PRI Membership swells to highest numbers since our creation !0

2018 promises to be another exciting year at the PRI – with more and more companies joining, not only from all corners of Europe, but a new wave of North American companies as well, each looking to get a foothold in the European Microbiota & Human Health industry, it should only be a matter of time before we see a marketing authorization in Europe for a Microbiotic Medicinal Product. Join the PRI and be a part of this new medicinal future.

Here are 5 of our newest members –

Cobra Biologics and Pharmaceutical Services – “Cobra provides a comprehensive biologics and pharmaceuticals service offering, with multi-functional and experienced project teams nurturing customers’ products from pre-clinical through to clinical and commercial manufacture within three GMP approved facilities.”

Visit the Cobra Biologics and Pharmaceutical Services website here.


“CSP Technologies, Inc. is a global leader in delivering innovative, high-quality product and packaging solutions that give customers a competitive edge and consumers a better product experience.

Our company is focused on pioneering new technologies and designs that ensure product protection and enhance brand recognition. We are a responsive, flexible partner committed to offering customers a single, reliable source for custom product design, development, and manufacturing. Our portfolio of products falls into four categories: vials, films and blisters, molded components, and specialized packaging solutions.

CSP Technologies, Inc. has developed solutions and services to address packaging concerns in a variety of industries, including pharmaceuticals, transdermal drug delivery, food, alternative tobacco products, dry powder inhalers, and sensitive electronic components.

Visit the CSP Technologies, Inc. website here.


Microbiome Insights, situated in the heart of the University of British Columbia (UBC) campus, was born from both the Life Science Institute and the Personalized Medicine Initiative. The scientific backbone of the company is formed by UBC professors Dr. Brett Finlay and Dr. Bill Mohn, and CEO Malcolm Kendall.

Understanding the microbiome is one of the fastest growing areas of science, and a critical part of investigating how microbes function in and interact with their environments. Our team of experts and testing methods combine to provide end-to-end service with comprehensive bioinformatics for clients interested in including microbiome analysis into their studies.

Please contact us at info@microbiomeinsights.com for more information on how we can work with you.

Visit the Microbiome Insights website here.


Nutergia Laboratory – Over 25 years of history and expertise in micronutrition.

In 1989 Claude Lagarde, a pharmacist-biologist, founded Laboratoire NUTERGIA, the laboratory for Active Cellular Nutrition®. His main concern was to encourage as many people as possible to take care of their own body through healthy nutrition.

And it is with the same commitment and ethical approach that his son Antoine Lagarde and the entire team of employees are passionately developing the NUTERGIA adventure.

So for 25 years already, Laboratoire NUTERGIA has been working in your interests to enable you to find balance and well-being thanks to more than 75 high-quality food supplements supported by expertise recognised by numerous health professionals.

We are also able to offer you advice for a healthy lifestyle and solutions to rebalance your nutrition.

Visit the Nutergia Laboratory website here.


PharmaBiome is specialized in the isolation, characterization and technology of novel intestinal microbes. Our unique technology platform optimizes the lean and efficient development and production of defined, function-based microbiome therapies to treat intestinal diseases.

PharmaBiome’s proprietary development pipeline allows a fast translation from the identification of mode of action to a product ready for clinics, using tailored, ecologically sound bacterial mixtures.

The scalability of our technology enables an efficient access to new markets addressing the increasing burden of microbiome-related diseases.

Using the entire diversity of the gut microbiome, we will deliver the next generation of bio-therapeutics.

Visit PharmaBiome’s website here.


Is your company a part of the European Microbiota & Human Health industry? If so, PRI membership is probably a key part to your regulatory strategy.

See full PRI member list here.

Microbiota Q&A Series – Probiotics International Ltd (Protexin)0

Who are you? What do you do? Tell our readers about your company.

We are Probiotics International Ltd based in the UK and a manufacturer of Probiotics formulations for humans and animals for over 25 years.

What does your company bring to the industry?

Our purpose-built manufacturing facilities are cGMP certified by the MHRA. Specialising in the Probiotic manufacturing industry and supplying over 90 countries including the UK, EU, US and Australia, we have extensive experience in registration requirements in many countries worldwide. We also have experience of placing products directly onto the market as well as business to business customers. Our employee skills also include new product development, marketing and sales.

What exciting changes have you experienced in your time in the industry?

The regulatory requirements for Probiotics as Food Supplements in the UK, in contrast to the para-medicinal classification in other countries, along with our customer base expectations has required us to work to continuously improve our manufacturing and product formulation as well as research standards. The customer need and expectation for published clinical trial evidence has motivated us to meet with this changing expectation.

What’s the next big challenge for LBP’s and Microbiotic Medicinal Products?

Establishing guidelines so that we understand the expectation on our processes in order to meet with appropriate medicinal requirements.

In your opinion, what should be everyone’s priority for pushing this industry forward?

Raising the standards in all areas of product formulation, manufacturing and research and communicating these improvements to the final consumer so that they have confidence in product efficacy and quality standards.

What areas of medicine will soon involve the human microbiome?

Personal preventative medicine including LBPs.

Where do you see the science of the human microbiome in the next 5 years?

At the consumer level, such that an individual will be able to utilise the technology to individualise medicines.

What can we look forward to from your company? Anything in your pipeline that you can share with our readers?

High standards of product specific clinical trials combined with high standards in quality.

Successful North American tour for the PRI0

San Diego, Washington DC, New York ! What a fantastic holiday I hear you say….NOT.

Despite a day at the Zoo in San Diego (see very cute Panda ) it was all go in the US for the PRI. First stop San Diego after 20 hours of planes and airports with visits to several potential new members in La Jolla followed by the Global Engage – Microbiome R&D and Business Collaboration forum with over 400 attendees gathered together under the San Diego sunshine!

The sunshine played “second fiddle” however to lots of interesting presentations from the world of the Microbiome from the likes of Jack Gilbert, Rob Knight, Sarkis Masmanian and some really interesting commercial input from Ken Blount of Rebiotix and Ashton Harper of Protexin, amongst others!

A quick overnight flight across the US and the next morning I was in Washington DC, the nation’s capital, where it was, as you can see, raining; goodbye California sunshine! The Microbiome World Congress was run in conjunction with a Precision Medicine summit and was a more low-key affair than San Diego. However this gave me the opportunity to understand the FDA’s approach to interacting with LBP drug developers, as well as to meet with several potential new members of the PRI.

So far we have come back from the US with 4 new members for the PRI and hopefully several more in the coming weeks.

  • Matrisys Bioscience, founded in 2015, the company is developing rational microbiome therapies based on Dr. Richard L. Gallo’s basic and clinical research for the top 5 dermatology and skin care conditions – Acne, Atopic Dermatitis (AD), Rosacea, Psoriasis, and skin infections, which have a huge impact on patients’ quality of life. More than 230 million patients suffer from these 5 skin diseases. We’d like to welcome Mark Wilson and the team to the PRI.
  • Microbiome Insights, situated in the heart of the University of British Columbia (UBC) campus, was born from both the Life Science Institute and the Personalized Medicine Initiative. The scientific backbone of the company is formed by UBC professors Dr. Brett Finlay and Dr. Bill Mohn, and CEO Malcolm Kendall. Understanding the microbiome is one of the fastest growing areas of science, and a critical part of investigating how microbes function in and interact with their environments. Our team of experts and testing methods combine to provide end-to-end service with comprehensive bioinformatics for clients interested in including microbiome analysis into their studies.
  • Quay Pharma – is a UK based CDMO with an exceptional depth of knowledge and experience that enables them to design novel and effective drug delivery systems built on a fundamental scientific and technical understanding of their clients’ requirements. They offer every client a bespoke approach matched precisely to their needs and circumstances.
  • Siolta Therapeutics, born out of the Lynch Laboratory at UCSF, they harness information from human microbiome studies to design next-generation microbial therapeutics that re-engineer the human microbiome to prevent or reduce inflammatory processes. Initial drug development is around asthma in children with many other therapeutics in the pipeline.

For those of you who don’t know us, the PRI is a European non-profit clearing the regulatory pathways forward for Microbiotic Medicinal Products, operating the only network in the Human Microbiome Supply Chain and promoting scientific exchange among our members. We also host a PharmabioticsGlobal conference in Paris every year in March!

 

The PRI is an interesting place for start-ups – CEO of Indigo Therapeutics, Pierre-Yves Mousset, MD0

Dr. Pierre-Yves Mousset, CEO of Indigo Therapeutics, discusses why joining the PRI is interesting for his start-up; regulatory affairs intelligence and making critical contacts in the industry of Live Biotherapeutic Products.

Pierre-Yves Mousset, MD; 20 years of experience in scientific medical consulting, former CEO of Draft Healthcare & Proteines communication agencies.

PRI grows by almost 60% in 2017 – Why not the US?0

The PRI membership has grown by approximately 60% in the last financial year. A mixture of pharmaceutical companies, traditional LBP developers and manufacturers, several start-ups (which is great because each one brings different science and innovation), sampling, DNA sequencing, CRO’s, CMOs, consultants, investment funds…the list goes on!

This growth in membership of course is a fair reflection of the buzz being felt in the Human Microbiome space and justifies our decision to focus on Microbiotic Medicinal Products (in particular LBPs). Another point of focus is of course that we are a European organisation looking to offer a clear regulatory pathway for our members when they take their products to market in Europe. We feel strongly that in order to do this we will also need to attract new members from North America and in the long term Asia.

November will be an interesting month; I’ll be traveling to the US and will be meeting with many people at the following conferences –

I’ll be happy to meet with people interested in the PRI at any of these events or even companies based in San Diego/La Jolla, DC or New York! Email or call on 0033661245717 and we can set up a meeting.

Richard Ellis, Business Development Manager, PRI