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Process map

The ATMP process map aims to clarify what needs to be addressed in what stage of ATMP development and by which expert stakeholder. We hope that this resource helps developers to put together a team containing the competencies needed to address all aspects of development and at the right time. Essentially prompting the ’needs to be considered early’ that we hear so often in retrospect…

The process map activity germinated already in 2020 when it was noticed that different Swelife-ATMP projects were using different terminology to describe ATMP development and groups would develop resources ”Xx for ATMP”, where it was not clear that multiple expert stakeholders were required to fulfill those tasks. Stakeholders involved in the development since 2021 include Anders Kvanta, Helder Andre, Per Ljungman, Aud Solvberg, Heidi Ekelund, Dag Larsson, Pontus Blomberg, Michael Wagner Christiansen, Miriam Idar, Sharon Longhurst, Ida Duprez, Luisa Lundin, Björn Skölving, Joanna Applequist, Jan Talts, Catharina Brandsten, Ulrica Eistrand, Angelica Loskog, Martina Johannesson, Axel Ståhlbom, Jenny Gustafsson, Juliana Kovacka, Adam Wegelius, Jozsef Vasi, Alexandra Patriksson, Kinga Täckström and Ola Tuvesson. I thank you all for your engagement…..the resource may seem simple but a lot of thought has gone into the building of the structure.

DISCLAIMER: We must live in the reality where we generalise processes for many ATMP modalities and are aware of the slightly different views of stakeholders. Our objective here is to provide a valuable navigation resource from which stakeholders can make contact with the right competencies for their product specific needs. The resource is intended to evolve and update so please provide feedback!

Please submit feedback on on a specific stage and stakeholder here https://forms.gle/RrCq9UEhS3YpZx2z5

Product Developer

  • 1. Research adaptation

  • 2. Process qualification

  • 3. GMP manufacture

  • 4. Clinical Trials

  • 5. Market approval and reimbursement

  • 6. Standard of Care