Overcoming Challenges in the Clinical Development of Nutrition-Related Microbiome Interventions

Posted by: | February 12, 2019 | Comments

Arrowhead Publishers has announced the return of their Nutrition track, sponsored by Reckitt Benckiser, to the 5th Annual Translational Microbiome Conference. This year’s nutrition track will have two complementary goals: to address the challenges faced by industry when undergoing clinical development for a microbiome-based intervention and current advances in the research, production and use of probiotics with particular focus on their role in maintaining health and preventing disease.

They are proud to announce the addition of Mary Ellen Saunders, Principal, Dairy and Food Culture Technologies, to the speaking faculty for this track. She will provide her perspective on the future for probiotics. In order for the field of probiotics to continue to grow, she believes that companies must rely on something more tangible than simply asking consumers and medical professionals to trust them with respect to what’s in the bottle. Robust human clinical data and third party verification, akin to the USP label applied to vitamins and supplements, will be needed. Industry is poised to drive those standards and she will discuss next steps.

Duffy MacKay, ND, Sr. VP, Scientific & Regulatory Affairs, Council for Responsible Nutrition, will discuss the challenges associated with bringing probiotic products from bench to market in the US. According to Dr. MacKay, the first stage of probiotic product development is determining if you intend to market a food, dietary supplement, or drug because each pathway to market is distinctly different and has a significant impact on the product development pipeline. This session will provide a top line discussion of the FDA regulatory requirements for bringing a probiotic product to market as a food, dietary supplement, or drug.

To view the rest of the speakers and presentations in this track visit www.microbiomeconference.com

Event Details
Location: The Westin Copley Place, Boston, MA
Dates: April 16-18, 2019

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