Personalised medicine: a view from Roche

Rebecca Aris interviews Dr Horst Kramer

Roche

Personalised medicine has received a lot of hype in the media. Over-promising and exaggerations have led to common misconceptions, which if not properly managed, could lead to frustrations.

‘Personalised Healthcare’ is at the core of the business strategy at Roche. So we spoke with Dr Horst Kramer, PHC expert at Roche, on its definition of personalised medicine and the importance of clear communication in this area. Dr Kramer also shares his views on the applications and requirement in this area, in addition to the importance of reliable diagnostics if this area is to flourish.

Interview Summary

RA: Dr Kramer, please could you start by explaining your background and your focus in your current role?

HK: My background is medicine. I’ve got a PhD in medicine, and I have been with Roche in Basel, Switzerland since 1989. I have worked across various functions for the last 20 years, in communications in pharma, in diagnostics, and I’ve also served as spokesperson for a number of years for the Roche group. My current focus is to oversee all the communication activities, to share information on personalised healthcare internally, externally and across the globe.

RA: What is your definition of personalised medicine?

HK: We do not have a ‘cast in stone’ definition. We follow the line of ‘fitting the treatments to the patients’. What we want to do in this context is better understand the differences in disease, what drives the disease and what is the disease mechanism. We want to better understand the differences between patients, why do some patients respond well to a therapy and other patients with the same disease don’t? We want to also target treatments, optimise patient care, and it’s also very important to us to optimise our development efficiency to make best use of the resources that healthcare providers and we have.

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“We want to better understand the differences between patients, why do some patients respond well to a therapy and other patients with the same disease don’t?”

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RA: In practice what does personalised medicine require above and beyond drug treatments to be effective?

HK: It starts with a reliable, specific and sensitive diagnosis. You need to find the right treatment for the patient, or the other way round, you need to be sure whether the patient in front of the physician has a high likelihood to benefit from a specific treatment. In addition, you have to have up-to-date understanding as a health professional of what therapies are at hand, what therapies are emerging, and what kind of treatment strategy will have a long-lasting, long-term impact for the benefit of the patient. For drug research and development you need to have a sound understanding of the technology, the diagnosis and the biology of diseases.

RA: What potential applications are there for personalised medicine, and what disease areas do you see it benefitting the most, both now and in the future?

HK: Right now we are most advanced in the area of oncology, because of the research activities in this indication in recent years. In the past 10-15 years, we have become more advanced in understanding the disease pathology in cancer compared with other disease areas. We are also more advanced in terms of approved and established products in the area of cancer, examples are breast cancer, stomach cancer, lung cancer, and more recently skin cancer. Another area where we also have advanced our knowledge is in virology, such as hepatitis C, or HIV infection.

But we are working very extensively in the area of the central nervous system. While we are somewhat behind oncology or virology, we are catching up.

Inflammation and metabolism are also areas where our conducted activities are somewhat lagging behind oncology.

RA: What best examples of treatments are there that currently represent personalised medicine?

HK: The most recent example that immediately jumps to the mind is a treatment for metastatic skin cancer, or melanoma. The European authorities approved this treatment just earlier this year. The compound targets a specific protein that results from a mutated gene, which is existent in about 50% of patients with that disease. So you need a test to identify this 50% subset of patients, as the drug only works in those patients that have the mutated form of the gene. It will provide no benefit for patients without that mutation. As a healthcare provider, you want to target that treatment to those patients that benefit.

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“…the approach of personalising care does not in itself trigger enormous additional costs”

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RA: In reality aren’t all treatments personalised medicine, because all patients respond differently to treatment?

HK: I would disagree with this kind of broad statement. There are many variations in response to treatments, but the approach of a personalised healthcare is to find subgroups of patients within a syndrome who respond alike to a given treatment. It’s not narrowing down to the individual level, but to a meaningful subgroup of patients that you can target.

RA: With the huge development costs incurred by personalised medicine how can we drive it forwards in the face of cost containment?

HK: We face increasing demands by healthcare providers, by society, by patients, who all want to see increasingly more clinical benefit from their treatments, with less risk. This drives development for the pharmaceutical companies towards more targeted approaches and to have a better understanding of which patients will benefit from a given treatment. So personalised medicine is a response to the pressure build up in today’s market reality. In addition, the approach of personalising care does not in itself trigger enormous additional costs. The costs are intrinsic by the drug development as such.

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“Diagnostic methods and tools account for about 2% of healthcare expenditure, which affects approximately 70% of decision-making.”

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RA: How can we better communicate what personalised medicine is to healthcare providers and patients?

HK: It’s very important that we manage expectations and realise that in drug development it takes 8-12 years from the idea to hit a specific malfunction, until you have an approved drug in your hand. If we talk it up today we will not be able to fulfil the expectations we generate within the next 8 to 10 years. So we need to communicate realistically here.

We also have a responsibility to change the unrealistic perception that there will be a pill for the individual patient. What we can do is communicate the drive to understand the mechanisms of disease, understand where to target a disease, correct this malfunction, and to identify those patients with the best likelihood to benefit from this specific treatment.

RA: How do you see diagnostics and treatments integrating in the future in the area of personalised medicine?

HK: Diagnostic methods and tools account for about 2% of healthcare expenditure, which affects approximately 70% of decision-making. With personalised medicine it affects even more, because we need to understand which patients will benefit from a treatment, and we need to apply tools to identify these patients. So in terms of personalised care, the element of a reliable high quality diagnosis is even more important.

RA: Doctor Kramer thank you very much for your time today and for your insights.

HK: You’re very welcome.

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About the author:

Within Roche Group Communications Dr Kramer has the global lead of communication activities concerning the Roche Group strategy of ‘Personalised Healthcare’.

Since 1992 he was responsible for a range of communication tasks within the Roche Pharma and Diagnostics divisions and spokesperson for the Roche Group.

Dr Kramer studied veterinary medicine at the Free University in Berlin and received his PhD degree in Hanover, Germany in 1989. Since then he has been with F. Hoffmann – La Roche Ltd, Basel, Switzerland.

How can communication around personalised medicine be improved?