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
Product Developer
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1. Research adaptation
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2. Process qualification
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3. GMP manufacture
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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: Establish process, clinical and commercial strategy
Product Developer
1. Identify your quality/CMC experts and manufacturing partner
2. Formulate a TPP - product format, indication and commercial opportunity
3. Adapt raw materials, process and analytics to GMP compliance
Tools & Tips
Connect with a patient organisation to understand patient need and product design optimisation
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2. Process qualification
Goal: Process approved for GMP manufacture
Product Developer
1. Risk assessment and specification for start/raw materials and product
2. GLP document all process and analytics qualification
3. Design clinical trial and qualify product stability/suitability
Tools & Tips
Do you have a plan for health economy assessment of long term efficacy v upfront...
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3. GMP manufacture
Goal: Clinical trial for manufactured product approved
Product Developer
1. Evaluation of OOS or deviations impacting quality/safety
2. GMP batch manufactured, tested and released
3. CTA submitted with IMPD, IB and clinical study protocol
Tools & Tips
Make sure you have a clear definition of drug product and drug substance
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4. Clinical Trials
Goal: Proven safety and efficacy for regulatory approval
Product Developer
1. Securing funding to take your product to market approval
2. Adapt analytics to predict clinical outcomes
3. Scale manufacture and define comparability
Tools & Tips
Who is going to be out raising capital to support your product through clinical trials...
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5. Market approval and reimbursement
Goal: To pass regulatory approval and health economic approval
Product Developer
1. Applying for marketing authorisation
2. National healthcare negotiation and pricing
3. Manufacturing optimisation - reduce CoGs
Tools & Tips
What other global markets will you apply for?
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6. Standard of Care
Goal: Providing effective and affordable healthcare solutions
Product Developer
1. Effect data, safety and reporting
2. Extension applications for new indications
3. Global markets, logistics, manufacture and quality considerations
Tools & Tips
What can you expect in terms of data exclusivity and market protection?
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