Peg Crowley-Nowick 0:30
Welcome to the first season of Medical Affairs Unscripted. I’m your host, Peg Crowley-Nowick, President and Founder of Zipher Medical Affairs, a full-service consulting firm. During this podcast, we’ll explore a range of topics related to the strategic role of Medical Affairs from the perspective of industry experts. Through these conversations with our guests, we will share firsthand experience to provide the listener with insights and knowledge about the evolving role of Medical Affairs. Please stay tuned at the end of the podcast to learn more about Zipher.
My guest today is Meg Heim, President and Founder of Heim Global Consulting. Hi, Meg, it’s great to see you today.
Meg Heim 1:23
Hey, Peg, thanks for having me on.
Peg Crowley-Nowick 1:25
Oh, thank you for joining us, I think we have a really exciting topic. I’m particularly very excited to talk about the impact of Medical Affairs over time, and I would say that this is one of those topics that’s the holy grail of Medical Affairs. One of the reasons I wanted to talk to you is I believe that you found a way to really measure impact, and I’ve enjoyed talking to you about the methodology that you’ve employed. But on top of that, I think both of us agree that you start with strategy. And from the strategy, it’s easier to measure impact. So today, I’d like to have an in-depth conversation about the work that you’ve done, how you measure impact over time, and some of your thoughts on what is happening with this from a medical affairs perspective.
Meg Heim 2:15
Thank you, I would love to talk about this, because it is the one thing that people are always trying to measure — the value of medical. I think everybody comes at it from a different way, but it is not a commercial team. So, you know, return on investment doesn’t work. So, it’s got to be the impact of medical and the patients we serve.
Peg Crowley-Nowick 2:40
Absolutely. Well, before we start, why don’t you give us a brief introduction of how you journeyed into Medical Affairs.
Meg Heim 2:52
I started honestly, I’m a nurse by training and Advanced Business degree. My background really is after my clinical time, I always like change and new technology. And when I started, I started working for startup companies, so I’ve had commercial roles. I’ve been a Vice President of sales for US and Europe. My last role was Vice President Marketing for a med device and a health IT company when we were first certifying EMRs in the US, and we had one of the first forty certified. And I was in charge of all product development and health IT. And in doing all of that, and working at it over the years, I always worked with different advocates and scientific societies. Because honestly, the science really does drive what happens in guidelines, in policy and in access meds and devices for patients. In doing this, I worked with many large pharmaceutical companies as partners. And I was eventually asked would I come to Bristol Myers Squibb to work with the advocacy and policy which was housed in Medical Affairs. And I know that isn’t the norm for a lot of companies now, but when you think back when you’re working with your scientific societies, I think it goes back and forth between external affairs and Government Affairs. And then really where the focus of the company is at that time, so I did advocacy and policy for Bristol Myers Squibb. Some of the medics that I worked with and one in particular, moved on to Sanofi and brought me on as the Chief Patient Officer for cardiovascular to really build the strategy around the globe: on how we would bring innovative medicines to patients. After that role, I was asked to come back to North America to work with the team as they, too, were reorganized, and took five disparate groups. And we’re really building their medical capabilities in North America in diabetes, cardiovascular, and then, which also included established products. So, it was an exciting time. As you can hear, I like change, and I enjoy building these types of teams. I was in that role and was then selected to move into the Chief Medical Office about two years ago to really build the medical team for the future, and I’ve done that for the last two years. I’ve just recently left and started my own business in Heim Global Consulting.
Peg Crowley-Nowick 5:58
Meg, that’s a really interesting history of your journey, and it also ties back to our podcast from last month where we met with Zhen Su. He was talking about how important it is to walk in the shoes of other functions in the pharmaceutical industry; to understand how you really affect the business; and your story fits so perfectly with that. I don’t want to take us off track from the purpose, but I also thought the statement about having worked in advocacy is so important, and that it was part of Medical Affairs. You see today that many advocacy groups in companies are not part of Medical Affairs, I think it’s a loss. I think that bringing the science and the medicine into the advocacy piece is an important piece of how you could advance Medical Affairs, but I know that’s probably a topic for another day.
Meg Heim 6:50
I think there are some groups that are really being very progressive in how they look at advocacy, and looking at the scientific societies versus the non-governmental organizations and patient advocacy groups, and where are they in the lifecycle of a product. Are they in R&D? And do they have advocacy at that point? But really spending some time being thoughtful about the scientific societies, and where medical impact can really be shown, and where you have the opportunity to align your strategic initiatives with those of the scientific societies of bringing medicines to their constituents and the patients they serve.
Peg Crowley-Nowick 7:41
I think that’s another topic we could dig into at another time, much deeper. But before we go on to our topic of impact over time, could you describe the aha moment when you realized the potential impact that Medical Affairs could have?
Meg Heim 7:58
When I went to work for my first pharmaceutical company. We had a product that was coming third to market, and it was just exceptional science. I really looked at it, and I thought, wow, this is amazing. This is amazing. And then my mom’s friend got sick, and they called me from the hospital to say, you’re always talking about how great the science is, this is what’s happening, and what’s the name of that drug? And he got it. And when we had one of our first meetings with commercial and medical, he came as one of the patients to tell his story, and I got to interview him. I also got to dance with them at my mom’s 80th birthday party. I think through the things that you look at the business of healthcare, and then you realize we’re all consumers of health. And if we have a piece to play, where we can actually communicate science in a way that people understand, not in big white papers, not in scientific forums, which we all, we just do great. But at the end of the day, is the right patient at the right drug, and does it extend their life and quality in a way. If I can do that in a Medical Affairs standpoint, then that’s the best advocacy in the world. Because I started out as the nurse to really make an impact with patients, and now I can do it in a much broader way, and I’ve had the opportunity, and people have trusted me with their products. So, it’s been great.
Peg Crowley-Nowick 9:57
It’s a powerful story and one that I think a lot of medical affairs professionals will be able to tell themselves and understand how you’re thinking about this. So, let’s now transition into what does Medical Affairs have to do to demonstrate their impact? What does it mean to you when I say, “Measuring impact over time”? These are words that you’ve used with me many times. …And how does that resonate through an organization?
Meg Heim 10:28
I think from a Medical Affairs standpoint, it is a very important piece of the pharmaceutical puzzle. Okay, I think that Medical Affairs is not a support organization. Medical Affairs leads the scientific story. Medical Affairs also needs to be able to speak in a language that their commercial counterparts understand, and they need to understand. As I said before, you know, you are a medical, it’s not just a commercial group, that’s an extension, it truly is a working partner. And I think that you can have firewalls, you can maintain your independence, however, you need to be aligned on scientific strategy.
Peg Crowley-Nowick 11:34
If I have a strategy in hand, now, I have my goals; I know what’s important to us and why we’re doing this; and I have tactics worked up to go after the strategic levers. How do I then measure impact?
Meg Heim 11:53
The first thing is when you present your strategy, and you negotiate your budget. Are you on track? Are your milestones and timelines? With R&D, and commercialization and market access? What do you have to offer that team? Are you allowed to go out and speak with payers prior to launch? Do you know the timeline of the formulary contracts and discussion? These are all items that medical can be so well ahead. And, you know, it’s kind of the language of love, as they say, because you are speaking the language of everybody else on the team, and you’re thinking much further than just medical. But what can medical do to support that? So that’s the first component. Do you have your KOL’s that were in R&D? Are they now being identified? And your Key Opinion Leaders planted? Are you pulling that through? Are you working with your R&D people? No need to start from the beginning. These people have been working on this product, so why not bring them to your field team ready to go, educated, knowledgeable and really, influencers? Whether it be for access, approval, or regional. Something not to be missed. Once you have all these items aligned, you’ve built your milestones, you have your budget, keep an eye in case things change. Are you going to be going to congresses? Also, what’s happening competitively? Are you first to market? Are you third to market? What congress strategy do you have in place, and who’s presenting data before or after you? All of that knowledge and insights are very important, but they’re not just important for you. So, you need to build a feedback loop, so that as you get this information, whether it is two questions that you focus on a month or three, and then some open dialogue. And then how do you take the funnel of information down and distill it in a way that is feedback on the strategy? What you’re hearing what’s going on in the marketplace? Do you need to pivot? Does something need to come before something else? Did you run an IME program that confused the market? You may have run it in three cities. I would say that what we also did with all of these different strategies and tactics was working with our vendor partners. Okay, so we have consulting partners. No company has enough people with the right talent to help from day one and understand every one of these pieces. So, make sure that your consultants become part of your team if you’ve worked well with them, and that they’re trusted—trusted by you, trusted by the team. I’ve worked with similar consultants at many different companies from med device and health IT all the way through Pharma. And I think that you’re able to bring in the pieces that you need at very important times, and support until you’re ready for a full-time person, or maybe not. You’re planning, if you do not have strategic people on your team, don’t wing it. Bring somebody in that can help you set your strategy. I also started to look at the impact over time. I looked at what else we already had in the company. Who was buying data on Key Opinion Leaders on? There’s a number of companies out there now. They can look across the globe, not just North America, and measure publications and how many times they’re mentioned. People did not have time for that on my team, nor was it an expertise. I brought another company in that was very good at it, and they became those people that measured our KOLs. And what they were saying at meetings, our data on publications, our scientific story, and was it resonating? That’s a big undertaking, and we had to get a lot of buy-in to do it.
Peg Crowley-Nowick 17:04
Meg Heim 17:06
Peg Crowley-Nowick 17:06
Once you have it set up, does it become something that easily runs in the background, and you can get reports regularly and be able to evaluate the impact?
Meg Heim 17:18
Yeah, I think there’s lots of reports. There’s so much data with the data lakes now of what every company has. We had amazing data. What we needed to do was to assimilate it into ten slides per product; that took a little bit more expertise that we decided was better through an outside company, but it does become very automatic, and so, you are measuring the same things. Three, six months. I’ll give an example. We had an ad board which we had our strategy, we had our medical planning; and the medical leadership and team said, okay, we want to use this doctor to lead it. We were able to go into the data and say, you know, when he’s speaking at meetings, he really doesn’t buy in 100% into our strategic imperatives based on what he’s said in print and at meetings. So, he may be a wonderful catalyst, but do you want him to lead your ad board? And if you do, that’s fine. Or he does not understand the scientific imperative and the data that you’ve been presenting. So, is this something? Does he need more knowledge and information? Or, you know, just let’s use the data for what it’s worth. And it really was a knowledge gap. That then the Medical Director, the MSL, and the Scientific Director met with him to discuss the data that he was often presenting. And quite, you know, he believed the data, he was one of the authors, but there were components of it that he was not fully knowledgeable about. We saw a shift in knowledge and education. So, I believe that really is where you can start to look at what happened. Was there information that wasn’t clear? Was there data presented in a way that wasn’t clear? We realized that our large datasets were not being understood. As the MSLs went out, now they do a wonderful job when they were looking at here’s the data following up. What happened? Did they understand it? And we realized that we needed education on HEOR and how to read the data set.
Peg Crowley-Nowick 20:07
Well, a really important point that you’re bringing across here is, there’s metrics to see if people are doing their job. And then there is impacting data that you collect so that you refine strategy so that you make better decisions. And all of the information that you’re collecting there is designed to find where you have gaps and what you need to fix, or what is really working. And I don’t see that I see so many people just talking about measuring numbers, knowing that we’re getting people out there checking boxes, doing what they should, but what you’re talking about is refinement of strategy, understanding where the gaps are filling those gaps, and then testing to see if it really has worked. And I guess I don’t see that very often. And yet, it’s really the heart and soul of putting together a great strategy, isn’t it?
Meg Heim 20:56
It is, and it takes time, it takes a lot of buy in. If you want to measure impact, you cannot measure it by how many times somebody has touched base with a key opinion. Okay, it tells you nothing. It tells you that you were measuring widgets and brainpower, I mean, medical teams are so knowledgeable. And I think the strategy component is learning how to provide information that also makes a commercial team comfortable with what’s happening, because they’re used to measuring, like, how many doctors a rep sees? Okay, so that is, that’s the full scope of, I see a rep — He sees fifty doctors, she sees fifty doctors, this is what happens. What we started to do is say what are the components that really show influence from a standpoint on scientific knowledge. And that is something of measuring how many minutes is the MSL with the physician, we were averaging 50 to 60 minutes. That is very different than a commercial interaction. When you start to get insights and feedback that change the brand strategy, that’s where you’re really starting to see the aha moments that a syringe needs to hold more product (because they’re using your drug for a patient that needs more than what was originally thought of when you first launched the product) that type of feedback—when you start to get feedback that influences what happens in brand planning. We also understood from our payer customers, because we had a field team that provided scientific exchange through formulary discussions. And we’re saying we need feedback, even though you know both groups are allowed in there under strategy as they’re talking about patient groups and data and not individual patients or customers. And we took our leadership to brand planning. They had never been there. And a couple of them were like, I had no idea that our insights were utilized this way. So now they’re sitting there with our market access partners. And that levels the playing field, because now they’re part of that same team that are providing insights and overview of what’s happening in the payer space.
Peg Crowley-Nowick 24:07
So, getting exposure, and recognizing how the business works in other areas is so important to strategic thinking.
Meg Heim 24:17
Yeah, I think that the in-house medical gets very used to the in-house. And even though you speak with the field-based teams, they don’t necessarily know your reality. So, when you say you’re having brand planning or you’re doing your budget exercise, they only know the part that they’ve been involved with. So, when you start expanding, start teaching strategic planning, and then really bring them into the business discussions, your leadership team. Those are aha moments, and it was an aha moment for me, because I thought. “Oh my goodness! You’ve been in this company for 15 years. You’re leading this team for us, but you’ve not been in that senior level brand planning budgeting conversation.” And so, what I would say to anybody is, if you can bring your team along, you won’t be able to bring all of them, but be thoughtful in your approach to grow your people to replace you. They need to understand budgets, They need to understand strategy. And they need to be ready to have a seat at the table when the seat opens up.
Peg Crowley-Nowick 25:40
Fantastic piece of advice. And I would say that when I started in the industry as an MSL, that’s exactly the type of exposure I was given. And my acceleration into learning the business and my ability to take on other projects and think strategically about what we needed to accomplish comes from the fact that someone took the time to bring me in and get me involved in exposure and teaching. And sometimes, I think today, we forget that because we’re all so busy, and we’ve separated field from headquarters maybe a little bit more than it was in the past. What a great conversation. I think there’s so much opportunity for Medical Affairs to really demonstrate their impact. I see the strength of the scientific knowledge that they have. I see a shift on a patient focus, on a data focus. And as the Medical Affairs organizations just grow in importance to pharma, all of the pieces that you’ve talked about making sure that the team has strategic thinking capabilities. Make sure that the technology is in place to work, so the team can actually collect the information that they have. Make sure that there are feedback loops to incorporate the data that you’re collecting. And then strategy is not a static document—there should be refinement. There should be an assessment to see if you’re on track with what you thought, what your plans were in whether or not the tactics that you’re doing are really getting you closer to your goals. And that’s how you measure impact over time for Medical Affairs. Thank you so much, Meg, it was fantastic talking with you today.
Meg Heim 27:19
Peg Crowley-Nowick 27:29
Zipher Medical Affairs is a full-service consulting firm dedicated to providing strategic services to Medical Affairs organizations. Programs designed by Zipher can help you recognize the most critical insights from your in-house and field teams and then capitalize on that data to develop strategic Medical Affairs plans, strengthen your engagement with thought leaders and build cutting edge data generation programs. Success in these areas allows the medical team to provide leadership and demonstrate maximum value to your brand and organization. Zipher Medical Affairs is here to help you. You can reach Zipher at info at Zipher med.com that zi P H ER med me d.com or phone us directly at 508-748-3007.