Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due to the complex nature of ATMPs involving gene and cell therapy products, product development can be challenging. Regulatory approval and the final commercial reimbursement needed for an adequate return on investment can also be difficult to obtain. The ATMP development programme should aim to streamline development and avoid known pitfalls in order to produce a viable product that will fulfil its potential in the real-world setting.
This paper discusses an innovative and collaborative approach that needs to be adopted from discovery through all stages of development for ATMPs.
Published on: June, 2017
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publication by
Cécile F. Rousseau, PhD
Senior Director, Nonclinical
With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices,…
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Emmanuelle Sabbah-Petrover, PhD
Director, Complex Biologics
As Director at Voisin Consulting Life Sciences, Emmanuelle manages projects involving cellular and gene-based medicinal products; from early stages of…
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