Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA

by PRI | Aug 29, 2022 | PRI Publications

Paquet J-C, Claus SP, Cordaillat-Simmons M, Mazier W, Rawadi G, Rinaldi L, Elustondo F and Rouanet A (2021). Front. Med. 8:716266. doi: 10.3389/fmed.2021.716266 | https://www.frontiersin.org/articles/10.3389/fmed.2021.716266/full During the last decade, a plethora of...

Live biotherapeutic products: the importance of a defined regulatory framework

by PRI | Aug 29, 2022 | PRI Publications

Cordaillat-Simmons, M., Rouanet, A. & Pot, B. Exp Mol Med 52, 1397–1406 (2020). https://doi.org/10.1038/s12276-020-0437-6 | https://www.nature.com/articles/s12276-020-0437-6 Probiotics have been defined as “Live microorganisms that when administered in adequate...

Live Biotherapeutic Products, A Road Map for Safety Assessment

by PRI | Aug 29, 2022 | PRI Publications

Rouanet A, Bolca S, Bru A, Claes I, Cvejic H, Girgis H, Harper A, Lavergne SN, Mathys S, Pane M, Pot B, Shortt C, Alkema W, Bezulowsky C, Blanquet-Diot S, Chassard C, Claus SP, Hadida B, Hemmingsen C, Jeune C, Lindman B, Midzi G, Mogna L, Movitz C, Nasir N,...

European Commission makes public proposed revision to BTC regulation

by PRI | Jul 15, 2022 | News & Events

On 14 July 2022 the European Commission published a draft proposal of its revision to the Blood Tissues and Cells (BTC) legislative framework. Following the announcement of the revision to the BTC legislation in 2019, it became apparent that this updated legislation...

Microbiome standardisation efforts progressing at the NIBSC/MHRA

by PRI | Jul 7, 2022 | News & Events

The microbiome field is suffering from limited reproducibility and comparability between studies, especially in large human cohorts. This lack of reproducibility and comparability is a major hurdle in the emergence of microbiome-based biomarkers. The emergence of...