Peg Crowley-Nowick 0:33
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.
The ultimate goal for Medical Affairs is to lead during a launch. And this is a time that’s pretty stressful. But it’s also a time of high visibility for a Medical Affairs team. And it’s the one time you have to really demonstrate your value. I remember if I go back in time to an earlier stage in my career, one of the things that I was told was, you only get to launch once. So, if you only get to do something once, you better do it right. In order to think about getting ready for launch, there’s several different stages. One is building the Medical Affairs organization, doing the right planning, and then putting through the execution. Today I have with me Chris Keir, who is Vice President of Medical Affairs at GRAIL, Inc. And we’re going to talk a little bit about the stages of getting ready for launch, and what it means to really be prepared and what it takes to have a successful launch. So, Chris, it’s great to have you on today.
Chris Keir 2:16
Thank you for inviting me.
Peg Crowley-Nowick 2:18
Last June, we did a webcast together: accelerate launch readiness strategies to stay ahead of the curve. It was a great conversation at that point, very specific about some of the steps and things that you would do to accelerate a launch. Today, I think it’d be fun to talk about all of your experience in the different launches that you’ve been involved in. I know that you’ve been involved in a global launch, you’ve been involved recently in a pharmaceutical launch in the United States. And now in a diagnostic launch. That’s quite a bit of experience. And it gives you an opportunity to look and see what works, what doesn’t work. So, I’m excited to hear what your story is and to understand how you think about it as you’re entering a new launch.
Chris Keir 3:02
Excellent. Should I give a little background about myself?
Peg Crowley-Nowick 3:06
It would be great to hear about your background. Yes.
Chris Keir 3:09
So, I’m a Hematologist Oncologist, I was at Cornell and was working in a lab at Memorial Sloan Kettering. I’m actually also married to an oncologist. So, we talked about cancer constantly. And during my training, so I was at Georgetown, and then I was I worked at Tufts and at Harvard, you know, I got to see how some drugs were coming to market and how we can implement those drugs. And I think that really was an impetus for me to figure out as an oncologist how I can make an impact moving forward. So, you can do a footprint that is regional, or you can do a global footprint. And I was really excited about the opportunity to go to Novartis where I eventually was the head of Global Medical Affairs for their CAR-T Cell Program. And that was a true paradigm shift in how we treat certain leukemias and lymphomas. And from the Medical Affairs standpoint, there’s a lot of work that went into being able to train people and teach people about a new way to treat cancer that had never been done before. And so, that was a heavy lift for me. I think my “aha moment” of how impactful Medical Affairs could be, was when we met in July 2017, with the ODAC here at the FDA. So, that’s the Oncologic Drug Advisory Committee, which I know you’re familiar with. We had worked so hard to present data to this review board and sometimes the FDA requires us, and other health agencies require this to kind of see what’s the benefit of the treatment that you’re doing. And we had a twelve to zero approval from the ODOT Committee in terms of moving the CAR-T Cell Program forward. And for me, that was the aha moment of all the work that we’ve done and our ability to interact with people on from advocacy groups, to physicians to our clinical development team, and to be able to really tell the story, and relate the story and then create all of the resources to provide, you know, both patients and treating healthcare providers with what we were doing. I felt like had won. I was nervous, though, at that point, because I was only forty, then, and I thought, I hope I haven’t reached the pinnacle of my career in terms of innovation in what we’re doing. And luckily, I’ve been able to work with several companies. So, I was at another company called Array that was procured by Pfizer. And now I’m in a diagnostic space at GRAIL. There’s been a broad exposure to launches and how we move forward and what makes a successful launch. And I think that’s the exciting thing because I’m learning stuff every day to in terms of what are the best techniques for how you make things successful, and it really does depend on your audience and your space and your target.
Peg Crowley-Nowick 6:31
Which brings in the planning. Let’s just talk for a minute about your aha moment. Because one of the things that’s interesting about that, as some people would not think about Medical Affairs, as you’re entering into that ODAC presentation, and you’re bringing in the concept that Medical Affairs was involved well, before you reached ODAC. And how critical that was. Can you talk a little bit about the timing of when you were involved in Medical Affairs leading up to that? When did they bring it in? And what was the thought process around starting that?
Chris Keir 7:04
Certainly. So, you know, the one thing is when you’re told you have an ODAC, you’re on someone else’s schedule. But we had the supposition that since this was such a new paradigm changing in the advent of new treatment, that that we would have won. So, I would say eight months before we were trying to like collate things that would be helpful for us in terms of how we prepped for the resources that we need, et cetera. And you know, it’s a true partnership with your regulatory colleagues, as well as your clinical development colleagues, to be able to really make this come to fruition and for everyone to be prepared.
Peg Crowley-Nowick 7:46
It’s so important, and it will lead perfectly into our topic today, because so often I see companies trying to hold back on Medical Affairs, wait until you’re close to knowing that you are going to have probably a positive readout, you were ready to launch and then they’re trying to bring Medical Affairs on by the time everything gets up and going. It’s almost too late, you don’t get the advantage of what you were talking about in your aha moment.
Chris Keir 8:11
Yeah, and I, again, bringing Medical Affairs in at the very beginning is only going to make you successful, because we really are the bridge between development and bringing this to the public from a commercial standpoint. So, that bridge has to be constructed first, frankly.
Peg Crowley-Nowick 8:30
Absolutely build the runway. Without the runway, nobody is going to be able to take off and really have success here. So, we’ve almost made that transition from knowing about your background and your journey into Medical Affairs. Now into our topic. So, let’s just take a minute and let me ask you a question about the differences that you see between pharma, actually pharma, biotech, and diagnostics. Is there a big difference when you’re getting ready for a launch?
Chris Keir 9:02
You know, I think what’s interesting to me is what the regulatory constraints are between or even guidance, frankly, between diagnostics and the pharma world, you know, I think they’re different. They’re completely different territories, frankly, and the way we outreach in terms of GRAIL versus how we would do outreach in my past pharma experiences are different and also the audiences are different. And I think that’s really important is understanding your target audience and really, really demanding a very concise and granular target product profile. Because that’s how you weave your entire Medical Affairs strategy is based on that.
Peg Crowley-Nowick 9:54
Understanding the target profile, understanding then from there who your stakeholder is, then it defines means how you have to build your organization. And that might be the unique aspects between diagnostics and pharma or biotech.
Chris Keir 10:07
So, I would say exactly, it, when you think about if you have drug X, and you know what the audience is, and you know who the prescriber is, that’s, it’s very, it’s clean and clear cut. When you’re in the diagnostic space, there are multiple people that could use that diagnostic, right. And so, you automatically — the umbrella under that diagnostic becomes much bigger in terms of how many users there are. And they often need different types of resources or education, to be able to really understand and implement what you’re providing for their best use. So, I think that the audience for Medical Affairs in the diagnostic space can often be much larger than what you’d anticipate when you have a targeted drug X, that you know, who’s going to be prescribing it, and who you need to educate that drug about upon?
Peg Crowley-Nowick 11:10
Excellent. Let’s, let’s talk about what you think about when you’re entering into a new position and starting to build Medical Affairs. What are the components that you think are critical? What’s the order in which you try to build your organization?
Chris Keir 11:26
So, this, I think, is extremely important. You really have to optimize your Medical Science Liaisons, and have a strong team concomitantly, while you’re developing the MSLs. You need to, and this seems strange, but you need to make sure that you have a very strong med info that is prepared to deliver answers as you move forward. The MSL part, to me is interesting in terms of how you figure out where to map MSLs, where you need more MSLs, what the reasons are, et cetera. And again, it’s really product dependent, in terms of, are you focusing on academic institutions versus broad swaths of countries, etc. The MSLs are the face of Medical Affairs for the most part, right? And so, they have to be trained, and they have to be comfortable with the material as you move forward. But they also are critical for making relationships in terms of will we work with these institutions, etc., for clinical trials moving forward? And so, I think a strong MSL force is kind of the backbone of Medical Affairs.
Peg Crowley-Nowick 12:53
Chris, can I ask if we start with the MSL team, when you say strong, you mean, scientifically strong? Ability to speak? They’re the culture of your company, that that’s what everybody sees.
Chris Keir 13:04
Yeah, again, I do think it’s the face of the company. And so, you know, they have to have the scientific acumen. But they also have to have the gravitas of you know, not just recapitulating what’s been taught to them in a slide deck, it’s really being able to talk not only about the product that, you know, we are working on but the landscape and how that can affect why we differentiate ourselves, etc., but really understanding the landscape. And, you know, I think as people move in the last several years, I’ve seen how companies have somewhat tried to use medical science liaisons in a different fashion, necessarily, they’re really there as educators, and they’re really good at their jobs. When you get ones who know the data and they know the landscape.
Peg Crowley-Nowick 14:00
I have to agree with you that I see some, some organizations trying to change how they utilize liaisons. However, if good, solid, well-speaking, scientific liaisons are there representing your company, they’re the face, the culture, and they’re the driving force for people to have an interest in continuing to engage with the company.
Chris Keir 14:21
Peg Crowley-Nowick 14:22
And the engagement is interest in research, is interest in how to educate further. There’s so much to that that type of relationship. But as you said, it depends on the product that you’re bringing to market. So, you might need a broader group of liaisons in the field, doing different specific stakeholders is how I would think about it. Is that also the way you’re approaching it?
Chris Keir 14:48
Absolutely. And you know, the other thing that I have learned in my time in Medical Affairs is what are the metrics that you look at when you look at it MSL performance. And you know a lot of people in these large pharma companies, there are lots of boxes to check, etc. What I would say — to me, what makes a fantastic medical science liaison is when they reach out to a healthcare provider, they pick up the phone, and they call them back. Because they recognize the true utility of that MSL. And they feel like there’s a dialogue that they can have between the two of them. So, you know, I’m maybe a little bit different about other people who run Medical Affairs organizations in that those metrics, you know, of how many hands you shake in a moment, well, not in the pandemic, but how many interactions you have with health care providers, those numbers, they don’t mean anything, if they’re not impactful, and they’re not educational, and there’s not this dialogue between the two. So, yeah, I think that’s one of the differences of how I manage Medical Affairs versus maybe others.
Peg Crowley-Nowick 16:07
So, Chris, when would you bring on — let’s just say you’re hired early as leading an organization, and now you’re building the organization? What are we talking about? Are we talking about eight months? Are we talking about a year, two years before? What’s have you, you’ve probably seen it done multiple different ways. But what is the ultimate time to bring in a liaison team?
Chris Keir 16:29
Oh, a year minimum, you know, I think the industry standard somewhere, you know, because it takes a while to train them, etc., depending on what their backgrounds are. But I would say, a year before you launch — crucial, because also you want to, you want them to already have relationships with investigators and physicians. And you know, that also takes some time to cultivate that. So, I believe, at least a year if you want to be successful. Now, I have been thrown into companies where we had six months towards the launch, and then we had to double the MSL force, etc. So, you know, you can make it work, but if you were prudent, and you were thinking ahead, you would, I would say a year, that would be my rule of thumb.
Peg Crowley-Nowick 17:18
And I personally like the concept of having them launched at a year, which means you need that three or four months ahead of time to make sure you’ve hired and trained and get them out in the field. However, the MSLs are only as good as the tools that you have. So, they have knowledge, they can use those tools. What are some of the other functions that you’re looking for fairly quickly?
Chris Keir 17:41
Yeah, so as I mentioned earlier, I think medical information, having them on board and having a cohesive message from the tools that we’re creating, the tools that commercial’s creating, they are somewhat disparate, they shouldn’t be the same, you know, but having that info kind of watch everything. I think that that certainly is crucial. You can’t have a disparate message.
Peg Crowley-Nowick 18:10
Message, right? So, it has to be consistent across the organization, based on the science?
Chris Keir 18:15
Yeah, it’s imperative that there’s consistency across the organization, whether it’s your colleagues that are in government affairs versus other aspects of the company, who really have this consistent message.
Peg Crowley-Nowick 18:33
And I am going to go back to that as we start talking broader about the overall team because I think the thread that ties everyone together is the scientific data and the way that’s getting communicated. And lots of times, it’s not consistent, it’s very disparate across the organization, because someone hasn’t put a clear platform together of how you’re going to present that data. And I think that that’s an important question, but let’s just close out the section on thinking about the medical team itself and not only do you need MSLs, but you also need Medical Directors.
Chris Keir 19:13
So, you know Medical Directors are crucial for being able to go out and discuss the data as well as the MSL, so they are their partners, true and true. I would say that there are other aspects that you also have to focus on, that Medical Directors will help you with in terms of what the CME programs are, that that you’re that you’re supporting. And as well as the IST or Investigational Sponsor Trials that you do and the partnerships that you have with other academic centers. So, you know, everyone in Medical Affairs wears a lot of hats but the Medical Directors — you really rely upon them to execute on multiple functions. A lot of Medical Affairs also is in charge of health economics outcomes research. So, it depends on you know, the size of the company, etc. But you know, pulling those people in and really having a consistent story is something that Medical Affairs is in charge of, too.
Peg Crowley-Nowick 20:24
Excellent. How about scientific communications? Do you outsource all of that? Do you need somebody who’s the lead over that? Can that be handled by a Medical Director? What’s the best approach?
Chris Keir 20:36
Yeah, I think that that could be the Achilles heel for launch, if you do not have a really strong scientific communications team, you know, most companies and launches are a hybrid. So, there are internal people who function in that role. And then we work with agencies as well to do some of the grunt work. But in general, this is the — if you don’t have the data released before the time of launch, you have done a disservice to your company. So, I think making sure that the data is available and citable are keys to any launch success. And those are the people who make that come to fruition.
Peg Crowley-Nowick 21:25
Absolutely, and their planning is so critical. When we go a little bit further out thinking about patient advocacy, how do you see that crossover with patient advocacy? That’s not usually a function of Medical Affairs, but a critical piece of Medical Affairs engaging with patient advocacy? What are your thoughts there?
Chris Keir 21:44
Yeah, absolutely. You know, patient advocacy, that’s what helped change the paradigms of how we treat things. And I think a perfect example of that is the HIV world and how those medications were really pushed forward by health agencies based on such a vibrant patient advocacy group. So, you know, what I would say is that, from a Medical Affairs standpoint, you really need to listen and have meetings with patient advocacy and see what their concerns are. And you can adopt those into your own clinical trials moving forward, but also the educational needs that they require, and what are the resources, whether they’re electronic versus paper resource? You know, there’s such a broad gift to being a partner with advocacies that can really help you figure out your best way to educate as you move forward.
Peg Crowley-Nowick 22:46
So, is that your whole team engaging with patient advocacy? Or is it your Medical Directors leading that with maybe your communications?
Chris Keir 22:55
Historically, it’s your Medical Directors who are working with the advocacy groups, alongside sometimes corporate communications. And also, I mean, it depends on the scope of your company. You know, some companies have people that only focus on advocacy. And also, government affairs, can often, you know, partner with them to learn more as well. So, again, I think it depends on the scope of the product, but also the company in terms of it. But it’s a key piece that we have to be better at as we move forward in terms of really fostering relationships with advocacy groups and learning from them about what they need.
Peg Crowley-Nowick 23:37
So, we’re starting to see the team come together. And I think one of the key things to think about, and I often don’t see this is that hiring the head of Medical Affairs, and then bringing the team on is probably an important aspect in the timing. So, sometimes we companies move directly to MSLs and then work to find the head of Medical Affairs. But by having the person in charge, who has the vision and can see where this is all going can help to build the organization — Bring in the MSLs, make sure you have a strong scientific communications organization. You’re suggesting around medical information, that it’s a critical component, not only just from the call center perspective, but also from insights and thinking through how the communications and how the evidence story is told is what I’m hearing from you. Is that Is that what you’re saying about medical information, because some people think of that as a regulatory requirement, outsource it, and we don’t worry about them too much.
Chris Keir 24:35
You know, I think the mistake that many people make is that medical information is an afterthought, but it’s not I really do believe that it is the backbone of how we operate in terms of our interface externally with the information in the data that we have. One of the other issues that I have seen in the past is that people don’t use insight from both their medical information team and their medical science liaison team to really adapt, pivot, and make a change from the feedback that they’re giving. So, you get a lot of collation of data, but you don’t necessarily act upon it. And I think, you know, med info, they hear the questions that people are asking, and they hit multiple parts of the company, necessarily, but I think it’s acting, it’s collating, and then acting appropriately on the med info input is crucial for you to really succeed.
Peg Crowley-Nowick 25:39
Excellent. And I completely agree with you and I, I see that as an area that has great opportunity to continue to expand and to offer new ways of delivering information. So, I think it’s, it’s really an important area. Who leads your data generation program? Do you lead that from your level? Or do you lead that from a Medical Director level even though there are different parties involved in the different aspects of data generation? Who should lead that? How do you centralize that, so that you have consistency in a data generation program?
Chris Keir 26:13
Yeah, so you know, it’s a family, really. I do think that the head of Medical Affairs should lead that in terms of an IST or data generation program. But you know, it is with a constant dialogue with our clinical development colleagues and development colleagues who are already working on things. So, you know, you have to do things concomitantly; regulatory also needs to be involved with that. And then you really should have a strong relationship with your scientific colleagues and the scientists who are part of developing the drug or the diagnostic as you work for it. So, it’s a family, but Medical Affairs, in my past history is successful when they lead it themselves.
Peg Crowley-Nowick 27:01
And the timing of starting to think about that. So, you’re trying to get your MSLs in the field a year ahead of time, your medical information probably comes on closer to the time of launch. You have your scientific communications organization, probably on working, even before the MSL is over there. What’s the timing of thinking about a data generation program?
Chris Keir 27:23
So, it’s variable depending on the product, and also the risk and the population that you’re reaching out to?
Peg Crowley-Nowick 27:30
Yeah, when do you just when do you start thinking on a Medical Affairs perspective, about what our gaps are going to be once the pivotal data is complete?
Chris Keir 27:40
I think you should start looking at data gaps, the day you join the company, I really do think you have to look at the landscape. And to be successful in Medical Affairs, you have to really understand the landscape and see what’s needed, what’s available, what’s feasible. So, I would say, even at least a year before launch, but in the perfect world, you would start looking at data gaps a year before launch, two years, even if you had that luxury.
Peg Crowley-Nowick 28:15
Yeah, well, I think that luxury becomes pretty important. I know, it’s a big investment for companies to make in Medical Affairs. We’ve done a great job of describing the Medical Affairs organization as you’re going to build it, in the timing that you’re going to try to put that together. I know that may seem unrealistic to some smaller biotechs, who are waiting a little bit longer to get their Medical Affairs organization in place. But we’re trying to talk about what would be the ultimate situation to build that runway. So, if we transition from building the organization and the timing of the organization over into execution, what’s one of the areas that’s the most important from your perspective, in a piece of the execution?
Chris Keir 28:56
Yeah, you know, I do think using the insights that come to us are extremely important. You know, Medical Affairs — I often make this metaphor is that it’s a barge, not a skiff. And so, if you need to pivot, you know what, it takes a while for you to do that, you know, in terms of this is the data that needs to be generated, or we have to put this out there. And so, I think, making sure that you really do have your ear on the ground in terms of what the insights you receive are coming in and doing something with them. I think that is what’s so crucial, and they can come from many different aspects of the company. But you know, our MSLs really do see things immediately and do get feedback immediately. So, I think that, and making sure they procure that is crucial to success as well as the insights that come in from that info. You know, that can help you pivot your scientific communications and your publications based on you know, the questions that people are asking that you might not have realized, were a blind spot for you in the company. So, I think making sure that you really listen to what’s coming in and do something with it will make you successful.
Peg Crowley-Nowick 30:16
And how do you approach that?
Chris Keir 30:18
So, in my current company, what we do right now is we have an insight team. So, things are collated, brought to us, we kind of rate them in terms of what’s prioritized high versus low. And then you know, we spread those through the company in terms of maybe this is a different direction we should go for, or maybe these are other resources that we need to do. Or maybe these are the populations that we have to educate upon. That happens in a biweekly cadence right now, I think what’s most important is when you first launch a product, or a diagnostic is that you keep your ear to the ground, immediately, you don’t necessarily pivot because the in is very small there. But you need to know what the feedback is initially, across broad populations. So, I would say that the insights at the very beginning of the launch are crucial in terms of what you’re doing right and what you’re doing wrong. And where those educational gaps are.
Peg Crowley-Nowick 31:27
A couple of important points that I hear you saying is, watch the trends, you don’t need to act on them immediately. But you need to make sure that you’re tracking them that people in the company, the people out in the field, who are your boots on the ground, know what the trends are, what you think you’re hearing, so that you can really validate those before you act on them early in the launch. But that that’s a critical piece. I know, we talked, we’re talking about launch, but insights are such an important aspect of what goes on in Medical Affairs and, and how you look at those over time of the lifecycle of a product is critical. So, that early cadence that you’re talking about is so critical, not necessarily the same after five years in the market.
Chris Keir 32:10
Yeah, and you know, Peg, one of the things that I think is important is that, oftentimes, in companies, people don’t want to relay negative insights. But those are crucial as we move forward. And they, you know, the CEO, and the CMO and all those people, that’s our job in Medical Affairs to relay things that are problems. And innately a lot of people don’t want to call out problems, but I think to do a really good job in Medical Affairs is to make sure that that you’re highlighting things that are issues, and you feed that up throughout the company.
Peg Crowley-Nowick 32:47
Absolutely. And do you use advisory boards, then to validate maybe some of the things that you’ve heard in the field as insights?
Chris Keir 32:55
Absolutely, I think advisory boards are crucial to a company’s success. That being said, I’ve often seen people pick participants and advisory boards, who are going to only give positive feedback. And I think that’s really, there’s an art to seeing, who attends an advisory board, depending on the topic. But I think you really want honest feedback. And then that comes back to you know, really being transparent about what you’re seeing on the ground. And so, I think that that’s an important aspect, too. Advisory boards are extremely crucial, but make sure you don’t have everyone who was an investigator in your trial.
Peg Crowley-Nowick 33:39
Right. Really look for advice, rather than just the pat on the back that you made it and you’re, you’re successful here. So we go from insights, validation, incorporation into your strategy as the year progresses, and continuing to execute on the launch. Some of the things that you’ve talked about are really critical for that statement that I made in the very beginning, as you only get one chance to launch. And if you don’t do it right, you’re going to have a problem. So, it really does depend on building the right team, doing the planning and timing. And that timing is important around when you build the team. When you get them out in the field. When the data will be released. You can’t miss those data releases, how it’s going to be presented probably in congresses. And then once things are up and going, making sure that you’re really paying attention to the insights in the field. And doing that not because it’s a download from a computer system. But because you’re really thinking about what comes in, what those trends are validating them and then making the pivots as necessary. If you really want to have a successful launch, those are some of the key pieces of making it work.
Chris Keir 34:46
Peg Crowley-Nowick 34:48
Chris, it’s been fantastic having a chance to talk with you and discuss something that I think is really important because there’s so many small biotechs out there right now, in phase three, getting ready to think about what it means to launch how to build their organization, how to put into place all the process and hire and what do we need to do. And there’s so many aspects to it that just hearing from you that one, it can be done, too. It can be done in and there’s some pretty good easy steps to follow is a great help. So, thank you for joining me today and going through this topic.
Chris Keir 35:23
Thank you for having me. You know, I do believe that Medical Affairs is so extremely impactful as we move forward and we’re changing people’s lives. And it’s an exciting space to be in.
Peg Crowley-Nowick 35:34
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.