Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
| Autor: | Frédéric Elustondo, Magali Cordaillat-Simmons, Jeanne-Céleste Paquet, Georges Rawadi, Sandrine P. Claus, Wilfrid Mazier, Laure Rinaldi, Alice Rouanet |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Drug
FIH clinical trial Medicine (General) media_common.quotation_subject Single strain Food and drug administration R5-920 Policy and Practice Reviews LBP Health care European Medicines Agency Medicine Quality (business) Regulatory science media_common business.industry Food and Drug Administration General Medicine First in human Product (business) Risk analysis (engineering) regulatory science Live Biotherapeutic Products Microbiome business |
| Zdroj: | Frontiers in Medicine, Vol 8 (2021) Frontiers in Medicine |
| Popis: | During the last decade, a plethora of novel therapies containing live microorganisms as active substance(s) has emerged with the aim to treat, prevent, or cure diseases in human beings. Both the Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines and Health Care (EDQM) codified these biotherapies as Live Biotherapeutic Products (LBPs). While these innovative products offer healthcare opportunities, they also represent a challenge for developers who need to set the most suitable designs for non-clinical and clinical studies in order to demonstrate a positive benefit/risk ratio through relevant quality, safety, and efficacy data that are expected by the drug competent authorities. This article describes how YSOPIA Bioscience, supported by the Pharmabiotic Research Institute (PRI), addressed the regulatory challenges during the early development phase of their single-strain LBP, Xla1, in order to obtain the necessary authorizations to bring this drug to the clinical stage. |
| Databáze: | OpenAIRE |
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