Microbiome testing in Europe: navigating analytical, ethical and regulatory challenges

by celine PRI | Jan 10, 2025 | PRI Publications

Rodriguez J, Cordaillat-Simmons M, Badalato N, Berger B, Breton H, de Lahondès R, Deschasaux-Tanguy M, Desvignes C, D’Humières C, Kampshoff S, Lavelle A, Metwaly A, Quijada NM, Seegers JFML, Udocor A, Zwart H; Human Microbiome Action Consortium; Maguin E, Doré...

State of the art and the future of microbiome-based biomarkers: a multidisciplinary Delphi consensus

by PRI | Sep 5, 2024 | PRI Publications

Julie Rodriguez, PhD, Zahra Hassani, PhD, Carolina Alves Costa Silva, PhD,∙Fay Betsou, PhD, Federica Carraturo, PhD,∙Prof Alessio Fasano, MD,∙Mads Israelsen, PhD Anandhi Iyappan, PhD, Aleksander Krag, PhD, Amira Metwaly, PhD, Robert Schierwagen, PhD, Prof Jonel...

Gut Microbiome Integration in Drug Discovery and Development of Small Molecules

by PRI | Jul 8, 2024 | PRI Publications

Patrick Jimonet , Céline Druart , Stéphanie Blanquet-Diot , Lilia Boucinha, Stephanie Kourula, Françoise Le Vacon, Sylvie Maubant, Sylvie Rabot, Tom Van de Wiele, Frank Schuren, Vincent Thomas, Bernard Walther, Michael Zimmermann; Medicen Microbiome Drug Metabolism...

Postbiotics in the medical field under the perspective of the ISAPP definition: scientific, regulatory, and marketing considerations

by PRI | Sep 27, 2023 | PRI Publications

Gabriel Vinderola, Céline Druart, Luis Gosálbez, Seppo Salminen, Nina Vinot and Sarah Lebeer (2023). Front. Pharmacol. 14:1239745. doi: 10.3389/fphar.2023.1239745 | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10515206 Diverse terms have been used in the literature to...

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...