For the development of „Advanced Therapy Medicinal Products“ interdisciplinary co-operation and special knowledge are needed. The way starting from basic research over pre-clinical and clinical evaluation to authorisation of marketable products or procedures is highly complex, long-standing, and cost-intensive. The legal regulations for market authorisation of cell- and tissue-based products are still novel. Now, standard guidelines are effective European-wide, but nevertheless member state-specific different exception-regulations must be considered. Therefore, depending on the type of product and intended application distinct strategies must be pursued in order to launch an innovative product. Reimbursement issues should also be considered early on.

Potential founders, start-ups, as well as some established companies and public institutions are wondering if their work on the advanced therapies and procedures has the chance to be profitable in times of short resources.

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