home > epc > autumn 2013 > editors letter
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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.


Print this page
Send to a friend
Privacy statement
News and Press Releases

Surge of Indian biosimilars market forecast in 2019

16th April 2019: New data from CPhI shows that, despite ongoing reputational challenges, India’s biologics market is set for robust growth in 2019 driven by biosimilars production. The India specific findings from CPhI’s bio league tables predict strong ‘bio growth potential’ in India throughout 2019 in the build-up to the 13th edition of CPhI India 2019, which will take place at the India Expo Centre in Delhi NCR.
More info >>

White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach


In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
More info >>

Industry Events

DIA 2019 Global Annual Meeting

23-27 June 2019, San Diego Convention Center

DIA 2019 is more than just a meeting: it’s where brilliant minds come together to create solutions. Thousands of global innovators will convene to engage in discussions on today’s hottest topics in the life sciences field, propose ways to combat daily challenges, and network to create lasting connections.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement