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…
Find the complete stakeholder specific maps here! Clinical needs, Commercial aspects, GMP manufacture, Product developer, Regulatory Affairs
DISCLAIMER: The resource is intended to introduce concepts, not explain in a product specific sense. 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
Clinical
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1. Research Adaptation
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2. Process Qualification
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3. GMP Manufacturing
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4. Clinical Trials
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5. Market Approval and Reimbursement
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6. Standard of Care
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1. Research Adaptation
Goal: Develop clinical trial strategy
Clinical
1. Guide: Ansvar och roller för ATMP
2. Guide: Tillståndskarta för hälso- och sjukvård
3. Guide: Sjukhusapoteksfunktionens roll vid Avancerade cell- och genterapier
Tools & Tips
Contact your local ATMP Centre!
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2. Process Qualification
Goal: Prepare clinical infrastructure
Clinical
1. Hospital pharmacy and/or dose preparation capabilities
2. Legal aspects around agreements and regulatory interpretation
3. Guide: Märkning av celler och vävnader inklusive ATMP:
Tools & Tips
Check that patients need/want the medicine you are offering
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3. GMP Manufacturing
Goal: Clinical trial protocol submitted
Clinical
1. Qualification of clinics
2. Clinical study protocol for ATMP
3. Clinical trials applications and essential documents
Tools & Tips
Increasing competencies of staff for ATMP handling
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4. Clinical Trials
Goal: Safety and efficacy proven!
Clinical
1. Adapt potency testing to reflect clinical outcomes
2. Effectivise clinical processing and delivery of the product
3. Patient reported outcomes for Quality of Life measures
Tools & Tips
Horizon scanning for healthcare budgets
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5. Market Approval and Reimbursement
Goal: Healthcare prepared for coming ATMP modalities
Clinical
1. Prepare hospital pharmacy for commercially approved medicine
2. Engaging leadership/KOL to establish national infrastructure 'Marknadsavtal'
3. Process for patient eligibility and payment
Tools & Tips
Healthcare and public education on coming medicines
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6. Standard of Care
Goal: Healthcare able to provide equitable access to patients in need
Clinical
1. Collection and reporting of data for conditional approval
2. Submit to relevant registry (national and international)
3. Establish and share treatment guidelines
Tools & Tips
Maximise effective and affordable patient access for improved life quality
Ensuring compliance
The science of the product
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. Thank you all for your engagement!
This is now a community resource and will be updating as necessary. If you have corrections, additions, links of interest, please submit through the following link. Submissions are stage and stakeholder specific manner. https://forms.gle/RrCq9UEhS3YpZx2z5