Medical Affairs, Engagement for Digital Interventions: Industry Perspectives, and Lessons Learned.

“It can be really daunting to young companies if you go out and get a quote for Medical Affairs work, or if you think about the people that you're gonna have to hire. And you look at the 200 things in a launch playbook or something that you have to do—the cost is in the millions. But you can start with a publication strategy when you know your endpoints, you can plan a lot of this ahead of time and really do that In a more scrappy manner with fewer resources, especially if you choose your resources wisely.” Andy Molnar, CEO of Digital Therapeutics Alliance

Did you enjoy our webinar on Medical Affairs, Engagement for Digital Interventions? Or are you just coming across this content for the first time?

Conventional wisdom would often have it that hindsight is 20-20. With that in mind, imagine having five respected and experienced biotech leaders share their hindsight and recommendations on Medical Affairs to help you learn and take action as you start or continue your biotech journey. That’s the essence of this webinar and recap.

Moderated by our in-house expert Rachel Killian, PhD, Senior Consultant at SSI, who is part of our Medical Affairs team, each of these esteemed contributors expand on:

  • The importance of Medical Affairs across a variety of biotech stages
  • What to consider when building out a Medical Affairs team
  • When to engage in Medical Affairs
  • Overcoming challenges and more

Meet Our Panelists:

Everett Crosland, CCO, Cognito
Sharief Taraman, M.D., CEO, Cognoa
John Wagner, MD, PhD, CMO, Koneksa Health
Owen McCarthy, President, MedRhythms
Andy Molnar, CEO, Digital Therapeutics Alliance

Now onto the best practices and collective wisdom, starting with this perspective from Sharief.: Medical Affairs never finishes partly because it helps you stay ahead of competitors, among other key functions.

As you’ll see demonstrated in the dialogue throughout, having a degree of flexibility when it comes to starting, growing, and maintaining your Medical Affairs team is paramount.

Below are other pertinent takeaways.

What Medical Affairs Look Like By Stage

Most of our panelists are at varying stages in their biotech. To help provide a glimpse of what Medical Affairs looks like across early orgs vs. mature orgs, Rachel’s first question addressed the current role and activities of Medical Affairs.

Everett kicked things off. “Cognito is a late-stage Alzheimer's company focused on neurodegeneration in Alzheimer's as well as Parkinson's, MS, and other CNS diseases. We are currently running our phase three medical affairs as well as real-world evidence and health economic evidence. Medical affairs, for us right now as a late stage clinical company, is really dedicated to clinical trial recruitment, clinical trial design, as well as partnerships with key opinion leaders and institutions that will validate our medical device. This is critical for our launch readiness, as well as company readiness, and market shaping efforts that we're engaging in as early as this year and going into our launch in the coming years.”

Owen shared his current stage next. “We just finished our clinical trial and are now pivoting into the commercial phase. We’re building out teams really transitioning from that clinical development into the commercial phase of medical affairs. And saying to ourselves, ‘Okay, who are the top KOLs in this space? Can they help us figure out what the unmet need is? And then, can they help us lay out the evidence generation strategy to make sure that we can be most efficient at solving, reaching patients?”

Sharief spoke to the uniqueness of Medical Affairs for a digital therapeutic.“You know, what we're actually doing here is really thinking about how do you drive clinician adoption or clinician perspectives around the digital part, which is interesting and different and a very unique space. And so, as much as our Medical Affairs is the science, the presenting at conferences, the finding the KOLs and early adopters within the condition or the area of therapy or diagnosis, it's really also about the digital components, too.”

Koneksa has a more traditional Medical Affairs function. John Wagner, CMO of Koneksa, emphasizes how important it is to amplify the patient voice and work with advocacy groups.

Tune into the webinar replay to hear more about that.

When Did You Start Medical Affairs

Unanimously, each panelist shared that their Medical Affairs work started on Day 0–whether they knew they were doing Medical Affairs or not at that time.

Owen drove a critical point home, especially for very early-stage biotechs just starting to formalize. “For those out there listening that are thinking about Medical Affairs as this fancy thing, right? It isn’t. Think of it across the whole spectrum of development; I’ve found that to be very helpful. I probably spent my first 6 to 12 months thinking about Medical Affairs and then putting that in a pitch deck and telling a story to investors on how they should fund that work. We didn't have a full-time FTE on that. We had to learn on the fly.”

Circling back to Sharief’s original quote on flexibility, he cautions: “Medical Affairs is going to evolve over time, but making sure that you actually have a strategy around it is really important. There are a lot of complexities with it, and there's a lot of moving parts, and it will change. You don't want to be in a situation where you go, ‘I wish I should have. Coulda, woulda, etc. Don’t wait for hindsight to show that you actually had the opportunity to do it earlier.”

To that point, Rachel weighed in on strategy and efficiency supporting the long-term impact of Medical Affairs. “You can be very efficient about what you need to do now versus what “could be” cool 20 years down the road or whatever horizon depending on where you'd like to be.”

Rounding out this question, John and his team at Koneksa also see the value of Medical Affairs immediately. Listen for specifics around his answer and Everett’s input as well.

On What Biotechs Can Learn From Pear

Those who pave the way often blaze a trail. Such was the case with Pear, who, despite early momentum in the space, recently had to file for bankruptcy. On the heels of this news, Rachel shared that the Pear team cited payers as one of the major challenges that they faced, which prompted her next question for the group. “How are you approaching things differently or or taking the lessons learned there?”

Andy had a profound reminder to share. Biotech leaders are visionaries, and scientists, and entrepreneurs as well.

“As entrepreneurs, it's really hard to believe that the timeline and the financials needed to really collect the proper data for people to make coverage determinations are difficult.”

Everett contributed additional context, especially for biotechs creating a new market.

“This is a long, arduous, costly process that requires just mountains and mountains of evidence as well as that “slugging it out” to drive demand as well. There are a number of us that are not necessarily in need of creating a market. We will be selling novel products into an existing market with existing reimbursement pathways. That path is less long, less arduous than just creating a market de novo. At the same time, there is a need for digital therapeutics. There's a need for the democratization of healthcare that is afforded by digital therapeutics, and that need is recognized in multiple different disease states, and it'll just take time. I firmly believe that in the coming years, we'll see Pear’s vision or some iteration thereof.”

A spirit of gratitude was felt across the panel for Pear’s work and advancements in the sector.

As this question came to a close, John was quick to point out the power of advocacy groups and consortia-like groups. Koneksa specifically works with the Michael J. Fox Foundation. “Consortia kinds of efforts really shouldn't be ignored because they end up becoming areas where there's an exchange across different kinds of stakeholders, and that helps drive adoption.”

How To Educate On Digital and Mitigate Risk

Moving the conversation forward, Rachel then shifted to the topic of additional education and the work that has to be done for payers around digital therapeutics. KOLs need education, too. “The education and the messaging is specific to ‘what is digital, what questions should they be asking?’ And then to also think a bit from a risk mitigation strategy for the scientific messaging. What are some risk mitigation strategies and how do you meet that educational need on all those fronts kind of proactively?”

Here’s what Owen weighed in. “Just because we can do something with technology for clinicians doesn't mean we should, right? And so we need to really understand their workflows and not overburden them with new information that's unnecessary because I think sometimes, as technologists, we get really excited about what we can do and overlook the facts at the heart of why they would care about our products.”

Sharief also added if the science is solid, you can keep it simple. “For us, for example, in the Autism space, there are questions you're going to get around, ‘What is this digital stuff? What is this AI stuff that you're talking about?’ But at the end of the day, as long as the science is solid, you don't necessarily need to overcomplicate it. You do need to address it and have thoughtfulness about it. Plus, there are advantages actually, too. So communicate the advantages of digital, a big one being accessibility.”

With their expertise in digital biomarkers, John stated, “One of the powers of digital biomarkers is the power of repeat measures. Digital measures allow those repeat measures to be taken but the data is not that different from what the in-clinic assessments are.” Why this matters: when it comes to education, an example John cited was specific to mobile spirometry and how Medical Affairs can explain the similarities between digital data vs clinical data.

Advice On Results from Medical Affairs and Level Setting Moving Forward

As you can tell from their answers, each panelist was honest, transparent, and encouraging. The same goes for their answers on the upfront investment of time, energy, and capital that Medical Affairs requires but is well worth it for the long-term.

Rachel wanted advice for those about to dive in.

Round-robin style, here’s what each panelist said.

Sharief: You don’t need an FTE, have flexibility, and swap out resources.

Everett: As you scale commercially, your Medical Affairs team will be one of your core value drivers! And it's also a key source of market insights about what matters most to physicians.

Andy: Always have an ask.

Owen: One very important bridge is between Medical Affairs and Product Development, particularly regarding patient needs.

John: Set appropriate expectations for Medical Affairs and deliver on those expectations. They can’t be unattainable, so lay out a timeline.

To get the panel's final thoughts, context, and takeaways on best practices, sign up for the webinar replay!

You’ll also hear about the First Inaugural Conference in Washington, D.C., hosted by the Digital Therapeutics Alliance. We hope to see you there.

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