Open Letter to PRI Members – Winter 2019
The following is an open letter to the Members of the Pharmabiotic Research Institute (PRI).
Dear Members, partners and friends of the Pharmabiotic Research Institute (PRI),
As the year 2019 ends, we find ourselves reflecting on the last 12 months and what has been learned, discussed, accomplished, and what work still lies ahead…
In 2020 we will celebrate the 10th anniversary of the Pharmabiotic Research Institute (PRI), a neutral and financially independent industry Association dedicated to identifying and clarifying the regulatory and scientific challenges facing the development of microbiome-based drug products, which since its creation has strived to achieve two principal objectives:
Become Europe’s main representative organisation solicited by the competent authorities regarding future EU pharmaceutical regulations on Live Biotherapeutic Products (LBPs) as well as Microbiotic Medicinal Products (MMPs),
Become the number one network for the European microbiome pharmaceutical supply chain.
Achieving the first objective has been made possible by several factors, notably our initial strategic vision, and by pursuing this mission patiently and incrementally, year after year. The PRI exists as a French non-profit association (loi 1901), which has two critical implications for our strategic approach: we are an independent corporate entity, which allows us to remain neutral among several industry members who (at times) may have competing interests; this also means that when interacting with national and European health authorities, we can avoid any overt conflict of interest. While it is true that most of our Members hail from industry, each of them joins the PRI according to the same set of obligations and benefits.
Our Regulatory strategy relies on a ‘virtuous circle’ of initiatives and regulatory intelligence activities, what we refer to as our unique “Share & Learn Approach”.
The PRI has accompanied several of its Regulatory Members in their request for Scientific Advice at the European Medicines Agency (https://www.ema.europa.eu/en) – this has been the basis for our regulatory and scientific knowledge on the future requirements for medicinal products based in the human microbiome.
An important milestone which we can attribute to this strategic approach is the PRI’s involvement in the EDQM’s setting of quality requirements for Live Biotherapeutic Products (LBPs), which is the first of its kind and stands as a significant first step in clarifying the regulatory requirements for Microbiome-based drug products.
An important milestone which we can attribute to this strategic approach is the PRI’s involvement in the EDQM’s setting of quality requirements for Live Biotherapeutic Products (LBPs), which is the first of its kind and stands as a significant first step in clarifying the regulatory requirements for Microbiome-based drug products. You can read more of this information here.
The PRI will continue to apply this strategic approach to the regulatory developments surrounding the larger microbiome-based drug products field, expanding our efforts and research to innovations such as whole microbiome transfer-based therapeutics, complex bacterial consortia, non-living biotherapeutics, and bacteriophage therapy. Each technology will have its own set of regulatory and quality challenges, certainly: however, it has become more and more apparent that many of them have a set of core challenges in common. It is also of great importance to any nascent industry to be visible to health authorities, to ensure that assessors and quality and standards agencies are aware of the challenges they face.
We continue to strive to become and remain the number one network for Europe’s microbiome pharmaceutical supply chain.
We continue to strive to become and remain the number one network for Europe’s microbiome pharmaceutical supply chain. Today the PRI counts over 80 members from nearly every point in the microbiome medicinal development chain. We work with all types and sizes of industry members, as well as Academic and Translational Research institutions. PRI Membership is open to any organisation involved in the development of microbiome-based drug products for the European market (Microbiotic Medicinal Products).
PRI Annual Member Event – 3-4 December 2019, Paris, France
The PRI Board of Directors along with the PRI Staff were pleased to welcome the members of the Association at the annual Member Event in Paris. This year we organized the annual General Assembly, Regulatory Members Session, and the second annual Partnering Showcase. PRI Members also attended two Task Group meetings – Clinical Studies (2nd Meeting) and Non-Living Biotherapeutics (1st Meeting).
12 PRI Members had the opportunity to present their activities in the 2nd Annual Partnering Showcase – members who presented were the following (in the order they presented):
This annual industry scientific event takes place 10-11 March and is shaping up with some really exciting talks around Microbiome-Host interactions, Microbiome-Drug interactions, Women’s Health and Fertility, Neurological Disorders and more with the likes of Georg Gerber, Lita Proctor, Jeroen Raes, Hervé Blottière, Ted Dinan, Gregory Buck and many more.
More information on the speakers faculty, sessions and preliminary conference program are available here.
With 200 delegates having attended in 2019 and the exhibition sold out, we wanted to invite all PRI members who have not yet registered to do so: if you have not already registered, then please do so here at your earliest possible convenience – there is an early bird discount currently available until the end of December. PRI Members benefit from a discounted attendance fee (this is not cumulable with the early bird fee).
Task Group Initiatives
The PRI Staff in coordination with key representatives from within the PRI membership, both hailing from the industry and academic fields, are currently working on several cutting-edge Task Group initiatives – here are some updates:
Safety Task Group – This group’s work has been completed and will result in a collaborative publication. This publication is currently going through internal review and we hope to have it published in the Spring.
/OMICS Task Group – This group’s first working meeting was held last month in London (15 November). Over 2 dozen microbiome drug developers and their service providers met with the PRI to continue the important work of identifying and quantifying the nature of bias in microbiome measurements, how to make these measurements reliable and reproducible, and how to connect innovation in this field with developers.
This Task Group’s next meeting is tentatively scheduled to coincide with the Pharmabiotics 2020 Conference & Partnering Event slated for 10-11 March 2020.
Clinical Studies Task Group – This group had its second meeting this month in Paris alongside the annual Member Event. This task group is dedicated to supporting the development of microbiome-based drug products by addressing the key challenges when designing and carrying out robust clinical trials.
An article about this topic was recently published on The Microbiome Times – (you can read the article here). PRI Members Accelsiors CRO and Biose have taken an active part in laying the groundwork for this Task Group and were interviewed for the article by microbiome journalist Kristina Campbell.
An important aspect of this group’s work is to ensure that both developers and clinical research organisations interact in a meaningful way when addressing these challenges. This goes to the heart of the PRI’s “Share & Learn Approach”.
Non-Living Biotherapeutics Task Group – This group met for the first time this month in Paris alongside the annual Member Event. This task group is dedicated to supporting the development of microbiome-based drug products based on micro-organisms that have been inactivated or stabilized.
An important aspect of this group’s work is to help developers identify the various regulatory and scientific challenges they will face when characterizing and testing products based on dead, inactivated, or lysed bacterial cells.
IMM-ETG – Industry group coordinated by the PRI
The Intestinal Microbiome-based Medicines European Task Group has set about the challenging but important work of proposing a harmonized, pan-European, regulatory approach to intestinal microbiome whole ecosystem-based therapeutics.
Caelus Health, EnteroBiotix, Ferring Pharmaceuticals, and MaaT Pharma which are developing drugs from the microbiome whole ecosystem, in coordination with the PRI, have established a joint collaboration focused on creating a proposal with recommendations for a common European regulatory framework for human intestinal microbiome whole ecosystem-based therapeutics.
Through this new collaboration, IMM-ETG hopes to gain valuable insight and feedback from the competent authorities with the aim of establishing a harmonised regulatory landscape for such products across the European Union.
Conferences & Events on the PRI Staff Calendar
Below is a list of events that PRI staff members will attend either as a delegate or presenter for the next 6 months (January 2020 to June 2020):
Microbiome Movement Drug Development Europe 2020 (Hanson Wade) – 4-6 February 2020, London, UK
Probiota 2020 (William Reed) – 10-12 February 2020, Dublin, Ireland
Pro/Prebiotic 2020 (Prostir) – 21 February 2020, Kyiv, The Ukraine
Pharmabiotics 2020 Conference & Partnering (I² Communications, hosted by the PRI) – 10-11 March 2020, Paris, France
Microbiome Therapeutics Europe (Informa Connect) – 23-25 March 2020, Paris, France
Microbiome and Probiotics R&D and Business Collaboration Forum (Global Engage) – 18-20 May 2020, Rotterdam, The Netherlands
14th International Scientific Conference on Probiotics, Prebiotics, Gut Microbiota and Health IPC2020 (C-IN) – 22-25 June 2020, Prague, Czech Republic
8th IHMC Congress 2020 (FLS Science) – 28-30 June 2020, Barcelona, Spain