Several kinds of Human Microbiome Therapeutics (HMTs) are emerging as excellent candidates for innovative health strategies, but some scientific and regulatory challenges remain. Despite no current market authorization, Fecal Microbiota Transplantation (FMT), phagotherapy and Antimicrobial peptides (AMPs) are positioning as forthcoming novel solutions to infectious disease. They should benefit within a short time from multiple regulatory working groups and scientific committee initiatives. Long-term investigations with microbiome analysis and associated clinical parameters will make it possible to judge the relevance and safety of these therapeutic indications. In this post, Kristin Wannerberger (Ferring Int. center S.A. ) tells about the historical context of her work on HMTs and her point of view on this thematic.

KRISTIN WANNERBERGER is Director Alliance Management in R&D where she is involved in early stage development projects and working with multiple academic institutes and companies. Her background is a MSc in Chemical Engineering with Food and Dairy Technology as a specialty as well as a PhD in Biophysical Technology. She has 20 years of experience working in the Pharmaceutical Industry (AstraZeneca and Ferring Pharmaceuticals) and in the last 10 years she worked in Project Management as Global Project Director. During her carrier she was part of several product approvals both in Europe and the US.

 

“My interest was always towards chemistry, nutrition and health and specifically fermented products. I made a thesis on the effect of lipid oxidation by acidification on fish by using lactic acid bacteria instead of adding acids. This was in the 1980s. With my PhD in Biophysical Technology I joined Pharmaceutical Industry and got insight in the field of drug development. I always kept referring back to my physicochemical background and when the moment came to look into the human microbiota I could see so many connections. The biggest challenges in Human Microbiome Therapeutics are regulatory pathway and clinical development strategy, for sure.

 

Our business strategic positioning is very broad. We do early-stage studies in large cohorts of subjects with the objective to try to understand what is ‘normal’ with respect to the human microbiota. We also run several projects including both bacteriophages and bacterial strains. We also naturally include any metabolites of the microbiota in our strategy. With the growing interest from the world around us and more evidence that e.g. FMT has a positive effect you could expect that the regulatory environment will change. Today we divide between the drug and the food route. Perhaps in the future these will merge into something in between the two. You have to provide clinical data and it must be relevant. To what extent and when is something that should be discussed and agreed with the regulatory bodies.”

 

HMTs are still challenging but a promising alternative therapy. Guidance and safety are lacking to respect regulatory requirement for market approval. However, many clinical trials are currently underway, which may result in scientific support for future approvals. One other future challenge is the functional characterization of HMT and its impact on the whole microbial-host ecosystem.

KRISTIN WANNERBERGER Director R&D Alliance Management, FERRING, International Center S.A., Switzerland.