Jason Goldsmith
Senior Director, Microbiome Sciences Nestle Health Science
Jason Goldsmith is Senior Director, VOWST & Microbiome Sciences at Nestlé Health Science, where he leads pharmaceutical discovery, VWOST Clinical Strategy, and serves as the medical officer for the donor program. A physician-scientist with expertise spanning R&D, clinical development, and CMC, he serves as medical and scientific lead for microbiome therapeutics, including VOWST. Jason oversees clinical laboratory, analytical, translational, and data sciences teams, with a focus on validated biomarkers, companion diagnostics, and data-driven innovation. He has led successful regulatory submissions in novel therapeutic areas and brings extensive experience in gastrointestinal, inflammatory, and immunology-focused drug development.
Seminars
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.
- 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
