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Redefining disease

The shortage of good new drugs in the pipeline; the imminent expiry of the patents on numerous blockbusters; intense competition; a more demanding market that has begun to specify the sort of innovations it wants, and what it is willing to pay for them - all these challenges are making life hard for the pharmaceutical industry. Furthermore, patients are increasingly becoming more aware and involved in their own health management - a trend that throws into sharp relief the long-known fact that most drugs work only for between 40 per cent and 60 per cent of the patients for whom they are prescribed.

Yet two great advances - a better understanding of the molecular sciences and the development of powerful information technologies - could help the pharmaceutical industry transform not only its pipeline, but also the quality and effectiveness of the drugs it produces.

Genetics, genomics, and proteomics will eventually enable pharmaceutical companies to define diseases more accurately and create healthcare packages for patients with specific disease subtypes, rather than making one-size-fits-all drugs for patients with similar symptoms but essentially different diseases. They will be mainly biologics, rather then traditional chemical compounds. Biologics are typically less toxic than chemical entities and behave more predictably. They will include a network of services for diagnosing, treating, monitoring, and supporting patients.

The drug Herceptin, developed by Genentech, is one of the first success stories of this type of 'targeted treatment'. It works for the 25 to 30 per cent of women who contract breast cancer as a result of over-expression in the HER2 receptor. A diagnostic test to identify patients who show an abnormally large amount of the HER2 protein was developed alongside the drug itself. A more recent development came in May 2004 when AstraZeneca published very promising results for its new lung cancer drug Iressa, which depends on a specific mutation in the tumour cells - allowing for patients to be tested, and potential responders and non responders to be identified before the drug is prescribed. Early targeted treatments like Herceptin and Iressa are sign of the new era of so called 'personalised' medicine.

Key to the transformation of the pharmaceutical industry will be information technology. In a recent report, Pharma 2010: Silicon Reality, IBM Business Consulting services identified the seven key technologies which, it believes, will underpin the transition to targeted treatment solutions over the next decade:

1. Petaflop and grid computing give the industry access to unprecedented levels of computing power. By 2006, a new generation of petaflop computers, including IBM's Blue Gene, will enable large-scale biomolecular simulations, such as protein-folding studies. Grid computing (which harnesses the idle computing power locked in companies' desktops and servers), will enable companies to undertake such tasks as screening for DNA sequence matches, and analysing sales and marketing data in real-time. Several research grids have already been set up, one such example being the Smallpox Research Grid, which has screened 35 million drug candidates with processing power provided by two million PCs from volunteers around the world.

2. Predictive biosimulation is the use of sophisticated computer-generated models to simulate how a biological system works as a whole. Predictive biosimulation enables pharmaceutical companies to significantly reduce the number of wet lab experiments required to identify possible drug targets. In silico modelling also enables researchers to predict the effects of drugs on the human body, including their efficacy and safety. Various academic institutions are building computational models, including Indiana University's Center for Cell and Virus Theory, which is exploring how cells react to chemical disturbances.

3. Pervasive computing - miniaturised individual tracking devices, mobile telecoms, and wireless technologies - will ultimately transform drug development and healthcare delivery by facilitating the transmission and collection of biological data on a real-time basis outside a clinical setting. That, in turn, means it can be used to monitor patients and manage their health; to test new drugs in totally different ways; and to deliver healthcare anywhere, anytime. Several firms, including Philips Medical, are designing intelligent biomedical clothing; and Bang & Olufsen has devised a 'pill box' that reminds patients when to take their medicine.

4. Smart tags or radio frequency identification (RFID) tags - enable physical objects to be identified at any point during manufacturing and distribution. RFID will play a key role in eliminating typically slow and inefficient manufacturing processes, helping pharmaceutical companies to prepare for a future with greater numbers of more complex products produced in smaller quantities. It will also help companies to satisfy the increasing demands of regulatory compliance by enabling the monitoring of pharmaceutical products at all points in the supply chain, and will allow more innovative healthcare delivery.

5. Advanced storage solutions will provide the tools with which to manage and maintain the vast quantities of data now being generated. Sophisticated new storage servers, virtualised storage grids, and transparently integrated record management and archiving systems will help the industry comply with the increasingly tough requirements imposed by the Food and Drug Administration, the Securities and Exchange Commission and other regulators.

6. Process analytical technology (PAT) lets companies monitor their manufacturing processes continuously and automatically in real time, rather than intermittently and historically via samples and post-manufacturing quality controls. PAT improves manufacturing quality and saves money, because it is cheaper to adjust a production line immediately than to discard goods that have fallen outside the agreed tolerances. The FDA's new rules on good manufacturing practice will have a significant influence on the investment in PAT.

7. Web-scale mining and advanced text analytics use intelligent algorithms to scan all the digital information on the internet as soon as it becomes available. This new generation of data and text mining tools will enable pharmaceutical companies to quickly and efficiently draw meaning from huge quantities of research, marketing and patient data. Web-mining will help the industry conduct research, select potential targets for further study, identify trends, perform more active pharmacovigilance, anticipate potential crises and gain better patient insights.

Collectively, these seven technologies will effect a fundamental change in the way Pharma discovers, develops, manufactures, and markets new medicines. They will provide a much better understanding of the genes that correlate with common diseases; the dynamic interplay between different genes; and the relationship between nature and nurture. Companies that capitalise on the huge scientific achievements of the genomic era and learn how to make 'targeted treatment solutions' will reduce their pre-launch drug development costs to as little as $200m (a quarter of the current average cost per drug); cut average lead times from 12 to 14 years to between three to five years; dramatically increase success rates from first human dose to market; raise the quality of development and manufacturing processes; and deliver bigger shareholder returns than ever before. It will also mean that doctors will have a much better chance of prescribing a drug that actually works.

Guy Lefever is Pharmaceutical Industry Leader at IBM Business Consulting Services


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