People Always, Patients Sometimes Spencer Health Solutions

On this episode of People Always, Patients Sometimes we welcome Michelle Shogren back to the podcast. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We recently spoke to Michelle Shogren, a familiar face in the clinical trials industry, most recently at Bayer Pharmaceuticals. She recently left Bayer to form her own consulting firm called Innovate In What You Do! Michelle is parlaying her 25 years of experience fostering teams and developing an innovation mindset into her consultancy. Michelle and our host, Janet Kennedy, have a lively conversation about innovation, which I know you'll enjoy on this episode of People Always, Patients Sometimes.
 
Janet Kennedy: (00:47)
Hi, I'm Janet Kennedy and I'm a member of the Spencer Health Solutions team. It's always a pleasure to talk to Michelle Shogren on People Always, Patients Sometimes. We spoke to Michelle recently on an episode about innovation in clinical trials and the pharmaceutical industry. Today, we're gonna be talking about Michelle's new company Innovate In What You Do! Welcome back to the podcast, Michelle.
 
Michelle Shogren: (01:11)
Hi, Janet. Thanks for having me back again.
 
Janet Kennedy: (01:13)
I am so excited about your new company, but for those folks who might have jumped into this episode and hadn't heard the previous one, do you mind setting the stage a little bit and telling us a little bit about your background?
 
Michelle Shogren: (01:25)
Sure, happy to do that. So I've been in the clinical trial space now for about 25 years in different roles of patient caregiver study coordinator, site, director, marketing director on that side of the fence. Then I jumped over into the CRO world as a monitor and on to pharma to be a monitor, country lead monitor, study lead monitor, and eventually working in process excellence, and then starting an innovation function. The innovation function I created in 2015 with a team of six people who were working on something called fostering innovation. And we were trying to prove innovation made sense in R&D other than coming up with just the molecule. We were able to successfully launch that and grow it over the seven year period to a point where they said, "You know what, you're doing so much now, and it's so impactful for clinical development and operations; let's move you up to strategy portfolio and operations, and you can support all of pharma R&D," which included 11 functions now, instead of just one. So obviously we were doing something right along the way, and now I've had a chance to leave Bayer and focus on some family and some health needs. And I decided what a better time to start my own company to try to help even more people and stay close to the patients.
 
Janet Kennedy: (02:44)
All right. So I guess we're gonna start with a challenge. It's very comfortable, sometimes working for a very big organization with a lot of structure and benefits and support, and you've gone 180 degrees and you are now a self-employed entrepreneur. I understand that through work in innovation, you have to think like an entrepreneur in a big company. Do you think that that's laid the groundwork for your decision to start your company?
 
Michelle Shogren: (03:12)
I think it definitely made it easier for me. It's also something that I've been considering and thinking about for a few years and had planned as a later in life activity anyways. So when the catalyst of change came, I thought, "You know what? We can just go ahead and advance it and make it faster." But you're right. It's a little scary
 
Janet Kennedy: (03:31)
Well, there are a lot of folks out there to support you. That's the one thing that I would share with you; I did come from an entrepreneurial background, was very involved in startup weekends and innovation programs. And it is the most collegial group I have ever run into. Everybody wants you to succeed and they're all there to support. So I think even though you are pretty fresh on the

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are proud of the amazing work that pharmacies do to support patient health and wellbeing. The need for innovation in the clinical trial ecosystem has challenged traditional pharmacies to rethink their strategy since they are the ones with the greatest access to a diverse and underserved population. On this episode of People Always, Patients Sometimes, we hear from a member of the clinical trials team at Walgreens that recently announced a corporate launch into providing clinical trial services at neighborhood store locations. Adam Sampson, head of clinical delivery operations for Walgreens is one of the team members tasked with managing the plan at clinical trial services to brick and mortar locations by the end of the year. I hope you enjoy this conversation on People Always, Patients Sometimes.
 
Janet Kennedy: (00:53)
Hi, I'm Janet Kennedy and a member of the Spencer Health Solutions team. I'm looking forward to speaking with today's podcast guest, Adam Samson on People Always, Patients Sometimes. Adam is the Head of Clinical Delivery Operations for Walgreens, and he has a really big project in front of him. Welcome to the podcast, Adam!
 
Adam Samson: (01:12)
Thanks so much, Janet. I really appreciate you having me on the show.
 
Janet Kennedy: (01:15)
Well, you know, we've heard a little bit about you from my CEO, Tom Rhoads, but I'd really like to figure out how you got where you are today, especially from your startup background. So do you mind giving us a little bit of a catch up with your career and how you ended up where you are today?
 
Adam Samson: (01:31)
Yeah, I'd be glad to. So I started my career in clinical trials as many people do, you know the cliches - to say that we kind of fell into the industry. I was a registered dietician out of undergrad and very quickly found my way into interacting directly with patients as part of clinical trials and worked as a clinical research coordinator for a few years and transitioned from there about 10 years ago into the more business side of our industry. So I worked at a couple mid-size CROs, took a very standard path. I was a regional monitor, worked in project management in line management. And then about seven years ago, my wife and I moved out here to North Carolina and I worked at Duke Clinical Research Institute for a few years. While at Duke, I did a lot of work in government funded trials in the pediatric space and completed a master's degree through George Washington in clinical trials.
 
Adam Samson: (02:28)
And then I moved to a large pharma company and was conducting global, late phase studies. And then the pandemic hit, like many of us, I was, scrambling to keep my study going. You know, it's a hundred sites in eight countries. And how do we, possibly kind of keep operations, running lots of challenges. It was an eye opening experience around how in this industry, we really are under utilizing technology. That's no surprise to anyone we've gotten a bit better, but especially at that time, the start of the pandemic, getting even things like e-consent and other things approved was very challenging. So I decided to kind of take a leap of faith and join a very small time startup that was in the decentralized clinical trial space and had a great software product, but wanted to really build out their services and operations.
 
Adam Samson: (03:22)
I joined the team when there were about 15 people and was with the team until series B and about 130 people. It was a really exciting couple years and enjoyed working in that space of how do we bring trials into patients homes and give them additional options to participate in trials? The one thing that remains a pervasive challenge when we're trying to do decentralized trials is that technology of course, is not enough. Sometimes patients there's a lack of trust. If things come through via email or they see them on the internet, not everyb

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

The rare disease community has found strength in small numbers by banding together to share their stories. On this rare disease day, we would like to take a moment to recognize and celebrate the patient advocates and organizations that keep the focus on these underserved communities. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. I'm proud to announce that today's podcast will be the first in a series of conversations with leaders in the rare disease community. Our host, Janet Kennedy, welcomes Eden Lord to the People Always, Patients Sometimes podcast. Eden is the founder of the Dash Alliance and 24 Hours of Rare: a Global Celebration of Rare Disease. I hope you enjoy their conversation as much as I did.
 
Janet Kennedy: (00:49)
As we celebrate Rare Disease Day, I have the honor of bringing somebody to the podcast that, in my mind, overwhelms me with her initiatives and dedication to helping create community and conversation in the rare disease community. Eden Lord is the founder of multiple rare disease initiatives, including the Dash Alliance, the Rare Fare, 24 Hours of Rare, and Rare 72! So much happening to make it easier for folks who are in the rare disease community to come together for conversation. So on this special day, Eden, welcome to People Always, Patient Sometimes.
 
Eden Lord: (01:34)
Thank you so much for having me.
 
Janet Kennedy: (01:36)
You know, I actually had a chance to meet Eden a few years ago when I was invited - and I'm very proud to say - to sit on a panel during one of her virtual events. And it was a real eye opener. And, you know, we talk about imposter syndrome; I'm very fortunate in that I am a generally very healthy person. And when you are surrounded by people who are feeling the struggle of their health, every second they breathe, it sure does put things in perspective. And I was honored to be part of that program, but also humbled, by what a challenge life can be in living with a rare disease.
 
Eden Lord: (02:18)
It definitely is, but there are so many blessings that come with the path that you walk in the disease community and so many people - like yourself - that you get to meet who really have an understanding, or want to have a better understanding, of what it's like to be a patient or raising a patient and what that path looks like and how people can help. It's the attitude that we look for when we're building our communities. And it's definitely a hard road, but it is definitely a blessed road as well.
 
Janet Kennedy: (02:46)
Tell me a little bit about your background and how you became such an advocate for rare disease.
 
Eden Lord: (02:54)
Well, I, myself am a third generation rare disease patient. So it started with my grandfather, passed my dad, myself, and now we are raising four kiddos who all have a chromosome microdeletion, and it has manifested in multiple rare disease diagnoses for two out of our four kids, likely going to be three out of our four kids. So been hoeing this row for a while now.
 
Janet Kennedy: (03:18)
So from a rare disease perspective, I think the first challenge might be even figuring out that you have a rare disease?
 
Eden Lord: (03:26)
Definitely has been a struggle to walk that path towards diagnosis. And, you know, everyone's story is different. For us, the story that stands out is our daughter who was not caught on newborn screening panels with her condition. And it was four months before we reached a diagnosis and it was a significant medical crisis that precipitated her diagnosis. So that's definitely something that we're cognizant of is the path that it takes. I think, on average, it's seven years before you actually have that diagnosis in hand. And that's if you're one of the lucky ones; a lot of the times you won't have an answer and you will go undiagnosed. And then you're at a point where you're just treating symptoms.
 
Janet Kennedy: (04:02)
Now to be qualified - and I'm doing air quotes here

The last two years have been driving many discussions of the need for change in the pharmaceutical industry, particularly in the clinical trial arena. Discussions have not always led to actions, however. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. As we look towards 2022, I believe we will record this as a year of make it so. The time for moving on from debate is here, as patients are demanding action and forward momentum on today's episode of People Always, Patients Sometimes, our host Janet Kennedy has a conversation with the new executive director of the Clinical Trials Transformation Initiative, Sally Okun. Sally brings a unique and essential perspective to CTTI, as a former nurse and VP of Patients Like Me. They have a detailed discussion of the Transforming Trials 2030 initiative, one that Spencer Health Solutions is 100% behind. I hope you enjoy this episode of People Always, Patients Sometimes.
 
Janet Kennedy: (00:59)
It's very exciting for me to have today's guest. Sally Okun is now the executive director of the Clinical Trials Transformation Initiative. The last time I spoke with her was on the Get Social Health podcast, where she was the vice president of Patients Like Me. So interesting that we're going to have another conversation, but in a totally different role, and yet, still very patient centric. So please join me in welcoming Sally Okun to the People Always, Patients Sometimes podcast. Sally, I'm so glad to have you here. I know it's been very, very odd over the past few years in working and collaborating and life transitions, but we had an opportunity to talk to your predecessor, Pamela Tenaerts, who was the executive director of the Clinical Trials Transformation Initiative. We spoke to her pre-COVID. So now we're in the middle and maybe hopefully heading towards the end. And there are a lot of exciting things happening at CTTI. So welcome to the podcast, and I'd love to hear a little bit about how you ended up joining CTTI.
 
Sally Okun: (02:09)
Janet, it's so nice to be here, and I really appreciate the opportunity to talk more about the Clinical Trials Transformation Initiative, and certainly the shoes that Pam left are large, and I'm still trying to find ways of filling them, and I think that's gonna take some time. How did I get to my current role? Well, interestingly enough, I had left Patients Like Me in 2020 and I was working on a variety of interesting projects at the time across the health spectrum. You know, I was consulting on a variety of different things and also enjoying some newfound freedom of semi-retirement, which was an interesting experience for the first time in my career. You know, by about mid 2021, maybe in light of the time that we were all spending at home as opposed to spending out enjoying each other's company socially or professionally, I started thinking more and more about the next chapter of my professional career.
 
Sally Okun: (02:57)
So it wasn't long after that, that I was approached about the position of executive director at CTTI. And frankly, initially I didn't see the fit for me. You know, I've not spent my career in clinical trial work. I've spent a lot of my career in research and clinical research with patients and others, but hadn't really focused specifically on clinical trials and the clinical trial enterprise. So at first I really wasn't exactly sure it would be a good fit for me. However, after talking with some trusted colleagues and others, including the chairs of CTTI's executive committee, I was truly intrigued by the organization's impressive portfolio of work. I really hadn't been aware of just how much they have done over the last 15 years, 14 years, in terms of contributing to the improvement overall of the clinical trial experience, not just for participants, but for investigators as well as sponsors and others.
 
Sally Okun: (03:48)
So, you know, I then looked a little more closely at the transforming trials vision, and

Spencer Health Solutions was founded knowing that pharmacies are an integral part of the patient's health journey. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Pharmacy partners are key to supporting Spencer in patient homes for clinical trials and commercial programs, especially specialty pharmacy partners. To dig deeper in the specialty pharmacy and learn about some of the challenges and changes coming to the industry, we invited Sheila Arquette, CEO of the National Association of Specialty Pharmacy to come onto the podcast. I hope you enjoy this conversation with Sheila and our host, Janet Kennedy, on People Always, Patients Sometimes.
 
Janet Kennedy: (00:43)
We are honored to have as our guest, Sheila Arquette. She is the president and CEO of the National Association of Specialty Pharmacy. She joined NASP in 2017 and has been focused on increasing the value of the NASP membership. Some of her initiatives under her tenure have resulted in a substantial increase in their membership, also in member benefits and value, and she's expanded the annual meeting at expo that's held every year in the fall. Specialty pharmacy has a critical role to play in helping patients live their best lives, and I'm thrilled to have her on the People Always, Patients Sometimes podcast. Welcome Sheila!
 
Sheila Arquette: (01:24)
Thank you so much, Janet. It's a pleasure to be here with you today.
 
Janet Kennedy: (01:27)
Now I gave a very quick high level look at your background, and I'd love for you to fill it in a little bit more for us. Your relationship with NASP didn't start in 2017, did it?
 
Sheila Arquette: (01:37)
No, it didn't. I started in a volunteer capacity with NASP way back in 2013, in 2014, and I started off volunteering to serve on the membership committee. And then I was asked to co-chair our government affairs committee and just really loved the mission of this organization and the incredible group of people that were so passionate about specialty pharmacy and patient care. And so I started to get more and more involved and then helped with our first ever specialty pharmacy law conference. And one of our board members, Rebecca Shanahan, it was her vision to establish the Specialty Pharmacy Law Conference and provide continuing legal education credits for lawyers and specialty pharmacy, because it was really challenging to try to find those credits. And then she was also incoming president of the NASP board. And so she knew at the time that she was gonna need help running the organization. And so that's when they reached out to me and asked if I would consider coming on board, full-time.
 
Janet Kennedy: (02:38)
You know, Spencer joined in the not-too-distant past, and we're now members of NASP, and one of the first and frequent emails I get is about what's happening in Congress. And that is amazing, all the work that you're doing there. So what are the big topics that you're covering in the political affairs and government committee?
 
Sheila Arquette: (02:58)
We're very, very focused on ensuring that we have a competitive landscape in a fair imbalanced marketplace. That specialty pharmacy patients have access to the medications that they need and appropriate access, meaning that it's the right drug for that patient at the right time during their clinical treatment. But we also want it to be from the pharmacy of their choosing, right? So we wanna make sure that our pharmacies have access to networks. That reimbursement is fair, and it's not being used to keep them from participating in different payer networks. And we wanna make sure that patients have access and choice. And we're very focused on pharmacy DIR fee reform, right? And ensuring that pharmacies are compensated or paid for their performance and that, you know, that we're all driving to the same end goal, right? We're looking at enhanced clinical outcomes. And we also wanna decrease total cost of care because it's a huge issue, right