Drugs companies collaborate to unlock potential of 100,000 Genomes project

The 100,000 Genomes project was set up by the UK Department of Health (DoH) in 2012. It aims to sequence the DNA of 100,000 people by 2017 as part of research into the treatment of a number of chronic illnesses. This would create the world's largest database of DNA code in human cells, Genomics England said in a statement.

GlaxoSmithKline, AstraZeneca, Roche and GSK are among the ten companies forming the Genomics Expert Network for Enterprises (GENE) consortium, which will carry out a one-year industry trial looking at ways to use the genetic data, the statement said.

The 100,000 Genome industrial trial aims to identify the most effective ways of bringing industry expertise into the project to bring benefits for patients, Genomics England said.

Patients' genomic data is very useful to drugs companies, life sciences specialist Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said.

"Used along with other data it offers drug companies the opportunity to optimise the development of medicines by facilitating a more stratified approach. It could also enable new uses to be found for existing and possibly unused drugs in their portfolios," she said.

From an ethical perspective, Cline said, it is essential that these patients are adequately informed of both the current and the future use that might be made of their data, and also the advantages that they and others may derive from making their data available for biomedical exploitation.

The same data that can provide benefits can also do potential harm, she said. "For example, large-scale analysis of research on a disease, together with health data from electronic medical records and such genomic information, might lead to better and timelier treatment for individuals – but also, possibly, to inappropriate disqualification from insurance or jobs," Cline said.

In the UK there is a long-standing Concordat and Moratorium on Genetics, agreed between the insurance industry and the Department of Health that currently lasts until 2019, Cline said.

Under the agreement the results of whole-genome sequencing carried out in major research projects, like the 100,000 Genomes project, do not need to be disclosed to insurers because they are part of a research project.

The only test that people are currently required to disclose under the agreement is for Huntington’s disease for life insurance where the insured sum is over £500,000.

The next full review of the Concordat and Moratorium will take place in 2016.

Patients involved in the 100,000 Genomes project "donate their samples and information using models of informed consent approved by independent NHS ethics committees. Patients are explicitly asked if they are willing for commercial companies to be able to conduct approved research on their data," Genomics England says on its website.

Sir John Chisholm, executive chairman of Genomics England told the Financial Times that most of these patients were keen for their data to be used in research that might lead to a cure, and that drug companies would only be allowed controlled access to the data, in a process that is "more like a reading library than a lending library".

Sir John said that NHS patients "will be amongst the first to benefit from the discoveries uncovered by the project. That is why we are delighted to announce this partnership: working with industry from the start and making the most of their unique expertise in developing new diagnostics and treatments."

Martin Mackay, head of research and development at US biotech company Alexion, said "people with rare diseases often suffer for years without getting an accurate diagnosis". Collaborations like the GENE consortium "can accelerate the understanding of the genetic basis of rare diseases and ultimately lead to improved diagnostics and treatments".

The other members of the alliance are AbbVie and Biogen of the US, UCB of Belgium, Takeda of Japan, and Dimension Therapeutics and Helomics of the US.

Genomics England also said that "more than 28" teams or 'domains' made up of researchers, clinicians and medical students have now been established as part of a new 'Clinical Interpretation Project (GeCIP), to focus on a range of disease areas and also analytical and social sciences.