On the Fast Track

Regulatory changes taking place in Europe have resulted in an increased focus on first-in-man and other early phase clinical studies – a shift further accelerated by the TeGenero incident. Preparation for these studies involves many parallel tasks for the clinical team; the timely availability of the investigational medicinal product (IMP) plays a particularly crucial part. This process is often complex and time-critical for a number of reasons. API is usually still in short supply at this stage and often expensive, and a suitable formulation or method of administration needs to be developed. There may also be import issues and, most importantly, clinic dates are fixed well in advance and are costly to move in the event of delays.

Furthermore, the study design may be complex, requiring expert protocol interpretation and design of supplies. An innovative solution to this problem could take the form of a dedicated, multi-functional and cross-trained team which specialises in preparing materials for early phase clinical studies. This article will review the recent market and regulatory changes, and the impact this has had on the clinical supply process. It will share the experiences of such a team in improving the supply of early phase IMP, and examine project management, documentation, quality and other processes which reduce timelines to the clinic.