Europe and the USA have an enviable lead in "Big Pharma", the business of bringing major developments in pharmaceuticals to the market place. However, Asia is poised to catch up. India, for example, long content to build a business on the production of pharmaceuticals for which the patents have lapsed, is now set to carry out its own front line research. Meanwhile in Europe development costs of new drugs are climbing steadily, associated investment risk is rising and fewer innovative products are emerging from company pipelines.
A major conference on the Evolution of the Life Science Industries now being staged by Innogen, a branch of the Economic and Social Research Council in Edinburgh is exploring possible ways forward.
Challenges and opportunities for Big Pharma
R&D investment made by pharmaceutical companies accounts for 39% of all industry spending in the UK, according to Robin Fears, former R&D director of Glaxo Smith Kline. Speaking at Innogen's conference he says the result is "reduction in mortality from infectious, cardiovascular, respiratory and gastro-intestinal diseases that were the most frequent causes of death in industrialised countries. But there is industry concern that pharmaceutical R&D productivity is declining, particularly in Europe."
Another speaker at the conference, Dr. Ruth March of Astra Zeneca says, "Pharmaceutical drug development is a lengthy and inefficient process with new drugs failing to reach the market due to issues with efficacy, safety, and what has become known as "pharmacokinetics".
Tufts Centre for the Study of Drug Development reports that R&D costs for an innovative new drug approved in 2001 were $1.1 billion. However, the Centre's Dr. Christopher Paul-Milne, Tufts University feels these costs should and can be brought down. "Analysis shows that improving certain aspects of the drug development process: development times, success rates or early decisions on drug failures, can generate cost savings of several hundred million dollars. A common goal should be to foster management and regulatory practices that shorten drug development times and facilitate better decision-making", he says.
Astra Zeneca's Dr. Scott Boyer has investigated the use of data mining, modelling techniques and artificial intelligence to improve many of the previously laborious and ambiguous steps in drug discovery process.
Regional and local development
Up to now large firms have pursued the quest for competitiveness by transforming in-house R&D into innovations aimed at new market entry and enhanced productivity. However, this has proved too costly in knowledge-intensive industries like pharmaceutical biotechnology. Prof. Phil Cooke, Cardiff University says "Nowadays R&D and innovation are outsourced to university research centres, independent research institutes and smaller research consultancies. These are forming bioscience clusters, the best of which have grown exponentially. They bench-mark each other, identifying competitive and constructed advantages, niches and other forms of specialisation.
Research into cluster formation carried out by another speaker, Prof. Maryann Feldman, University of Toronto, shows that regions compete for cluster resources. "Rather than developing from small, early and perhaps accidental leads in growth of clusters, entrepreneurs respond to unambiguous signals of regional attractiveness. This has implications for regional planners", she says. Prof John Hagedoorn, Maastricht University adds that research partners consistently prefer contractual partnerships to equity-based alliances.
One of the major difficulties faced by pharmaceutical companies is that they may spend enormous sums on developing a new drug only to find that it works well with 60% of the population but not with the remainder. In the past this has always led to the product being shelved. A way out of this wasteful impasse, "Personalised medicine", is now available thanks to genomics research. Dr. Stephen Little of DxS explains "Personalised Medicine involves targeting drugs safely to individuals likely to respond well and it seems inevitable that in the future more medicines will be sold in this way."
Dr. Carlos Novas, London School of Economics feels the promises of biotech developments have been over-promoted. "Given the media hype about the expectation of treatments for hereditary illnesses in the near future, biotechnology firms are now educating the public and patients about what they can realistically expect from the science."
Amplifying this, Dr. Adam Hedgecoe, University of Sussex finds that "Learning the lessons of previous controversies such as GMOs, discussion of pharmaco-genomics by academic and industry scientists has been keen to spell out what they see as the ethical problems associated with this technology and to propose possible solutions."
Lest we are led to infer a sudden rush of altruism he goes on to say that this stance arises out of a perceived need to set parameters for public debate so that it can be more easily controlled.
Dr. Helen Wallace of Genewatch UK, a not-for profit group that monitors developments in genetics from a public interest perspective is worried by the controversial implications of large scale population bio banks for public health. The aim of bio banks is to quantify the risk of common diseases associated with different genotypes or combinations of genotypes and environmental factors. "Funders have sought to keep science and ethics separate, with public consultation limited to issues such as consent and confidentiality," .Dr. Wallace says. "They would benefit from more open discussion between scientists, decision makers and the wider public."
Opportunity for Scotland
Meanwhile, Prof. David Porteous, University of Edinburgh, sees an opportunity in "The combination of an unhealthy but stable population of 5 million that is supportive of medical research (and which) favours Scotland as a base from which to develop epidemiological studies." Scotland has accurate and worrying statistics on the incidence of cancer, heart disease and mental illness, he says, which have a strong heritable component as do asthma, diabetes, obesity and osteoporosis, all of which look set to increase with changing environment, behaviour and lifestyle, coupled to life expectancy. "As a result of the human genome project we now have the means to examine in precise detail the origins of genetic variation and relate this to disease susceptibility", he says. A project named Generation Scotland is being put forward to provide improved capacity for diagnosis and to develop and apply new treatment regimes.
As a round table discussion on the communication of biotech observed that it is widely thought that the general public have no idea what scientists do. "In fact", the participants said, "they have a very clear idea, which happens to be wrong! We still need to get away from the idea of Dr. Frankenstein."
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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-- Helen Keller