Side by side

28th Oct 2019

Published in PharmaTimes magazine - November 2019

David Evendon-Challis and Dr John Creek on why collaboration will be key in developing credible microbiome solutions

Fifteen to twenty years ago, few had heard of the microbiome. The fact that microbiome science has now evolved from a niche research discipline into a widely recognised field, both among the healthcare community and global consumers, is testament to how far we’ve come.

Technology has been key to this rapid progress, with advancements in artificial intelligence (AI) and machine learning techniques, such as deep learning, instrumental in unpicking some of the microbiome’s complexity. However, if we’re to continue on this promising trajectory and apply our growing knowledge to the development and delivery of microbiome solutions, then interdisciplinary collaboration will be key.

Demystifying the microbiome

Even after years of study, our understanding of the microbiome is little more than skin deep. Its complexity is partly due to its fluidity. The microbiome is a symbiotic relationship between us and the microorganisms that live on and inside our bodies. They’re constantly communicating with each other and with the cells of our body. Their behaviours are inextricably linked to our own.

It’s now well understood that microbiome health is impacted by diet, exercise and antibiotic use, but it will also shift in response to environmental factors, ageing and life events. The hygiene of the items in your home, the pets that live with you and your lifestyle behaviours can all alter your microbiome so someone who lives in the forests of Scandinavia will have a very different microbiome compared to someone who lives in a highly polluted environment, such as Beijing or central London.

While it can be beneficial to study the microbiome in isolation, the gut or skin microbiome for example, these areas are connected within one overarching microbiome ecosystem, which influences the entire body. It stands to reason that achieving bacterial balance within our gut will improve digestion – but it can also have far more tangential impacts for example on our skin.

Numerous research studies now point towards the wide-spanning influence of bacteria on and within our bodies. These have been shown to reduce cortisol levels, help manage cholesterol, help manage blood glucose and support vaginal microflora and health. Already we’re seeing the emergence of microbiome solutions (ie probiotics, prebiotics, etc), designed to help users sleep better, maintain cognitive health, reduce the severity of certain allergies and eczema, boost immune system, improve mood balance and even lose weight.

Consumer appetite for microbiome solutions

As our understanding of the microbiome grows, so does consumer interest in self-care solutions to support microbiome health. This is very much part of a broader trend we’re seeing towards self-care. Around the world people are eager to take their health into their own hands and adopt preventative solutions to ensure better long-term health outcomes.

The rise of the internet and the consequent access to scientific research and discourse has, in many ways, improved awareness of cutting-edge research. While the propagation of misinformation is a threat – and a growing one due to the rapid rise of influencer culture – the potential exists for global consumers to be better educated in regards to their health than ever before.

People are primed and ready to embrace solutions grounded in scientific research, including those developed to support microbiome health. Companies have been quick to provide these and we’re now seeing a range of products, from dietary supplements, foods and body care products to diagnostics, entering the market and championing their positive effect on the microbiome.

The impact of lifestyle shifts

The requirement for microbiome solutions is not purely consumer driven – or at least not consciously. As part of a recent report, Consumer Health Futures, we worked with leading researchers in the fields of microbiome science to determine how social and environmental shifts are likely to impact the microbiome health of global consumers over the next three decades. From here, it becomes starkly apparent just how far healthcare solutions will need to come to meet shifting requirements.

One of the key trends explored in the report is the global increase in C-section births, which rose from 12% of all births in 2000, to 21.1% in 2015. This method of delivery can impact an infant’s microbiome, as it is not exposed to the same types of healthy bacteria that it would be during natural birth. Research indicates that seeding healthy gut microbiota at the very start of life is critical to long-term health. Most of a baby’s gut microbiota is acquired during birth when it is passed from the mother and colonised in the gut. However, this is interrupted by the caesarean method of delivery, which can then affect gut health throughout life, and even heighten the risk of obesity, asthma and type 1 diabetes.

This issue is becoming a focus for healthcare innovators. Microbiome research and therapeutics group Commense has obtained a licence from New York University to develop a method that replicates the microbial exposure that a baby experiences during passage through the birth canal. The solution is likely to take the form of a gauze containing vaginal flora that is swabbed over the face and body of a baby after birth.

Meanwhile, Seres Therapeutics is developing Ecobiotic drugs to be administered post-birth. These contain combinations of selected microbes that may catalyse a shift of the microbiome from a state that supports disease to a state that supports health.

Another research interest in the women’s health space is the impact of lubricants and contraception such as condoms, on vaginal microbiome and the potential link to infections such as bacterial vaginosis. Whilst research is limited, as science progresses so does the opportunity for consumer health products that positively influence vaginal microbiome and improve female sexual health and well-being overall.

Another, and perhaps the most intriguing application for microbiomic research is the development of new drugs to treat chronic disorders such as lactose intolerance, which is thought to affect 40 million in the US alone. Ritter Pharmaceuticals in Los Angeles has developed the microbiome-based drug RP-G28 (currently in Phase II trials), believed to be the first therapeutic designed to reduce the symptoms of lactose intolerance.

While each of these solutions is being designed for specific scenarios in controlled healthcare settings, lifestyle and environmental shifts, combined with consumer appetite, will also drive demand for more accessible, OTC microbiome solutions.

However, developing these and delivering them into the hands of global consumers will depend on unprecedented collaboration within the healthcare sector.

Bridging barriers and making progress

Interdisciplinary collaboration has already been instrumental in advancing our understanding of the microbiome and will underpin progress moving forward.

It is only by working with data scientists and technologists, as well as with industry to make data more widely available, that researchers have been able to develop the AI and machine learning algorithms necessary to accurately analyse and identify patterns within these virtually indistinguishable data sets. This is a critical process – only by combining and stacking data do we stand a chance of fully understanding the range of bacteria within us, the molecules they produce and the far-ranging impacts they have.

But while we have access to the technology necessary for analysing phenomenal data sets, the availability of data remains a barrier to progress. Developing truly effective microbiome solutions depends on the analysis of a range of samples, including blood, saliva and faeces from numerous subjects. Achieving this will depend on research teams and healthcare innovators collaborating on robust, longitudinal studies using the right cohorts.

So many individuals and organisations are looking to develop microbiome solutions. We need to find a way of opening-up access to the latest research studies around metagenomics, metatranscriptomics and metabolomics, so we can pool findings to aid innovation. There’s also a need for quality control across the industry eg microbiome analytical guidelines that will be fundamental if we’re to create the rich data sets needed to develop credible solutions able to benefit global consumers.

Credibility is a key concern – there are several microbiome products already on the market, specifically in the self-testing space, that are backed by limited clinical evidence. Added to this, there are a number of self-proclaimed microbiome experts, who are highly influential in the consumer space but lack the necessary qualifications to broadcast advice on microbiome health.

Both present a double threat to consumers. Misinformation could lead to individuals taking action that may result in adverse effect on their microbiome health, while poor quality solutions could undermine consumer trust in in the healthcare sector. This could lead to people failing to capitalise on credible, beneficial solutions in future.

It’s imperative that the healthcare industry remains vigilant to the threat posed by pseudoscience and continues to only bring solutions – microbiome or otherwise – to market once backed by a credible body of evidence. This will enable the microbiome industry – including probiotics, to move beyond personal care and probiotic supplements with limited claims.

Greater education of the wider healthcare community and the dissemination of microbiome research through accredited modules and conferences will also help to ensure that this is filtered down to people correctly.

A bright future

While our understanding of the human microbiome may be limited at present, we know enough to recognise the incredible potential of further research and development in this field.

Over the coming years we will witness a race, to transform our growing knowledge into accessible microbiome solutions that are credible and beneficial to users. Both sector and interdisciplinary collaboration will be key to upholding this responsibility.

David Evendon-Challis is VP of Innovation and Dr John Creek director, Disruptive Innovation, at RB

PharmaTimes Magazine

Article published in November 2019 Magazine

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