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Innovative contracting for ATMPs in Europe: Recent learnings from the manufacturer experience

Adam Hutchings
August 2023

The past 5 years have been a period of great innovation for cell and gene therapy with a wave of very exciting and effective therapies approved in Europe. While the clinical potential of these products are great, there are recognised challenges to achieve reimbursement and patient access. Innovative contracting represents real opportunity to mitigate these challenges to Advanced Therapy Medicinal Product (ATMP) access.

This paper was developed by the Alliance for Regenerative Medicine (ARM) with the support of Dolon based on the experiences of ARM’s member companies. It is the first report to review the successes and learnings from innovative contracts agreed in Europe over the past 5 years from the perspective of manufacturers. The publication sought to understand how common such agreements currently are and how well they are working in practice. It provides recommendations on how to improve innovative contracting for ATMPs in Europe in the future.

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