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[Colin Miller]

Hello, I'm Colin Miller, CEO at the Bracken Group and this is Fractals: Life Science Conversations. Bracken is the professional services firm for life sciences and digital health organizations. Our intelligence ecosystem fulfils consulting, regulatory, marketing and analytics needs with an integrated and strategic approach.

 

In today's conversation, we're covering a global range of strategic marketing, international business, growth, profitable program building and communicative leadership. And I'm delighted to be joined by Mary Costello, an expert in all of the above. And I'm also delighted because Mary and I go back in our careers about 25 years, so Mary tells me, and I remember the first time we met and collaborated on a project.

 

So, it's really a pleasure to have you here, Mary. Your career is highlighted by international and domestic team leadership, patient advocacy directives, global marketing initiatives and clinical trial solutions. Your past roles have included head of site and investigator network at Medable, the vice president of clinical development and patient advocacy at Elego Health Research, vice president and global director of marketing and e-clinical solutions, Fisher Clinical Services and Covance.

 

And you're now working, I believe, at Evinova as a strategic marketing consultant. Welcome to the program, Mary.

 

[Mary Costello]

Thank you, Colin. Delighted to be here.

 

[Colin Miller]

So what do you think what’s shifted along with the industry’s growth, or maybe some things that have stayed the same?

 

[Mary Costello]

Well, I think what shifted, what hasn't shifted maybe are some of the problems still.

 

We're still dealing with timelines, recruitment, patient recruitment remains at the top of everyone's mind as long as I've worked in clinical research. And I don't know if this is the problem we'll solve in my lifetime or just approach it differently. I think from a marketing standpoint, the principles have remained the same, but perhaps deployment has changed most markedly influenced by two things.

 

I think the accessibility of more data, so you can make more data-driven decisions than you could in early on. And of course, digital, you know, if you told me 25 years ago, how much of what we spend our time in has gone away and gone by the wayside, and we don't even use those kinds of mechanisms for delivering messages would have saved me so much time and it would have saved the world so much paper, I think. But so, some of those changes are really good.

 

And some of them I think are perhaps because it can be deployed so quickly. Sometimes I see less thought put into it's a little more spaghetti at the wall when you're not going to have to commit to print runs and production, when you can just put, you know, a message out overnight and see if it works. And if it doesn't, you just take it down and go on to the next one.

 

And there's pros and cons to all of that, right?

 

[Colin Miller]

Yeah, there are. It's the same way you used to have to make slides up two weeks before a presentation because they'd have to be sent off to be made up. And now most of us are making them on the flight to the meeting.

 

[Mary Costello]

And unless you work for a company that wants them to—be go through a review process. That's true. That is very true.

 

[Colin Miller]

And I guess in that respect it hasn't speeded up much.

 

[Mary Costello]

No, and I think the way decisions are made still largely remains the same, which kind of defines when you look at this market, at least where I've always been on the service side, you have to understand the purchasing process. And we have a complex, you know, purchase process because it's made by a committee. It's… expensive decisions, and they take a long time. I don't think that's changed.

 

So, we're still operating. We're still playing tennis with a net. We just may have, you know, more technology in the tools we use to play the game.

 

[Colin Miller]

Yeah, probably a slightly higher strong racket. Let's hit that analogy. So interesting.

 

So how do you think in a marketing perspective, we can enhance clinical operations and site management in the current landscape, especially as we now navigate past a COVID-19 world and transition to an area where AI plays a significant role?

 

[Mary Costello]

Well, AI is so interesting to me because it's a little bit like that old expression, a drug in search of an indication. There's something that exists out there that we all have a feeling… will make things better, but how we do it. And so, it's a little bit like everybody wants a little AI used in what they're doing.

 

I certainly see efficiencies and help with scaling. So, you can reach decisions faster. You can get to a first draft of creative content.

 

You can have a lot of insight into what works and what didn't. And I think that's one of the biggest accelerators to all of that, which sort of answers your AI question a bit. But I think on how it can help clinical operations or patient recruitment; I think the marketing perspective is always a useful one to bring.

 

You have to understand who you're trying to reach. So patient recruitment requires a bit of marketing, doesn't it? You have to message.

 

You have to understand barriers. You have to gain trust. You have to do more than generate interest.

 

You have to initiate an action. And so I think trying to understand those gaps before you just reach out and start messaging and trying to recruit is time well spent. And I think people on your marketing team could always help the clinical operations and patient recruitment as they think through strategies like that.

 

I've always felt it was such a help in my career to get so close to what it was we actually did and to spend most of my time with the operations and kind of the thought leaders in the business, because they were a representation of the customer themselves. Listen to the way they talk about what it is they do and why it makes a difference is kind of the inverse of what the customer will hear. You know, and see, I started my career in this area in CROs, where you often just mirrored the pharma team by a concomitant one on the side of the CRO.

 

And so, if you talk to the scientists at the CRO, they were largely thinking how the ones at the pharma team were doing in the same way with operations. They understood inherently what the pharma operations wanted to do. I think what kind of got in the way sometimes was the procurement and outsourcing mindset, which had its own objectives in there as well.

 

But back to what we're really offering, which is at its core, something that has to be appreciated by patients, by investigators, by the operational and scientific staff. And when you don't have that, when you can't articulate that, that should give you some pause. And I think that's one of the things that's happening with tech sometimes, is you have a lot of people coming from outside the industry, which is great, new ideas, new energy.

 

But they have an idea they have so fallen in love with that they've forgotten that there needs to be a problem statement associated with it. So, here's an example I've seen, so much data mining of patient databases to identify the right patients more quickly, whether it's EHRs, claims data, pharmacy data. That is great.

 

We have a list. We have a solid list in a way we didn't used to. Remember when we were using IMS and getting down to kind of zip code and prescribing levels.

 

Now you actually know who that patient is, or you know you have a bridge to there. But the bridge is the important part. Knowing the patient is really helpful, but unless that information can be turned into an action, we're still maybe not that much closer.

 

We're just at the same point with a better list. So those are some, just some random thoughts, I guess, around marketing and the intersection of marketing and ClinOps and patient recruitment.

 

[Colin Miller]

Appreciate the insights there and pick up on a couple of points. You're absolutely right with respect to you. You go back a few years and being a scientist, I could build the perfect experiment in a clinical trial and write the full protocol, but didn't think about the patient, of course, in that because I was the scientist.

 

And your point is well made that, you know, CROs in those days reflected the people like, you know, who are on the pharma side and we build out the perfect protocol and we didn't become patient centric. And I think that aspect is really key. And although we see and hear the jargon going around on it, don't always think that that's followed through as much as it could be.

 

And I think your point about the large data sets now speak to that yet again. It's the data software teams that have got it and haven't thought about at the end of the day, it's a human at the other end, not a number and a piece of data. And I wonder how we break that down further.

 

I wonder, as you're looking at the process, how do you think about the patient and their patient journey and how to message correctly to them?

 

[Mary Costello]

Well, I think you're going back to your core point. Patients are people with complex lives. And I think sometimes we're always looking for the silver bullet.

 

I think maybe that pursuit of the silver bullet is what drives advancements. But there's so much human involvement and complex human involvement in people's, you know, health and personal lives and the reverberations there that it is, this isn't like as simple as a consumer decision, right? And I think a lot of principles have been brought into the patient journey map as kind of a one and done.

 

It's a great start, but we're not selling products that you would find on the open market. We're really selling an experience and a frightening decision and an impactful decision. And I think I worked a lot of years in DCT recently, riding that kind of tailwinds of COVID.

 

And everybody, I think, early on was convinced they'd crack the code. We're just going to do this in our homes. We're going to move televisits.

 

Medicine is going to be delivered differently, connected devices and sensors, and watch the tidal wave of patients start to enroll. It didn't happen. Still, we're tracking whether or not, are we getting different patients?

 

Are we getting the same patients? Are they happier in their studies? There's all kinds of information and things surrounding that.

 

But I think inherently, we forgot a little bit of that human connection. And so we had a site advisory council at one organization. And as we talked about the future in this brand new world, coming out of COVID, she said to me, my patients have been home for two years.

 

They visited with their grandchildren over Zoom. They've done family reunions and high school reunions over Zoom. They haven't left their homes.

 

They are dying to come back into the site. Well, that's an inconvenient truth, hitting those beautiful patient journey maps, right, of the future. So, I think part of it, we need to do an awful lot of verification and maintain a flexible model.

 

When we think about this, what is going on outside of our clinical trial? What's likely to go on in people's lives or their communities? What's going on in these macro issues, like when we had a global pandemic?

 

And how does that affect it? Instead of kind of, and also the decision that one patient represents a patient. And I think the DEI community particularly feels a little bit insulted by this, that if you get the feedback from one member of an ethnic group, that there's not any divergence there, whereas there's just as much divergent within a certain community as there is with patients as a whole.

 

And I think the main thing is that we should not aim to lock this, set this in stone. We really need to see that as a very fluid and dynamic process.

 

[Colin Miller]

I couldn't agree more. Bracken, actually one of our consultants, has been involved in the recruitment and engagement space. And I think they've mapped out something like 80 or 90 steps in sort of the process that patients go through when they're involved with some form of clinical care.

 

I presume you see the same thing and the challenges, where are they along that journey? How do you impact it positively? And that has to be a challenge.

 

[Mary Costello]

It is a challenge, I think. And, you know, there's also the challenge as we move into the next phase, that everybody's home situation isn't the same. So a lot of what we're going to do in the future relies on connectivity.

 

I mean, that's still, we're a fairly developed nation by most standards, but there's large parts of this country that don't have reliable access to the internet. And I think we're even shocked by how many people still don't use smartphones. Yet all these solutions are kind of predicated on that is the majority of the country.

 

So are we actually creating a new level of bias by creating solutions towards people that are able to afford a certain level of tech or comfortable with a certain level of tech? So I think the more we advance, it's sort of that step forward, step sideways type of thing. And I think we always need to be checking our assumptions on this, the same way you as the scientists are designing the protocol in absence of the feedback from the patient.

 

[Colin Miller]

Yeah, it's a very good point. It begs the question, should we be going back to paper diaries?

 

[Mary Costello]

Well, I think what we should do is not exclude people because either we have a provision for the tech and the training and the support, because it's not just one and done. Or we should understand, I think any evolutions require a great deal of flexibility. And what's our goal here?

 

Is our goal just to meet enrollment and certain population and then we'll figure the rest out later? Or to try to really design something that is more inclusive?

 

[Colin Miller]

Sort of going back to something we touched on at the beginning of this discussion and chat was AI. And it's the big topic, of course, at the moment. Where do you think AI is going?

 

Do you think it's too much hype? Do you think it's something we're going to use in clinical trial research? Or is it sort of it's here to stay and we probably milked it so far for maximum benefit?

 

What's your thoughts?

 

[Mary Costello]

Oh, no, I think we're only at the beginning of this journey. Maybe how I would use it right now, rather than just, you know, it was like, I think both DCT and RBM kind of hit this hype cycle a little bit. And there became kind of corporate initiatives just to get more RBM used in studies, to get more DCT deployed in studies.

 

And I think right now it kind of feels like let's use more AI in our process. The question is really optimally where? And so, I think everybody's trying different things.

 

I might start at either the site or the patient journey and say, let's look at every stop along this pathway. Is there a role for AI? And what do we think that role is?

 

Do we have a track record? Does someone have a track record out there? And let's try different things.

 

I think we're completely at the point of experimentation. The problem is, as we kind of referred to earlier, Colin, is that it's a risk-averse industry. And we have a lot of legal agreements and audits and other supporting processes to solve before we just turn over data.

 

We have different data restrictions depending on where that data will be used and how it will be used. So, it's not as simple as bringing someone in and throwing a trial at them. There's a lot of stops between here and there.

 

But I think we're scratching the surface. I love how much time it can save in terms of analytics. And I'm sure you're seeing this a lot in your work.

 

And also, in creative. I mean, I think, but it's not, I don't feel like it's replacing humans, and it wouldn't get to where it is without having been made smarter by the contributions of the human thinking to it. It still needs a lot of curating on the final end.

 

But I think if we can figure out kind of the scope of possibility and where the biggest gaps are, we could redirect teams and spend a lot more time there. And I'm thinking in patient recruitment, for me, this is sort of one of the biggest opportunities to figure out both patient identification. And then as we develop our campaigns to outreach, what's working really quickly and then leverage that going forward.

 

[Colin Miller]

Again, changing topics a little bit. If you were given something like $100 million to invest in industry or society, where would you invest it and why?

 

[Mary Costello]

This is such a great question. And you, full transparency, you sent this to me ahead of time. So it's not an off the cuff, I got a little time to consider this.

 

You know, in a global sense, I might say sustainability, because it's near and dear to my heart. Love the natural world, love to see us do what we can to preserve it. Saw changes happening in my lifetime.

 

But I'm actually very pleased right now to be working for a division of AstraZeneca who has a corporate commitment to sustainability. And it's going to take a lot, maybe more than $100 million. But then reflecting back, I thought, so if it's not just that, where else do I feel like I could see a difference being made?

 

I think in patient recruitment, which is the theme a lot about what we've talked about. And something I've always felt, the shortcomings are, is that we spend all this time bringing a drug to market. When it comes down to an individual trial, it's kind of a rush.

 

Once the protocol is confirmed and approved, it's off to the races. And everybody wanted to be more thoughtful or spend more time, but the clock has started ticking. And I think if we have some better pre-competitive collaboration in this industry to really help educate people about the benefit of research, far more than, it's not that nothing happens, but it's largely happens in pockets.

 

And it happens through resources dedicated to therapeutic areas like oncology, where somebody's life is on the line and clinical trials become a very viable option for many patients. But for chronic conditions, it's not kind of thought of the same way. And one of the most disappointing things I saw come out of the pandemic is actually with all the attention to the clinical research process, which I thought might accomplish this in and of itself, as people were home and paying more attention than ever before, mistrust in research and the process actually rose instead of declined.

 

And so, I think that's the other side of maybe the dark side of AI and information sharing is so much misinformation can very easily be shared. And it does bring to mind that whole saying that, a lie can travel around the world before the truth even puts socks on, pants on depends on what culture you come in. And I think the sensational nature of some of the news that's shared, it gets back to sort of human behavior.

 

People read something more sensational than just a nice story. So I think this information needs to start early. I think it needs to be ubiquitous.

 

I think it needs to be wherever we can meet people, whether it's at your Walmart, whether it's in your school, whether it's at employers in general. And part of that is preparing, it's like marketing, you have to prepare the ground so that when you drop the seeds, there's a willing and informed audience. You can't just hit people with a billboard and change their mind.

 

I think medical school and infusing physician's offices with a lot more understanding. So many community physicians I talked to say, I think a clinical trial is a good idea, but I have no idea how to access it. There was a great series put out by an emergency room doctor that recently lost her husband to cancer.

 

And she was publishing, I think, maybe on a Substack. I'll have to go back. Beth Stillman, if you hadn't seen it.

 

And it is a way of capturing how tough for her as a physician to figure out not just where to find the trials, but then which trials, where to go in. And then I think one of the most disappointing components to that story was even if she found everything else that lined up, she would contact a site and be told we've reached our threshold. Sorry, we're closed to recruitment.

 

And so I thought, well, if we could change one thing about clinical research, could it be that we don't have those thresholds that somebody will always intervene and lift it to make, because make it matter for a patient. So, $100 million, again, a drop in the bucket, but I think we could go a long way to really making a difference in an area you and I and many others have spent their entire career hoping to see improve.

 

[Colin Miller]

Yeah, very insightful. Perhaps that really goes back to where we started, where things moved and changed and not moved and changed. And your point is brilliantly made.

 

Well, thank you. And thank you for being your authentic self right the way through for the many years that we've known each other. Really appreciate it.

 

But no, that was a wonderful insight. And thank you for being here today and spending your time with me. Really appreciate your insights, Mary.

 

[Mary Costello]

As always, it was a pleasure.

 

[Colin Miller]

Well, thank you.

 

Fractals is brought to you by Bracken, the professional services firm for life science and digital health organizations. Subscribe to Fractals via your preferred podcast platform.

 

Visit us at thebrackengroup.com or reach out directly on LinkedIn. We'll be delighted to speak with you. I'm Colin Miller wishing you sound business and good health.

 

Thanks for listening.