Introduction
introduction A
re we at last seeing the ‘green shoots of recovery’ as far as new drug approvals are concerned? Some comments made by Dr Janet Woodcock of the FDA at Reuters 2011 Health Summit give some encouragement for that view. She noted that at the time of the meeting, the FDA had approved 12 novel drugs so far this year and anticipated that the total for the year would exceed the 21 cleared last year. She said that “the nadir has been reached and we are coming up the other side”. The increase would, however, be gradual and there is still a long way to go to reach the level of 53 cleared in 1996. Of particular interest is the fact that more smaller companies are now coming to the FDA with successful products. Dr Woodcock also singled out certain therapeutic areas where the clinical benefit would be such that drugs presenting somewhat higher risks might be acceptable. One of these was reversal of diabetes and we include an article which discusses the present and future challenges of that disease. The statistics are remarkable. It is stated that 6.4% of the world’s population (785 million people) suffer from diabetes and nearly three million deaths annually are attributable to it. Current treatments are designed to lower glucose levels and are beneficial but there is a need for agents which can target the many metabolic abnormalities associated with the disease. There are almost 1,000 Type 2 diabetes clinical trials running worldwide and some of the variety of therapeutic approaches being tested are discussed by our authors. Despite the optimism referred to above, everybody involved in drug discovery is only too well aware of the fact that the failure rate is still very high and we continue to receive articles suggesting how this situation can be improved. In another article the authors point out that “there have been many false dawns in small-molecule drug discovery”. They claim that although high throughput screening, combinatorial chemistry, etc, have all led to the rapid expansion of novel hit molecules and focused libraries, conventional medicinal chemistry is still the most effective way to optimise these hits. They suggest the integration of the next generation of flow chemistry and biology platforms could well transform the efficiency of drug discovery.
In four further articles, other technologies and techniques are described and discussed. In the first it is pointed out that the true promise of genomics will only be realised when the plethora of data produced can be fully analysed and exploited. To this end commercial laboratory information management systems (LIMS) are now available specifically for genomics and the authors discuss the criteria which laboratories should consider when selecting asysyem for their particular needs.
Another article reviews the current status and potential clinical applications of in vivo cell reprogramming (IVR) which is a new technology in which one type of cell (the substrate cell) can be reprogrammed to another type of cell (the product cell). The product cells are usually damaged or depleted cells assssociated with certain diseases. The authors discuss the potential clinical implications of IVR and the
Drug Discovery World Summer 2011
challenges which it may present.
The third technique discussed in these pages is in vivo preclinical imaging of small animals (usually mice) which is increasingly being used in drug dev- elopment, especially in the oncology ther- apeutic area. The main application is monitoring the response to potential new drugs to obtain an early indication of their potential effi- cacy. The imaging
modalities which can be used are discussed and the product offerings from 12 companies compared.
The case for obtaining an understanding of kinetics of candidate molecules at an early stage in the development process is made by another of our authors. She discusses available methods and technologies and points out that, as well as being expensive, none are ideal. She describes what, in her view, an ideal technology would look like and challenges innovators and vendors to get to work and develop one.
The measurement of biomarkers in the drug discovery and development process, specifically to detect cardiotoxicity, is advocated in another article. This should eliminate compounds with this potential at an early stage in development and thus save any further expense in developing them. We have included, in recent issues of DDW, several articles about personalised medicine in which there is stratification of patient populations who can benefit from a given therapeutic agent. An article in the current issue stresses the importance of introducing the personalised medicine concept early in the drug discovery and development process by, for example, categorising patient sub-types in advance. This should result in fewer failures in Phase II studies. Finally there is an article which explores the obstacles to innovation in the pharmaceutical industry. The conclusion is that “there is no clear strategy of how innovation should be encouraged”. Thought-provoking reading for all readers of this journal!
Dr Roger Brimblecombe PhD, DSc, FRCPath, FIBiol 7
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