Genetic research: DNA payday

After decades of reliance on blockbuster drugs, pharmaceutical companies are increasingly having to face up to the challenge of diversifying their businesses.

As drug patents expire, the world’s leading drugmakers are coming under pressure to find new products and revenue streams. Some of the highest-selling drugs losing patent exclusivity in the US this year, for example, include Amgen’s Sensipar (cinacalcet) and GlaxoSmithKline’s Advair (fluticasone/salmeterol).

While a generic version of Sensipar has yet to hit the market, Mylan has won approval from the US Food and Drug Administration (FDA) for a generic Advair inhaler.

This process is the natural lifecycle of a patent, and doesn’t come as any surprise; but it does highlight the growing need for pharmaceutical companies to focus on developing their product pipelines.

While mergers and new acquisitions are one way of tackling the problem, many leading companies are choosing to invest heavily in R&D and discovery programmes.

Successful R&D isn’t just about throwing money at the problem. Just as important is the quality of the data underpinning it, and genetic data in particular is becoming an increasingly valuable asset for companies looking to discover the next blockbuster drugs.

With this in mind four leading pharmaceutical brands have joined together with UK scientific institutions to help fund the “world’s largest” genetic research project.

Multi-sector collaboration

The announcement on September 12 that a consortium of UK government agencies, research bodies, and pharmaceutical companies has combined to fund the genome-sequencing of 500,000 volunteers at UK Biobank, based in Greater Manchester, marks a major advance in genetic research.

The project is striking for a number of reasons. While it is not the first major genome sequencing programme, it is unprecedented in its field in terms of its scale and ambition.

UK Research and Innovation (UKRI), a UK government agency, and The Wellcome Trust charity each provided £50 million ($62 million) in funding.

A further combined £100 million came from pharmaceutical companies Amgen, AstraZeneca, GlaxoSmithKline (GSK), and Johnson & Johnson.

"Collaborating with leading institutions is central to our approach of transforming drug discovery." - Carolina Haefliger, AstraZeneca

In return for their backing, the four pharmaceutical companies will share exclusive access to the data before it becomes open access for researchers.

The four will share “preferential access” to the data at the end of March 2020 for nine months.

Ian McKay, innovation lead for advanced therapies at Innovate UK, a part of UKRI, says the agency was keen to partner with the other organisations.

“We knew what we wanted to do, but we didn’t know how much it would cost, or whether it was technically feasible.

“We knew the industry would be interested in that data, but we didn’t know just how valuable it would be,” he says.

The project marks one of the “most ambitious sequencing programmes ever undertaken”, says Carolina Haefliger, head of the centre for genomics research, Discovery Sciences, R&D at AstraZeneca.

Speaking to LSIPR, she explains how the company expects the data to emerge from the project to be of great value to patients, as well as to AstraZeneca and its customers.

“The new insights we hope to gain from the collaboration will guide our drug discovery programme and will help us bring innovative new precision medicines to patients who need them most urgently,” Haefliger says.

Genomic sequencing is playing an increasingly large role in pharmaceutical R&D. Haefliger places the latest investment in the context of AstraZeneca’s Genomics Initiative, in which the company pledged to sequence two million genomes by 2026.

“By early next year, we expect to have analysed around half a million genomes and are on track to reach our goal,” she says.

This kind of project and the data it produces are central to the company’s strategy for pipeline development.

“Collaborating with leading institutions is central to our approach of transforming drug discovery and development through genomics,” Haefliger says.

AstraZeneca is not alone in putting genomics at the heart of its drug discovery strategy. Speaking at the time of the announcement, GSK’s senior vice president for research John Lepore said that “genetically validated drug candidates are twice as likely to become registered novel medicines, and efforts like this bring us closer to developing transformational medicines that can significantly improve patient health and change lives”.

A GSK spokesperson points to a four-year collaboration agreed last year between the drugmaker and 23andMe, a California-based company which provides personal genomic testing services.

The objective of the collaboration, GSK says, is to use genetic insights to drive drug discovery and develop new therapies based on genomic data.

Valuable data

The pharmaceutical companies’ role in the latest project at UK Biobank is seemingly based on the same principle, but on a far greater scale than anything previously attempted in the field of genome sequencing.

The potential value of the project to scientific research is hugely significant, McKay explains.

In terms of UK Biobank’s body of volunteers, the “richness of data is really unrivalled”, he says.

It is a significant advancement in the field. “There are databases of disease-specific sequences and there are commercial suppliers of genetic tests, but very few of these are based on whole genome sequencing,” McKay adds.

Abigail Taylor, deputy chief of staff at The Wellcome Trust, agrees that the project’s potential impact is “enormous”.

“There’s a new depth to the genetic information that’s available,” Taylor says of the UK Biobank sample.

While the four pharmaceutical companies will have preferential access, the data will eventually be of benefit to startups and small and medium-sized enterprises, she adds.

Healthy self-interest

The collaborative model between the private sector, charitable institutions and public research bodies is also in line with what the UK government has sought to promote under its Industrial Strategy Challenges Fund, Taylor points out.

McKay agrees that the collaborative method behind the project is significant. While the consortium isn’t especially large, “the difference for us has been the way the collaboration was built”, he points out.

In this case, each body had something to offer, whether it was technical expertise or financial backing.

“But it’s important to remember that the project isn’t a consortium in the traditional sense,” he says.

Each of the four pharmaceutical companies is working on its own independent discovery programme and will look to maximise the benefit to its own portfolio.

From UKRI’s perspective: “What we want to do is get these sequences done as quickly as possible and into the public domain,” says McKay.

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