Pharmabiotic Research Institute (PRI)

EU, US regulators apply similar mindset when advising live biotherapeutic product developer

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have applied a similar mindset when advising live biotherapeutic product developer YSOPIA Bioscience. This collaboration has provided valuable regulatory feedback for the company's clinical development efforts. The review highlights the need for harmonize...

SourcePharmabiotic Research Institute (PRI)·JournalFrontiers in Medicine·TypeCase study·DateSep 9, 2021

New live biotherapeutic products will require regulatory and scientific innovation

The review highlights the need for clear scientific and pharmaceutical standards when developing live biotherapeutic products. Key challenges include ensuring quality, demonstrating safety, and evaluating efficacy. The PRI's publication provides a framework for stakeholders in microbiome-based product development.

SourcePharmabiotic Research Institute (PRI)·JournalExperimental & Molecular Medicine·DateSep 17, 2020

Live Biotherapeutic products -- a new regulatory approach for the safety assessment of a specific category of biological medicinal products

The article recommends a risk assessment roadmap for LBPs, proposing adapted guidelines for non-clinical programmes and First in Human clinical safety trials. The approach focuses on strain characterization, history of use, antibiotic resistance, and virulence testing to ensure the safety of vulnerable populations.

SourcePharmabiotic Research Institute (PRI)·JournalFrontiers in Medicine·DateJun 19, 2020