Thanks to the popular reactions we've had on our approach to ATMP development we'd like to share this infographic
Academia and startups are usually more focused on getting the science right but are often less experienced regarding the development of a medicinal product. As a guide through the development maze, it is of utmost importance to create a development plan and identifying all the interdependencies between non-clinical, CMC, and clinical development, from an early stage on. Furthermore, a tailor-made regulatory strategy should be developed. This regulatory strategy should provide guidance and focus, especially in early development where engagement with regulatory agencies supports to align development milestones and assure regulatory compliance in the end.
Although each ATMP is unique and needs a tailored development and regulatory strategy, critical steps can mostly be identified and anticipated on beforehand.