14: Medical Affairs Should Start Long Before Product Launch : 14

The Emerging Biotech Leader
The Emerging Biotech Leader
14: Medical Affairs Should Start Long Before Product Launch : 14

In Medical Affairs, timing is everything.

If we had to summarize this next Episode of the Emerging Biotech Leader in one sentence, it would be “a deeper dive on both the impact and importance of Medical Affairs,” inspired by our interview with Rachel Couchenour in Episode 13. But that single sentence alone wouldn’t convey the robust takeaways and mindset shift that this episode provides.

Max Craig, Vice President at SSI Strategy, joins hosts Ramin and Kim for a detailed discussion, one where all 3 strategically remind biotech leaders of pitfalls to avoid and how to think and plan for Medical Affairs appropriately. 

One specific example that you will hear from Max: think about Medical Affairs metrics before it’s too late.

 As a preview of what’s to come in Episode 14, here’s more on what Max, Kim, and Ramin explored:

  • Telling the story of Medical Affairs in ways that are quantifiable. Instead of connecting Medical Affairs to ROI and dollars and cents, evaluating their impact based on opportunity cost
  • Patience plays a role in understanding Medical Affairs’ impact on patients, KOLs, and HCPs
  • Value is defined differently from biotech to biotech, depending upon the size and number of treatments in the market. That said, in Medical Affairs, it’s wise not to get prescriptive; avoid approaching value as a “one size fits all” model
  • While execution in Medical Affairs is important, strategy takes precedence, especially as Medical Affairs meet with the board 
  • The bare minimum for a Medical Affairs organization to succeed is two years. Ramin does share that if the need arises, Medical Affairs can be accelerated, but that’s not the status quo

We could keep going, but we don’t want to give this entire episode away in a recap. 

On that note, we’ll let you read it and then hit that play button! 

Expanding on Episode 13: The 4 Levels of Leadership 

One of the key themes of Episode 13 was working cross-functionally, specifically across all stakeholders. As a follow-up in Episode 14, this topic was broached once more. For Ramin, who has previously held roles in Medical Affairs, the best way to work across the entire enterprise is to first level-set, then expand your focus, and lastly, stay focused on the long-term vision: the patients and HCPs. 

“It’s hard enough to collaborate within your own function. How do you then collaborate outside that? And also, when it’s not your expertise necessarily? There’s a delicate balance. I think the first thing that I have done, and I’ve seen successful people doing actually much better than I have done, is to start thinking about across the enterprise and not just solely focus on your own function.” 

While this may not be a natural tendency when your biotech is experiencing urgency and needs to make every dollar and milestone count, thinking across the entire enterprise can be learned. This is where the 4 Levels of leadership come into play. 

First, Max observes that some of the best Medical Affairs talent understand working cross-functionally is an art of give-get. “Show up to your meetings with a purpose and be prepared to listen.”

Max also says it helps to think of your career and skills in Medical Affairs through a leadership lens, the 4 levels of leadership. There’s individual contribution. Then there’s being a “leader of leaders,” then an enterprise leader, and finally, an external leader. 

With these in mind, you can circle back to Ramin’s advice and stretch your thinking beyond your silo.   

Taking Time: Behavior Change Doesn’t Happen Overnight 

What does patience have to do with patients? Besides our play on words, a primary role in Medical Affairs, especially in rare disease, is involvement with patient groups, communities, and parents or caregivers. 

Yet the value from those efforts isn’t available on day one of forming the team. Results are a long-term game, and the specific results Medical Affairs drives occur from a sequence of events versus one stand-alone initiative or action. 

Kim shares this POV: “One of the biggest challenges with the value of Medical Affairs is that medical efforts take time. You can’t move behavior change in the medical community overnight. It doesn’t take one interaction to completely change sentiments. We’re talking about deeply ingrained understandings and behaviors that we have to shift mindsets and industries and behaviors related to. And that takes time. And most organizations are impatient, especially in biotech, where we don’t have the time and money to do it.”

This is where the idea of looking at Medical Affairs by way of opportunity cost becomes important. 

How do you measure opportunity cost? Kim shared a few examples. 

  • You can look at your sales team and imagine, without Medical Affairs, how they might take double the amount of time in the field? 
  • Another scenario is that without Medical Affairs, it could take longer for people to see the potential of your therapeutic.
  • Lastly, you can measure based on the true clinical pull-through compared to what you forecasted. With a Medical Affairs team in place early on, your results could vary from having a waitlist to having 40 patients on day 1. 

Again, these results become tangible in hindsight. And the data backing them up doesn’t lie. Max shares, “A lot of work has been done, and we have case studies saying the difference in uptake with different levels of market preparation by global 

medical affairs. Those uptake curves are so much longer when you haven’t had medical affairs out there beating the drum.”

Wise Words on Starting Medical Affairs Early

As we near the end of our recap, we’ll touch on the topic of timing–a key theme in this episode and Medical Affairs planning overall. 

To help biotech leaders evaluate their thinking specific to timing and when to start Medical Affairs, Kim turned to Ramin. 

Here’s what he shared: “Ideally, we want to start sooner and sooner, but you also have to keep in mind that sometimes the resources are not there. We also have to wait until the data release before we can activate MSLs, or we have to wait for X, Y, Z to happen, right? Especially for a smaller biotech company. I don’t think there’s anything wrong with that. You just have to sequence it, right? However, what you’re going to see as the trend going forward is getting medical affairs involved, just like what you said, Kim, early on. The earlier, the better, right? Even in the pre-clinical development, the studies and getting started getting those insights.”

Max added that you really have to understand the patient communities you are going into. 

“We would like two years as kind of the bare minimum for, you know, when you should bring medical affairs on for kind of your bigger value maximization. But you really have to understand the patient community that you’re going into, the HCP communities that you’re going into, and those really need to drive how and when Medical Affairs needs to be built up and how it should be structured.”

Kim, Ramin, and Max agree–all of these launches are just so different. Some are more field heavy, some are more education heavy. 

Regardless of how yours skews, after this episode, you’ll be better prepared to utilize Medical Affairs and adjust your planning–whether you are at the very early stages or you need to realign with your team and switch gears.

We’d love to hear: based on these past two episodes, what’s your new takeaway or understanding of Medical Affairs? 

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