Global Insight Perspective | |
Significance | AstraZeneca, GlaxoSmithKline and Roche are the first Big Pharma companies to invest in stem-cell research as a means to reduce risks and cut costs in clinical development. |
Implications | The drug-makers have signed on to the U.K. Stem Cells for Safer Medicines (SC4SM) initiative and will contribute funds for the development of liver tissue from embryonic stem cells. If successful, the move could eventually alter the way clinical trials are conducted in Europe. |
Outlook | Until now, drug companies have been reluctant to fund stem-cell research due to its controversial nature. A precedent has now been set, however, with economics dictating that costly late-stage development failures of new products are no longer a risk Big Pharma can afford to take. |
A new consortium has been launched in the United Kingdom that brings together some of the leading lights of the European pharmaceutical industry and British medical academia in the name of stem-cell research. Stem Cells for Safer Medicines Ltd, or SC4SM, is an independent, non-profit organisation that has the R&D backing of U.K. drug giants AstraZeneca and GlaxoSmithKline (GSK) as well as Swiss pharma heavyweight Roche, combined with support from the Association of the British Pharmaceutical Industry (ABPI), the U.K. Department for Innovation, Universities and Science, and the Scottish government. The goal of SC4SM is to use human embryonic stem cells as the basis for developing different forms of cells and tissues on which experimental medicines can be tested for harmful side-effects, before any testing on human volunteers begins.
Speaking at a press conference, AstraZeneca's Direct of Molecular Toxicology, Professor Ian Cotgreave, said that the move was as much a question of economics as anything else. A large proportion of experimental pharmaceuticals tend to fail at the final stages of clinical testing, with previously undetected side-effects causing the products to be scrapped after years of investment. With new medicines taking an average of 10-15 years in clinical development before they are ready to be filed for marketing approval, and total development costs reaching up to US$1 billion, Cotgreave described the situation as "scientifically ridiculous" and said that it was time for change.
Each of the three pharma companies involved in the consortium has contributed £100,000 (US$204,142) towards the funding for SC4SM's first year of research, according to Dow Jones, with an additional £750,000 coming from the U.K. Department of Health. A five-year programme is in the process of being drawn up, and SC4SM is aiming to build up an additional £10 million to help cover the costs for the remaining four years. The first stage expected to focus on the creation of viable liver cells from stem cells—most adverse effects of new drugs are initially detected through increased toxicity levels in the liver—as well as high throughput screening techniques that will allow for the simultaneous testing of many drugs. Future research plans include the creation of cardiomyocytes, or heart cells.
While AstraZeneca, GSK and Roche are the first members of the Big Pharma community to commit to investment in stem-cell research, SC4SM Chief Executive Dr Philip Wright—also Science Director at the ABPI—said that he expected more drug companies to join the initiative in due course. According to the Financial Times, Scottish biotechs CXR Biosciences and Cellartis could well become more involved with SC4SM's work, given that they are already conducting research on liver cells in measuring drug toxicity.
Outlook and Implications
The advent of Stem Cells for Safer Medicines is the first step towards embracing a technology that has long been held at arm's length by the pharmaceutical industry, mainly due to concerns over the controversial image of stem-cell research in the United States and other markets. Participation in the project by the likes of GSK, Roche and AstraZeneca will set a clear precedent for other companies, and indicates a tacit decision by some of Europe's largest drug-makers that the time has finally come to invest in some much-needed risk management in terms of clinical development. At a time when many of Big Pharma's top-selling brands are due to lose patent protection within the decade, companies are becoming increasingly reliant on the success of new drugs. This is putting added pressure on developers to ensure that new compounds emerge from the lab fit and ready to be marketed, which, as it stands, is by no means the norm. Testing experimental products for side-effects on liver cells prior to launching trials with human patients would not only reduce the risk to patient health, but would also help lessen the cost burden of expensive late-stage clinical trials, by knowing when to abandon the development of a problematic compound before human trials begin.
Dr Wright has said that SC4SM will operate within an ethical framework that will see the consortium's use of stem cells limited to those that are already in the U.K. stem cell bank, and has promised that an independent ethics advisory board will be in place as of 2008. Whether this will be enough to convince U.S.-based drug developers such as Pfizer, Schering-Plough and Merck & Co to invest in the project remains to be seen. The current regulatory and political climate in the U.S. is decidedly against the funding of stem-cell research; earlier this year, President George W. Bush vetoed a bill that would have seen state subsidisation for stem-cell research programmes (see United States: 11 April 2007: U.S. President to Veto Stem Cell Research Bill Again), and the U.S. biotech industry outside of California remains impeded in its progress in this area. The United Kingdom has become a world leader in stem-cell research in recent years, and the long-awaited launch of SC4SM should provide a much-needed boost to U.K. biotech industry.