UK drug development needs new path
method of developing drugs is unsustainable and must be updated if
the UK is to remain at the forefront of European bioscience.
The independent review headed by Sir David Cooksey calls for a new drug development 'pathway' to be established so that drugs that specifically address UK health priorities can be brought to market faster.
The UK bioscience sector is second only to the US globally. More than 10 per cent of the drugs in trials or awaiting approval were discovered and developed in the UK.
Although the UK government has recently taken several steps to ensure that pharmaceutical companies continue to locate their research and development here, those companies often find it easier to develop drugs elsewhere for reasons such as cost and access to patients for clinical trials.
Clearly any speeding up of drug development should be targeted towards the most pressing needs of the country, As such, the report recommends the first step should be ensuring that health funding should be prioritised towards medicines and therapies that tackle unmet health needs.
In order to achieve this, the Department of Health (DH) should carry out a review to identify what these priorities should be. Once completed, the report suggests setting up a new Office for Strategic Coordination of Health Research (OSCHR) to implement this targeted acceleration of drug discovery.
But what should those changes be? A high pedigree of science expertise and new opportunities, such as the 'Connecting for Health' IT database are attracting industry back but the development process is still bogged down in complex regulations.
The review outlines several steps to improve the current state of affairs, suggesting that the government, regulators and industry can work together to implement a new path to drug development.
The report also argues that Health Technology Assessment (HTA) happens too late in the development cycle. The HTA programme seeks to improve the way research information on the cost, effectiveness and broader impact of treatments is presented.
Cooksey calls for new drugs to be made available to patients earlier through 'conditional licensing', for example at the end of Phase II tests, as long as patients are kept fully aware of any risks. Submissions to the report suggests that often patients are much more willing to take a risk than regulators assume.
The National Institute for Clinical Excellence (NICE) should also be involved at this stage to evaluate the cost effectiveness of the drug as well as its clinical use. The NHS national programme for IT (NPfIT) can be used to help. The database can be used to recruit suitable patients for clinical trials and assess side effects and efficacy.
Once NICE has appraised a drug, the report recommends that there should a clearer process to follow up any recommendations for further research more rapidly and systematically.
In order to help manage these recommendations, and others mentioned in the report, the OSCHR could bring together the budgets of the Medical Research Council (MRC) and the Department of Health (DH) to guide government health research by setting its strategy and budget and monitoring how effectively it is delivered. The office will also communicate these priorities to industry by identifying qualifying public and private research as 'UK Priority Health Research Projects.'
Research projects would qualify on the basis of whether it targets an unmet need, its quality and the likelihood of the research having a significant impact. The report recommends that the newly branded projects could gain advantages such as faster approval for clinical trials in the NHS and swifter review by NICE.
"We are building a true knowledge economy and therefore a science society," said Malcolm Wicks, the Minister for Science and Education, speaking at Genesis VI, a biotechnology networking conference in London yesterday.
Much of the countries research into drugs comes from the academic sector or from 'spin-out' companies borne from university science departments. However, the funding for such new companies could be better distributed warned an MP for the ruling Labour party, Ian Gibson. Also at Genesis, he noted that research and development funding, especially from venture capitalists, seemed to focus on only one or two centres.
He said: "There are so many chances missed in this country. It's not all about Oxford and Cambridge. For too long, there have been black holes of innovation that we've never heard of."
According to Gibson, this situation could be partly rectified if academics made more effort to have a "meaningful relationship with industry."
Aisling Burnand, chief executive of the BioIndustry Association (BIA) welcomed the report.
She said: "In particular, the recommendation for a new drug development pathway could have a dramatic impact by reducing the cost of drug development, which can only be good news for UK patients," said.
"We also welcome the recommendation to improve the translation of research into health and economic benefits."
"What is needed now is action. It is important that the recommendations are implemented swiftly and that sufficient funding is provided to enable this."
