Precision medicine: the next steps

AstraZeneca’s senior vice-president and head of precision medicine, research & development, Ruth March, has been central to the company’s transformed approach to personalised treatment. We spoke to her about how precision medicine has changed and how it will continue to evolve in the near future.

Tell us about your role.

My role mostly concerns delivering companion diagnostics that are linked to AstraZeneca medicines, extending through all phases of development from early discovery to when drugs reach the market. I look at how we can best use those diagnostics and biomarkers to match the best treatment to the right patients. This covers our core therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.

A lot of the challenges but also a lot of the joys of precision medicine come from the fact that we work right across the business. That means our diagnostics experts work incredibly hard, but it’s a very exciting area to be in because everything is constantly changing and technology is improving and accelerating every day. We have a direct link from the basic science to seeing the effect of what we do on patients’ lives, and that connection has to be the most satisfying and rewarding element of the role.

Has precision medicine always been part of your career path?

When I started my career, precision medicine wasn’t even a thing.

I was in academia for around 12 years, where I was interested in variation between individuals at the molecular level. I started looking at differences in how individuals react with their immune system and particularly why certain individuals develop autoimmune diseases, and that led naturally to an interest in the molecular genetics of autoimmune disease. Then when I joined industry I expanded my focus to look at the genetic drivers in differences in responses to medicines.

Precision medicine didn’t become a major trend in industry until around ten years ago, coinciding with the time that AstraZeneca started to become a much more science-led organisation. That’s when precision medicine became a more central part of what we do, and my work in this area became much more prominent.

“The whole field has changed so completely; when you look at the landscape ten years ago, it’s like you’re looking at prehistory”

A lot has happened in the years since 2010 – what do you think have been the biggest changes over that time in this field?

Back then precision medicine in pharma was very much at the enthusiast level. It wasn’t impacting the mainstream. Today, every pharma company, including AstraZeneca, is using biomarker science and diagnostics linked to mainstream drug development, particularly in oncology.

Last year we celebrated our 25th diagnostic approval across three major global markets since 2014. That’s just so far ahead of anything that we imagined when we were putting together the original business case for personalised medicine. Back in 2009 we were really pushing ourselves to be extremely ambitious, and we thought we could launch one medicine linked to a companion diagnostic in 5 years. In 2018 alone we launched 10 diagnostics tests. The whole field has changed so completely; when you look at the landscape ten years ago, it’s like you’re looking at prehistory.

Given that patient experience is so central to precision medicine, how do you see that changing with new technologies?

Many cancer patients do not have a solid tumour specimen. If you don’t have a sample available for diagnostic testing, you don’t get access to precision therapy. Technologies like circulating tumour DNA can give patients greater access to treatments, and in diseases such as ovarian cancer, colorectal cancer and pancreatic cancer, they can also detect patients who are starting to develop tumours earlier. With early diagnosis, patients can receive treatment at a stage when it could be more effective.

Outside oncology, patients with conditions such as hypertension, diabetes or asthma, are typically not treated in the hospital setting but instead spend a lot of time with GPs where they might only have a six minute appointment. This means we have to think about much simpler technology and whether we can create a point of care test that gives results within minutes – perhaps using biomarkers that are already accepted in clinical practice. We’re thinking of what makes sense for patients’ care pathway and whether we can build that testing paradigm into what is going to be best for them. It’s a much more patient-centric way of looking at things.

“Research from CRUK shows that access to precision medicine can be a bit of a postcode lottery”

Are there any other changes you’d like to see in the industry that could positively impact patients?

Precision medicine is good for patients because they have a much greater certainty that a specific drug is going to work for them. The barrier is that if you can’t get tested, you can’t get access to the medicines. In the UK not all patients get offered the latest molecular tests – research from CRUK shows access can be a bit of a postcode lottery. In Europe likewise it seems to be that some countries do really well with some types of tests and other countries don’t, and that the differences may be down to logistical details rather than medical need.

It would be great to see patients who are most in need get access to testing and therefore get treatments matched to their needs.

How important is collaboration in developing precision medicines and diagnostics tests? What makes a good partnership?

At AstraZeneca we have chosen to partner with the best diagnostics companies out there for each therapy area and each drug. This gives us a wider choice and greater flexibility than developing our own in-house diagnostics division.

A key consideration when selecting companies to partner with is their regulatory ability as well as their technical ability. It needs to be a true partnership, because what people perhaps don’t appreciate is that when you are developing a companion diagnostic, the clinical data that the pharma company supplies is an integral part of that regulatory submission. The diagnostics partner is providing the technical, analytic data and we are providing the clinical data, and that all has to come together seamlessly. And if there’s any sort of negotiation with regulatory authorities we have to do that seamlessly too.

What would you consider to be your most notable achievement to date?

I’m very proud of our genomics initiative, which is going right back to the discovery phase and is a considerable investment in new technology, new forms of analysis, next generation sequencing, and analysing up to two million genomes from patients and biobank participants. It is important science which we are very pleased to see is working out well.

Do you have a recipe for successful innovation?

It may seem obvious, but keeping an open mind is important. There have been many times in my career where I’ve tried something with yesterday’s technology and it’s not worked. This landscape is constantly changing, and technology is improving and accelerating every day, and that opens up a whole realm of possibilities that weren’t there before.

The second thing is to triangulate your own opinions with external advice. When our CEO, Pascal Soriot, asked me to think about the genomics initiative I immediately knew that I personally didn’t have the expertise to answer all his questions, but I knew some people who did. I went to my external academic contacts and got the best geneticists in the world around the table to think about what we could do to deliver a world-leading genetics initiative.

Finally, you need to hire people who are brighter than you are, which is something I’ve had to get comfortable with, particularly as we’ve moved into this new era of analytics and machine learning. I’m proud to have hired early career researchers who are experts in the details of how these new fields work. That leaves me with the responsibility of ensuring that the output of their work can be used to transform drug development and make a difference to patients’ lives.

About the Author

George Underwood

George is part of the senior editorial team at pharmaphorum, previously working at PharmaTimes and prior to this at Pharmafocus. He is a trained journalist, with a degree from Bournemouth University, with specialisms including R&D, digital and M&A.

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