Personalised healthcare and the patient

Rebecca Aris interviews Dr Bob Holland

AstraZeneca

As our personalised medicine month continues, pharmaphorum interviews Dr Bob Holland, VP Personalised Healthcare and Biomarkers at AstraZeneca, on how personalised medicine will be changing the lives of patients.

As personalised medicine slowly becomes a reality it is easy to focus on the therapeutic advances and forget about the impact it has on the individual patient. AstraZeneca strives to put the patient first and its personalised healthcare strategy reflects this.

We spoke with Dr Bob Holland on AstraZeneca’s healthcare strategy, advances in personalised medicine and how he thinks it will impact on the patient in the future.

Interview summary

RA: Dr Holland thank you for agreeing to take part. Could you please start by telling me about AstraZeneca’s personalised healthcare strategy?

BH: At AstraZeneca we always try to put the patient first and so our personalised healthcare strategy has the patient at the heart of what we’re doing.

It’s about getting the right drug to the right patient at the right dose. The way we approach this is by trying to discover and identify markers, some of them biological and novel, some of them perhaps combinations of measurements that are taken as part of normal treatment practice, but markers that recognise and identify the patients who are going to get particular benefit from our medicines, whether it be improved efficacy or perhaps the avoidance of safety issues.

We can then carry those markers forward as we discover and develop our medicines, and ultimately try to get regulatory approval for those markers at the same time as we get the drugs approved so they can be launched together.

RA: In what disease areas is personalised medicine the most advanced, and what success stories have you noted with personalised medicine?

BH: Across the industry we all recognise the huge advances that there have been in understanding cancer biology. It’s that deep understanding of the molecular pathology of the disease that underpins a lot of the recent advances in personalised healthcare.

We see that in AstraZeneca as other companies have seen it in their own portfolios. But it’s not confined to cancer. We are now finding that it’s becoming important in all the disease areas. I recently reviewed the portfolio of drugs in development at AstraZeneca from first GLP toxicology through to and including phase III, and more than two thirds of the drugs that we have are following a personalised healthcare strategy – covering various therapeutic areas.

However, I think cancer leads the way, it’s shown us how it can be done, but we actually are trying to use the same approach across all the therapeutic areas in which we work.

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“…we can get the market access and the pricing that we need, because we’re providing genuine medical benefit to patients.”

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RA: In what ways can we manage the investment required of personalised medicine versus returns compared with the traditional drug development?

BH: Our new CEO, Pascal Soriot, said something really important – ‘follow the science and put the patient first’. If we live by what he said the investment will be appropriate for the way that we develop the medicines.

If we have a valid personalised healthcare strategy we identify patients who gain benefit from our therapies. The payers appreciate this because they know the patients are going to gain benefit. This means we can get the market access and the pricing that we need, because we’re providing genuine medical benefit to patients.

RA: How do you think personalised medicine is going to impact on big pharma operations in the future?

BH: We’re still in the early phase of understanding how best to discover and develop personalised medicines. However, there are some apparent trends.

We’re getting much greater efficacy in selected patient populations than we have seen in broader, unselected populations. This means that the efficacy studies can be smaller, and the approvals can be earlier, which was apparent with Xalkori, the Pfizer drug. But we still need to establish that the drugs are safe, and so the total number of patients that needs to be studied probably won’t be much reduced. We may get conditional approvals as we saw with Xalkori, with Pfizer still needing to conduct larger clinical trials post approval in order to establish the safety profile, and to confirm the efficacy.

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“…the diagnostics companies recognise the pharma companies as being important partners for the future development of their market.”

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RA: And how can big pharma manage the diagnostic requirements needed for personalised medicine?

BH: There’s no doubt it is complicated to simultaneously discover and develop both the drug and the companion diagnostic. There’s a complicated mutually dependent relationship in the development programmes. As an industry we’re learning about this and we’re evolving our operating models to be able to develop the two simultaneously. I think it will create organisations which are much more sophisticated in the way they think about both drug discovery and diagnostics discovery.

There are slightly different strategies being adopted by different pharma companies. At one extreme you have Roche Genentech who have their own diagnostics division, which certainly provides a lot of companion diagnostic support for their pharmaceutical products.

We in AstraZeneca have a slightly different, but well developed, strategy where we have formed strategic partnerships with significant global diagnostics companies.

Other companies have a less formal approach. We find increasingly that the diagnostics companies recognise the pharma companies as being important partners for the future development of their market.

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“What we’re trying to do is to make sure our drugs are used in those patients who will gain benefit…”

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RA: What impact do you think personalised medicine will have on the patient in the future?

BH: The patient is the reason that we follow personalised healthcare strategies. What we’re trying to do is to make sure our drugs are used in those patients who will gain benefit, and that the drugs are avoided in patients who won’t gain benefit, or who might be put at risk of side effects. That’s the whole purpose of the personalised healthcare evolution in the way that we discover and develop medicines.

I am passionate about this, because I think it will be the future of the way that medicines are provided to the patient, that there will be increasing differentiation of their diseases by a much better understanding of the pathophysiology of their diseases.

It can be quite different molecular abnormalities that generate apparently similar symptoms and signs. But by developing our understanding of the pathophysiology of the disease, and recognising how certain medicines will work in certain kinds of patients but not in others we will be able to revolutionise the way that we bring benefit to our patients.

There are a large number of studies that have been looking at how many patients actually respond well to the drugs that they’re taking. In many conditions it’s as few as a half, sometimes fewer than a half get a good response to their therapy. And so the patients are put through a cycle of trying one medicine, when that fails they try another one, when that fails they try another one. We’re going to move to a world where they will get the right drug from the very beginning of the treatment of their condition, and you will see a big improvement in the medical care that we provide through medicines.

RA: Doctor Holland thank you very much for your time.

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About the interviewee:

In July 2010, Bob Holland was appointed Head of Personalised Healthcare and Biomarkers after, most recently, heading the Neuroscience Therapy Area at AstraZeneca.

Bob graduated BM BCh, MA, DPhil from Trinity College, Oxford completing his medical training at The John Radcliffe Medical School. After medical practice in hospitals in the UK he joined the Pharmaceuticals Industry in 1985. During 27 years as a clinician-scientist in the industry, Bob has led clinical programmes across a wide range of therapeutic areas and across all phases of clinical research. For six years he was responsible for the clinical exploration of every new chemical entity produced by AstraZeneca and chaired the committee that decided whether a drug could be taken into man. In 2005, Bob was appointed Vice President and Head of the Neurosciences Therapeutic Area – leading the cross-functional efforts to discover, develop and commercialise medicines for psychiatric, neurological and pain disorders. Throughout his career, Bob has remained passionate about the use of biomarkers to select the right patients for treatment and to measure drug effects.

What impact will personalised medicine have on the patient in the future?