8:30 am Microbiome Leaders Panel Discussion
9:30 am Gut Microbiome Endgame: Ramping up cGMP Program Design to Ensure Regulatory Preparedness for Microbiome Products
10:00 am Shotgun Sequencing & Strain-Level Analysis: Study Design for Pre-Clinical & Clinical Development
10.30 am Morning Refreshments & Speed Networking
Track A: Pre-Clinical Development & Mechanistic Analysis of Microbiome-based Therapeutics
Track B: Clinical Translation, Manufacturing and Commercialization of Microbiome-based Therapeutics
Track C: Microbiome-based Biomarkers, Bioinformatics and Patient Stratification
Complexities of Identifying Novel Live Biotherapeutic
11.30 Discovery and Development of Rationally Selected Consortia of Live Microbial Biotherapeutics Based on Disease Relevant Mechanisms
Jackie Papkoff, Chief Scientific Officer, Assembly Bioscien
Clinical Learnings of Live Biotherapeutics
11.30 C difficile Infection and Microbiome Therapeutics: The Importance of Understanding Your Disease Target
Barbara McGovern MD, VP Medical Affairs, Seres Therapeutics
Identifying and Validating Microbiome-based Biomarkers
11.30 Biomarkers for Risk Stratification and Treatment Response: Critical Considerations for Microbiome-Targeted Drug Development
Gerard Honig, Associate Director, Research Innovation, Crohn’s & Colitis Foundation
12.00 Targeting Host Inflammation and Immunity with Microbiome Therapeutics
Matthew Henn, Chief Scientific Officer, Seres Therapeutics
12.00 A Human-First Discovery Approach: Leveraging Clinical Data to Identify Microbial Communities Driving Positive Clinical Outcomes
Sonia Timberlake, VP Research, Finch Therapeutics
12.00 Novel Machine Learning Approach to Microbiome Based Biomarker Discovery
Assaf Oron, Chief Business Officer, BiomX
12.30 Bioinformatic Analysis of Microbial Communities for Patient Stratification and Rational Design of Live Biotherapeutic Product
Daniel van der Lelie, Chief Scientific Officer, Gusto Global
13.00 Next Generation Microbiome Profiling
Tuval Ben-Yehezkel, CEO, Loop Genomics
12.30 Prevention of Recurrent Clostridium Difficile Following Treatment with Microbiota based Therapy: Clinical Results and Considerations
Ken Blount, CSO, Rebiotix
12.30 Panel Discussion: Reviewing the Role of the Human Microbiome in Biomarker Discovery & Development
Gerard Honig, Associate Director, Research Innovation, Crohn’s & Colitis Foundation
Bruce Roberts, Chief Scientific Officer, Vedanta Biosciences
Matthew Henn, Chief Scientific Officer, Seres Therapeutics
Assaf Oron, Chief Business Officer, BiomX
Microbiome Chemistry Small Molecules
14.00 Small Molecule Approaches to Target the Gut-Brain Axis
David Donabedian, Co-Founder & CEO, Axial Biotherapeutics
14.30 Outlining Enterome’s Onco-Mimics Program: Microbiome-Derive Immunotherapy for Treatment of Cancers
Christophe Bonny, CSO, Enterome
15.00 Leading a Chemistry-Driven Approach to Targeting the Microbiome
Johan van Hylckama Vlieg, CSO, Kaleido Biosciences
15.30 Delivery, Survival, Engraftment & Activity of LBPs in the GI Tract
Massimo Marzorati, CEO, ProDigest
Designing and Executing Clinical Trials – A Clinician’s Perspective
14.00 Designing and Executing FMT Clinical Trials
Jessica Allegretti MD, Director Clinical Trials, Brigham & Women’s Hospital
14.30 What Does it Take to Think and Design a Clinical Trial for Live Biotherapeutics?
Sahil Khanna MD, Associate Professor of Medicine & Consultant, Mayo Clinic
15.00 Presenting Case Vignettes to Highlight the Critical Importance of Good Clinical Practice, Education and Safety Monitoring in FMT
Majdi Osman MD, Clinical Program Director, OpenBiome
15.30 Presentation from Wacker Biotech
Biomarker Applications in Drug Discovery and Patient Stratification
14.00 From Association to Function to Action
Aaron Del Duca, VP Microbiome Platform, Day Two
14.30 Enabling Precision Medicine and Discovery of Novel Microbiome-based Therapeutics
Ryan Toma, Research Scientist, Viome
15.00 Exploring & Modeling the Impact of the Microbiome on Vaccine Response
Geoffrey Hannigan, Associate Principal Scientist, Merck Exploratory Science Center
15.30 Early Break for Afternoon Refreshments
15.40 Afternoon Refreshments & Networking
Track A: Pre-Clinical Development & Mechanistic Analysis of Microbiome-based Therapeutics
Track B: Clinical Translation, Manufacturing and Commercialization of Microbiome-based Therapeutics
Track C: Microbiome-based Biomarkers, Bioinformatics and Patient Stratification
New Approaches to Pre-Clinical Assessment of Microbiome-targeting Therapeutics
16.00 Translatability of In Vivo Models in Microbiome Research
Betty Theriault DVM, Assistant Professor, University of Chicago
16.30 Born To Be Wild: Uutilizing the Common Link Among Mammals to Improve Translational Research Models in Microbiome Research
Stephan Patrick Rosshart, Principal Investigator & Group Leader Translational Microbiome Research, University Medical Center Freiburg
17.00 An Ecological Framework to Understand the Efficacy of Fecal Microbiota Transplantation
Yang-Yu Liu, Assistant Professor of Medicine, Harvard Medical School
Manufacturing and Scaling the Microbiome
16.00 Scale Up & GMP Manufacture of LBPs
Jason Ryan, Head of Upstream, Luina Bio
16.30 Manufacturing Commensal Microbes for Treatment of The Microbiome
John Aunins, Chief Technology Officer, Seres Therapeutics
17.00 Development of Oral LBPS – a CDMOs Perspective
Ryan Wilson, Head of Live-Bioprogrammes, Quay Pharma
17.30 Overcoming Hurdles in the Development of Live Biotherapeutic Products
Stacy Burns-Guydish, VP Biotherapeutics Development & Manufacturing, List Laboratories
Developing Microbiome Diagnostics in Cancer & IBD
16.00 Leveraging Bacterial Risk Factors to Improve Pediatric Asthma Prediction
Ricardo Valladares, VP Research & Development, Siolta Therapeutics
16.30 Leveraging the Microbiome to Deliver Safer and More Efficacious Drug Therapies
Marcus Rauch, Chief Scientific Officer, AlphaBiomics
17.00 Developing a Non-Invasive Diagnostic for the Early Detection of Colon Polyps and Colorectal Cancer Using the Human Microbiome
Keri Donaldson, dCEO, Prescient Metabiomics
17.30 The Blood Microbiome: New Source of Biomarkers for Infectious and Cardiometabolic Diseases
Benjamin Lelouvier, Chief Scientific Officer, Vaiomer