Critical Path Institute (C-Path) reposted this
🚨Our publication about ‘Regulatory Readiness Level framework’ is out! We propose the implementation of a Regulatory Readiness Level framework. Designed to streamline regulatory pathways for innovation in Rare Diseases, the framework aims at making rare disease drug development more attractive and sustainable for approval and access. Allowing public–private collaborative work to further stimulate the integration of high-quality regulatory science in research can demystify regulatory requirements and potentially reduce investment risks. By leveraging existing infrastructures, resources and developing innovative tools such as Drug Development Tools, the Rare Disease Moonshot initiative strives to create a more efficient and sustainable ecosystem for rare disease research. The initiative's strength lies in its emphasis on multistakeholder collaboration, bringing together expertise from academia, industry, patient organisations, and regulatory bodies. This collaborative, regulatory-science-focused framework promises to accelerate the development of much-needed treatments for patients with rare and ultra-rare conditions. https://lnkd.in/dT2isCJR Thank you to all the authors and the advisors 👇 Cécile Ollivier Dr Solange Corriol-Rohou, MD Marta del Álamo Roseline Favresse Johanna Kostenzer, PhD Mathieu Boudes, PhD Anton Ussi Klaus Viel R. Michael Linden Magda Chlebus Ralf Herold Victor Maertens Stefania Alessi Claire Skentelbery Adrien Samson Manuela Pausan Daria Julkowska Gareth Baynam EFPIA - European Federation of Pharmaceutical Industries and Associations EURORDIS-Rare Diseases Europe EUCOPE - European Confederation of Pharmaceutical Entrepreneurs EuropaBio - the European Association for Bioindustries EATRIS ECRIN (European Clinical Research Infrastructure Network) BBMRI-ERIC Critical Path Institute (C-Path) european joint programme on rare diseases ejp rd International Rare Diseases Research Consortium (IRDiRC) #RDMoonshot #LaunchR #RareCareCentre #Rare Diseases Moonshot-Australia (RDMA)