The Adrian Salter Lecture 2007
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MEETING REPORT
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The Adrian Salter Lecture 2007† Future Challenges For Drug Discovery Lecture delivered by Patrick Vallance Senior Vice-President, Drug Discovery, GlaxoSmithKline, London, England
1. The Current Environment It is often reported that large pharma is in trouble. Development pipelines are said to be drying out, patents are expiring and, in some cases, financial exigencies are becoming acute. What might be driving such a picture? I would argue that there are two sets of reasons: internal and external. Internally, there is a serious question as to whether large pharma has lost its focus on innovation. Large pharma appears to have ceased to believe that innovation is a function of scientific imagination. Innovation is not a rote process, whose results are automatically proportional to the resources thrown at the problem. Externally, this loss of focus by large pharma has been accompanied by something quite different, namely, an atmosphere of public mistrust; this external problem could best be countered by the generation of better medicines and the clear demonstration of benefits to the general public. After all, there can be no question that unmet medical needs remain high. But to fix the external perception, it is clear that solving the internal challenge must come first. These internal and external challenges have arisen, paradoxically, in an environment of unparalleled growth in the biomedical, scientific knowledge base. Journal articles, and journals themselves for that matter, multiply annually by rates that would be regarded as extraordinary in the financial world. The paradox resides in the fact that this growth in scientific knowledge has not been translated into a commensurate increase in the development of new and useful drugs. For example, consider the approval of new chemical entities (NCEs) by regulatory authorities; in 1996, some 53 NCEs were approved by the US Food and Drugs Administration, but by 2006 this had dwindled to just 18 NCEs.
So why the disconnect? How can we square the explosion in biological knowledge with the apparent decline in advancing therapeutics? Can progress be regained, and will this counter the negative public ethos? 2. Practical Problems The first practical problem faced by those interested in making new medicines is that the placebo response is still not well understood, both scientifically and in the public perception. And contrary to common perception, the placebo response is not just an issue for diseases that are less well defined or subjective in their characterization. Consider Fabry’s disease. This lysosomal storage disease is Xlinked, and is caused by α-galactosidase deficiency. The phenotype is expressed in many organs of the body, and failure of the kidney, heart, or pancreas are common complications. Enzyme replacement seemed an obvious treatment and yet proving its benefit under double-blind, placebo-controlled conditions, with quality of life as an endpoint, has not been straightforward, and has b
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