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Joseph Kim:
Welcome to Clinical Research Confidential. On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health. But it’s not for the faint of heart. And so, on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
Hi, everyone! I’m so glad to be here with Michelle Shogren, who has a very interesting career over clinical research and has actually seen it from all sorts of different angles like me, but maybe more so because you worked at a site. Michelle, first of all, welcome to the show.

Michelle Shogren:
Thank you so much. I’m excited to be here. I love listening to your episodes, so it’s cool to be in this seat.

Joseph Kim:
Yeah, no, I’m excited to interview you because we’ve known each other for a while, but I’ve never actually been in this role of interviewing you outside of just talking to you as a normal friend, I’m excited about this too. So let’s start first with your career, because you’ve done so many different things in this industry, but you weren’t, as they say, you weren’t born with a silver spoon in your mouth. You started out at the, at boots on the ground, working at, as a clinical research coordinator. Tell us about that experience, how you got into that role, because a lot of people just end up in it by accident.

Michelle Shogren:
Yeah, I was actually working in an internal medicine office just as a regular nurse and seeing my patients and having a lovely time with that, and very rewarded with the fact that I could help the people that were sitting in front of me have a better life and better health and interactions, it was very rewarding. And I fell into research because I had heard that there was an office upstairs that was doing clinical trials, and I brought that to my doctor and said, hey, I think this could be a good option for us, it’s a chance to offer more opportunities and choices for someone’s care, and also, it’ll make us look innovative, which has always been something that is part of my core, to say, hey, we’re cutting edge, we’re looking at things that are out there and that are new and coming; and it was another way to have a revenue stream coming into the office, so I thought, okay, that’s a win too. And we decided to go ahead and go down that road, and we created a site and got our first study in and did a really great job, and we were able to get more studies. And I was with that office for several years until I had to move, and I moved from Atlanta to California, and I lived in Northern California, and I decided, okay, this research thing, so, I actually started out looking for research instead of looking for nursing; and part of that was because I had a patient in a GI study and it was for irritable bowel syndrome, and I had the most moving experience ever from that study because she called me crying one day because she was so happy she was able to go on a hot air balloon ride and she never thought that was possible because there’s no bathrooms on a hot air balloon. And I thought, how amazing is it that I could give somebody this experience? They would have never known that there was a clinical trial out there. They had struggled and struggled with the current treatments available, and now they were able to go into this study, and they felt confident enough after six months on the trial to make this leap of faith, because there was a leap of faith, to be able to do it. I was like, this is where I’m meant to be. I have to be in clinical trials. I have to make a difference for people like this. And so I moved to California, I continued working in clinical research, and I did that in two different sites out there in different roles. I became a site director and a marketing director, as well as a coordinator trainer, I was training medical assistants, how to be coordinators, and also just an actual coordinator myself. So it was a very rewarding nine-year chunk of time.

Joseph Kim:
Yeah, wow, that’s nine years is enough for you to become an expert in almost anything. I would say, by all accounts, nine years makes you an expert in clinical research context, certainly at the site level. Two quick questions, though. What was surprising to you when you did that first trial? Because you never forget your first. Was it all that you had expected? What were all these different? Because this is very different from nursing, from actually delivering healthcare.

Michelle Shogren:
It was very different. And in nursing, you’re always trained anyways, if it’s not documented, it never happened. But the amount of documentation in a clinical trial, holy guacamole, there was so much of it, and then that was still back in paper CRF days, and the ripping parties, that was my favorite. Like, we got to the point where I could give them these case report forms, and we would rip all the different parts, and everything was a whole lot, such a feeling of success.

Joseph Kim:
One thing, real quick, by ripping, you mean the pink-yellow-white, yeah, separate, so people don’t.

Michelle Shogren:
… take them all apart. And then we kept some, and they got some, and things went to other people because we had it, we were with the CRO, so CRO got some and sponsor got some, and it was great. But I think that the other thing that really surprised me was the amount of lack of understanding of what life is actually like by the CRO, in my opinion. I didn’t really understand it was from the sponsor level at that point, and I just blamed the CRO. Like, why are they getting so uptight about these visit windows? What does it matter that was one extra day out of window? Or what does it matter that they missed one pill? The grand scheme of things, I’d probably miss more than one pill in my day-to-day vitamins, so why are they getting so uptight about everything? I had to learn and understand and really have a lot of whys explained to me before I completely embraced it. And some of the things they did was just like stupid to me, I thought, who designed this? Who planned the order of activities that we’re doing? Because it’d be so much better if it was done in a different order, but you had to time-stamp everything, and I’m like, I want to do it this way, but I have to do it this way. So yeah, the amount of rigor was surprising.

Joseph Kim:
And not to jump the gun, but how much has changed between those days and today? Because, to foreshadow the audience, for people who don’t know Michelle, she ended up moving into sponsor role. And we’ll get there in a second, but first, yeah, how much has changed?

Michelle Shogren:
Unfortunately, not a lot. It’s amazing how much that, I got into the point, when I came over to the sponsor world, I was really championing the site because I was thinking, after nine years, I always felt like the site voice just wasn’t heard enough. And I was always like, do you know what it’s really like at a site? You understand what they’re doing, and they’re not just doing your studies? Surprisingly, so much hasn’t changed, but there’s only been like more complexity added, in my opinion. I don’t know that we’ve really removed a lot of the complexity yet.

Joseph Kim:
No, yeah, no, we haven’t. And in fact, if I had to place a $100 bet, I would bet that it would, it’s going to get more complex than simpler, which is sad. We need other things to simplify if we can’t simplify at the root cause, for sure. So let’s jump into the next chapter of your career. So then you moved to Bayer, is that, no, maybe you went to a CRO first, and then you went?

Michelle Shogren:
Yeah.

Joseph Kim:
Yeah.

Michelle Shogren:
I had to move from California to Saint Louis, Missouri, and actually worked for a doctor I absolutely loved at Sacramento Research, Dr. Ferreira, shout out. I think he’s retired at this point, but best PI ever, really loved working there. But I thought, you know what? If I have to change jobs anyways, maybe I’ll look into this whole working as a CRA thing because I had so many CRAs come in and say, oh, you’re so detail-oriented, you’re so good at documentation, you’re so good at all these things, you should really look into doing this. I think it would be like a bump up for you and you would be really happy. So I said, oh, okay, I have to move, I have to change, I’ll just look into it and see what happens. And I applied to three different CROs, Icon, PPD, and INC Research, and they all offered me a job, which just blew me away. I’m like, Oh my God, what are the chances that they all said yes? But Icon wanted me to move to Chicago, PPD wanted me to move down to Research Triangle Park, and then INC said I could stay home-based, which was what was important because I just moved, I couldn’t move again. So I said, okay, yes to INC Research, which is now Syneos, and I did that for about a year before I worked on a study that was actually sponsored by Bayer, and I got the luxury of going to Berlin to represent the US CRAs because of my report writing. And they said, okay, I think it’s really nice for you to come over here, and you can represent the US, and we want you to meet with all these people, and I love the culture, I love the people that I met and everything about there. I was so impressed, and I really thought, gosh, these are like good quality people, like in their hearts and souls, they’re good quality people, these are my people, kind of thing. And I remember leaving that thinking, one day, when I get my dues paid, and I can go to a pharma company, I’m definitely going to look at Bayer. And a couple of weeks later, I got a call from a headhunter wanting to know if I was interested in working for a pharma company. And I was like, I’ve only been here a year, I think you have to, everybody said two years before you could actually make the jump to a sponsor company. They’re like, I think you have an option right now. And I’m like, I don’t know, I really like where I work. I did work for INC, I also liked the people there, a lot of travel, but I did like it. They said, well, really look at it. I, really, I think you should consider this. I’m not supposed to tell you, but it’s Bayer. And as soon as they said Bayer, I was like, okay, I’m interested, and then the rest is history. I worked for Bayer now for 14 years, which is a long time and a lot of different …

Joseph Kim:
Yeah, it looks like you started out in innovation at Bayer. Is that true? Yeah. Well, okay, somewhere else.

Michelle Shogren:
I started out as a CRA, and it was funny, my, the lady who hired me, Judy Volker, she had a fight to hire me because of the timing of things and the ability to meet all these checkboxes. Everything has so much, I don’t know, administrative burden to it, in my opinion. But to hire somebody, I was like a couple months shy of what they were looking for in the job description, which was silly because by the time the hiring process is done, it would be there anyway. But yeah, so she hired me, and I worked as CRA for a while. I started out in oncology and then also some cardiovascular stuff, and then I moved up to the next level of CRA to, and then I moved into being a country lead monitor, so in charge of all of the CRAs for the US. And then we created this study lead monitor role, and I ended up getting moved up into that which was covering for the whole globe, and at the same time that was happening, they were creating another role as well, which was a regional training and quality manager, and these were set regions around the globe, and they had thought, Michelle, you’re perfect for this. You should be involved in it. Because I really loved looking at a situation. We would look at the inspection findings, audit findings, anything monitoring reports, things like that, and we look to say, okay, where are our risks? Why are they here? Do you need training, or do you need something else? And then if you need training, we had to develop the training and give it, and they said you’d be perfect for this, So that became my dream job. And I went into that, and I was responsible for US, Latin America, and Israel, because that makes sense, as well as our emerging markets. And I had anybody who was working in clinical operations under my kind of scope to make sure that they were properly trained and that we were mitigating risks, so that was a crazy job. And then, I went into process excellence and innovation.

Joseph Kim:
Okay, so let’s take a beat right here because I want to connect the dots between what your job became and what we said earlier in the conversation. And don’t trust me, I’m not trying to ambush you here, but remember how we said like ten minutes ago, you said things haven’t changed that much since the days of you as a coordinator. So now that you, when you arrived at the sponsor, did you think, oh, I’m going to change a bunch of stuff? And then how much of that were you able to actually realize?

Michelle Shogren:
I did make a point of, we had a lot of trainings and a lot of time being intentional with our relationships with sites and starting to ask more questions, like get curious instead of getting angry. A lot of people would go to anger, or something went wrong, and it wasn’t the right thing to do. Like, you need to start being curious, why did this happen? Don’t just automatically assume you understand the story or how it happened. So we did see a lot of change through that and also gamified a lot of our clinical trials. When I was a country lead monitor, instead of training on rave because almost everybody had rave, and they’ve been in this space for a long time. I’m like every investigator meeting, we got to train on this, this makes no sense. So I did a big game show, and they had to race up and hit the button if they knew the answer and stuff like that, and if they were getting the answers, I didn’t have to train on it. But when they started getting answers wrong, then we would train on it. So they had the best time, the best investigator meeting. And so I feel like I did make it better for sites and a lot of different ways, but I don’t know if I made it in the bigger, insurmountable kind of mountain ways. I think I did a lot of smaller things.

Joseph Kim:
Yes, that’s a good transition, because as an individual person, you can certainly innovate pretty easily on some levels. And then, but when you move into a department that’s innovation like you did at Bayer and ended up becoming the head of the clinical innovation, now you’ve actually opened your own shop called Innovate In What You Do! So we’ll talk about that for sure. How did you start to think about innovation as, oh, I can make a difference here in the investigator meeting versus this system has to change, and we need to do it differently? So how did you think about transitioning one and then versus the other, which would be your day job at Bayer eventually?

Michelle Shogren:
So I think that once I got into process excellence, it was really around looking at how we’re doing things and where do we have way too much complexity and that we really are struggling with it, it’s causing us extra risk, and how do we do that better? And then we did a, like an initiative called Fostering Innovation to see if they even made sense, we didn’t have an innovation function at Bayer, and we worked for about six months talking about it and said, yes, it actually makes sense to look at internal innovation, and one of our big reasons for that was to be able to say, let’s handle the bigger topics. Let’s handle not just deal with a workaround or a one-off to improve this little small thing, but let’s really look at how we do things on the big scale and make it better and look at problem identification because that was missed a lot. A lot of people tried to solve symptoms but not solve the underlying big issue, and that’s why we saw so much incremental innovation versus the bigger monumental innovation that came later, yeah.

Joseph Kim:
Well, what might seem like the root cause, or causes, of some of the headaches we have in clinical research, the one thing we’re looking at at ProofPilot is that we were, as an industry, we only rely on written, the written language to describe what we want to do. That, to me, is becoming a root cause of a lot of things. Have you started to think about, gosh, this is all boiling down to this again or to that again? Have you found, have you started to think about these big root causes of why we have hardship and complexity in research?

Michelle Shogren:
I think we have two major ones, and that’s one of them. I think the fact that everything is done in a scientific method tells us you have a hypothesis, you’re going to test the hypothesis, and you’re going to document everything that happens along that journey to what your final understanding is of the situation. Did you confirm it or dispel it? So everything is highly documented, everything is really explained to the Nth degree when we do document things. So our informed consent forms are a stack of 100 pages, it feels like, maybe not 100, but it feels like it, and it doesn’t take into account how people learn and process information. We figured it out in our educational systems, finally, they said, hey, you know what? I have this epiphany that kids don’t all learn by just reading something out of a book. Like some people have to hear it, some people have to interact with something, some people have to visualize it and see pictures or flowcharts or something. We figured that out in education, but we can’t seem to figure it out in clinical trials, and that’s something that affects and causes us problems in every aspect, not just our informed consent forms, but definitely. And that’s one reason I don’t understand why e-consent, true e-consent, hasn’t been picked up more broadly other than the Internet connection problem, because I think it really allows you to have that audio and have the visuals and watch a video and learn and understand in different ways for people. But it’s even in our protocols, it’s in our SOPs, it’s in everything that we do. All of our trainings and information is so much overkill of the written word, and there’s so many lawyers looking at everything considering, are we setting up for a liability or an issue if we omit this information? Like we have to cover our butt before anything else, and that’s a problem.

Joseph Kim:
Yeah, we’ve all seen the schedule of events table, and it’s funny how these things are, they’re ordered. Like when you see that, you interpret that as, oh, these are the things that have to be done in this order. But then you start reading the footnotes and Section 5.6 and 6.2, and oh no, you have to do these things first. And then I’m thinking like, why even display it this way if it’s not even the order in which things are done? So even worse than the written word, but equally worse is like the fact that we’re not even precise there. It’s just, a lot of it’s just confusing. All right, so that’s one like key focus. What about another root cause of why we’re stuck in the past? Because you’ve mentioned things haven’t changed all that much. Why are we sticking to the old ways?

Michelle Shogren:
I think we have a problem with clinical trial awareness. People don’t know they exist. Even with COVID, I think it’s spurred it and more people understand they’re there. They don’t ever get offered it. We don’t have it, it hasn’t diffused into the world the way that other healthcare options have, so that’s a big problem. So that affects all of our ability to find the right patients, to get to the right people, to have the right people represented. There’s so many trickle-downs that we have to figure out. And then the interoperability, I think, is another big, huge problem because we have these different ways of working, and that could be interoperability of how does a site work and function versus how do we want them to function for our particular study and how does that company want them to function as that company want them to function? And that could be their just regular day-to-day ways of working, or it could be the technology that they’re using, or their SOPs don’t match our SOPs, or how do you handle the interoperability of people, and then of technology is a whole nother layer on top of that. So that’s, we don’t have enough user voice in what we do. Everybody is designing based on what they think they need and what is the best for what their needs are for this piece of the equation, but it doesn’t work that way. To set us up for success, we have to bring in all the different user voices to the equation, and then I think we could do so much better.

Joseph Kim:
I love that you mentioned this sort of interoperability, but not from an IT standpoint but from a human standpoint. And I think the idea that, and you alluded to this earlier, which is research is somewhat of a, it’s a care option. You didn’t, you said it, right? So it’s an unusual model where a site basically represents the delivery of care, quote-unquote, which is research, but from all different algorithms, like everyone wants to do it differently, right? Bayer wants to do it differently from Pfizer. And then the site wants to do it a certain way themselves, so they’re just delivering care in a very different models of care, which has got to be hard to do. To you, what has made a good site, and what has made a good sponsor? What are the hallmarks of a good site and a good sponsor? Because they can’t both be right, or they can’t both be wrong, right? They can’t both be right.

Michelle Shogren:
They can’t both be wrong, and I think they could pull different ways. I think you kinda have tools, but I think communication is key. Communication is the foundation and the cornerstone for any good site, any good sponsor, and any good relationship between the two. If a site can articulate their needs, and their concerns, and their opportunities that they also see, or potential solutions that they see, that makes them a really good site. If I have someone coming to me saying, You know what, this stinks over here, and they just complain about it, I’m like, okay, that’s not really adding value to the world at this point, it’s just complaining. But if have the same site and then come back and say, you know what, this sucks, this makes no sense, but I think if what we do is we readjust this, or we tweak that, then it’s going to really make a huge difference. Can you go back and talk about that amongst your people and let me know what you think kind of thing, understanding that maybe it can change and maybe it can’t change, but at least you put it out into the world, and there’s a chance to work on it. That’s an amazing site to me. Same thing with the sponsor company. If a sponsor company will say to a site, hey, I really want to understand where are you having difficulties? What are your pain points in this? And maybe this is the protocol, maybe this is a technology piece, maybe this is recruitment, whatever it is. Where are you at? What are you feeling right now? What are you dealing with? What are you juggling outside of just what I’m needing? But in your world, your ecosystem here, what are you dealing with that’s making it hard, and what can I do to help remove those hurdles? Sometimes we can, sometimes we can’t, sometimes we can’t for this study, but maybe we can for the next study. So having that communication, and asking the right questions, and sharing potential opportunities when you share pain points is a huge thing.

Joseph Kim:
Yeah, I love that. Clearly, you’ve just been hard-wired to be this way for many years. But as you said earlier, it wasn’t an innovation job just yet. At what point did they start, did Bayer start to create an innovation role, and how did you get involved in that?

Michelle Shogren:
So, in 2014 and ’15, we had that innovation kind of initiative to see if it made sense and if we should have people involved. And in August of 2015, we presented to the leadership team and said, yes, we believe, we should have internal innovation, not just new molecules, because there was a super innovative company, when you think about it. And they did a lot with new development and new treatments, but not in the R&D world. Everybody thought it was too regulated. So we said, we really think we can make a difference, we can help with complexity, we can bring in new ways of working. If we had an innovation group and we asked for a head, and then I think we asked for four full-time innovation managers, and they laughed and they said, we have to see if this is a really good work. We’ll give you a head, and we’ll give you what they called four innovation champions, which had a percentage of their time that were allocated. And they said, okay, if you can provide proof that this makes sense and that it can create some ROI on it, then we’ll look at expanding this later, but if at the end of the year we don’t have anything showing that we’re moving the needle in one way, it could go away. So just so you know, and I was dumb enough to apply for the head and say, I think I could do this, and I did, and I got it. And I had to set up the infrastructure for innovation to exist, and then I had to find people and figure out the champion thing. And honestly, that leadership team was super smart and suggesting the champion concept because that’s what the power was in the innovation function at Bayer. Having people that were close to the front lines and whatever they did for their job, but also connected to innovation, made all the world of difference because a lot of companies do it like an ivory tower of innovation, and they throw things over, or you try to pull stuff up into it, and that transition doesn’t work. The champion aspect is what made it great. And over that six-year period of time, we grew from that into having, when I left, we had people, and nine people working full time on innovation. We had, I think, 26 champions across clinical development operations, and in January, we had just moved it out of clinical development and operations and up to cover all of pharma R&D so that all 11 functions that were there could benefit from innovation. So it really is a success story that happened, but the key ingredient was that champion style and aspect, because the more brains that are closer to the action and the voices of the users being involved in the innovation makes all the difference.

Joseph Kim:
Yeah, you didn’t pat yourself on the back enough, but like the fact that you’ve done these things at the ground level, at the staff level, and you were, you yourself were not an ivory tower person, right? You weren’t some, you didn’t come from some consulting firm, or you weren’t some entrepreneur who built a widget like you. You’ve done the work, so I think that certainly had a lot of. So this is, I’m surprised, right? I told you, I’ve never really interviewed you, and like to hear all of that in the last five minutes was really eye-opening for me. And so, let me go back to like your year one, then. They said, you need to show some ROI, move the needle, quote unquote. What did that really look like in terms of quantified business?

Michelle Shogren:
That was a huge struggle because innovation is slow. Innovation is not fast, and it’s extra slow, and in a big pharma company that has no internal innovation culture yet, like you had to build the culture before you could have an output of a product. I was lucky. I was very lucky. Because of the fact that when I was in process excellence, I had pushed, I said, in order for me to come and take this job and process excellence, you have to let me work on e-consent, and this was before e-consent was something big. And I said, I really think this is where we’re headed, I think we’re going to need it more and more. Where we’re going to become more individualized focused for our clinical trials, we need to look at this. And I had already started the research on that, so I got to leverage the research I started on, and actually put it into practice during that first year of the innovation function so it counted as an innovation project, and I was like, Thank God, because otherwise it would have been really hard to ramp. I had to create the idea greenhouse where people could submit their ideas and opportunities that they saw and the whole process that goes along with that. I had to create a network of different champions and figure out how do we meet, how do we interact, how do we share data and information, identify gaps and opportunities, and put something into place? So it was good that I had that already started. And then it was also good that I had a study team that was willing to say, you know what, let’s pilot it, let’s try it and see what happens. We didn’t finish it in the first year, but the fact that there was enough willingness from the study team to experiment and to try it and take on that extra burden, because I was able to show the potential benefits to the point and the benefit burden trade-off, it allowed us to move forward.

Joseph Kim:
Sorry, did you have your own budget for this, and how much did that help?

Michelle Shogren:
Yeah, so that was another thing. I was, they were pretty much, first they tell me when they did the interview, they said you’re going to get a half $1 million for this and but not your first year, not your first year. So we think you’re going to have to set things up, you’re not going to really be ready to spend money yet. So maybe your first year you get $50,000. What am I supposed to do with $50,000? And they said, oh, you can fundraise around the company, it’s fine. So if you get a study team that’s, wants to do this, they can put some money in. And I said, No, we have to bear some of the burden. So I convinced them I got 250, and I actually stuck with $250,000 for several years and was a master negotiator and benefit and business development kind of consideration person with my poor solution provider companies, which it turned out to help them too, but they did, we did a lot of stuff with just equal blood, sweat, and tears in the game. And it was hard though, for big things, like for big things, for real implementation it, there wasn’t enough there because even at $250,000, I could do a $50,000, that was like my max for any kind of proof of concept I wanted to do, and then implementation became the businesses, me. So my job was idea to proof of concept and show that there really is value there and to do that as cost-effectively as possible and then be able to pitch it and sell it to the business and then pick up the price tag for the implementation piece, which was always the larger piece.

Joseph Kim:
What’s interesting to me is not only as an innovator do you need to innovate, right, the verb, you have to know how to innovate with people, which is in and of itself a different skill, right? So you had to set both of those things up because knowing how to innovate isn’t always just, it makes innovating fun, but it in itself is not the fun part. The fun part is actually doing the new ideas. So you’re giving us a couple lessons here. One is you need to put some money into the game. It doesn’t have to be a lot, but you need some. You have to learn how to innovate, not just innovate at scale. And this thing, this notion that innovation takes time, thank goodness you started this consent project beforehand because that ship had sailed, and then you get to, what would have happened if, so let’s go to the first year, what’s success defined as e-consent started in a study, like how did you define success that first year?

Michelle Shogren:
We, first year, success was innovation, culture, immersion. So innovation culture immersion means that you have people that are saying, you know what, I’ll raise my hand, I’m willing to work on an innovation project. I’ll raise my hand, I’m willing to consider an innovation for my study, for my department, for my team, whatever it was. If they’re saying pick me, then you have immersion of this culture, this willingness to experiment, but that means I also had to create the psychological safety of the space to fail, right? And that was an intriguing part. And I think by having an innovation function, instead of just trying to go through your hierarchy, that was easier to do. When people try to go through their hierarchy, we know 90% of ideas die in middle management, and it’s not because it’s a bad idea, they just don’t know what to do with it, it’s not part of their objectives that they’re getting measured on. They’re like, what the heck do I do with this? So it helped having a function.

Joseph Kim:
Yeah, let’s talk about failure a little bit, right? Innovation is mostly about failure because that’s how you decide what works. Can you talk about some of the failures that sort of never saw the light of day, but maybe kept you up at night?

Michelle Shogren:
Yeah, a lot of different things where we were trying to do things like, we had the concept years ago to have this modular consent. So we would have different pieces where it’s always the same. Let’s go ahead and say, look, this is the wording, let’s get it as good as we can, and let’s not present it to legal all the time to review it over and over again, because sometimes it’d be exactly the same that they approved last year, but now this year it has to have an extra paragraph. Let’s not do that, and then also have things where we can really get it. Okay, we know if we’re going to have a genetics portion that we’re going to have this, and we’re going to supplement with this tool over here. We have this, all this kind of mapped out and laid out, and we wanted supplemental information for our informed consent. So we wanted to have a quick reference guide. We wanted to have, that people could have a little brochure of the key points. We wanted to have a little video for things that they could watch in advance, all these things, and it got shot down, left backwards, forwards, every which way. Fast forward a couple of years, it’s like that flower that only blooms at night, and you don’t think there’s a problem with the flower? What’s wrong with this thing? It never blooms. And in reality, it is blooming, it’s just not blooming when you expected it to, it bloomed at nighttime, and that’s what happened with this informed consent thing. So years later, after everybody gave up on it, it’s resurfaced again, and now they’re doing that. So I think that was a huge learning for me too, not to get so crushed when things didn’t work. And you spent all this time and effort and energy, a lot of energy, and then it doesn’t go anywhere because archive it, keep it. Like BMW has, they have the blue book, and what it is, they put them even on coffee tables in their offices and stuff, of all these ideas that weren’t ready to go anywhere yet. And then executives and stuff will flip through these books when they’re waiting for somebody to come in or something like that, and they might be like, oh, actually that could work now. So we did the Green Book because Innovation Greenhouse, the Green Book, and then we would flip through it and say, okay, why didn’t it work before? Did something change? And maybe we can try it again.

Joseph Kim:
Great idea, because there’s always a graveyard of ideas, and it’s very hard to, because when, listen, when it doesn’t work, you almost want to forget about it, which is a strength to be like, okay, that’s a failure, move on, but then, you don’t want to forget about it. Not like, having this sort of green book sounds amazing. So let’s talk about the final years of or the final sort of chapter at Bayer and what you do now, because it’s not that you didn’t like to innovate or didn’t like to innovate in pharma. Now you’re doing it all the time, not that you weren’t. So tell us about the transition out of Bayer and into this new company you’ve created.

Michelle Shogren:
Craziest transition in my life. Like I’ve never left a job that I wasn’t either really pissed off at because something wrong happened or super excited about this great opportunity I never expected, right? Usually, those are the two reasons you leave a job. I didn’t have either one. I had a situation with my mom, and we had gone on a cruise in March, she fell, she broke her wrist, and we thought she was going to have surgery. Luckily, she didn’t have to because we had amazing care on the cruise, but she came and she was here with me for a couple of months, and during that time, I found out that she has a rare eye disease, and it was progressing to the point that I was worried about her being able to drive, and she’s going to be blind soon, and how could she be by herself in Texas? So I was going to Germany like every other week because the leadership team was all German and all there. And I thought, I can’t, if I need to help my mom with something. And she was also having some memory problems and a couple other little things from aging and I thought, I can’t keep going to Germany every other week, what can I do? And I decided I was going to take some time off, I was going to try to move her from Texas to New Jersey and this was going to not be able to be done while I was working. So I decided to quit Bayer, take a few months off, do some consulting in the interim, and then I thought, okay, like September, October time frame, and I’ll go ahead and go back maybe to Bayer or go to another company. That was my original plan, but I called my old manager, he retired in April, Walter Beck, and he’s always been like a mentor to me. He says, Michelle, what the heck are you talking about? You had an idea to create your own company, why don’t you just do it now? And my original plan was at 50, I was going to take a year off, travel the world while I’m still able-bodied, get to really immerse myself in all these cultures and people. I love people so much, and I really wanted to be in the mix in those places. So I’d go for a few months, come back, and then I was going to come back and start this company. And I’m like, I’m not 50 yet, I’m only 47, that’s like still three years away. He’s like, do it now, it doesn’t matter. Do it now. And so I decided to do it. So I left there at the end of June, and on 4th of July, I made an announcement on LinkedIn saying that this is my plan, I’m going to open this company, and I wasn’t going to open it till September because I was still trying to deal with my mom and figure out everything, which she ended up not moving to New Jersey, it could kill her. But we did find a different solution for her that was rather innovative, and everything happened just like it should. Everything happens the way it should, I think. And so, even though my launch date at the company was actually September 6th, I started with client meetings like right away, and I had several. And it was really nice because I saw people saw an opportunity to leverage what I was putting out there as an option to improve what they were doing. So it’s really, it’s called Innovate In What You Do, because I don’t want you to innovate in what someone else is going to do because that’s what we do normally. We come up with these plans, and we say, like the sponsor says, okay, the sites are going to do this now, or the solution providers are going to do that now. Like we make plans for other people, but we don’t innovate where we are. So we need to start innovating where we are, and then we need to do that with the user voice. That’s a big piece of that. And I wanted to be able to share, some consulting is in there, but it’s really innovation consulting. It’s new ways of working because I have so much experience in all these different ways, but really it’s a lot more about workshops and bringing in the different users to have a discussion around something early enough that you can make changes based on it once you see how the users interact with it. So that’s the core of it. But then I also have this approach that I created after all those years at Bayer, and I call it the Two Eyes Wide approach. Actually, a guy that was on my team, Mark Doughty, came up with the name, and it was perfect because the abbreviation of Innovate In What You Do is II, so two Is, and then W Y D, and you would say that wide. And he says, that’s what you do, that’s, you keep your eyes wide open throughout the entire process along with your ears, but to be able to set up for success. And he says, why don’t you call, that’s what your approach is. So I’m actually writing a book that’s going to get launched next year, and it talks through the four pillars of that which we have. First, the innovation infrastructure. So being intentional in innovation. So we have intention, then we have ideation in what you do. So how do you come up with the ideas? How do you figure out what your problems are? What are the little simple tools that you can do in a regular meeting to actually be documenting all these ideas that come up and being able to do something with it? Then you have incubation. So you have to figure out, what do I have to do to set it up for success? How do I find success factors? How do I build my champions before I ever go to pitch? And how do I deal with the change management that needs to happen between the idea and the pitch? Not afterwards. Everybody does it at the wrong time. They all do change management after pitch, so that’s the incubation part. And then the implementation part, which is the final fourth pillar, is about how do you pitch properly and make sure you have the right information for your, I call them the high five, the people who’s the decision maker, the budget holder, and your three main influencers. So they have the right information to make a decision. And then what do you do based on the decision? So a lot of people don’t ever think about that. But if they say yes, what does that mean to you? What do you have to do after this? Do you have to have hyper care for the idea? Are you still involved with the idea? You just hand it over and say, here you go, good luck with that. What happens with the Yes, but also what happens with the No? So if they say no, you’re out. Do I do iteration? Do I have to do a pivot? Do I archive it for later? What do I do after the answer, is also another big piece. All four of those are part of this two-eyes-wide approach, and I’m doing innovation camps next year on each one of them to help people learn about them. So I’ll do my first one in February, I’m actually launching it today, and it’ll be in Nashville, Tennessee, and that’s on the intentional innovation. So how do you be an innovation leader, both as a team leader as well as a leader within your company, and set up the right culture and infrastructure, and that ability to create the infusion effect that was necessary?

Joseph Kim:
Yeah, this is a fantastic approach. I think, a couple of things I just learned today from you is the idea of change management. You’re right, I’ve always been doing it in the wrong order. Like you need to have some plans even before you pitch because the question will eventually come up, you may as well have done the work beforehand, I think, for sure. And then this final step is what if, the easy one is if they say no, because everyone’s dreading that, and they always think about what if they say no, but what if they say yes? That’s a whole other, oh no, I’m going to need a bigger boat to do something. So yeah, thanks for those two. What’s the name of the book called? What are you going to call it?

Michelle Shogren:
The Two-Eyes-Wide Approach to Innovation.

Joseph Kim:
Okay, great. And when do we expect it out? Do you have a specific date?

Michelle Shogren:
Yeah, so it’s supposed to launch in February. Fingers crossed, everybody send good juju out. So it should coincide with that first innovation camp so that they’ll get the book along with the camp.

Joseph Kim:
Yeah, yeah, and so you’re still connected to the pharma industry, the clinical research industry specifically. How are things changed now that you’re on the outside? You’re not with a sponsor company, but you’ve seen it from really every aspect. Like, now you’re neutral, right? You don’t have to be in defense or favor of anyone. Like, where does the next big change need to come from?

Michelle Shogren:
I think that, if you really look at what innovation is, there’s a book called Why We Innovate, and it talks about innovation over the years. Innovation is not someone coming up with a new way of working. It’s taking that new way of working and massaging it to the point where it’s implementable, it’s cost-effective, and people want it. If you can’t get those three things, you don’t have innovation. The people who can do that end up in the history books. So there’s so many people that have worked on a similar thing, they don’t get the credit in the book because they couldn’t make those three things happen. So I think that’s where we are now. Let’s all work together, let’s bring in the user voices. Let’s really do a human-centered approach. And now, that doesn’t mean I’m going to make everybody in this ecosystem feel good about themselves and feel good about the product and the process. That doesn’t happen necessarily, but at least be intentional and be thoughtful about it and weigh when you need to cause a burden and when you don’t need to cause a burden, and I think I’m in a nice position to do that now.

Joseph Kim:
Yeah, and I would be remiss if not, if I didn’t ask you this question because, so the whole concept of decentralized trials is a big hot topic. A lot of it is, some of it is hype, some of it is totally real, some of it is like things we should have done 20 years ago. How are you yourself defining a decentralized trial? Is that a, is that the right term? I argue with Craig all the time over this, and I’m going to have him on the show eventually so he can defend himself.

Michelle Shogren:
I told him I’m boycotting that term. I don’t like it. I don’t like anything that is not quickly understood by all parties involved. But I really think we should just call them flexible clinical trials, that’s what they are. We’re making them more flexible, we’re making them where it’s a community-based, device-enabled, it’s just a more flexible trial. And if that’s something everybody can understand, I don’t care if you’re a patient, you can understand what does flexible mean. It means it’s a little give and take, it’s not so rigid. If you’re a doctor or a nurse at a site, you can understand we’re flexible. I can’t tell you, at SCRS, how many different sites came up to me and were like, How do you define decentralized clinical trials? Does that mean I’m not going to have a job anymore? Is that, they’re so confused by this term. It’s caused, the term has caused more chaos than help, in my opinion, and the same thing in a sponsor company, like so many people are like, what does that really mean? But if I say it’s a flexible clinical trial, we can all get on board with it. And how we provide the flexibility is fit for purpose, fit for person, and then we’re okay. It should make sense whatever we choose to do, it should answer a question, it should answer a need, it should provide an opportunity, but it should make sense in itself.

Joseph Kim:
Yeah, so I’d hate to argue with Craig when he’s not on the show yet, but I’ll argue with him directly. But one thing I’ve tried to help him understand is, in one breath, he’ll say it doesn’t really matter what we call them, but my position is if you’re going to try and measure that, it’s better, then you better have defined it well. So how did Bayer define what a DCT was? I know you yourself can boycott it, because you’re an individual private citizen, but how did Bayer think about a DCT?

Michelle Shogren:
They’ve actually handled DCT very well, I have to really give them a pat on the back for it. They approached it in a manner where they said, okay, what are components that would fall into a DCT? And then, if we looked at it, what would be required for it to be a virtual trial or a hybrid trial? And then those were the two aspects underneath the DCT platform, and then traditional ones just weren’t under a DCT, right? They might be a device-enabled study, but they weren’t a DCT study, and it was an interesting approach. They had several different work streams to work on it. They had people looking at, what’s the data flow for something like this? What are the different devices or technology pieces that might be needed? And then what about the people in the process? So the head of clinical operations was always really big on the triangle approach. So he said, okay, at the top of the triangle, we have different things, and then it’ll merge around depending on what it is, but usually, you’re going to have people process and technology anywhere that’s in this concept. So let’s figure all three of those out and figure out how they work together, and so they did really well. And we even got to the point where people were saying, hey, pick my study, and that just normally doesn’t happen. A lot of people think pilot equals punishment, but they were like, no, I’m willing to try it. And I think that the team did a really nice job in communicating and explaining, and the change management at the right time, also again, during incubation, not during implementation, and that made a world of difference over there. But it, now what they have is they have a checklist, and they say, okay, these are all the different elements that could fall into a DCT, which of these makes sense for this study? Which of these add value to this study at every study list? And I think that’s the right approach. And it’s not shiny object syndrome, let me throw it out there, it’s what value does this approach bring to the study? So it’s bringing it more data. Is it helping the patient directly? Is it getting access to more people? Like why are we adding this piece in?

Joseph Kim:
Yeah, it goes back to your eye. What’s like what’s the intention of this? What are we actually trying to do? Is it a hammer looking for a nail? Hopefully not, but sometimes you just that’s how people are interpreting these things. Oh, I have a DCT, I must use it, without the intention part. So I think that’s really important for sure. So who’s taking who’s filled your shoes? These are big shoes to fill at Bayer. How did you leave? Are they lost in the desert or what?

Michelle Shogren:
And I have to say that was the hardest part, and it’s still gut-wrenching at this point not to have my team with me. My team became a family, we were so close on so many different levels and they’re brilliant, they all bring something special to the table. And when it was time for me to leave, like it was just, it was the hardest thing in the world to do. And the new guy wasn’t able to start right away, there was like this two-month gap, and I agonized over it, agonized over it. But the guy who came in is Christian …, …., we say his name wrong, and he’s over in Germany and he is like such a good fit for this. He’s had experience doing open innovation stuff, he did business consulting for bringing innovation stuff into Bayer in different areas and everything, he’s really a good person. For the knowledge, he doesn’t, he didn’t, he’s not a cookie cutter of me, but they don’t need a cookie cutter of me. They need somebody to lead them and to help remove the burden and the hurdles that are associated with it. Because innovation is a hard job, it’s not easy. There’s a lot of failure, there’s a lot of visibility, there’s a lot of experimentation, and there’s a lot of feeling uncomfortable, but you need to have someone that’s going to support you while you feel uncomfortable so you can grow, and I think he’s the right person to do it. I miss them so badly, and it’s so nice, they call me still, and they’ll message me, and it’s so nice. They’ll check in, they’ll tell me about their lives. Really great team over there.

Joseph Kim:
Yeah, the good news for Christian is that you started all the framework, right? So he doesn’t have to do that. You got everyone out of the orbit, and hopefully, Christian can take it to the next level.

Michelle Shogren:
He is in a tricky spot, too, because like I said, in January, we got moved up from supporting, like for the first six years, we just did clinical development operations, and now we had to scale it to support all. And so I led the first six months of the scaling activities and we used design thinking, and because we got to practice what you preach, and, but it’s still 11 different functions, all working a little differently with different innovation cultures and needs and things like that. He’s got a big job ahead of him. It’s not an easy one, but it’s got a good team to support him.

Joseph Kim:
And I know he has a good outsourced talent. He can come to you if for some reason the job gets a little too big, which come on, jobs can get can certainly get bigger than you want. So what’s next for Innovate In What You Do? What are we going to see out of you before the book? So fingers crossed, the book comes out in February. Are we going to see you at CNS Summit or Scope?

Michelle Shogren:
Both, yes and yes. I will be there and I’ll also be, Florence is doing research revolution, I guess it’s their very first year in Atlanta, the first of the third, so I’m going there. That’s my next thing, and then I’m headed over to CNS Summit after that and then I will meander on over to Scope too, in February. So you’ll definitely see me out there on the circuit trying to help more people and talk about more stuff and inspire more innovation and what people are doing, for sure. And then hopefully, some people will sign up for our innovation camps for next year too, so that they can get some skill sets to bring in, and I’ll continue doing workshops for some really cool companies. A huge thank you to everybody who has put their trust in me, and I have two sponsor companies, four vendor solution companies, a site, and a patient advocacy group, all trusting me to help them innovate, and that’s really, it feels really good, and I appreciate that amount of trust.

Joseph Kim:
Michelle, you’re one of the most authentic people in the industry, so it’s no surprise people are coming to you. Not that you need more people coming to you because you sound pretty busy, but how can people get in touch with you?

Michelle Shogren:
Yeah, so they can go to InnovateInWhatYouDo.com and there’s lots of different clicks to reach out: you can schedule a free consultation, you can see all the different services and things like that that we provide, they can also sign up to be part of the user network. We need every type of user, everybody who’s in this ecosystem. I need people like that willing to join a sounding board or workshop to share what were your pain points, where are the opportunities when we have different things come up so they can get involved that way, but yeah.

Joseph Kim:
Okay, yeah, maybe I’ll join one of those groups too myself. I didn’t know all this, so it’s great. Michelle, thank you so much for joining us. It’s been awesome to hear about your story, and how you’ve tried to apply innovation, and how you’ve succeeded, and how you failed. I love your new framework, the book is coming out in February. It’s an exciting time. Thanks for, thanks again for joining.

Michelle Shogren:
Thanks so much, Joe, for having me.

Joseph Kim:
Thank you for tuning in to Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some war stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com. This show is presented by ProofPilot and is powered by Outcomes Rocket.

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