Jason Goldsmith
Senior Director - Medical, Translational, & Data Sciences Nestle Health Science
Seminars
Monday 9th November 2026
Validating Novel Assay Technologies to Demonstrate Identity Potency & Viability for Regulatory Confidence in Microbiome-Based Therapies
1:00 pm
Measuring complex, multi-strain microbiome products remains inconsistent, with biased culture assays, unclear regulatory expectations, and no validated industry standards. This workshop shows how to adopt novel assay technologies and build product-specific analytical strategies that demonstrate identity, potency, and viability, enabling confident regulatory interactions.
Workshop highlights:
- Assessing emerging technologies that quantify complex microbial consortia while capturing strain-level identity and live viability without biased culture workflows.
- Defining product-specific analytical strategies aligned with evolving FDA expectations to validate potency identity and release assays across development stages.
- Comparing approaches to measure multi-strain abundance and function including sequencing viability assays and synthetic biology readouts to strengthen mechanism claims.
- Walking through end-to-end processes for selecting labs piloting methods and validating assays to generate reproducible data satisfying regulators.
Wednesday 11th November 2026
Expanding Microbiome Therapeutics Strategies to Unlock European Market Opportunities & Overcoming Regulatory Hurdles
3:45 pm
- Understanding critical US and EU market regulatory differences, including SoHO, to streamline market entry and avoid delays
- Navigating complexities of establishing European trial sites and novel regulatory pathways to de-risk therapeutic development investment effectively
- Outlining key strategies for successfully introducing an approved US drug into the European market to ensure effective penetration
