Last week over 220 attendees joined together in Lyon, France for the 8th annual Pharmabiotics Conference & Partnering event. The 2023 edition focused on the main theme of ‘The Future of Microbiome-based Medicinal Products’, and brought together research and translation from all along the microbiome product development spectrum.
The Regulatory Journey of the first FDA-approved microbiome-based drug, Rebyota
The Conference Keynote Presentation was given by Dr. Ken Blount, CSO of Rebiotix (a Ferring Company), and VP of Microbiome Research at Ferring Pharmaceuticals.
His talk was titled, “A Regulatory Science Journey to the First FDA Approved Microbiome-based Drug”. According to Dr. Blount, the guiding philosophy supporting Rebiotix, the company which has just been granted approval for Rebyota, was to ‘emphasize patient accessibility, efficacy and safety while developing standardized manufacturing processes.’
European Regulatory Landscape – SoHO Revision
Another key update during this year’s edition is the revision to the SoHO Legislation in Europe. Two representatives from European institutions shared insights into the future regulatory framework for so-called ‘substances of human origin’, and how materials such as human fecal microbiota and maternal milk will be included in this future regulatory framework (you can read more about this here and here).
Congratulations and Thanks to the Conference Operations team led by Nick Gallo
On behalf of the PRI President Sandrine Claus, Executive Committee, Board of Directors, and the PRI Staff, we wish to extend our warm thanks and gratitude to the Conference Operations team led by Nick Gallo at I-Squared Communications for their expert execution and production of this year’s edition – we can’t wait to see what the future has in store for this great collaboration!
(Some) Key Talks & Takeaways from 2023 Pharmabiotics Conference & Partnering
Fundamentally-sound science drives research and translation
- Ravid Straussman of the Weiezmann Institute of Science (Israel) presented cutting edge research on the Tumor Mycobiome, in order to better understand the dynamics of the microbiome’s role in immunotherapies.
- Genevieve Hery-Arnaud of the University of Brest (France) shared her research on the utility of lung microbiome markers and improving diagnostic and therapeutic approaches in chronic pulmonary disease.
- Laurent Debarbieux of the Institut Pasteur (France) presented his group’s work on researching phage therapy treatment.
- Sarah Lebeer of the University of Antwerp presented fundamental and translational work on the development of an innovative (topical throat spray administration) LBP candidate to reduce/prevent SARS-CoV-2 infection.
- Ruben Vazquez Uribe, Co-principal Investigator at the Novo Nordisk Foundation Center for Biosustainability, presented his group’s work on employing genetic modification to develop microbial therapies.
The value of and need for collaboration is stronger than ever
- Jun Terauchi of the Japan Microbiome Consortium and CSO of Metagen Therapeutics shared with the audience the research and therapeutic landscape in Japan, highlighting the value that a collaborative approach can afford a nascent field.
- Florent Gerbaud, Lead Advisor for the Invest in Lyon development agency, presented the “Cynbiome” Research Network, an innovative approach to sharing a research/CRO identity for collective benefit.
Confirming the regulatory path for probiotic strains as active ingredients in medicinal products
- Staffan Strömberg, CEO of Infant Bacterial Therapeutics (Sweden) presented the latest updates on his company’s clinical programs – find out more about his company here.
- Chiara Bertarello’s (Proge Farm, Italy) talk was titled ‘Regulatory Science Challenges Over the Life of a Microbiotic Medicinal Product: A Case History’ – where she detailed the recent success of one of Europe’s few registered microbiome-based medicinal products, based on a Lactobacillus plantarum strain (P 17630).