500 strong cohort of colorectal cancer patients.

• Understand how observational data was leveraged and linked to metagenomic and metatranscriptomic data.• Learn how a multi-omics approach was used and how the lessons learned can be used in future studies.

Mingyang Song – Associate Professor –HarvardT.HChanSchoolofPublicHealth

Meta-analysis improves identification of microbiome associations with anti-tumor response in melanoma, lung, and kidney cancer patients treated with checkpoint inhibitors

• A bioinformatics platform that improves on existing pipelines by standardizing critical preprocessing and downstream analysis tools, enabling comprehensive evaluations of taxonomic and functional signals across sequencing datasets.

• Identification of novel bacterial signatures associated with clinical responses that could potentially be used as biomarkers in patients undergoing treatment with checkpoint inhibitors.

Fyza Shaikh – Postdoctoral Fellow – TheJohnsHopkinsHospital

An immunotherapeutic approach to colorectal cancer interception

• Understand how microbiome research enables identification of crucial “event cascades” that link microbiome composition to molecular pathways that ultimately produce disease.

• Deep dive into one well-defined event cascade that is leading to colorectal cancer (CRC) in susceptible individuals, including the potential drug targets for interception.

• Understand how Scaled Microbiomics are applying avian (IgY) antibodies as target-specific tools for disrupting the CRC cascade of events and treatment of colorectal cancer.

• Learn how to use SHIME and M-SHIME simulators to demonstrate the impact of the therapeutic including the latest preclinical data from 2020.

Julius Goepp – CEO – ScaledMicrobiomics

Using synthetic biology and bacteriophages to treat colorectal cancer

• Discover how the presence of intra-tumoral F. nucleatum promotes tumor growth and treatment resistance in colorectal cancer.

• Assess the latest 2019/2020 in vivo data on how to engineer phage to target and eradicate specific bacteria (F. nucleatum) in the tumor microenvironment for therapeutic response.

• Understand the mechanisms of action of phage therapy in colorectal cancer and the phase 1 clinical studies being designed to study these mechanisms further.

Assaf Oron - CBO - BiomX

IMMUNO-ONCOLOGY&CANCER


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Developing Live Biotherapeutics to Target the Gut-Brain Axis to treat Parkinson’s

• The poly-pharmaceutical nature of LBPs offers new therapeutic avenues to treat multifactorial disease such as Parkinson’s Disease.• What are the LBP candidates with complementary activities that protect against specific neurodegenerative readouts and the latest understanding of their

mechanisms of action?• What are the bacterial metabolites (including short-chain fatty acids) that influence gut-brain axis communication at multiple levels and how do they

operate in molecular mechanisms?

Imke Mulder – Research Director -4DPharma

Using dietary inulin to enhance systemic metabolism and reduce neuroinflammation in mouse models

• Assess the microbial taxonomic data and system-wide metabolomics data, investigating the impact of dietary inulin on the metabolites and• species present in mice. • Understand how the mouse model was designed to include a human AP0E4 gene and why this is relevant to Alzheimer’s Disease.• Discover the therapeutic potential of inulin in reducing neuroinflammation and the inflammatory biomarkers used to measure this.

Lucy Yanckello – Graduate Research Assistant – UniversityofKentucky

• AMA-101: An example of a small molecule drug against Parkinson’s disease.• Preclinical data demonstrating the AMA-101’s mechanism of action.• The unique set of metabolites that are produced by a healthy gut microbiota and the maintenance of health and their mechanistic importance in

Parkinson’s disease.• Utilising Amabiotic’s microbiome indication screening process for small molecule drug discovery.• How microbiome-derived diagnostics can pave the way for personalized medicines to treat gut-brain disorders such as Parkinson’s.

Nicole McKnight – COO – Amabiotics

GUT-BRAIN-AXIS&NEUROLOCIALINDICATIONS


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Designing customized phage therapy cocktails for treating chronic IBD

• Understand the latest 2019/2020 preclinical data describing Phage’s molecular mechanism of action in gastro-intestinal indications.

• Discover the key considerations for designing a phage cocktail therapy for IBD treatment using synthetic biology.

• Be the first to learn about the measurable microbiota biomarkers of efficacy for phage therapies in IBD.

Assaf Oron – CBO – BiomX

From academic research to product: EnteroSatys development

• How are Targedys utilising molecular mimicry to develop bacterial metabolites and small molecules to target the gut-brain axis and treat obesity?

• Understand the role of the gut microbiome in the regulation of the appetite and the accompanying data describing the molecular mechanisms and metabolites involved.

• Learn how Targedys selected the strain for their product and designed animal proof of concept trials to demonstrate efficacy.

• Discover how Targedys formulated, scaled-up and ensured the stability of the final product and the lessons learned along the way.

• Designing successful human clinical trials and consumer studies to get your product to market faster and at a lower cost.

Gregory Lambert – CEO – Targedys

Sergei Fetissov – Professor – RouenUniversity

Biomarkers for inflammatory bowel diseases: Needs & opportunities for microbiome-targeted drug development

• Why biomarkers are critical to address unmet patient needs and accelerate drug development in the IBD field.• Examples of microbiome-based biomarkers for risk stratification in IBD.• Scientific, regulatory and commercial criteria for biomarker selection in IBD drug development.

Gerard Honig PhD – Associate Director of Research Innovation – Crohn’s&ColitisFoundation

ART24, a novel Live Biotherapeutic Product in development for the prevention of CDI

• Discover the key in vitro characteristics of ART24 related to its direct activities against C. difficile and its toxins

• Learn how the in vitro properties translate in an animal model of CDI • Explore the in vitro and in vivo impact of ART24 exposure on the faecal microbiota • Describe the clinical development plan for Phase 1 focussing on safety and tolerability

Laurent Chesnel, PhD - Vice President Research and Development – ArtugenTherapeutics

Using microbiome-derived biomarkers to design better clinical studies in GI conditions

• Understand the taxonomic and metabolomic biomarkers used to evaluate and design clinical trials across a range of GI indications including recurring C. difficile and IBD.

• Factoring sample collection standardization and logistics into clinical trial design to ensure comparable data and benchmarking across microbiome studies.

• Connecting microbiome biomarkers with blood biomarkers to improve patient stratification and treatment in GI conditions.

Glennda Smithson – Director, Translational Biomarker Research –Takeda

Treating Colitis through synthetically engineered clostridia

• Learn how engineered clostridia have been developed to produce and deliver therapeutic molecules to the mucosal lining of the gut to reduce inflammation, address microbiota imbalances and support mucosal healing.

• Assess the preclinical studies and biomarkers demonstrating efficacy and validation of the synthetic biology approach to treating IBD.

• Break down the engineering and manufacturing methods used to support a pipeline of living medicines, applicable to several therapeutic areas including infectious diseases and oncology.

Ben Bradley – Head of Partnerships & Licensing -ChainBiotech

GASTRO-INTESTINAL&METABOLICINDICATIONS

microbiomeconnecthuman-usa.com

+44 (0)20 3696 2920

[email protected]

REGISTERNOW

Designing microbiomemodulating

therapeutics for the treatment of neurological,

cancer, metabolic and gastrointestinal indications.

JUNE 3 - 5, 2020 VIRTUAL EVENT

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Designingmicrobiome-modulatingtherapeuticsforthetreatmentofneurological,cancer,metabolicandgastro-intestinalindications

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:JUNE3-5,2020•VIRTUALEVENT

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JUNE 3 - 5, 2020 • VIRTUAL EVENT | EDT TIMEZONE · Drug Discovery, Microbiome Research Takeda GUT BRAIN AXIS With multiple preclinical and clinical studies demonstrating gut-brain