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EMA & FDA apply a similar mindset when providing scientific advice for Live Biotherapeutic Product development

PRI Blog08/09/2021Blogdrug development, live biotherapeutic products, Microbiome, pharmaceutical standards, regulatory science, scientific advice

BORDEAUX & NARBONNE, France – The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) apply an aligned and complimentary mindset when advising the clinical development steps for live biotherapeutic products (LBPs), YSOPIA Bioscience and the Pharmabiotic Research Institute (PRI) have found. YSOPIA Bioscience and PRI coordinate EMA/FDA scientific advice mechanisms to […]

Open Letter to PRI Members – Fall 2020

PRI Blog16/10/2020Blog

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 […]

New live biotherapeutics will require regulatory and scientific innovation: the importance of a defined regulatory framework

PRI Blog17/09/2020Blogdrug development, live biotherapeutic products, Microbiome, pharmaceutical standards, regulatory status

Live Biotherapeutics developers will need to incorporate gold-standard pharmaceutical development techniques and approaches in order to reach market and patients in need The Pharmabiotic Research Institute (PRI), Europe’s only regulatory expertise centre for the development of microbiome-based drug products, has announced the publication of a review titled “Live biotherapeutic products: the importance of a defined […]

Live Biotherapeutic Products and Safety Assessment

PRI Blog20/06/2020Blogdrug development, LBPs, Microbiome, Regulatory Affairs

Live Biotherapeutic Products – a new regulatory approach for the safety assessment of a specific category of biological medicinal products NARBONNE, France – An article has been published in Frontiers in Medicine: Regulatory Science section, which proposes a new set of recommendations for addressing the various regulatory and technical challenges when assessing the safety of […]

Open Letter to PRI Members – Winter 2019

PRI Blog20/12/2019BlogEurope, LBPs, Microbiome, PRI, Regulatory Affairs

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 […]