At the 3rd mRNA Hanson Wade Health Summit, I had the privilege of chairing a crucial regulatory session engaging with distinguished regulators from the #EMA, #MHRA, and #Swissmedic, expertly facilitated by Huzefa Rupawala,. We delved into the complexities of the European mRNA regulatory framework, focusing on groundbreaking mRNA therapeutics and emerging treatments. With Marco Cavaleri (EMA), Ka-Wai Wan (MHRA), Julia Djonova (Swissmedic), and Duccio Medini,(Wellcome Leap) on the panel, we underscored the urgent need for the scientific community to unite against misinformation about mRNA products and to rethink their #GeneTherapy definition in the #PharmaPackage. We also explored the varying interpretations of #PlatformTechnology and debated if a platform technology master file approach could streamline regulatory pathways, potentially accelerating development and approvals without compromising safety and efficacy. The session underscored the imperative for collaboration between Regulators, Academia, and Industry to address public health concerns, clarify mRNA medicine classifications, and build a consensus on platform technology. Our collective goal: to strengthen public trust in mRNA medicines. #mRNARegulatory #PublicHealth #Collaboration #Innovation
Janine Jamieson
4mo
Hi Maren, Thanks for sharing this - sure it was a fantastic session with great engagement encouraged by your passion! Coincidentally, at #WCBP2024 this week FDA was talking about formalizing platform technology approaches with a designation program. You can read about it here and let me know if you'd like me to send the slides - #CASSS make the slides freely available. https://www.raps.org/news-and-articles/news-articles/2024/1/pharma-industry-questions-fda-on-platform-technolo
Ann Gidner
4mo
Excellent session, thank you,
Wonderful Maren von Fritschen, PhD ! So thrilled to see this
Claudia Baldauf
4mo
Liebe Maren, so ein wichtiger Beitrag! 🏃♀️
Leiterin Advanced Therapy Medicinal Products bei Swissmedic
4moThank you Maren for the very interesting discussion; it was a excellent opportunity for regulatory and stakholders to exchange views on important issues.