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European Pharmaceutical Contractor

On the Fast Track

As early phase clinical studies increase in complexity and number, Keren Winmill at Penn Pharmaceutical Services Ltd discusses the quickest route to Phase I

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.


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Keren Winmill obtained her degree in Pharmacy from the University of Wales in 1975, qualifying as a Pharmacist in 1976. Keren initially worked with the Technical Secretariat to the Committee on Safety of Medicines, and then, after 10 years in various roles at Ciba Geigy in Switzerland and the UK, she joined Penn Pharmaceuticals in 1990 to build the new clinical supplies group, later becoming Business Development Director. After a period at Quintiles, Scotland, as Business Development Director, she returned to Penn as Director of Clinical Supplies and to join the management buy-out team in August 1999. Since June 2006, Keren has acted as an independent consultant, working with Penn and other leading pharmaceutical companies.
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