Big Pharma and the Microbiota1

Many pharmaceutical leaders strangely quiet on the subject

Here at the PRI we’ve noticed an increase in the number of senior scientists from big pharmaceutical companies attending and presenting at the numerous conferences that have emerged around the Human Microbiome in recent years. Conferences in Amsterdam, Paris, London and Berlin have all featured senior strategic decision makers from companies such as Pfizer, Merck, J&J, Boeringher Ingelheim, Sanofi, Astra Zeneca and many more.

From the perspective of an association like the PRI whose objectives are the promotion of Microbiotic Medicinal Products such as LBPs (medicinal probiotics), Phages, FMTs, etc., this could only be seen as positive. The number of conferences is growing, there’s more interest from organisations with real financial clout, more and more start-ups/spin-offs, and plenty of wonderful buzz about the microbiome all around the globe. The science is certainly there and members of our association are all progressing in the right direction with several of them at stage 3 of clinical trials and with a strong chance of gaining drug market authorization in the very near future.

However, despite all of that, the commitment from ‘Big Pharma’ has been very low risk. I’ve listened intently to many presentations from these same senior scientists who demonstrate a strong understanding of the potential; and yet propose little in the way of action towards what may be the next revolution in health, personalized medicine (perhaps as fundamentally important as the x-ray and vaccines).

There are of course some exceptions: J&J has invested heavily through its pharmaceutical arm Janssen and their Human Microbiome Institute in Belgium which is enabling several start-ups to equip themselves with top notch R&D facilities, and there’s been plenty of movement from other pharmaceutical companies such as Ipsen and Ferring who are showing real ambition in this area as well. Merck have recently opened an exploratory science centre in Cambridge, Mass., which will be dedicated to microbiome research. However it is not yet known whether they will focus more on novel microbial drugs and therapies (Bugs as Drugs), or the more traditional Molecular route (drugs for Bugs). Boehringer Ingelheim has also developed along these lines in Connecticut.

The other big pharma companies remain quiet, watching the space. Most of the presentations that we have witnessed so far have seen these companies lay the emphasis on products and therapies along the traditional molecular route with no real desire to throw themselves into the complex world of microbes. Furthermore, the need for causation and mechanistic understanding which is possible with molecular drugs is not necessarily the right solution for microbial medicines where the ecosystem is completely different. Once again the option to sit and wait whilst the start-ups do the hard development seems to be the approach. Such is the way in the pharmaceutical industry!

In the meantime the complex regulatory challenges around these microbiotic medicinal products remain a challenge and will of course be obligatory for all partners at whatever stage they decide to commit themselves. Here at the PRI we are well-placed to assist companies who are looking to take their product or therapy to market in Europe as a medicine. We have the scientific desire from academics and start-ups, there are already several ambitious financial partners and funds involved but we will also need the support of all the major pharmaceutical companies involved in this arena to bring about the microbiome revolution.