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European Pharmaceutical Contractor

As Time Goes By...

 

Plus ça change c’est toujours la même chose’ as they say in France – the more things change, the more they stay the same. As presented on page 28 of this issue, Uwe Schneider of Grünenthal GmbH recently gave a presentation at Partnerships In Clinical Trials in Lyon, which discussed how little he felt things have changed over the past 12 years. This opinion was largely supported by his audience, but an old friend of mine, Mike Sitton, thinks that Uwe is putting things too mildly; he feels that many of the problems the industry faced in the 1970s are still prevalent today, and I have been working with him to produce evidence that supports this view. Nevertheless, things have changed over the years; CROs are no longer treated with quite the scepticism that there were 20 or 30 years ago. The view expressed by one vice president of a large pharmaceutical company that “nobody any good would ever work for a CRO” would no longer be given house room in any conference today.

One challenge that the pharmaceutical industry faces that is certainly not new is the diffi culty of developing new chemical entities. New technologies have arrived that, in theory, ought to have made the discovery and development of new drugs easier, but this does not seem to have yielded the benefi ts that might have been expected. Looking for a new drug is often likened to looking for a needle in a haystack. One professor of chemistry of my acquaintance commented that technologies such as combinatorial chemistry have not eased the search but rather made the haystack bigger. Likewise, pharmacogenomics has complicated the issue of drugs for specifi c people and, although personalised medicine is no longer quite the sexy subject that it once was, the pharmaceutical industry still faces the prospect of a diminishing number of potential patients for each drug as patient specifi c adverse events and benefi ts become more evident through the use of pharmacogenomics. Another reason for the diffi culty in developing new drugs is, in my view, that many common diseases are well treated by existing drugs. It has become increasingly diffi cult to prove that your drug gives a major improvement on the existing treatments, so that larger and larger studies may be necessary, along with the increased cost and time that these imply. However, it looks as though 2011 was a good year for drug approvals. The FDA has approved the highest number of drugs for a number of years but, unfortunately, I do not see that approval rates will return to the 40s and 50s that occurred in the 1970s.

But some changes have come. The phrase ‘emerging markets’ was fi rst coined in 1981 and, after three decades of astonishing growth, these markets now account for over a quarter of the world economic activity. These markets are largely free of the debt problems that trouble the west and may well hold the key to the growth of the global economy. This dramatic change in buying power has meant that the pharmaceutical industry that had to concentrate on global expansion, particularly into areas with vast populations, such as China, India and Indonesia. Over the years, established companies have attempted to acquire or buy into companies in the emerging markets. A considerable shift has occurred, with Chinese and Indian companies now acquiring pharmaceutical companies and CROs in the west. So perhaps more changes than we think are afoot, and I hope that EPC will enable its readers to keep track of some of the more important developments in the global pharmaceutical market.


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Graham Hughes
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