PRIME and Adaptive Pathways: A True Acceleration of Drug Development and Approval?

by Dr. Diane Seimetz

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Drug development times have increased enormously over the past decades with excessive investments of $1 billion for new drugs. Therefore, the EMA has launched the following two initiatives to improve timely access for patients to new and promising medicines: PRIME (PRIority MEdicines) and Adaptive Pathways. As PRIME and Adaptive Pathways are still young and up to now no PRIME designated products were approved, it is time to take a first look on their relative contribution to accelerate drug development and approval.


Diane Seimetz discusses the following questions related to PRIME and Adaptive Pathways:

·       What is Adaptive Pathways and how can it be used

·       What is PRIME and how can it be used

·       Can Adaptive Pathways and PRIME be used together

·       What other tools are available to facilitate drug development and approval

·       What is the value of the two concepts and further recommendations