EMA PRIME scheme – room for improvement

While in principle the scheme is to be welcomed, it could stand to be a little more ambitious. The total lack of mention of predictive modelling and simulation as early proof of concept is out of step with the more progressive side of the pharmaceutical industry. The lack of inclusion of the EMA’s Working Group on Modelling and Simulation in the decision making process here may have something to do with this.

The PRIME scheme acts as a useful case study of how in silico is currently regulated at EU level and how such data is considered – not explicitly allowed but also not necessarily inadmissible. This confusing state of affairs needs to change and the PRIME scheme could be a good place to start.. Providing a mechanism for accelerated assessment of medicines at the extremely expensive exploratory trials stage is too late.

If decisions are to be made on which drugs the EMA should hedge its bets, then advanced predictive models could play a major role in identifying prime candidates (pun intended). Demonstrating potential product value is a key challenge for the pharma industry and without predictive models, more often than not true value is only considered at a very late stage and after considerable investment. In future activities the Avicenna Alliance will look to engage with the EMA to show how modelling and simulation could help demonstrate the potential viability of a new medicinal product in fulfilling an unmet need.

More information about the new EMA PRIME scheme can be found here.

The full text of these Amendments can be found here.