Karine Roget

The Pharmabiotic Research Institute (PRI) is Europe’s first Microbiome Regulatory Science expertise center – our purpose is to support and foster the development of innovative therapeutic and diagnostic products emerging from microbiome science, by bridging stakeholders in industry, academia, and EU regulatory representatives, for both human and veterinary medicine. Our mission is to educate and contribute to the conditions of success for future medicinal innovations emerging from microbiome science by supporting and communicating on regulatory science developments within and outside of our ecosystem. Our ultimate objective: see these therapeutic innovations achieve EU marketing authorization, thereby giving European patients access to registered microbiome-based medicinal products or validated diagnostics. To realize this vision, we apply a collaborative method called the ‘Share & Learn Approach’ – a pre-competitive process which combines microbiome expertise with strong regulatory science principles. These efforts are fundamental to identifying and confirming the specific requirements for the development of microbiome-based medicinal products. Founded in 2010 by microbiologists from industry and academia, we operate as an independent, non-profit organization, employing only full-time paid staff, and adhering to a transparent governance structure, required by French law according to our corporate status (association loi 1901). This ensures that we avoid any overt conflict of interest when interacting with national and European regulatory authorities.