“The uncomfortable truth about Medical Affairs”

1. When we were working on the title for your course, you said you wanted something riskier. One of your suggestions was “The Truth about Medical Affairs”. So, let’s start there. What is the truth about Medical Affairs that people in the industry don’t say out loud?

Across the industry, Medical Affairs teams face one key challenge. And it’s a fundamental challenge of identity and purpose. Let me explain what I mean. If you ask a group of people, “What’s the purpose of pharmaceutical R&D?" It’s a fair bet that the vast majority would give you an answer. Moreover, most of those answers would be similar and by and large they’d be accurate.

“They invent new medicines,” they’d say. “Simple!” And the same would largely be true for other core functions: clinical, regulatory, marketing, sales, manufacturing… 

But ask the same about Medical Affairs and you’ll get a very different result. 

Sadly, even among pharma insiders the true importance of Medical Affairs is often poorly understood. And that leads to a major issue among key stakeholders. What difference does Medical Affairs make? What value does it add and how can it help me and my function? How does Medical Affairs fit alongside other core functions in getting the right medicine to the right patient at the right time?

Until we can provide convincing answers to these questions, Medical Affairs will struggle to have the influence it deserves and the resources it needs. 

This course sets out to bring real clarity to the Medical Affairs function, not only exploring the skills and capabilities that define the role, but also how it should work alongside internal and external stakeholders, how it can gain greater recognition and how it can show its true value. Most importantly, how excellence across Medical Affairs can contribute to improved patient outcomes.
 

2. Your course opens with a blunt before-and-after. Yesterday’s Medical Affairs: reactive, tactical, “policing”, disconnected from commerce, under-resourced, isolated. Tomorrow’s: proactive, strategic, leading. Of the teams you actually walk into, and you’ve supported over 50 medical brands, what proportion are genuinely living in “tomorrow”?

Overall, I would have to say that the vast majority of Medical Affairs leaders and their teams share the objectives of proactive and strategic Medical Affairs. They understand the value of medical insight and the MSL function and are committed to devising medical strategies that support brands and open the way to improved patient care.

However, I believe that many of them have some frustration over interactions with other functions. True medical insight can be of great value to regulatory, clinical development, marketing and market access teams, but few of the teams I talk to feel that their strategic advice is sought or valued. Without this cooperation across functions, the value of Medical Affairs cannot be fully realised. 

There is one important exception to this, and that is rare diseases, particularly smaller rare disease specialist companies. Their products are often based on complex science and with few specialist centres, building peer-to-peer medical dialogue with leading physicians is of paramount importance. Under these circumstances, the importance of Medical Affairs is clear and as a result their strategic influence to the brand is often greater.

3. You call Medical Affairs “the third pillar of pharma”, alongside R&D and commercial. Do Medical Affairs teams themselves believe that? Does their leadership?

That’s an interesting question. I first came across this description of Medical Affairs as the third strategic pillar in a McKinsey report, “A Vision for Medical Affairs in 2025”, which I think was published in 2019. 

It allows us to fill the gap between the upstream functions of R&D, regulatory affairs and clinical development on the one hand and the customer-facing activities of commercial, marketing, sales and market access. There is no doubt that much of the Medical Affairs function does indeed build some form of bridge between these two pillars. It translates the science behind the indication and the molecule into the basis of education and messages that can define unmet need and therapeutic potential. And at the same time it ensures that understanding of physician and patient needs are built into developmental programmes, clinical trials and product label submissions.

But I am not sure that Medical Affairs can yet describe itself as a true structural pillar like the other two. Because the other two pillars are perfectly able to carry on their own functions without heeding or being guided by this new intermediary. At present, Medical Affairs reminds me of the walkway between the two Petronas Towers.

Medical Affairs should be a key driving force within the upstream pillar. It should also be a driving force within the commercial pillar. Medical Affairs may be a third pillar, but to be effective, it should be fully integrated into every function of the pillars on either side. At present, I believe this is true in only a minority of pharma companies. There is no point in asserting the importance of this third pillar if it becomes simply a third silo whose voice does not carry out of its own space.

4. You talk about insight as being distinct and different from information. What’s the most common thing you see teams present as an insight that simply isn’t one?

To me, medical insight is one of the key areas where Medical Affairs can demonstrate its value. Through our MSL teams and our one-to-one discussions with clinicians, patients and carers, we have a privileged ability to get behind the facts and spreadsheets and to get a glimpse into the thought processes that affect how people deal with disease. And that’s important: true insight doesn’t lie in identifying what people do in a given situation, it’s about understanding why they do what they do.

True insight into the behaviour of an HCP or a patient can have great value for brand strategy. But learning how to get past the ‘what’ and into the ‘why’ is a skill. It takes practice and it takes time, as Pasteur said, “Discovery favours the prepared mind”.

Getting good medical insight is like mining for diamonds: they are very rare and we have to be continually vigilant to make sure we spot them. It is not like mining for coal: you can’t get more just by working longer on the same seam. I think that is a risk with adding the number of insights to the KPI dashboard in Medical Affairs. If you ask your MSL team to make sure they report more insights over the next quarter, you can bet that the quality of those insights will go down.
 

5. The course is now built around six keys to success. If a Medical Affairs leader could only work on one of them this year, which one returns the most, and why that one?

The development of these six keys to success has taken several years and they are based not only on my direct experience but also on the invaluable feedback we have obtained from literally hundreds of Medical Affairs professionals who have attended our Medical Affairs excellence course over the past 10 years. During that period, the Medical Affairs role has evolved as the science has become more complex, the number of stakeholders continues to increase and the scrutiny over our work becomes more intense.

In the light of this evolution, we have identified the following six keys to success: own the data; devise strategies based on insight; master the art of scientific storytelling; use science to maximise value; lead with clarity and vision and finally, maximise stakeholder engagement.

If I had to pick just one of these, and this may surprise some people, I think I would pick the last one, maximise stakeholder engagement. Of course, I am assuming that we all have the scientific knowledge to understand the nature of disease and the mechanisms of treatments. But for everything else, the single most important skill is to be able to build relationships with a wide variety of stakeholders, both inside and outside the organisation. Inside, this is essential if we are to understand the challenges of colleagues upstream and downstream and also to help them understand what Medical Affairs is doing and how our insight may add value to their efforts.

Externally, the ability to build true peer-to-peer relationships with clinicians at all levels, as well as with patient representatives, is paramount. These are often the most important sources of insight and they are the primary groups from whom we can learn and with whom we can communicate the science behind our indications and our brands.

Knowledge capabilities are the essential background, but it is only with excellent interpersonal skills that we bring them to fruition.