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AstraZeneca: An Embarrassment Of Riches
Medical Affairs has seen unprecedented growth in both size and scope in recent years, so new skills and capabilities are needed, says AZ’s Mark Mallon
2017 was a busy year for AstraZeneca. With 19 major new drug approvals in the US, Europe and Japan, many are looking to the company’s rise in R&D productivity described by Mene Pangalos, head of its Innovative Medicines and Early Development unit, in a recent Reuters article as “less people, less sites and less money”.
With so many launches, it was also a very busy year for Medical Affairs, says Mark Mallon, EVP, Global Product and Portfolio Strategy, Global Medical Affairs and Global Corporate Affairs.
“2017 was unprecedented – one of the best company performances in the industry – but, with so many launches occurring at the same time, we had to find ways to appropriately support them, to make sure that physicians got the right information on how best to use our products. With so much strength in our pipeline, resource prioritization is a big part of what we’re doing right now,” he says.
As with many companies, Medical Affairs at AZ has changed beyond recognition in recent years.
“If you look back a few years, Medical had two parts. There were global medical affairs teams that worked on phase IV studies and helped run global symposia or worked with opinion leaders, but it was a pretty narrow scope compared to today. Then, in the markets, you had smaller, local medical affairs groups that primarily provided education and answered questions from local opinion leaders. There was not a great connection between the two groups,” says Mallon.
“Today, we’ve increased our size and connectivity substantially as we have more specialty and complex products, which means that physicians – and even opinion leaders – need much more support.”
Keeping it local
The increase in the size of Medical Affairs reflects the rapid expansion in its scope.
“Now, Medical Affairs helps accelerate the development of exciting new medicines,” he says. “We launched a project, which looks at the challenges of finding the right patients for immuno-oncology studies by leveraging country-based Medical Science Liaisons. We’re not replacing our clinical operations group, but by leveraging local teams who really understand the centers and the physicians – as well as local guidelines – it can make a real difference.”
A big change at AZ is the increase in important programs being carried out locally. “For example, five years ago, we had very little evidence generation coming out of China but this year we’ll probably have more than 100 publications coming out of China, all locally run using local investigators, which is really important as payers and physicians wants to see data on their patients. Many of these will be published in high-impact journals, including the first local research partnership recently published in The Lancet.”
Helping to create the value story for a new medicine at the local level has become a crucial job for Medical Affairs, says Mallon. “We have teams in all the countries, both Medical Affairs but also what I’d call payer teams that include health economics, real-world evidence, and other capabilities. With the support of the global team, we’re training them as we would with sales reps around launch but focusing on the science and the disease, on how the product works and what’s the best way for physicians to appropriately use it.
“We’re also training our local payer and medical teams on the value story and providing them with tools like healthcare models that look at the cost impact, cost optimization or cost effectiveness, and explaining the quality of life and other patient-reported outcome (PRO) benefits. This really helps them to pull the story together,” he says.
Such patient-centric measures are increasingly important, says Mallon, citing the company’s new treatment for non-small-cell lung cancer. “In our studies, we have hard endpoints like progression, overall survival and response rates, but we’re also capturing PROs about how patients feel when they’re taking the medicine. Payers are looking for information on both, and then they want to understand what it’s going to cost to get the medicine and what impact the product might have on the healthcare system and we’re prepared to do all that now,” he says.
“Payers are right to demand how we impact the healthcare systems from a cost and value perspective, and there’s still work for us to do to get better at this, although we’re making progress.”
Pharma has some of the best expertise and capabilities to analyze payer-side healthcare. “Medical Affairs has a key role to play in making recommendations on how patient and care pathways can be changed or improved. A good example is an exciting new product, our IL-5 biologic for people with severe eosinophilic asthma. Today, if you have severe asthma, it can take years before you get to the right specialist who really understands your disease well enough to know the best solution, which may be a biologic,” says Mallon.
“We’re mapping this out in each country and identifying potential areas for improvement, we’re collaborating and supporting key opinion leaders in the healthcare system to make suggestions for improvements.”
Yet another key capability that has expanded recently is Medical Affairs' management of externally sponsored research collaborations. “In only five years, we’ve gone from a few dozen research collaborations to nearly 1,500 today, which is a really dramatic increase that’s been supported by this global and locally networked medical affairs capability.”
Mind the (skills) gap
Looking ahead, Mallon sees a real need for new and better-developed skills within Medical Affairs. “As the quality of the science increases, we will need more academically focused clinicians. Fortunately, I believe that such clinicians will more and more want to be a part of a pharmaceutical company because of the breakthrough medicines we are creating and our focus on leading science.”
Yet, scientific expertise is not all that’s needed. “Leaders in medical affairs also need to develop their overall leadership skills – we have to connect with so many parts of the organization now, particularly commercial and product development, that strong communications skills are essential.”
Tech savvy will also be a key capability, he says. “Digital technologies, which are already having a huge impact already will continue to force change. As we can capture more and more data, it will allow us to understand disease and treatments far better, as well as how well we’re actually treating disease. We need to leverage new ways of communicating with these technologies too.
What’s more, these technologies will allow us to put more of the patient’s voice into what we’re doing, shaping how we develop our drugs, and influencing how we communicate with physicians and the nature of the information we provide to patients.
“All of this will become increasingly important and Medical will be at the center of it all,” says Mallon.
Mark Mallon will be joining us at the eyeforpharma Medical Affairs event at Barcelona in March.
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