Building the medical affairs organisation of tomorrow

As medical affairs increasingly engages with new stakeholders – HTA bodies, regulators and patient groups – it must upskill and upgrade its data and collaboration capabilities

Medical affairs has a lot on its plate. As the pharma model has been shifting from primary-care, blockbuster-drug discovery through to more specialised medicine and gene therapy, the science has naturally become more complicated. ‘


The rise of artificial intelligence and big data means evidence generation now goes far beyond interventional studies, while the environment continues to demand more discussion around value and pricing. 


Unwrapping complex science and value makes for a challenging remit for medical – without adding the shifting demands caused by the changing working patterns and global uncertainty of the COVID-19 pandemic. 


Now, more than ever, is the time to meet stakeholders where they are, which may be somewhere very different to where they were merely months ago. 


The diversification of the stakeholder

“Medical affairs is a unique department,” says Charlotte Kremer, EVP, Head of Medical Affairs, Astellas. “It’s not only clinical trials, it’s not only communication – it’s both. It is really a combination of evidence generation and scientific exchange. I always consider medical affairs the stewards of knowledge.”


If the department’s main external stakeholders have historically been HCPs and academic thought leaders, it has long since widened out to include communication with payers and HTA bodies. 


A further stakeholder, however, is emerging as a key focus for the future. “Lately, with patient-centricity groups either collaborating in medical affairs or sitting in medical affairs organisations, it really demonstrates that patients are the new stakeholder for medical affairs,” says Kremer. 


“Patients today can shape the success or failure of a clinical probe,” says Michael Zaiac, Head of Medical Affairs, Oncology, Europe, Novartis. “They are the key decision makers where their own adherence to our medicines is concerned. 


“They are increasingly becoming regulatory advisers. They are consulted by payers. They elect politicians, who of course instruct payers, and they may eventually choose between different medicines of the same efficacy and efficiency by looking at patient-reported outcomes.”


This makes it fundamental to respect and understand the patient community perspective, says Zaiac, conducting responsible clinical trials, expanding access and recognising the importance of transparent reporting to all patients. “We have to go beyond product data presentations to have patient-focused therapeutic area presentations, looking at how our product fits and what it means for the HCP and the patient.” 


The varied nature of the stakeholders medical now engages with require the modern field force to move beyond peer-to-peer conversations with physicians about clinical data to communicating comfortably with HTA bodies, regulators and patient groups. 


The substance of these conversations also continues to change, says Emma Booth, Director Head of Medical Strategy and Operations, Amgen, with stakeholders looking further than demonstrations of clinical efficacy and study data.


“Stakeholders’ needs and desires have also evolved,” she says. “They want to go beyond data discussions to talk about value across all paradigms, so the societal impact, as well as cost and traditional measurements of value. They also want to be able to reach you when they want information, so the way we make ourselves available also needs to change.” 


Upskilling for a data-driven future 

This unquestionably requires a drive towards digital engagement. There is great opportunity to harness retroactive database and real-world data analyses to benefit from the best of virtual interactions and to maintain momentum with fewer physical interactions.   


Data sits at the heart of the future of medical, says Zaiac, citing the 2017 Bain & Company report Reinventing the Role of Medical Affairs, which said that, “the most competitive pharma companies in the future will be masters of data and digital technology… they will be able to generate and analyse vast volumes of real-world data and excel at communicating scientific evidence.”


Making the most of digital tools and extracting new insights from data will require filling knowledge gaps and learning new hard skills, from different ways of data generation through to better uses of existing data, advanced analytics and health economic models, says Kremer. 


“Everybody is familiar with the traditional capabilities of scientific knowledge, a good understanding of compliance, business acumen – those are a given. Medical affairs needs to get ready and gain capabilities in the new areas, either training ourselves or hiring the right data analysts.” 


The use of data is also shifting towards a more collaborative footing, she says. “In the past that was much more inside-out communication of data about our products, but external stakeholders may soon have equal or even more data about our products. So working with them to generate this together through collaborative research or big data analysis is key to the success of pharma, and medical affairs can take that on.”


Changing the conversation  

Moving beyond data, there is a raft of softer skills around communication which medical teams should be investing in, says Zaiac. When Novartis examined its field interactions with customers, it discovered a notable opportunity for change. “In an average conversation, we spend more than 50 per cent of the time talking,” he says. 


“We have to give our customers more airtime. We have to be more curious, inspired and self-aware. We have to stop pushing our information and generate conversations which customers can pull, as and when they like.”


The shifting environment created by COVID-19 brings the importance of this home. “Agility couldn’t be more important,” says Zaiac. “We have to change not just the way we communicate, like talking via our virtual technology, but also what we communicate, making it relevant in the changing times we’re living in. I believe the institutions which learn this best will emerge more successful in the aftermath of this pandemic.”


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