The following blog pertains to the 2017 SOT Annual Meeting Scientific Session "Scientific, Regulatory, and Safety Considerations for Probiotics and Microbiome Targeted Therapeutics."
Recent years have seen increasing interest in the microcosm of the human body—specifically, how the microorganisms that live on and inside of each person contributes to individual health and well-being. This personal microbial world is known as the microbiome, and it has become the object of interest for many companies and researchers hoping to develop therapeutics that manipulate it. Of course, with any new frontier, there are plenty of challenges, both for regulators and for formulators, that must be navigated to ensure consumer safety.
Alexandra Lobach, Intertek Scientific & Regulatory Consultancy, and Solange Henoud, Lallemand Health Solutions Inc., explored the complex regulatory hurdles that companies and governments face when regulating products which target the microbiome—sometimes called “probiotics.” The definition and regulation of probiotics changes from country to country, and both presenters highlighted the tremendous discrepancy between regulatory frameworks imposed in the US, Canada, Europe, and the rest of the world. Presenter Lobach summarized the regulatory schema for the US and the European Union while Presenter Henoud went into some detail about the Canadian government’s approach to regulation. By comparing and contrasting the myriad policy frameworks, the speakers identified aspects of regulation which appeared to stifle innovation among probiotic producers (namely the regulations imposed by the US and the EU) and which regulatory frameworks appeared to energize the market for probiotic products, but have bedeviled regulators (as is the case in Canada).
Attendees got a microbes-eye view of the microbiome-therapeutics field from Michael Pariza, University of Wisconsin-Madison, who presented a workflow his group developed to guide the safety evaluation process for probiotics and microbiome-targeted therapeutics. The workflow he presented uses microbiological data to work through a flowchart that aims to prevent the introduction of pathogenic or possibly deleterious strains into the market.
Appropriately, the following presenter, Christopher Elkins, US Food and Drug Administration (US FDA), detailed the genomics strategies employed by the US FDA to ensure the health and safety profiles of such products both before and amidst product availability to consumers. Elkins demonstrated that these microarray and sequencing tools are not just useful for ensuring compliance and product safety, but could be used to drive innovation and product development, a topic that John Eid, Whole Biome, Inc., the final presenter, took on.
Presenter Eid presented multiple cases of therapeutic development and explained the pros and cons of pursing each of them. Compared to the challenge of developing a microbial cocktail to combat microbiome-related diseases, traditional pharmaceutical development seems much easier! Because while there may be a shorter development timeline for something like a fecal microbiota transplantation, the regulatory path for such a treatment is exceptional, compared to the well-worn path to pharmaceutical approval.
Overall, this excellent session highlighted the tremendous promise and astonishing complexity that comes with the exploration of a new field of therapeutics. The speakers raised important points about the need for honest and detailed discussions between regulators, companies, and patients (or consumers) to determine an appropriate regulatory tone and, further, that governments will need to work together to harmonize those tones into a satisfactory regulatory chorus.