With a lack of adequate therapeutic options for the great number of patients living with serious diseases, both the EMA and FDA have, independently, taken measures to address this gap by enhancing the development process, leading to an increase in the availability of significant therapies.

In July 2012, the FDA established their Breakthrough Therapy Designation, which allows for priority review in cases where a therapy offers substantial advantages over any existing options. Since then, over twenty products have been approved via this fast-track pathway. More recently, the EMA launched the Priority Medicines scheme “PRIME”, supporting the development of medicines that target these unmet medical needs, and speeding up the evaluation process so that they can reach patients earlier.

Through both these pioneering schemes, the Agencies are encouraging developers to focus on medicines that are likely to make a real difference to patients and to seek ways to accelerate the regulatory assessment process.

Key learning objectives:

  • An overview of the EMA’s PRIME scheme. To understand its association with Conditional Marketing Authorisation route and established procedures such as Accelerated Assessment, Adaptive Pathways, etc.
  • An overview of the FDA’s Breakthrough Therapy Designation, how it relates to expedited tools such as Fast Track, Priority Review, etc.
  • A comparative review of both PRIME and Breakthrough Therapy Designation.
  • Listen to practical experience of Breakthrough Therapy Designation applications, and discuss examples of eligibility assessment in PRIME applications.
Peter Embley, PGDPRA, MTOPRA Senior Director, Regulatory Science, Drugs & Biologics

Peter Embley works as Director, Drugs and Biologics at VCLS. Through his position of Director of Regulatory Sciences at RRG/VCLS, his role is to provide client regulatory project management and consultancy services, specialising in the development and life-cycle management of small molecule and biotech products.

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