Interview with Mollie Roth, JD
Executive Director of The Microbiome Coalition (TMBC)
What is The Microbiome Coalition and what’s its goal?
The Microbiome Coalition (TMBC) represents a variety of commercial entities working toward commercial success in the microbiome field, united by their desire to promote greater public understanding of the role of the microbiome in human health and wellness, and the desire to advance appropriate regulation, needed investment and required infrastructure.
Recognizing that a shift in how microbiome based medicine and research is implemented will not happen simply because a body of scientific evidence suggests it should, TMBC has identified key goals to support and advance the industry, including: Education, Regulatory Engagement and Standards. You can learn more about what we are doing on all three fronts at http://www.themicrobiomecoalition.com/
How did TMBC come to be formed?
Although I started my career as a litigator for the pharmaceutical industry, I have always had an affinity for making business run better. I spent 10 years working with a precision medicine consulting company helping pharma drug development teams understand how to co-develop and launch companion diagnostics.
In early 2013, I started working as a consultant in the microbiome space and became interested not only in the vast body of research that was happening across multiple industries – pharmaceutical, diagnostic, consumer products and nutrition – but in the challenges for companies to become a commercial success. Many of the hurdles and challenges this industry faces mirror exactly the experience in the precision medicine field – an unclear regulatory path, unclear business models, a lack of standards, differing reference databases among others.
It was my opinion, based on my experience in the precision medicine field, that a coalition of companies in this space could better address and overcome these challenges than any one company could. Thankfully the founding companies agreed with me and TMBC was born.
You said one of TMBC's goals pertains to standards, is there a problem with standards in the microbiome space?
In scientific research, standards allow for and ensure quality in research and the generation of quality evidence that can be compared across researchers and companies. Absent uniform standards, the quality of scientific research can be uneven and lacking in credibility, making it difficult to make confident, concrete assertions or predictions regarding evidence for improving practice or consumer outcomes.
For example, in the precision medicine space, we saw the lack of standards cause issues when it became apparent that there were no standardized practices for how samples being used to generate clinical data for diagnostic tests were handled. There are a number of groups already hard at work on two distinct standards issues in the microbiome space – how samples are handled and sequenced as well as how the vast volume of information generated in this space is processed.
TMBC will serve as a clearinghouse for these activities already underway and will bring these disparate groups to the table to ensure they are engaging with each other so the industry ends up with a set of conformed standards, rather than numerous sets of non-interoperable standards.
What companies formed TMBC?
The founding companies are a visionary set of innovators who quickly understood the need for a coalition of companies working toward commercial success in the microbiome space and have provided seed support and substantial resources to get the coalition off the ground. They include AOBiome, Whole Biome, CosmosID, Abbott Nutrition, The Mayo Clinic, Diversigen and Second Genome.
How important are collaborations in the microbiome space?
As incredibly important as they are in any area of new scientific research!
There are literally hundreds of small startup companies making incredibly exciting discoveries with regard to the microbiome, but without the resources or global reach to complete their research or get products approved and launched. Collaborations with larger companies, carefully crafted to ensure a win-win, are not only vital but imperative to move this space forward.
Further, now that we are a few years into the “age of the microbiome” we are starting to see a convergence between microbiome therapies and precision medicine, as companies consider how patients might need to be stratified based on their microbiome to determine who best to treat. The business models of how pharma and diagnostic companies can best collaborate and work together will continue to be vitally important as these two spaces continue to merge.
Is membership in TMBC open and to whom?
Membership in TMBC is open and we welcome any company, association or individual with an interest in advancing the commercial viability of microbiome based therapies, diagnostics, consumer or nutrition products to address and improve human health and wellness. You can learn more about membership options at http://www.themicrobiomecoalition.com/become-a-member/