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 info@hansonwade.com

MICROBIOME BIOMARKERS: OPPORTUNITIES AND CHALLENGES

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

Synopsis

• 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

Synopsis

• 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

MICROBIAL SIGNATURE REPRODUCIBILITY & STANDARDIZATION

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

Synopsis

• 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
Lunch

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

Synopsis

• 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

BIOMARKERS IN CLINICAL TRIALS / REGULATORY REVIEW PROCESSES

1:40 pm Panel Discussion & Q&A

2:10 pm Group Discussion

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

Synopsis

• 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 info@hansonwade.com