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European Pharmaceutical Contractor
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| 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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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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GEMÜ goes to Russia
Moscow, 27th May 2008.
At the opening ceremony the founder of the company and
managing partner, Fritz Müller, gave the starting signal for the new sales and
marketing subsidiary “OOO GEMÜ Russia” which will be managed by Mr Hans-Joachim
Götze. The guests present at the ceremony included the executive board of the
GEMÜ Group and Russian customers. GEMÜ Russia is the 16th sales and
marketing subsidiary in the GEMÜ Group.
More info >> |
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