by Dr. Diane Seimetz
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