Hi, I’m Tom Rhoads, CEO of Spencer Health Solutions. Today we have the first of two interviews with Michelle Shogren. Michelle is a familiar face on conference stages as a 25 year veteran of the clinical trials industry. Most recently as Senior Director of Business Excellence and Innovation for Pharma R&D at Bayer Pharmaceuticals. She recently left Bayer to form her own consulting firm, but more on that in a later episode. For now, I know you enjoy this discussion on innovation in the pharma industry with Michelle Shogren and Janet Kennedy, on this episode of People Always, Patients Sometimes.
Janet Kennedy: (00:40)
Hi, I’m Janet Kennedy and I’m a member of the Spencer Health Solutions team. It is such a pleasure to have Michelle Shogren as our guest on People Always, Patients Sometimes. We’ve known Michelle for a few years and have followed her leadership posts on social media even longer. Welcome to the podcast, Michelle!
Michelle Shogren: (00:58)
Thank you so much, Janet, for having me. I’m really excited to be here today.
Janet Kennedy: (01:02)
You know, you’ve heard a little bit about Michelle from our CEO, Tom Rhoads, but I’d really like to dig in and learn a lot more about you and your background. So can you kinda gimme the short version of how you got where you are today?
Michelle Shogren: (01:16)
I think like many of us, I kind of fell into clinical research. I started out as a nurse and someone upstairs was doing clinical trials and got to go to cool places for investigator meetings. And I said, I wanna do that too. And I convinced the doctor that maybe this was also a good way to show our patients. We were forward thinking and we were looking at additional options and have another revenue stream to come into the office. And we kicked it off from there fast forward, 25 years later. And here we sit today, having had a chance to be a patient in trials, a caregiver for my family, as well as be on the site side of things as a site director and marketing director, as well as a study coordinator. And then on the CRO and pharma side, as a monitor and someone leading the studies at different levels, as well as having an opportunity to start an innovation function at Bayer.
Janet Kennedy: (02:07)
Well, that really was a short introduction and I have like 10 questions just from hearing that. You know, it’s interesting – you really have walked the walk. So it isn’t just an esoteric type of job description; you have participated in and are living the life that many of our patients and our colleagues just talk about.
Michelle Shogren: (02:31)
Yeah. I actually have personally experienced the value that can come from clinical trials as someone, as an individual who needed help and have offered this kind of help to my friends and family by helping them search for trials and finding ones that might meet their needs because it’s an often missed opportunity for patients out there.
Janet Kennedy: (02:53)
So when you joined a pharmaceutical company, was it a big shock? Was it very different from what you were expecting or did it feel like a natural evolution?
Michelle Shogren: (03:03)
I think one of the most surprising things for me was I had always heard that big pharma was only after your money and they couldn’t trust them. And when I came to pharma and I started meeting all the people who are in research and development, I found that so many had stories like me, so many were connected to someone who had some condition and they were trying to find hope for them. And so many were dedicating their lives to really make people better or bring new opportunities there. And I was blown away by the size of the hearts from these people.
Janet Kennedy: (03:33)
But from a size perspective, many pharmaceutical companies, and certainly say top 20, are huge organizations. So somehow I have a hard time getting the word ‘innovation’ and big, giant, slow moving tank of a company in the same place at the same time.
Michelle Shogren: (03:53)
Absolutely. So when we started the innovation function at Bayer, it was funny because at the time back in, I guess it was 2015, we were doing an initiative called fostering innovation cause nobody thought we needed innovation in R&D other than finding the new molecules themselves, which is very innovative – I give it that, but there’s so much more involved. And we had to do an eight month long research project to find out exactly, does this make sense or not? And then we had to pitch it and say, Hey, we really think this does make sense. And we can make a big difference for Bayer for our patients out there who need it and for the rest of the world, by having this. And it was a little bit of a tough sell. They’re like, “Oh, I don’t know. You know, we’re really regulated here. I don’t know how much we can do that’s different.” But we convinced them to do it. And it was a little struggle to get it going. And the culture change around. It was also hard. People were used to doing everything the same way for such a long time, but it was amazing to see the changes.
Janet Kennedy: (04:50)
So when you joined the innovation group and I’m looking here for officially your role there, so you moved from business process manager, process excellence, to head of innovation. That seems a very dramatic switch.
Michelle Shogren: (05:06)
Yeah. So I guess my whole career, I was always innovating in what I did anyways. I was always finding things that I said, there’s gotta be a better way and then posing solutions and in process excellence, a lot of that is part of what they were doing. They were looking for. How do you bring the excellence into our ways of working? So once we did this initiative, which I was a team member with six people, we needed to have a head for this new function that we had created and I applied and was lucky enough to get that role. And so that’s where I made the jump, but it felt very natural for me, especially having been part of innovation for so long in different ways.
Janet Kennedy: (05:45)
So I’m interested in the definition of innovation from a pharmaceutical company’s perspective. I’m feeling like early on innovation was all in the lab, but now it’s really every department ought to be thinking about how they can innovate.
Michelle Shogren: (06:01)
Yeah Janet, you’re exactly right. It was always about bringing those new molecules to life or new products on a shelf. And people missed the opportunity to innovate in how they do things and their ways to gain efficiencies, to decrease time to market, to improve their business models of their own working groups, even. So this shift that we had, a mindset of, how do you apply innovation to your day to day activities was really monumental going forward. And we had a corporate innovation function that was starting at the same time as our innovation function, which formed an umbrella of services, which was absolutely wonderful. I don’t think we would’ve been able to really get off the ground as easily as we did without having that group there. But it became very evident that we could do a lot here. And especially when we started really focusing more on our users and their involvement earlier on in our processes, that was a big change that came about with bringing in innovation.
Janet Kennedy: (07:02)
Well, I definitely wanna talk about patients in a little bit, but let’s stay focused for just a second on this idea of innovation. Now we know that telehealth has been around for over 20 years, and in some cases, people are thinking like digital health just grew up in the last two years or the last three years. But when you think about the kind of things you were recommending innovating way back when in the dark ages of 10 years ago, what kind of things were you actually focusing on?
Michelle Shogren: (07:31)
I remember one of the first things that we were really bringing in at the time was eConsent and we had looked out into the industry and we saw this coming and there was a lot of pushback for it and not really a sure belief that it made sense or how could we even be sure that the actual patient was the one consenting and is this really adding value or just complexity? So that was one of the early on ones. And then now we have it as optional tool for all of our studies. So a lot has changed since then. And we were able to show that, just like children learn differently – some of them need to have something that is written, others wanna hear it, others have to interact with it to really understand things – especially our informed consents needed to have the same type of opportunity for our patients.
Janet Kennedy: (08:19)
Oh, that’s fascinating. So then things really start to take off in the startup health space, which doesn’t necessarily mean that they were funded by or driven by pharma, but it’s all happening outside. So how did you go about as a company evaluating some of these new, very green ideas?
Michelle Shogren: (08:40)
That’s a funny thing. So while technology involves so quickly in leaps and bounds, unfortunately, big pharma companies move much slower. We’re used to having several years to get a drug to market. And these tech companies are launching new products left and right. So for us just to stay up on top of what’s out there and what’s being offered and being able to see how does this even fit into our regulated environment? What are the risks associated? Where are the real benefits at was a daunting task? And I think most pharma companies also felt that when you add in our archaic procurement type of process, which worked well for many, many years, for many different reasons, all of a sudden it didn’t work well for this new style of work, this technology business situation, we would vet companies based on how long they’ve been around and you know, their financial ability to stay afloat. When you think about needing the data from these tech companies for many, many years later, you’re sometimes just hoping and praying they stay afloat to the end of your study. How are you gonna be sure that they’re gonna have the audit trails and the data that’s necessary to go to the health authorities if we get an inspection many years later. So a lot of things had to change. A lot of mindsets had to change in order to be able to bring some of these things in
Janet Kennedy: (09:58)
Well now, with those needs for oversight, the FDA plays a little bit of a role here. Have you felt like they have partnered well with digital health in order to enable pharmaceutical companies to actually use this digital tool?
Michelle Shogren: (10:13)
They’ve done a lot of different things. They have offered some kind of measures that are trying to have a call to action, to have more things electronic. They have also enabled things like the 21st century cures act to be able to present data in different ways that we could capture in different ways, but they fall short of telling us how to do things and what exactly do they want and what is really acceptable, which is the part that makes it very difficult for the pharma companies. If you’re spending millions and millions of dollars to run a study, the risk that you go to present it then to those health authorities and they throw it out simply because the way you captured data with one of these tech companies or you interacted on a medication adherence tool or something else like that, that could be very detrimental.
Michelle Shogren: (11:02)
And it would mean that maybe we can’t do more studies because we’ve wasted, now the money on this. So the pharma companies are asking for the regulators, “Hey, throw us a bone, let us know what do we need to have for you.” So we make sure we’re spending our money in the right ways and we are heading in the right direction. But then you have the health authorities and they say, Hey, we wanna see change here. We wanna support this, but this is not our area of expertise either, so you need to come with proposals. You need to show us things and make recommendations to us and talk through your ideas and we’ll be happy to talk about them. And there’s a bit of a mis match around well, whose job is it to really make these decisions at this point?
Janet Kennedy: (11:44)
Well, I’m also curious about people within a large pharmaceutical organization – and I’m not necessarily speaking specifically about Bayer. You have been on, on the stage at multiple national conferences and trade shows and addressing with your colleagues, some of these issues. So I know you can also speak to the industry at large, but when I think about all the different players in a clinical trial from patient to the lab team, I can see that a lot of folks are traveling at different speeds. And that obviously a patient perspective is I want it now, I want it yesterday, to the general, just idea generation of what the new drug is going to be. My question really has to do with, do you feel like innovation and the idea of using new tools for clinical trials – is it reaching all personas that might be involved? Are principal investigators – for instance – are they forward thinking? Are the people writing protocols? Are they forward thinking? And if they’re lagging or dragging their feet, does that make this whole thing hugely inefficient and not successful?
Michelle Shogren: (12:56)
I think it’s an interesting question because of the fact, I think in general, people want to be forward thinking and some of them really think they are forward thinking, but then we have this little glitch in the system, which is almost built into our DNA from caveman times, even I would say, which is our protector mode where, you know, back then it was, Hey, don’t touch the fire, cause it’s hot. Now we use the protector mode for our families, as well as our work environments where we’re out there to say all the challenges that we see as soon as we see something new, like, Ooh, step back, watch out. You know, this could cause this problem or that problem. And these are the risks could be associated with it. And we have a hard time being willing to jump that hurdle. Then when we identify all these potential risks of maybe sometimes just the unknown and this holds us back in several different areas, there’s a mix of people in every job and every role, some of them are groundbreakers and they’re pushing the envelope every day and every night other people are working the opposite side saying, Hey, that sounds great, but it poses too much risk for us.
Michelle Shogren: (14:04)
And that’s where we have the little bit of the battle. But one of our biggest battles I think is having even awareness about our clinical trials and having enough patients to recruit, to be able to go into them. And that seems to be the biggest slowdown for getting drugs to market.
Janet Kennedy: (14:20)
Now, does that mean you need more principal investigators across the country? Does that mean you need just a better way to communicate trials to patients?
Michelle Shogren: (14:30)
I think it’s definitely a better way to communicate trials to patients. One of the things that came out of COVID was the fact that everybody has heard of a clinical trial at this point. And many people feel like they’re part of a really big one, right? So in one way, I think that’s helped some for the awareness, but people don’t always realize that there’s clinical trials out there and available for a multitude of different reasons. And it’s not necessarily a one stop shop. We know that amount of people that actually hear about a clinical trial as a care option for them is in the single digits of percentages, which is just crazy. We have to find a way to democratize access to clinical trials and share the awareness to patients as well as community doctors and having the right PIs and the right sites out there are really helpful. But having been on the site side of things, I can tell you, you know, sometimes it’s just trying to find somebody who would reply to an and for a clinical trial can be challenging or having the right patients. Once you get through all the crazy inclusion, exclusion requirements for the trial is also a challenge. So we might have enough PIs out there, but we could always use more in different communities and add some diversity into our clinical trials as well.
Janet Kennedy: (15:46)
You know, when I think about myself, for instance, and admittedly I’ve been in healthcare, so I’m a little more aware obviously of what a clinical trial is or about, but I’m like, “Eh, I take a little of this and I take a little of that, but gee, nobody would want me in a clinical trial. I’m healthy. I don’t have a rare disease. I don’t have a hugely debilitating condition.” So of course it wouldn’t even occur to me that somebody would be looking for someone like me.
Michelle Shogren: (16:12)
Yeah. And I think that’s one of the biggest problems. Like how do we increase the awareness? I remember my dad was lucky actually he had high blood pressure, pretty simple. Right. And why would you need a clinical trial for that? And my mom reached out to me and she was like, “Hey Chelle, I gotta tell you, they just offered Joe a clinical trial.” And I’m like, “Wait, what? For what?” And she said, “For his blood pressure.” I’m like, “He’s a horrible patient. Why would they offer him a clinical trial?” And she said, “Oh, because of the fact he is a horrible patient. They really think he needs more monitoring. He needs somebody to help him get on a good path going forward and take the medication on a regular basis.” Because he was great about taking it for about a week. Once he got a new one.
Michelle Shogren: (16:51)
And then you didn’t go back to the doctor for three to six months. So he’d take it for about a week before he saw the doctor again and who knows what happened in the middle. So they thought, you know what, he’s really having a hard time with his heart. He needs to have more structure to it. So by going into a clinical trial, he was going in every four to six weeks and he was able to take a medication that didn’t give him some of the swelling and other problems that the ones that he had tried before did. So he was actually more willing to take it. So it turned into a really nice thing for him and people just don’t realize those kind of studies are out there.
Janet Kennedy: (17:24)
Well, it’s funny, you mentioned that cause I’m going through some interesting challenges with my own parents, but part of their problem is they’re just beyond the digital divide. I mean I’ve noticed them not being able to interact with the television as easily as they used to just a few years ago and indeed traded televisions with them because I had a simple Roku remote that only had six buttons – and that’s still a challenge. So we also have an issue of being digitally savvy. And as you looked at tools for your company or for the other panels and scenarios that you were a part of, how do you think digital intelligence digital experience comes into play with some of these tools?
Michelle Shogren: (18:08)
Well, I definitely see a difference between our digital natives, which have grown up with technology their whole lives and the digital immigrants as we call them for the ones who had to come over to this way of working. But it’s also an interesting thing that we found that through our mythbusting sessions, sometimes we would have people that were in that digital immigrant category, helping us to troubleshoot and problem solve when the technology went bad. So they were sometimes even more savvy than we were. So it’s not a one size fits all approach, but there is definitely a difference for how much bandwidth somebody can handle at what time. And this is also where we run into a little bit of problems because a one size fits all approach, seldom does. So how do we ensure that when we bring technology into a trial, we can hit these different needs and capabilities of our patients while they’re in the study and really make them feel supported while still achieving the goals that we have.
Janet Kennedy: (19:04)
And does the patient have a role in this process, a physical role – a person who actually represents the patient at the table?
Michelle Shogren: (19:14)
Yeah. So that’s one of the big things that I pushed for. I call myself a ‘patient passioneer,’ which was a word that came up from somebody within our organization. And I absolutely loved it and I have kind of stolen it from him. Thanks Oliver, if you’re out there! But I feel like we have to do better here. A lot of times when we were first starting, we were saying, “Okay, it makes sense. You know, I would see that a patient would need this or would like this.” And we thought we understood them. And sometimes we even talked to doctors and doctors of course knew what the patient needed or wanted, because they saw them face to face. So we trusted them. Then as we move forward, we started seeing, we were rolling things out, and there were problems. And there were difficulties for the patients.
Michelle Shogren: (19:56)
They were trying different things than what was intended. And it became a bit of an eye-opening experience that, hey, maybe we didn’t think this through all the way. Or maybe the people that we thought knew didn’t know as much as we had hoped because there’s so many different variables out there. And that’s where we started really trying to bring the patient voice in. And as an industry, this is something that we talked about for a few years. And now I think it’s something that we’re doing for the last couple of years as well, but we can still do better. And we also have to bring it in earlier in the process. A lot of times people are throwing this in right before they launch a trial. Like just to see, is there an oh crap moment ahead? And we need to come up with a quick help desk support plan for it before it rolls out. It’s too late in the process to really make big changes. So we’ve gotta do it sooner. And we even need to think about it in the design process at the very, very beginning. And we’re just now moving as an industry towards that, but I’m really excited that we’re having those conversations.
Janet Kennedy: (20:58)
Do you see more and more patient advocate committees or designators at pharmaceutical companies?
Michelle Shogren: (21:06)
Yes, definitely. There are some companies which were faster moving than other companies and there’s some still lagging. So it’s a nice call to action for those laggards out there to bring more patients in. But I do see this changing and moving, especially if you look at now versus probably five years ago, it’s dramatically different. And even with having COVID and that crisis out there, we’ve managed to bring patient voice in through different means. Maybe sometimes an interview that’s on the phone. Sometimes it might be a survey with a couple of people they could do at home. Other times it might be with a focus group or a sounding board that is probably more digital lately, but it’s happening more and more. And I’m really excited when I see things where brand teams have now added some type of a patient committee or at least a patient advisor into the overall conversations on a regular basis and then go to them on maybe a quarterly basis saying, “Okay, this is where we’re at right now. What are your thoughts about X, Y, and Z?” That to me, shows progress
Janet Kennedy: (22:09)
Putting on your industry, prognostication hat for a second; obviously the pandemic was a game changer on pretty much every level. What do you see from the past has been the most important changes that have come to clinical trial innovation as a result of the pandemic. And looking ahead at just a few years, because there’s no point looking further ahead than that for right now -what do you see being the biggest game changers in the industry?
Michelle Shogren: (22:40)
Well, I think with the pandemic, one of the big things that we realized is we were kind of getting in our own way when it came to technology sometimes because the sites embraced it and often offered it before we were ever ready or prepared to have the conversation. So where we were thinking that the sites wouldn’t wanna do it, or they were worried about the burden, they were the ones saying, Hey, we’re already doing telemedicine visits with our patients. And some of the sites were already FedExing medication to the patients. And we were like, oh no, we have to figure this out. Um, so one big learning was that there might be more of an appetite when there’s a need than when it was a nice to have. And I think the study teams also were quicker to embrace it because they realized we always put our patients safety first and foremost in everything that we do.
Michelle Shogren: (23:26)
So they needed to make sure how are we gonna keep our patients safe if we can’t bring them in the office all the time. And if we’re not able to do those blood draws in the clinic, because a fear of contaminating them with COVID. So hopefully all of these things that we learned will be able to continue. And I’m one of the people that signed up for the #NoGoingBack pledge. And I hope everybody listening to this did as well, but I’m already starting to see some seepage back into the old ways of working where we say, “Okay, we only did this because of the pandemic. We don’t have to do this anymore.” And you’re right. We don’t have to do it anymore; but we could do it. And it might decrease burden on patients. And we might be able to really make a big difference to someone who wasn’t previously able to do a trial by leveraging things like telemedicine visits, for example.
Janet Kennedy: (24:13)
Well, excellent. Michelle, this has been a fabulous conversation and one that I would like to pick up in the near future. I can’t thank you enough for being a guest on People Always, Patients Sometimes.
Michelle Shogren: (24:25)
Thank you so much, Janet, for having me.