Open Letter to PRI Members – Fall 2020

Open Letter to the Members of the Pharmabiotic Research Institute (PRI),

Fall 2020

This has been a truly exceptional and distressing year for many in the world – both professionally and personally. We the Staff at the PRI on behalf of the President Bruno Pot and the Board of Directors would like to extend our thoughts to you and those close to you during these challenging times!

The PRI Staff and Board of Directors have however continued to execute the PRI Vision & Strategy during this time and are pleased to report a number of accomplishments from the last several months. Please also take a moment to note the following scheduling changes for the PRI activities program for the new fiscal year (October 2020 – September 2021).

 

The Pharmabiotics Conference & Partnering 10-11 March 2020 (Paris, France)

Despite suffering a number of last minute speaker and delegate cancellations, the annual Pharmabiotics Conference was by many accounts a great event, and for nearly all present the last industry conference they were able to attend on the eve of the initial lockdown periods due to the COVID-19 pandemic. Many in attendance appreciated the extra effort made by those speakers who were not able to travel in person but were still able to deliver their presentations remotely or by way of recording. We would like to extend our heartfelt thanks for those who made the event possible!

The PRI Staff along with our Conference Director Mr. Nick Gallo have already begun planning the 2021 edition and should be communicating news about the event in the coming weeks. We hope that you all can join!

 

COVID/Confinement Period in France (mid-March to mid-May)

Immediately following the Pharmabiotics Conference 2020, the PRI Staff were confined to work remotely from mid-March to mid-May (in France). This was however a rather busy time for the PRI Staff as much had to be done in terms of re-equipping the PRI offices to be in compliance with the new sanitary requirements, as well as balancing work and personal responsibilities while working mostly from home, as we are sure many of you are well aware and also had to manage as well!

 

Two important LBP publications: Safety Task Group Paper and LBP-Regulatory Paper (please share among your professional and academic networks)

Following nearly three years of research and discussions, the PRI Safety Task Group brought to the field an important piece of regulatory science research for the microbiome industry: “Live Biotherapeutic Products, A Road Map for Safety Assessment”, published in Frontiers in Medicine, Regulatory Science section. Please take a moment to share this publication with your colleagues and professional connections, and feel free to distribute the link to your professional network online!

Also an important article published only a month ago – PRI President Bruno Pot, Regulatory Affairs Associate Dr. Alice Rouanet, and PRI Executive Director Dr. Magali Cordaillat-Simmons coordinated their experience and expertise to address the broader issues surrounding the regulatory status of live microbes in pharmaceutical applications: “Live Biotherapeutic products: the importance of a defined regulatory framework”, published in Nature’s Experimental & Molecular Medicine. Please take a moment to share this publication with your colleagues and professional connections, and feel free to distribute the link to your professional network online!

 

Task Group Updates (/OMICS, Clinical Studies & Non-Living Biotherapeutics)

The three running PRI Task Groups have managed to continue their work despite the ongoing health crisis. Just like many of us we have had to adapt our methods of working and meeting in the context of the COVID pandemic. The /OMICS Task Group has recently completed its three sub-group meetings (Pre-Lab, Lab & Analysis sub-groups) and will be announcing intermediate progress reports to the greater PRI membership in the weeks ahead. The Clinical Studies Task Group is working on its initial work roadmap, and the next working meeting (remote) will be scheduled in 2021. The Non-Living Task Group has just completed its second meeting and continues to identify and define the set of challenges facing those in the industry developing biotherapeutics based on inactivated or lysed bacterial cells.

The PRI Task Groups are a critical aspect of the larger ‘Share & Learn’ Approach, where PRI members work together in a pre-competitive spirit and try to address the common challenges which face all those working to develop microbiome-based medicinal products. Only current PRI Members can participate in Task Groups, and they can do so at no charge (access to these working groups are included in the PRI membership fee).

 

Annual PRI General Assembly will be rescheduled (for mid-December) and held virtually

Following discussions between the President and members of the Board of Directors, and considering the logistical and sanitary challenges required to meet in large groups in person, it has been decided to hold the annual PRI General Assembly virtually (using a webinar system). Also, the date for the event (initially set at 1 December) will have to be rescheduled for later in December due to another large microbiome industry event being rescheduled for 30 Nov. / 1 Dec. (also virtually…). We thank you for your patience and look forward to confirming these dates in the coming weeks.

 

Annual Regulatory Members Session & Task Groups Working Day will be scheduled as standalone virtual events in January 2021

Usually scheduled to be held at the same time as the Annual General Assembly, this year’s Regulatory Session (restricted to PRI Regulatory Members only) will be delivered in a new format this year due to the ongoing health crisis. This meeting is intended to address common regulatory challenges for the field and is organized in the form of a seminar/training style meeting, and we feel it is a valuable process for PRI Regulatory Members and their regulatory, R&D and clinical development managers. This virtual meeting will be accessible to PRI Regulatory Members at no charge, and is considered a key Member benefit for Regulatory members.

Also planned for January is a new event: the Task Groups Working Day. This virtual meeting is intended to showcase and give a ‘mini-update’ on the various projects within the current PRI Task Groups: Clinical Studies, /OMICS, Non-Living Biotherapeutics. The PRI Staff see this event as the perfect opportunity for Members to integrate the current state of learning/progress within each Task Group as well as give input and feedback to the Task Group Leaders for future progress. This virtual meeting will also be accessible to PRI Members at no charge.

 

Pharmabiotics Online Web Series: A Month of Microbiome Innovation & Science (Oct. 2020)

Don’t forget to log on to our first ‘Pharmabiotics Online Web Series‘, which still has two afternoon sessions left in the month of October! This week’s second Session (Thursday, 15 October) addressed the various Pre-Clinical challenges and innovations in microbiome studies and drug development. Session 3 (Thursday 22 October) will showcase the exciting field of Developing Synthetic Microbiome Ecosystems, and the final Session 4 (29 October) will dig in to the various Regulatory Affairs challenges when developing Microbiome medicinal products. PRI Members can connect at a discounted rate, and academic members can attend free of charge! If you are an academic member or colleague of the PRI contact Joseph directly for more information on how to join – joseph@pharmabiotic.org

 

Find out more about the event and speakers here: https://www.pharmabioticsonline.com/event-program

 

The Pharmabiotic Research Institute (PRI) is a French non-profit Association (loi 1901) whose mission is to identify and confirm the specific Scientific and Regulatory requirements of Microbiome-based Medicinal Products developed for the European market.