Microbiome Insights - Ferring Pharmaceuticals
Could you introduce yourself and share your experience working in the microbiome therapeutics space?
I'm the Chief Scientific Officer of Ferring Microbiome and VP of Microbiome Clinical and Product Development at Ferring Pharmaceuticals. Officially, I've been in the industry since the days of early to mid-stage clinical trials when we all hoped to one day apply for FDA approvals. I've now been through that approval process and have supported the launch of the first in the space. Coming full circle we are now developing the next generation of follow on products which leverage learnings from our first round. These are now in early clinical trials in our company and others.
What do you see as the biggest challenges facing microbiome therapeutic developers today?
I would say that of course we would like to see more standardized analytical methods and perhaps regulatory frameworks. However, I think there remain some more fundamental questions that hold us back. Our statistical methods for microbiome analysis simply aren't good enough. Our application and interpretation of traditional drug development concepts needs to evolve--PK, PD, ecology as a mechanism of action. At the moment, it is challenging to have the necessary space and time to address these questions, because investor and pharma/market customer confidence are not high enough to afford us the necessary patience. I think we all hope for clinical successes that provide an infusion of that confidence and the associated time and space needed to more thoroughly ask those fundamental questions.
How is our understanding of mechanism of action evolving across microbiome-based therapies?
I don't see that our understanding of the mechanisms of microbiome-related diseases has evolved that much in the past five years. For example, our most commonly proposed mechanisms by which microbiota can correct ulcerative colitis are still short-chain fatty acids, immune cell modulation, pathobiont containment and control, bile acid metabolism, and a few more. I think that we generally understand these concepts rather well.
What we haven't done well enough is translate that the ecology of the microbiome is the mechanism. Our treatments are not traditional target-receptor interactions that can be reduced to biochemical descriptors. They are ecological therapeutics that can activate and mobilize an entire community, eliciting tremendous polypharmacology. Perhaps instead of striving to be reductionist in our MOAs to make them more approachable for traditional pharma, we should bring those audienced toward the strength of ecological polypharmacology.
What role do pharmacokinetic and engraftment analyses play in building confidence among regulators, investors, and pharma partners?
I think PK/PD/engraftment analyses can be profoundly valuable to investors and pharma partners. We all love science for science, and investors/pharma love sciencey descriptions of how drugs work. Perhaps the challenge is that we're often not all singing from one hymn, so those stakeholders can't hear a harmonized song about PK/PD/engraftment.
As for regulators, I don't see that the US FDA is particularly concerned about these concepts just yet. They're waiting for us to show how these concepts drive clinical efficacy or safety in a meaningful way. Outside the US, there is more apparent interest, but no consensus view.
What are you most looking forward to discussing with your peers at the 11th Microbiome Movement USA Summit?
I'm looking forward to hearing the current pulse check on the industry, investor interest, new developments and wins, and new approaches.
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