Diagnostics are rising up the pharma value chain

Pharma interview: Anssi Pulkkinen from Roche Diagnostics, Finland on the increasing prominence of diagnostics

As many voices have said in these pages before, the age of the blockbuster drug is something that is increasingly a past era for the pharma industry.

Where opportunities expire, however, new ones emerge, and greater technology, superior scientific understanding and improved research methods are paving the way for targeted drugs for specific variants of diseases.

Scientists have long known about different types of cancer, for example, but it’s only recently that research has allowed them to understand the genetic mutations associated with an increased risk of disease.

According to the US National Cancer Institute, about 12 per cent of women in the general population will develop breast cancer sometime during their lives. However, if a woman has the BRCA1 mutation, there is a 55 to 65 per cent chance she will develop breast cancer by the age of 70, while women with the BRCA2 mutation have about a 45 per cent chance.

Despite the crucial role of labs, they have been in the periphery of the healthcare value chain, down in the basements

These genetic mutations – which also include Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) in lung cancer – have become targets in medicines research, allowing companies new avenues to develop personalised drugs that are superior to more general treatments in certain patients.

This area of interest, which is by no means limited to cancer, would mean nothing if we didn’t understand what patients were suitable for specific drugs and who would likely benefit. This is where new diagnostics can play a hugely important role. As an industry, diagnostics are not new and have, in fact helped guide treatment decisions for decades. But their importance to pharma has grown in recent years in line with a greater ability to understand the personalised nuances of different diseases.

One man who is able to see this change of attitude in action is Anssi Pulkkinen, head of strategic marketing at Roche Diagnostics Finland – the Finnish diagnostics business of the Roche Group. “One of our senior managers said that everything starts from the right diagnosis,” says Pulkkinen. “If you do it wrong then you take your first treatment steps wrong and then you might end in trouble.”

Despite this significance, Pulkkinen suggests that diagnostics have remained an unknown aspect of the health industry, accounting for only 2 per cent of expenditure on healthcare. “I think laboratories and their suppliers are really challenged by this,” he says.

This historical lack of interest has meant diagnostics has not been at the centre of healthcare businesses, says Pulkkinen: “To paint the picture, despite the crucial role of labs, they have been in the periphery of healthcare value chain, down in the basements.”

Things are changing, however, and diagnostics are getting some of the floorspace currently favoured by other fields. “The labs are moving to epicentre of campuses because clinically-relevant data is being produced and the pathologies are being researched in big numbers.”

Patients as consumers

The prominence of diagnostics is also being driven by wider changes in healthcare attitudes, with Pulkkinen repeating the now widely-held view that patients need to be treated as consumers with their own mind rather than just as an endpoint of a doctor’s decision.

“We are moving towards a more consumerised healthcare,” says Pulkkinen, noting the influence of such tools as TripAdvisor, which give the public the freedom to look for a hotel and make an informed choice based on other customers’ recommendations.

“The old heroic roles of healthcare professionals are changing. They are going to be the consultant advising the customer,” Pulkkinen notes, adding that, for diagnostics, an illustration of this can be seen in the choices of a certain Hollywood superstar.

“Take Angelina Jolie for example. She had a family history of cancer [her mother died of ovarian cancer in 2007] and so she initiated the testing process to see if she was at risk.” Unfortunately for Jolie, the test results showed she had mutation in the BRCA1 gene, meaning she was more likely to get breast or ovarian cancer. With this knowledge, Jolie opted for a double mastectomy to offset the risk of breast cancer. “She gave a face for the current times of the medicines,” says Pulkkinen. “She initiated the investigation by herself, of course with support of medical experts. The doctor was helping with the samples, but it was a consumer who started it.”

Diagnostic drivers

It’s not just this idea of changing public attitudes that is creating renewed interest in the diagnostics sector; the sector is also influenced by the wider forces affecting every aspect of healthcare.

“The ageing population needs more testing,” explains Pulkkinen. “That is self-evident. As the proportion of people is more elderly than young, you see testing needs and volumes get higher.”

Diagnostics also has a part to play in that pressing issue of reducing healthcare costs, according to Pulkkinen. “What we see more is how we add value to our customers. And as I said the clinical labs are getting a more central role in that healthcare process. We used to be supporters of healthcare, but now labs are taking a more active role.”

Relationships with pharma

This changing role can be seen with the increase in the number of companion diagnostics approved alongside important new drugs, including Roche’s FDA approval for Tarceva in lung cancer, which was backed together with Roche Diagnostics’ cobas EGFR Mutation Test. GlaxoSmithKline and Boehringer Ingelheim have had similar approvals for new cancer drugs if used with a companion diagnostic.

Diagnostics companies have to get used to having a greater impact on healthcare decisions though, says Pulkkinen. “As always when there is a culture change, it takes a lot of effort and energy to change thinking to take a more central role.”

The relationship between diagnostics and pharma will continue to grow in any case, and for Roche Diagnostics, it’s not just a case of supporting Roche’s pharmaceutical division. “As commonly known, we work with lots of different pharma companies,” says Pulkkinen. As evidence of this, Roche Diagnostics’ collaborative work includes a deal to provide diagnostics for Boehringer’s cancer portfolio. As for what closer collaboration means for drug development, it is likely that links with diagnostics will come in earlier phases.

“As medicines become molecular, why not start as early as possible. With translational science, everything starts from knowing how the disease is affecting the body,” says Pulkkinen. “It will be interesting to see how many companies are actually doing it from the very first steps.”

Bioinformatics

One area to keep track of is the amount of data associated with diagnostics, and the need to interpret it in a meaningful way as more people have access to information. “The challenge is that people get more and more data and start to interpret and value their own data, with consultants or doctors. It’s a challenge for society – how it can cope,” says Pulkkinen.

He adds: “What do we do when a person says they have a mutation of this type of cancer and there seems to be a drug. The human would say ‘of course go for that drug’, but the system is not yet designed to cope with that. To develop new contemporary and comprehensive systems to cope with the emerging needs will be a great challenge but also an opportunity,”

More thought is certainly being spent on incorporating diagnostics into regulatory systems, but still more does need to be done if the area is to truly advance. As with any step going forward, a key point for every healthcare stakeholder is understanding the role diagnostics play in a holistic approach to healthcare.

Pulkkinen concludes: “The thing I hope is that my colleagues in pharma would find time to go and see what the labs are like and how they work, what they produce, and what’s their value. It is an interesting world to discover. Go and see!”

Source PMLive http://www.pmlive.com/pharma_thought_leadership/diagnostics_are_rising_up_the_pharma_value_chain_594399

Diagnostics are rising up the pharma value chain