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| home > epc > spring 2003 > organisation and culture in drug development - do we need to change the mindset? |
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European Pharmaceutical Contractor
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If drug development were really performing to world-class standards, the pharmaceutical industry could be forgiven for a degree of satisfaction with how it manages the process. If the number of NCEs entering development were rising steadily, if new and innovative drugs were reaching the market in larger numbers, and if big pharma companies were standing strongly on their own two feet without the need for regular mergers, we could happily accept the dictum 'if it ain't broke, don't fix it'. Sadly the evidence is not uniformly in support of such a scenario (1, 2). The present focus on merger and acquisition activity is a distraction from the real long-term need to improve the cost-effectiveness of getting profitable drugs to market (3). To address this, the drug development process has been the focus of a number of initiatives among pharmaceutical companies in recent years. The idea is that if the process is improved, then the outcome must improve. There is however an alternative approach, which we will explore in this article.
The Process is the Objective
We are seeing a process-centred approach in many walks of life, not just in pharmaceuticals. The pressure to drive down costs in all competitive industries fuels more and more standardisation, with increasingly intensive training of staff to follow clear and precise procedures. What happens when you phone your car insurance company? The person at the other end calls up your record and then follows the procedure. It works something like: 'if you see this, do this'.
That ought to work every time, but occasionally something happens which is not in the procedure. In my experience, two alternatives can then take place. Either nothing is done because the procedure is of no help, or the wrong thing is done because that is the nearest approximation. What is unthinkable is to do anything that's not in the procedure. Following the procedure has become the reason for doing the work.
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By Les Rose, Managing Director of Pharmavision Consulting Ltd
Les Rose has worked in the pharmaceutical industry since 1974, mostly in clinical research and related areas with his main professional interest being project management for drug development. Since 1987 Les has headed a specialist CRO, and recently led a venture in the use of the Internet in clinical project management. He has trained and advised many drug companies in R&D management, and his experience covers all clinical phases as well as the interfaces with non-clinical development.
A graduate biologist, Les has served on the Biomedical Sciences Committee of the Institute of Biology, as well as the Committee of the Pharmaceutical Industry Project Management Group, and is a chapter author in Pharmaceutical Project Management (Marcel Dekker Inc, ed Dr Tony Kennedy). Les now practices as a Consultant via his company Pharmavision Consulting Ltd, working as an Interim Project Manager, as well as helping clients to develop their own project management systems and processes.
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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
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Improving the patient recruitment process is imperative to avoid wasted
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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
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