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Infographic - ATMP Development
18-11-2018

#Infographic - ATMP Development

Thanks to the popular reactions we've had on our approach to ATMP development we'd like to share this infographic.


As the face of modern medicine is changing, so should the development strategies of new medicines, including advanced therapy medicinal products (ATMPs). In the infographic, we present essential steps in ATMP development; how to design a valuable project plan, set critical milestones, and the identification of development gaps that can be intercepted without compromising on safety and efficacy, all to smoothen and speed up the process from ATMP development to marketing authorization.

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.

Check it out here!


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