Post-Conference Biomarker Workshop Day – Hosted by Microbiome Therapeutics Innovation Group

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Friday June 24, 2022

Please note this workshop day is by invite only, attendance subject to approval. For more information or to apply to attend, please email Aiden Dollin on


9:00 am
Opening Remarks

9:10 am Methodologies for Analyzing Microbiome Biomarkers

  • Cynthia L. Sears, M.D. Professor of Medicine, Oncology and Molecular Microbiology and Immunology, Johns Hopkins University School of Medicine


• Clinical variables impacting microbiome assessment in disease
• The impact of technical and computational variables
• Status of microbiome biomarkers in human disease
• Perspective on needs for Clinical translation and action

9:50 am Opportunities for Microbiome Biomarkers Translationally


• Background on microbiome epidemiology.
• Types and methods for microbiome-related biomarker discovery.
• What microbiome biomarkers tell us about basic biology (e.g. molecular mechanisms).
• Opportunities for microbiome biomarkers translationally (i.e. different types of biomarker applications).

10:30 am
Coffee Break


10:50 am Panel Discussion & Q&A

  • Lutz Krause Chief Scientific Officer, Microba Life Sciences
  • Warren Flood CEO , Bio-Me
  • Bill Shannon Co-Founder & Managing Partner, BioRankings
  • Scott Jackson Group Leader - Complex Microbial Systems, National Institute of Standards and Technology (NIST)
  • Chrysi Sergaki Principal Investigator, Microbiome Group Leader, MHRA / NIBSC

11:20 am Group Discussion


• Which steps in the generation and analysis of microbial and host -omic data are most likely to introduce inconsistencies in data across experiments?
• Which methods for -omics data generation and analysis are more accurate (16s vs. WGS)? What are best practices for Internal QA and benchmarking for -omics based biomarker analyses?
• Given the rapidly evolving state of the field, what types of standardizations across different microbiome therapeutics developers are feasible?
• What public resources are available that could be leveraged for standardization and validation? What resources could the federal government make available to foster these efforts?

12:00 pm Report Group Discussion Feedback to Rest of Audience

12:20 pm

1:00 pm Microbiome Profiling in Diagnostics and Microbiome Transplants to Treat Disease

  • George Weinstock, Ph. D. Evnin Family Chair and Director, Microbial Genomics; Professor, Dept. Genetics and Genome Sciences, The Jackson Laboratory for Genomic Medicine; Univ. Connecticut Health Center


• Present successful examples of microbiome profiling in diagnostics
• Present successful examples of microbiome transplant in treating disease
• Challenges in standardizing these methods
• Challenges in setting quality and reproducibility standards for these methods


1:40 pm Panel Discussion & Q&A

2:10 pm Group Discussion

  • Christina Casén Senior Vice President, Clinical and Medical Affairs, Genetic Analysis


• What is the translatability of biomarkers identified in preclinical models into the clinic? How can early trials be used to validate biomarker relevance to disease and treatment?
• What is the role of biomarkers in improving clinical trial design by enriching for patient populations that could benefit from potential treatments?
• What is the role of biomarkers as endpoints in later stage clinical trial (e.g., surrogate efficacy endpoints?) What are the regulatory considerations in using biomarkers as endpoints in clinical trials?
• What role could biomarkers play in terms of commercialization?

2:50 pm Report Group Discussion Feedback to Rest of Audience

3:10 pm Closing Remarks

Please note this workshop day is by invite only, attendance subject to approval. For more information or to apply to attend, please email Aiden Dollin on