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European Pharmaceutical Contractor

Editors Letter

Risk is part of every human endeavour. From the moment we get up in the morning until we get back into our beds at night, we are exposed to dangers of different degrees. For much of human history, risk and survival have gone hand in hand. The same can be said of the pharmaceutical industry, but as Heather Fraser of IBM points out, the variety, magnitude, scope and reach of the risk experienced by the life sciences industry has become ever-more demanding. She discusses how the various executives within a company must deal with the increased levels that the industry is experiencing.

In a second article on this subject, Lisa Bolitho and Mark Nelson Tyrrell of ICON Clinical Research discuss benefit/risk analysis, taking as their starting point a quotation from a New England Journal of Medicine paper by Hamburg and Shafstein: “Some benefits are not worth the risk and some risks are worth taking.”

The authors wonder whether it is time for mandatory reporting of adverse drug reactions by healthcare professionals to be introduced. They advocate that product information be made available on the internet – free from commercial bias and accessible to all patients. Discussing the impact of recent pharmacovigilance legislation, they hope that new regulations will help ensure that patients are central to the provision of safety information, and are given real opportunities to decide whether or not to participate in a specific treatment.

The risk taken by patients in participation of treatment prescribed by a physician is reasonably quantifiable. However, self-medication introduces a further level of danger that, in theory, should not be present with medicines available through prescription only. This is the risk of counterfeit drugs. Mark Davison of Blue Sphere Health considers the opportunities available to the pharmaceutical industry to combat fake products, building on the landmark Falsified Medicines Directive, introduced in Europe in 2011.

Mr Davison demonstrates how manufacturers might take various approaches to comply with the Directive and other worldwide legal obligations, and examines the options which can be taken to add value for patients, as well as increase profitability. He notes that anticounterfeiting is an ongoing process, and believes that drug companies addressing the problem can reap genuine business benefits from the new legal obligations, while still playing their part in keeping patients safe.

One threat an increasing number of us are facing is that of cancer. Ken Pennline from LabCorp Clinical Trials reports that the Chinese Food and Drug Administration has approved a diagnostic test based on circulating tumour cells (CTC). He goes on to discuss the way in which CTCs can be incorporated into clinical trial protocols, and how they may be increasingly used as a new generation of biomarkers in the development of oncology drugs.

Mr Pennline hopes that over the next few years, CTC technology will allow physicians and drug developers to fully characterise a tumour in a cancer patient without having to resort to the current invasive procedures. He feels that for China and the rest of the developing world, the potential of this technology to improve cancer drug treatment is immeasurable.

Finally, let me also highlight a paper by Oliver Bohnsack from Perceptive Informatics on imaging in oncology studies, which further adds to the armamentarium of the physician in the fight against this terrible disease.

I would like to thank all our contributors for their perceptive contributions and look forward to the articles to come in our December edition.

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