It is always a great pleasure to engage with clinical trial innovator and thought leader Craig Lipset. We asked Craig to join the People Always, Patients Sometimes podcast to share more information about DTRA, which stands for Decentralized Trial and Research Association. As an industry, we have embraced more fully the idea of serving patients better with a decentralized clinical trial. As we bring the corona virus under control, it's important that we don't become complacent and return to business as usual. Give a listen to the podcast and I hope you'll join us in declaring there is no going back.   Janet Kennedy: (00:43) It is always a pleasure to welcome Craig Lipset to the podcast. He is a man that really needs no introduction, but I'm going to give him one anyway. As the former head of clinical innovation and venture partner at Pfizer and on the founding operations committee for TransCelerate Biopharma, Craig is recognized as a leader at the forefront of innovation in clinical research and medicine development. He is a frequent speaker at healthcare and pharmaceutical conferences, and he has also led the call to innovate and recognize that there is #nogoingback to improve clinical trials. Today though, we're talking about DTRA, Decentralized Trials and Research Alliance. Welcome to People Always, Patients Sometimes Craig.   Craig Lipset: (01:29) It is such a pleasure to be back with you, Janet, thank you for everything that you're doing to give so many voices the opportunity to share.   Janet Kennedy: (01:38) Oh my great pleasure. This is always a learning opportunity for me. I am not a journalist, but I do play one on this podcast and I get to ask all the air quotes, dumb questions, that I'm sure a lot of people want to know about, but sometimes they get caught up, that something's already rolling ahead. And they're like, did I miss it? Did I have a fear of missing out what's going on?   Craig Lipset: (02:00) Absolutely. You know, there's so many different ways for people to stay current and stay connected. And you know, sometimes we have to hit a lot of different channels to make sure that everybody gets that opportunity to, to connect and to stay current with what's going on out there.   Janet Kennedy: (02:18) So on the connection aspect, we obviously have been dealing with the pandemic for gosh, a year now, and this time last year we were preparing for the last in-person event, which might've been SCOPE, and then suddenly things spun out of control and we were all sent home. I think things have changed a lot for you as well. So I'm curious, being able to look back a year over how things happened in 2020, what do you think has really impacted clinical trials with folks being sent to their rooms?   Craig Lipset: (02:56) You know, I think a lot of people will expect me to say things telemedicine and remote monitoring and risk-based monitoring. I would say that the thing that's really impacted us is willingness to adopt. And what I mean by that is so many of the things that have been so important for business continuity this year, the things that have kept our trials running weren't solutions that had to be cooked up in a lab in the year 2020. Most of these were solutions that already existed. They were just struggling for adoption, usually struggling for adoption because we operate in a very risk averse environment. But when the risk changed in the environment and all of a sudden, some of these things that might've been viewed as risky, suddenly became risk mitigation, they became the way to maintain business continuity. 2020 became a story about adoption, about so many great solutions that had been at our feet that had been at the doorstep suddenly seeing their moment in the sun when study teams and organizations were able to pick them up and bring them into their studies and bring them into their portfolios. And that's an exciting way for us to now get 2021 going, because now our organizations have seen that we can bring these different things to life, whether it's risk-based monitoring decentralized trials or whatever other solution your listeners were able to bring into their organizations to keep their work going.   Janet Kennedy: (04:23) Well I think that's an interesting point and you've been fortunate in that you've been able to sit a little bit in the cat bird seat because you've had an opportunity to participate in a lot of virtual conferences. You advise a number of companies. So you've been able to get feedback from a lot of different sources, as opposed to, if you were solely ensconced at Pfizer, you might not have access to the kind of information I'm thinking of. So here's my question. Do you believe that all companies, saw that opportunity to innovate and to accept and to accelerate? Or do you see that there's been a, sort of a separation of the wheat from the chaff and there are the companies that already had a innovation growth mindset, and then there are the folks that are just struggling to keep up?   Craig Lipset: (05:11) I think that in that April, May, June timeframe, a lot of organizations were all in the same boat. They were all trying to scramble to keep their portfolio going. They were rushing to introduce whatever countermeasures they could to keep patients being monitored, keep drug supply flowing, and keep capturing data. So that studies didn't wind up futile. But, Janet, I do think that we start to see some separation when we look to the latter half of 2020, because in that latter half of 2020, then we start to see that there are some sponsors out there that are starting to commit to some of these changes they're putting in place, new resources, they're relooking at some of their SOP and processes. They're expanding their vendor and partner lists some really starting to rethink how they write protocols and introduce some new training. These are the companies that are really starting to show commitment. They're really looking at the things that were adopted earlier in the year and being thoughtful about what's needed now to instantiate these and make them a part of our organization going forward. And that's different from some others that just maybe haven't been able to step forward to make those kinds of organizational commitments yet because they're hard.   Janet Kennedy: (06:35) Well, not only, they're hard; you may not even have the environment within your company that can embrace that kind of change and thought process. You really do need leadership that is willing to invest in that kind of information and that kind of structure, those kinds of individuals.   Craig Lipset: (06:53) Absolutely right, Janet. If there's one thing we saw in 2020, it's that these new approaches, well, they don't need special regulatory permission. Yes. The FDA produced some really important guidance for the industry about running clinical trials during the pandemic. But I encourage people to take a close look at that guidance. They didn't lower the bar on what technologies or approaches to introduce. They just said, use them and use them thoughtfully engage with your regulatory reviewers. And so from a regulatory perspective, these solutions were available; from a technical perspective, they were available. What does that leave? Exactly where you're pointing - culture, and our organizations ready in terms of their own internal culture and receptivity and willingness to change, or is it the culture that will ultimately stand in the way of those organizations being able to commit to and adopt these new approaches that were introduced last year?   Janet Kennedy: (07:51) I imagine that's a big part of what you do as a consultant is helping companies revision how they look at the growth of their company and expanding their capabilities through innovation.   Craig Lipset: (08:04) You know, Janet, I can only help organizations that are ready to be helped, but when they call, I'm certainly happy to be there. And mostly what I do professionally, whether with pharma companies, tech companies, or with others, is to help them make their strategies fabulous. And to help them make their implementations resilient. I can't fix the culture on my own. I can't show people solutions that they're not ready for. And so, you know, I can really only come in if leaders are ready to commit to these areas.   Janet Kennedy: (08:39) So you had a lot of time on your hands where you might've been traveling on airplanes, going places, and you obviously found a nice little hobby on the side where you decided to get together with some other thought leaders and launch a new initiative, the DTRA, the Decentralized Trials and Research Alliance. So I'd love to know the backstory. How did that come about?   Craig Lipset: (09:04) With all of that free time? Really Janet. So, it's interesting. DTRA is planning actually preceded the pandemic. It dates back to just prior to the pandemic when a friend and colleague Amir Kalali, who is well known in the industry from his time at Quintiles leading the neurosciences, and his time as the leader for the CNS summit Amir reached out and that he was exploring some different convening opportunities around decentralized. And we both appreciated that the world didn't need another conference on this topic. But when we have talked about decentralized in different meetings and events, there was always something left on the table. There was something that would come up at every one of those conversations about an opportunity to make the field better together. That was then left behind when that conference ended. And so we started to explore together what could be really sustaining and help to change this field.   Craig Lipset: (10:02) And then, the pandemic emerged. Which, in many ways, amplified everyone's attention around decentralized, but also was pretty distracting in terms of people needing to be heads down and keeping their portfolio going. And so while there was a lot of interest from a lot of my network around coming together with the DTRA, we did have to push some of our plans out to later in the year and give people in their organizations time to make the adjustments that they needed to, internally. By the end of 2020, in early December, we were ready to go live. And so made a public launch of DTRA, the Decentralized Trials and Research Alliance. We had over 50 founding organizations as members. These were groups that really took a chance with us believing that there would be a community that came together to try to make adoption of decentralized research, easier and help drive the scale that we know as possible, but it's hard.   Craig Lipset: (11:04) And so with that, we launched DTRA. Now we're at about 85 members. I think we'll probably be at a hundred member organizations and over the next month or so, we keep posting those updates on LinkedIn and Twitter. So what is DTRA? There's really two aspects to the decentralized trials research Alliance that I speak to. One is the work that we're doing together. The initiatives that we're taking on, and the second is the network and the community that we're creating that can support B2B transactions and raising more awareness and activity in the field. For the initiatives, our leadership council, our members, defined four priority areas together. The first is around definitions and how we agree on archetypes and key performance indicators to help reduce some of the tower of Babel in this category and help make sure that we're talking about the same things in our conversations with one another.   Craig Lipset: (12:06) The second area has been around best practices considering that our members, whether pharma, whether CROs, tech companies, site networks, advocacy groups, and the FDA themselves, our members have been involved in most all of the decentralized research studies that have gone out in the last few years. What are the learnings, the best practices that we can identify together to help make implementation easier? The third area for us is themed around education, because so many of us get stuck needing to bring our organizations along or other stakeholders, like investigator sites or patients and their caregivers. What type of educational resources can we begin to aggregate and share, and in particular, use data and evidence to drive that education? As an example, we all talk with enthusiasm about the potential for decentralized research to improve diversity in clinical trials. But where's the data and the evidence to back that up?   Craig Lipset: (13:10) We believe that by having a multi-stakeholder initiative in a nonprofit space like this, we'll have the opportunity to gather the data and evidence across our members. A fourth area, the fourth priority for us is around removing the remaining obstacles that stand in the way to meaningful adoption. And so those might start to include topics like interstate licensing or global regulatory variability, or other priorities. that our members are working together right now to identify and prioritize. Now I know firsthand from my time at Pfizer that we are not the only initiative collaboration consortia operating in this environment. And in fact, we have identified and begun to engage with over a dozen different initiatives, consortia, collaborations that cover a number of different topics, but might have a work stream, a taskforce, a work group that's looking at decentralized trials together and trying to solve a specific problem.   Craig Lipset: (14:12) We've begun to reach out to each one of those organizations and have been really well received in our call for transparency and collaboration. And by that, what we're looking to do is pull together the overall roadmap across the different collaborations in this space, because when it comes to decentralized trials, it's the only thing DTRA cares about. It is our sole priority. And so we're very well positioned to help show our members and others what different work is already happening here. Make sure there's no redundancy. Make sure that there are handoffs when it makes sense. And Janet, I mentioned earlier that there are really these two areas; one around our initiatives, and the second is a bit the leans in more around network. We realized that our members are the buyers, the sellers, the implementers of decentralized research. Our initiatives are very specifically a non-selling zone there to get work done together.   Craig Lipset: (15:09) But people in our community want to know about the capabilities of one another. It might spark business to business collaboration among different tech companies or tech and service providers or opportunities to engage with sponsors that might not have otherwise known of certain capabilities. We're also starting to explore opportunities to help some of the younger companies in this category with access to capital, and what ways we can create showcases for investors that are very interested today in decentralized research, and make sure that the spotlight is shown on those that are growing new capabilities here. And so whether for these initiatives or for these network opportunities, or a little bit of both, that seems to be what's drawing this community together.   Janet Kennedy: (15:53) Gosh, have you said this before?   Craig Lipset: (16:00) Maybe in my sleep. I'm sure my kids are sitting in the other room saying, "Really dad? Again?"   Janet Kennedy: (16:07) Okay. So I have a couple questions. I'm curious about the membership. You said you're hoping to grow to about 85 to a hundred members and maybe beyond that, but that sounds like it's all pretty corporate members. Is there an opportunity for individuals to engage in this?   Craig Lipset: (16:25) That is a fabulous question, Janet. And right now our members are organizations. They can be corporations, they can be nonprofits. We have a number of advocacy groups, and obviously we have the FDA and our opening engagements with other regulatory agencies. The idea of individual members is something that our leadership and our board have been very actively exploring. Individuals might be between gigs. They might be independent contractors. Maybe they're just great advocates for this field, that want to grow their career in this direction, but their current employer isn't a member because it doesn't align to their employer's goals. We are finding ways to engage with these individuals. Today, those might be roles that are based a little bit on sweat equity, where some individuals want to step forward and help to manage and lead some of our initiatives and work streams. Going forward, though, we are going to be looking later this year for other ways, to open our doors for individual members. And so I would encourage those who are individuals whose organizations might not be members today to visit dtra.org and click to sign up for more information, so that you'll be on our email list. And as new opportunities emerge, you'll be right there among the first to see them.   Janet Kennedy: (17:47) Obviously just the concept, a decentralized trial, I would assume, that its foundation is 'because that's what's best for the patient'. How are patient advocates and the patient experience part of the DTRA planning?   Craig Lipset: (18:04) While in 2020, a lot of implementation had to be rushed to try to salvage and maintain studies, in general, our clinical research community is eyes wide open today to actively including patient input and insight from day zero of the earliest plans, whether for a protocol, or if they're smart, for a new technology they're looking to implement. And so for that reason, we wanted to make sure from the very beginning patient voices were an active part of our community. Two of our earliest member organizations, the FasterCures TRAIN Network and the Genetic Alliance joined in many ways, because they're not representing a single disease, but represent a community of different disease specific advocacy groups. And so in each of those instances, while that is a seat of one organization, that one organization is disease agnostic and includes constituents across a broad range of different therapeutic areas. Now, as more patient groups have been reaching in, many of them are actively offering to help serve as a channel for patient input and insights as DTRA initiatives and other priorities start to identify, be they educational needs or other areas to go after. I think we're developing a very nice stakeholder base of patient groups that will be there by our side and help to serve as a fresh channel for getting patient input into our work.   Janet Kennedy: (19:36) Is there a concern at all that if this is primarily fueled by and funded by for-profit organizations, even though DTRA is a nonprofit organization, that there might be an imbalance of the size of the voice?   Craig Lipset: (19:53) It's a very fair question. Right now, every organization, whether for profit, nonprofit, whether service provider, tech provider, sponsor or otherwise, every member has one seat in one voice in our leadership council. But to your point, we do want to maintain fairness and equity and the different voices that are out there. I think that we have enough active leaders in this organization that are keenly aware of thoughtful of, and sensitive to patient voice today, that well, shall I say in most cases when the patient voice is raised, most people are smart enough to take a step back and make sure that voice is being heard. And if they don't, they're probably going to hear about that from their peers today.   Janet Kennedy: (20:41) Excellent. I am curious about how does a company, a member actually engage? Are you having monthly zoom calls? Are you actually working via email? How do you plan and implement some of the programs that you're doing?   Craig Lipset: (20:59) Every member organization has a seat on our leadership council, which has a quarterly business meeting. In these business meetings where we're reviewing the status of the various initiatives and other work that may be happening. We also have a quarterly community meeting for that leadership council. This is a bit softer. It's not covering the hard topics such as what initiatives progress and status is looking like. But in contrast, these are a bit softer topics that our members have flagged to us as being important to them. One great example there is exactly where you started this conversation, Janet, around culture. Are there tactics that different organizations have been able to introduce in their organizations, large or small, that have been particularly successful or unsuccessful that we can use this community to help share and propagate with others? As I mentioned, in addition to our leadership council, we do have several initiatives that are underway and those initiatives will meet much more frequently. As they get going, they're meeting weekly. And as they get moving that cadence may back off a bit. But right now we're very much in the prioritization stage. It's a pretty busy time right now, as these initiatives are getting going. And so the cadence is a bit busier than it probably will be as we move into more of a steady state.   Janet Kennedy: (22:26) So the pandemic has gone on long enough and will continue to go on long enough that anybody who was hoping to wait it out, I'm sure has learned that, to their detriment, that they were slow off the starting blocks. I assume now it's sort of full steam ahead for the concept of decentralized trials, or are you still feeling that there are folks hoping that the good old days will be back again?   Craig Lipset: (22:53) You know, Janet, I think that our community is like any other and we have a distribution of individuals. I think that we have individuals in all of our organizations at the far right of the adoption spectrum; they want to be the first, they want to embrace the new. I think then we have a bolus of colleagues that are receptive to doing the new, if it feels safe, and if it feels supported. we have others that may be a little more indifferent. And then we'll always have that tail of the other end of the continuum who are very comfortable that really don't want their cheese moved, and well, to be honest, are perhaps most likely to trade out, given how dynamic and how much change occurs in all of our organizations every year. You know, I often think about, Janet, the Ted Talk with the video of the dancing man.   Craig Lipset: (23:45) And if folks in your audience haven't seen this one after the podcast, they should go Google this one up because it's a great voiceover of a story of a concert taking place on a hill. And in this video, you start off with a bunch of people that are listening to the music, sitting on their picnic blankets. And then there's a guy who just gets up and starts dancing. Well people are looking at this guy, and he's the only one standing there dancing. And you know what you're probably thinking - he's looking like a nut. But after that, there are two or three other people that start to get up and dance. Once they do, it validates for everyone else on the hill. Now it's not just a story of one nut dancing by himself, but it's a story of a small crowd that is much safer. And once that happens, it's that rapid tipping point. Everyone else on the hill is now off their picnic blankets and up and dancing. And so I think about it that way with so much of our change in this space. There'll be some people that don't want to get up and dance ever, but once it's made to feel safe, once there's just a couple that are getting up and making it happen, the rest of our community does step forward. They will be up there dancing as well.   Janet Kennedy: (25:04) Well, on behalf of a dancing man representative, I believe that that is an exciting place to be - out there, by yourself, trying, doing what feels right, feeling that emotion of just doing the thing that really is right for you. And when other people join you, that just makes it that much sweeter.   Craig Lipset: (25:29) Sometimes it takes time. Sometimes you might feel like you're out there dancing for a while, but I totally agree with you, Janet. We are so fortunate to work in this industry. Our community does amazing work, developing medicines for patients with unmet medical needs. But even within this space, we know there's so much more we can do. And we know that there are things that we can do just because they are the right things to do. And so a lot of us do, you know, get up and dance and take that chance. And sometimes it takes a little while, but if you're doing the right thing, others will get up and dance with you. It just may take a little time.   Janet Kennedy: (26:07) Absolutely. Well, I would love to get more people involved in DTRA and also following the news that you're going to be sharing. So tell folks a little bit about how to find out more about Decentralized Trials and Research Alliance.   Craig Lipset: (26:22) Three ways for folks to do that. For those who are social, the first two ways are LinkedIn and Twitter. We're really committed to keeping content flowing, to helping to serve as a trusted news and resource for folks on LinkedIn and Twitter about activity in the decentralized trial space. And then finally, check out dtra.org. If you're interested in learning more, either about organizations participating or just yourself staying current, go ahead and sign up there to stay connected with DTRA.   Janet Kennedy: (26:55) Thank you so much for sharing that, Craig. I had a lot of questions and you were very patient about answering all of them.   Craig Lipset: (27:02) You're fabulous Janet. Thank you, and thanks to your audience for spending some time this day.   Janet Kennedy: (27:07) So if you want to find the link to the dancing man video, or of course, a lot more information about DTRA, please go to spencerhealthsolutions.com and you will find the post of this podcast on our website, under podcast. And we'll have all the links there as well as the links to find Craig in social media as well. Craig, thank you so much for joining People Always, Patients Sometimes.

One of the foremost conferences in the field of clinical trials is SCOPE, which stands for the Summit of Clinical Ops Executives. While held virtually this year, the conference was packed with interesting and innovative presentations. Spencer Health Solutions served as a premier sponsor of the event and co presented at the conference with a client and collaboration partner, Otsuka Pharmaceuticals. Our content was presented in the track, focusing on accessing and generating real-world data. The presentation was titled Implementing a Transformative Medtech Device Program to Gather Real World Data. Our co presenters were Tom Rhoads, CEO of Spencer Health Solutions and Kelly Roland, Associate Director, Otsuka. In planning this presentation, we decided to show a little bit behind the curtain of how a large pharmaceutical company evaluates digital health technology before it is written into a patient protocol. Let me set the stage. My name is Janet Kennedy and I'm the host of the People Always, Patients Sometimes podcast. Coming up is a conversation between Tom and Kelly walking through Otsuka's reasons for creating an internal focus group to evaluate the Spencer SmartHub. As part of the evaluation, Spencer health look forward to having Otsuka learn about and experience our deeper data and a more comprehensive look at how patient real-world evidence can be used to support the patient and improve outcomes. I hope you enjoy this candid conversation between Tom Rhoads and Kelly Roland on People Always, Patients Sometimes.   Tom Rhoads: (01:42) Hi, I'm Tom Rhodes, CEO of Spencer Health Solutions. Spencer is and FDA class one medical device for use with medication management, patient engagement and data collection. The Spencer SmartHub is being used in care management for about three years now. And in 2019, we added the clinical trial and commercial pharma division and launched Spencer SmartHub into both the clin trials, as well as post approved commercial farm applications. We're really pleased to be presenting at SCOPE this year, and we're very proud to be joined in the discussion today by our partner in an innovative internal focus group program. With me is Kelly Roland, Associate Director of Otsuka Pharmaceuticals. Hello Kelly, how are you doing today?   Kelly Roland: (02:23) Hi Tom. Thanks so much for inviting me to join you today. I'm excited to be here.   Tom Rhoads: (02:28) Well, that makes two of us. Kelly, our presentation in the SCOPE track is focused on accessing in generating real-world data, which is having a greater impact on the design and clinical trials and patient programs more than ever before. But before we jump into a discussion of our focus group, could you share any insights on why real-world data is a priority for Otsuka Pharma?   Kelly Roland: (02:49) Happy to. So as you know Tom, real-world data, real-world evidence - it's really information that creates action. So using this information, we're able to not only look at the improved design of clinical trials, but also conduct those clinical trials in new and different ways. Better data really lends itself to potentially faster analysis and better drug development overall, with really the aim advancing towards understanding both patients and drugs sooner. So from an operational standpoint, real-world data real-world evidence can enable more efficient, effective clinical trials and hopefully remove any friction for patients, investigators, and sponsors.   Tom Rhoads: (03:37) Well, it's interesting cause you know, as we were designing Spencer, the ability of patients to provide data back to the SmartHub was always central to our design. In fact, whether we're capturing biometric data passively through a Bluetooth connection, or from the patient's direct response for survey questions. We always wanted to be able to provide multiple layers of health data beyond the moment of medication dispensing, and our program today is really to share a rare insight into how a large pharmaceutical company can bring new technology to their patients and ensure that the internal team has buy-in on the new program. So Kelly, with digital health apps have been around for quite a while; why is the team at Otsuka interested in designing an internal evaluation before introducing Spencer to your patients?   Kelly Roland: (04:21) Otsuka is a company that's really dedicated to serving those with unmet medical needs, and we really strive to innovate and defy limitations. When we first evaluated Spencer, we felt it could really help us put the patient at the center of the trial first and foremost. And at the same time, we also knew it would break those current processes and operational logistics that you have for more traditional ways of running a clinical trial. So by getting out of our comfort zone and kind of embracing this new way, this new technology, a new way of doing things, we decided to pilot our own internal focus group, Otsuka only. We could have easily outsourced this to another group to research for us. However, we thought that this internal approach would allow Otsuka functional area champions really, or subject matter experts with that really in-depth personal experience with the device. They could experience firsthand what the patient would experience and help to develop new processes and new solutions based on those insights.   Tom Rhoads: (05:29) You know, you remind me, as we went to develop Spencer, we developed it from the patient out. So to see pharma taking the same position of understanding firsthand what the patient would experience is truly innovative, and we were obviously thrilled to learn you'd be interested in having your team experience Spencer in person. So maybe let's break down a few reason why that's a good idea.   Kelly Roland: (05:52) Holding that internal focus group served a few key purposes for us. First, as I mentioned, gather those insights very quickly and you get that firsthand knowledge that you wouldn't have otherwise. We wanted our teams to look through the lens of the patient, the site, and actually their own functional area when evaluating Spencer. So in the case of Spencer, it's a new technology, it requires a bit more organization, a little more prep work on the part of the team. And we thought this could be an exciting new approach for us. So our goal was to really set up a focus group so we could better evaluate everything end to end from the program set up, data integrations, training materials, and overall how Spencer worked.   Tom Rhoads: (06:38) So when you think about really the protocol that you're outlining, why was it important for Otsuka to kind of evaluate Spencer in each of the different roles?   Kelly Roland: (06:47) So when we're planning protocols or planning our programs, we really want to anticipate as much as possible where there could be difficulties where there could be challenges. One such area are those new roles and skill sets, quite honestly, that need to emerge when you layer technology and roll real-world data into the mix. In the past, we've relied heavily on, I'd say more manual processes together feedback from patients and sites. But with new digital platforms like Spencer, we can be much more proactive in assessing how a patient's doing between their clinic visits, especially as decentralized trials become much more common here in the future. But that said, we can better respond as a company if we've lived the experience in those key roles. It makes our team more intuitive in designing a protocol, and also a little more creative in the support materials that they bring along as well. So a focus group like this creates a lot of change in the company, but it also creates change agents, I'll call them, because now they've lived the experience, they can spread the word to their colleagues and other functions about the tool. They can be that subject matter expert in their function and help others to understand either the value and or challenges of this particular tool. So I think a focus group is really interesting and great way to start that change management activity.   Tom Rhoads: (08:15) That's a great point. So as we kind of break down the roles, maybe we can take a deeper dive into the patient role for a moment. What were you interested in evaluating as a patient using Spencer in a clinical trial?   Kelly Roland: (08:27) I said it before. I'll say it again - I really think this is going to give us invaluable experience from that patient perspective for our greater team. You know, we know we're working with a tool that has really interesting data around adherence and engagement, and we really wanted to explore that further. You know, we're asking ourselves questions like, "could Spencer cause annoyance or frustration for a particular indication?" "Are there other indications that may lend themselves more readily to a Spencer device versus another?" Would the collection of biometric data in the home be more desirable to a patient or caregiver versus having to go to the doctor's office?" I think if COVID has taught us anything that does seem to be a much more desirable functionality that people are looking at now. All this to say, it's very different reading about a tool and assessing capabilities versus actually experiencing them and walking in the patient's shoes.   Tom Rhoads: (09:22) So when we look at some of the aspects of the platform, how does the ability to gather patients' answers, to post medications, dispense survey questions, factor into your plan for utilizing real-world evidence? For instance, we found some eliminating data on how different individuals - in fact, two different individuals, both were basically 98% adherent - can reveal very different situations for those patients. Just curious, how do your plans factor in for that real-world evidence?   Kelly Roland: (09:50) So I think, as you indicated, medication adherence is only part of the story. So the questions we ask patients via the Spencer device could potentially provide, I think, some interesting real-world data on how the patient is not only doing from a physical standpoint, but also a mental standpoint. I think the data can help us to potentially create algorithms that allow for some of these deeper insights. Wouldn't it be interesting to have the ability to predict a manic event in a patient with bipolar disorder, for example, using both biomarker data and survey questions before the event even happens? So finding ways to identify signals related to relapse, potentially diabetes control, et cetera. I mean, this would be something that could be explored by asking the right questions at the right time. And these types of scenarios I think are really what excites our team as we kind of look to take those data insights to the next level.   Tom Rhoads: (10:47) Oh, that is great. It does remind me of the story I mentioned a moment ago. We had two different individuals currently on platform. From a high level, they were picture perfect. They were both basically a hundred percent adherent. They were 98.9% adherent taking their medications during the time prescribed. So you think at this point, check the box and move on; nothing more to see here. When we dug in and began looking at answers to questions, we saw two very different individuals. In fact, there was about a 10 year difference in their age. One was female, one was male. Suffering from depression as a primary and other disease and comorbid. And when you dug down into the questions you found that one person was sleeping well, eating well, exercising; in many other aspects, basically was on a very good path, consistent with a high adherence rate. Yet the other person, even with the high adherence rate, was experiencing a totally different outcome. They were not sleeping well, not eating well, not exercising. And their depression was a bit spiraling. Those are the types of data and insights that we all hope to collect. And I think working with a leader like Otsuka to be able to apply, as you said, algorithms, so that we can begin to notice these patterns and alert against these patterns, are critical really for healthcare's future.   Kelly Roland: (12:11) Totally agree, Tom. I think that that's something that our team looks forward to learning more as we push forward. This is exciting.   Tom Rhoads: (12:18) The funny thing for me is often times we all go out and have a third party evaluate something for us; and then they give us a report and we read our reports and we make assumptions and decisions around those reports. You know, cause we're all busy. I think what's truly unique here is that Otsuka has decided to have their team do it. And I'll tell you, from my experience - just my past in marketing - having your own hands on, you're going to see things, ask things, question things more deeply than you ever could coming from a report. I think that's a really interesting aspect of this where companies really do roll up their sleeves to understand what it is they're evaluating.   Kelly Roland: (13:01) So Tom, we talked a little bit about the Otsuka focus group and the program that we've developed, and the partnership that we have. From your perspective, was creating the focus group program the same as launching into a new clinical trial? You know, were there many differences or any similarities you could speak to?   Tom Rhoads: (13:21) Well, overall it was a terrific experience for us. I guess on the firsthand we followed the same procedural pathway that we would use for clinical trial: treating it as a protocol and really following the regimen and structure and review process with very deep collaboration across the teams. By approaching it in this manner, I think we were better aligned with your team, certainly, with the expectations and the outcomes that you were seeking. I think the difference for us in this was that the focus group program really centered on feedback and modification to best support your long-term needs. And so for us, it was very refreshing, maybe not as nerve-wracking either - given that we had opportunities to modify and change - but being able to go in with a mandate to learn and collaborate was really critical, I think to the teams to provide honest feedback, questions, and have the necessary dialogue and how we can make things better overall, from an onboarding, a management, you know, a site management, and general support throughout the entire trial. It was a great experience for us, for sure.   Kelly Roland: (14:25) Thank you for that. And I agree, I think that some of the ease of the focus group was really around being able to be creative and work together in that kind of creative fashion, where if something didn't work or we wanted to pilot something different or add this or switch that, we had the flexibility to be able to do that. So I agree. I think that this was refreshing from all angles - ours as well. So definitely appreciate that. One other question for you. What do you think, again from your perspective, is an important thing that clients, pharma companies in particular or researchers, need to experience when working with new technology?   Tom Rhoads: (15:07) You know, digital health has been around for gosh, a decade now, I guess we've been talking about it materially, and I think clients, or really anyone looking at technology really need to understand how to best apply the technology, kind of what the upper and lower limits of the technology are. You know, where is it best used? Who best responds to it? How is it supported? Does it work for their needs or not? And you know, I think one of the things that Otsuka did such a really refreshing kind of remarkable job of is rolling up their sleeves and experiencing it themselves. I think too often clients look to third parties to evaluate technology and give them condensed reports on it. And it's hard to make decisions from that. But when you experience a technology firsthand, you're going to have a really insightful and deep understanding of the good and the bad, and be able to make decisions - and I think more informed decisions - and directionally support your strategy longer term. That was something that as we move forward, we'll certainly be sharing that as an important aspect to evaluating new technology.   Kelly Roland: (16:15) Perfect. Thank you.   (16:17) Well, thank you for having us and allowing us to present at SCOPE. We certainly hope you come and visit us in the virtual trade show hall. And it's really exciting to be able to share our focus group study. We very much look forward to sharing the findings that come out of this, maybe in the next SCOPE.   Kelly Roland: (16:35) Thanks Tom. I appreciate being here and agreed. I think we look forward to sharing our learnings in the future.

Welcome to People Always, Patients Sometimes, a podcast production of Spencer Health Solutions. I'm Tom Rhoads, CEO of Spencer. This year, we are pleased to be presenting a series of interviews with patient advocates, inspiring leaders, and influential patient organizations to ensure that we always live our motto of people always, patients sometimes. On the podcast today, is Brian Lowe, the founder and CEO of Inspire. Brian created Inspire 15 years ago with a goal of accelerating clinical trial recruitment, using safe, trusted online social networks, organized by medical condition for patients and their caregivers. Today Inspire has 110 health association partners and over 2 million members. I hope you'll enjoy our conversation with Brian on People Always, Patients Sometimes.   Janet Kennedy: (00:56) There are over 200 million people living with one or more of over 7,000 identified rare diseases around the world. Rare diseases have a wide diversity of disorders and symptoms that can vary not only from disease to disease, but also from patient to patient suffering from the same disease. Hi, I'm Janet Kennedy with Spencer Health Solutions. I am so pleased to welcome a special guest from the rare disease community to the People Always, Patients Sometimes podcast. With me today is Brian Loew, who is the founder and CEO of Inspire, a patient community unlike any other. Brian, welcome to the podcast!   Brian Loew: (01:39) Thank you. It's really great to be here.   Janet Kennedy: (01:41) You really have been quite instrumental in pulling together patients who have rare diseases and providing them an online community. And that is an amazing thing and an important aspect of caring for patients in this crazy world that we're in right now. I'd love to know a little bit more about how you came to found Inspire, and then let's talk about what you're up to.   Brian Loew: (02:08) Sure. When we started Inspire about 15 years ago, it was out of our observation that there was a real need for patients and caregivers to connect safely online. And that there weren't great spaces for them to do so way back then. And it seems like a long time ago, what you found at that time was online message boards, discussion groups. Many of them were kind of Yahoo message boards. A lot of them are unmoderated, and yet you saw the need was enormous. Patients and caregivers were trying to connect around their health. And we saw that there was a real opportunity, I think, to provide this safely and with scale, a reliable platform or patients and caregivers could join and talk about their medical conditions.   Janet Kennedy: (02:49) You brought something interesting to the table in that your background is in technology. You are not a medical professional perse.   Brian Loew: (02:57) That's right. I had a lot of interest in health and so did my co-founders, but I didn't come at this from the perspective of a doctor or a scientific researcher. It was more of a technology background. That's right.   Janet Kennedy: (03:07) So that probably gave you a great leg up in creating something that was going to work. And you're much more aware of the issues involved, but how did you handle the medical side and even the legal and HIPAA related side?   Brian Loew: (03:21) Sure. One of the things we did from day one was we partnered with experts in this case, national patient advocacy organizations, which is, you know, there are about 2000 of these in the United States and they're organized often by specific disease. A very large number of these non-profit organizations are in the area of rare disorders. And in fact, our very first partner was the Children's Inn at the NIH, which is this extraordinary place at the National Institutes of Health to help support the families of children who are undergoing treatment, usually for rare disease or cancer at the NIH. This expanded to other national patient advocacy organizations like women, heart and the ovarian cancer research foundation and osteoporosis foundation. And over time, we now have 110 of these partners and about half of them are in rare disease.   Janet Kennedy: (04:13) So for instance, something like American Heart Association or American Cancer Society, those are very, very large organizations. But on the other hand, I imagine there's obviously more than one kind of cancer or one kind of heart issue. So do they have subgroups underneath an umbrella of their organization?   Brian Loew: (04:33) You're absolutely right. That as you said, if you look at the 7,000 or some estimates are now that there are as many as 9,000 rare disorders, there was enormous overlap with rare types of cancer. For example, where people have rare conditions that might be, you know, historically called a kind of cancer and now recognized as a rare subtype. And then there are other things that have always been thought of is rare disorders, things like Wilson disease or Von Hippel-Lindau syndrome or scleroderma or sarcoidosis or Ehlers Danlos syndrome. And we have partners in all of those areas. And I think what we're coming to realize is that kind of, as you pointed out, rare diseases are quite prevalent, even though they're officially defined as conditions for which there are less than 200,000 people in the United States with a disorder. It's estimated that one in 10 humans have one or more rare disorders. And so, you know, we're talking in the United States of over 30 million people who have a rare disease.   Janet Kennedy: (05:26) I'm going to ask a lay person's question here, and I know you are not a medical professional, but I'm going to take a great leap. It's not that there are now nine or 10,000 rare diseases that are new it's that our science is getting better and better, And we're able to much more specifically identify what these issues are?   Brian Loew: (05:45) Exactly Right. Exactly Right. And a lot of this is due to incredible advances in genetics over the past 20 years, the identification of things, which before weren't known to be conditions, syndromes, or disorders as such. One of the things that we see in Inspire all the time is what's come to be referred to as the diagnostic odyssey. Patients will have a collection of symptoms. It's clear that something is going on and what the patients are wondering is, do I have something that's recognized as a disease for which hopefully there's treatment? Or am I alone? Am I an 'N' of one? There's some things that are often observed only in a single person. And this is actually kind of an incredible aspect of rare disease, which is that many of the patients who find Inspired do so because they're searching online, searching for their own symptoms and what they discover is conversations going on in Inspire among other people who have the same rare disease that they do. And so there are many people on Inspire who have written to us and said, I discovered that I have this certain condition by connecting with others in your communities, and then going to my doctor and then getting genetically sequenced and discovering that I had a certain condition and that's really gratifying.   Janet Kennedy: (06:55) Well, and while it's nice to finally put a name to the thing that you're feeling, it must be incredibly frustrating if there isn't actually a treatment or a cure for that. So how is Inspire really helping to change the game?   Brian Loew: (07:11) Right. As your listeners may know, only about 5% of rare diseases, 5% of those, you know, seven or eight or 9,000 actually have a treatment. And so the vast majority are known to be real conditions often with genetic markers, but there are not good treatments for them. So there's a real effort by scientists and industry to help find treatments for as many of these disorders as possible. One of the ways we're trying to help is we developed something called the Inspire Research Accelerator, and you can check it out at Inspire.com/accelerator where we've offered to academics, to scientists around the world. If they're working on a particular disease and they need help finding patients to participate in the research, we will invite our patients to participate in their research. There's no charge for this. Our goal here is really to help advance the science. It's something that the patients are happy about as well, because by and large, if you ask members of Inspire what they want most it's to be as healthy as they can possibly be. And so they are very motivated to help support scientific discovery.   Janet Kennedy: (08:13) How long does scientific discovery really take? If you are approached by a pharmaceutical organization or even one of your partner organizations to say, "let's try and get a solution here." I mean, it's years and years?   Brian Loew: (08:28) Years and years. In some cases, decades, right? To sort of understand the condition and the underlying mechanism, and then to begin to explore what treatments are possible. And then as you know, once a drug candidate is identified on average, it takes 12 or 13 years to bring that new treatment from concept to market. And there are many failures along the way. So it's a marathon for sure. It takes a long time to figure these things out. Most of the time, by the way, one of the biggest bottlenecks historically has been that a researcher who has great ideas, isn't able to find enough patients to participate in research. And then in rare disease, sometimes the number of patients required could be dozens that it's fairly small, absolute number, but the conditions are so rare that it can be difficult to find 10 or 20 or 30 people for the rarest of conditions.   Janet Kennedy: (09:19) Have you found that you are building a community where the patients are predominantly coming to you or do you actually have to actively recruit patients with a certain disease or condition?   Brian Loew: (09:29) It's mostly the former. So the way that a lot of patients discover Inspire because they're searching online. And as I mentioned, they find these conversations that are already going on. The second way is that these patient advocacy organizations. So for example, one of our partners is the Wilson Disease Association, Wilson disease affects 10 or 11,000 people in the United States. And it's characterized by excess copper in the bloodstream. This is an extraordinary organization that we work closely with many of the patients with Wilson disease learn about Inspire through the community that we provide with the Wilson Disease Association. And then, you know, finally many members tell their friends and family about the community as well. And so there's growth that way also.   Janet Kennedy: (10:11) So this isn't necessarily a community that is exclusively for patients?   Brian Loew: (10:17) Correct. I'll stand on my soapbox for a minute and say, I think all of us in society need to recognize caregivers for a moment. Every single one of your listeners probably either is, or has been, or will be a caregiver at some point in their life. In some cases, half of the members of Inspire are caregivers. And many people of course, are the caregivers for one condition and the patients for another condition. So very much so Inspires a place for patients and caregivers and researchers and medical professionals.   Janet Kennedy: (10:45) Well, that sounds like a very supportive organization of people. And I think one of the things that you, our newest members would find is the support system.   Brian Loew: (10:56) Right, right. A lot of people arrive shortly after they're diagnosed. There's this fire hose of new information. They're trying to learn as fast as they can and make decisions oftentimes with all this fresh information. And the support is incredible. People often say to us that they no longer feel alone or for the first time they found other people who really understand what they're going through. And there's a ton of support there. I want to point out here that what we're doing is not a substitute for the doctor patient relationship or medical treatment. I think what we're helping support is the practical and emotional support as well as patients understanding how to deal with this flood of information and what questions they should ask their doctors and how they should think about their treatment decisions.   Janet Kennedy: (11:41) I imagine that whatever condition you have, eating the right things or avoiding the wrong things, even simple things like how to exercise or whatever - that's not the kind of information you're going to find from your doctor simply because they're busy. They might give you a link or they might give you a handout. But a lot of the very specific "I have problems with my sleep," or "what can I be eating that won't taste bad?" or those really day-to-day living things you want to be talking, not necessarily to your doctor, because you don't expect them to solve that problem. This is about living. And I think only somebody who's been in that situation would be able to give you that kind of detailed advice.   Brian Loew: (12:28) That's exactly right. If you were trying to figure out how to get on an airplane with your wheelchair, you know, how do I travel with a wheelchair? Who's the best person to help you with that? It's probably someone who has done that before, who understands it. If you're trying to get reimbursed - and there's a lot of discussion about trying to get reimbursed for conditions from insurance companies and that kind of thing. There are a ton of practical tips about that. On a related note, we recently looked at the question of what should I know before I go into the hospital, if you have a planned hospital visit and we had this incredible outpouring of really, really practical tips about how to deal with your hospital stay. And a lot of these things are just better told from people who have been through them before and giving practical advice. I think most doctors would agree that that's not meant to replace what the doctors are providing it's to help support it.   Janet Kennedy: (13:16) Well, we are obviously dealing with COVID and will be for a while. Your community theoretically, should be at the front of the line for the vaccine. Have you found that to be true or does it vary from state by state?   Brian Loew: (13:31) We're in the midst of a really, really wide survey of all of our members about the COVID vaccine. And if you'd like, I can share with you afterwards and you can put it in the show notes. It's really extraordinary. What we're finding is that - this is an important point I should mention is that when you listen to the news about the COVID vaccine, oftentimes we're told things like on average, people are experiencing the following. And what we found is that those averages oftentimes are not really as useful as specific situations. So we're asking members of Inspire about their willingness and attitudes about getting the vaccine, their difficulty in getting, getting it when they've decided that they want it. And then there are concerns about getting it. And oftentimes these concerns are very different for different diseases. For example, we have many members who are taking immunosuppressive therapy, and there's a lot of question and concern about whether the COVID vaccine will affect them differently than people who are not taking immunosuppressive drugs and those kinds of conversations. We're still so early in the vaccine, there is not a great deal of published data about the relative risk for people with different diseases. So there's a real thirst for information and people with different medical conditions have different, but very specific questions.   Janet Kennedy: (14:43) So I imagine that that survey anecdotally is going to be extremely valuable, but is there any organization that's actually funding research into how the rare disease patient is dealing with COVID?   Brian Loew: (14:56) We're funding the survey ourselves, and we've also decided to make it a kind of gift to the world. So we're going to open source the data, and we're going to make all of these available to the general public, to browse through the aggregate anonymized results. And then we're also going to make the data sets available to the public and to researchers who want to explore it more deeply. One of the ways I think we'll be able to contribute is that we're breaking all of these data out by specific disease. So if you want to understand the experiences of patients with one rare disease versus another versus cancer versus chronic conditions, and looking at by age, gender location, experience with treatments and diseases, you'll be able to look at all of these data and kind of interactively explore them. I think it'll be a really great research experience.   Janet Kennedy: (15:41) How many patients have participated in the program so far? And are you specifically looking at patients, are you asking caregiver information as well?   Brian Loew: (15:49) As of today, we have about 25,000 who've participated in over a million data points, but we're only part way through. So I expect that number to grow a great deal and for it to be a, hopefully a really valuable resource.   Janet Kennedy: (16:02) Oh, this sounds pretty impressive to me. I think it's going to be exciting.   Brian Loew: (16:05) I'd love to share it. We're a couple of weeks away from sharing it publicly and I'll give you the information for that.   Janet Kennedy: (16:11) All right. That'll be very exciting. And I look forward to reading some of it myself, not with full understanding necessarily, but I definitely would appreciate getting that inside look. So tell me about clinical trials in general; is that the primary focus of Inspire?   Brian Loew: (16:27) When we started, that was a lot of what we did and we still do that. You know, the problem remains that recruitment for clinical trials is never as fast as, as everyone wants it to be, right? The patients, the scientists, doctors, companies that are developing treatments all want it to move faster. One of the biggest problems has been finding the patients and inviting them to participate. So we still do that, but equally important. And maybe a big focus for us now is understanding the health journey that all of us are on understanding the information about diseases and their progression and which treatments work and why. And so we're putting a lot of our resources towards these health journeys by disease, with equal of helping patients understand their own journey and helping science with the data that's required to help make discoveries. So I would say actually more of our energy now is in that area and it's producing great results.   Janet Kennedy: (17:17) You know, COVID has forced a big sea change in how clinical trials operated in those that were able to embrace a more decentralized experience for the patients seem to be rebounding a little faster than those that are classic come into the clinic. What's been the response from your community, and do you think that the patients have spoken and we're going to see a lot more decentralized trials in 2021 going forward?   Brian Loew: (17:50) Yeah, I would say yes, yes, yes. Some people have pointed out, this is maybe a silver lining of COVID. If there is one, is that what began years ago? And people like Craig Lipset have been involved in helping this happen more quickly. What began years ago is now jumped ahead by maybe 10 years or even more the idea of doing remote trials when possible is something which is now happening much, much more than it was one year ago. I think it's a great thing. Patients like it, most researchers like it, and I'm just thrilled that it's happening so much faster now.   Janet Kennedy: (18:22) I think that it's going to make a huge difference in being able to recruit particularly in the rare disease community.   Brian Loew: (18:29) That's right with rare disease, geography is a huge factor. In some rare diseases, the number of scientists working on the diseases is tiny, and if those people live a thousand miles away from patients that can be a real barrier to participation. And to the extent these trials can be done remotely, it solves that geography problem oftentimes, and can really accelerate progress.   Janet Kennedy: (18:50) If you had the opportunity to share with researchers one core piece of advice on working with the rare disease community, what would you recommend?   Brian Loew: (19:02) I would say please work with the patients in designing your research, and do that as early as you possibly can. If it's clinical trials, that means inviting patients to participate in protocol design. If it's developing therapeutics, work with the patients themselves and ask them questions and ask them to co-create solutions. There is an enormous amount of wisdom among the patients themselves, and also a huge amount of willingness to participate in. What we hear from patients oftentimes is that they wish they were consulted or involved in developing these because they have a lot to contribute and often are not asked.   Janet Kennedy: (19:35) All right. So that's, I think the key thing is consider your patients partners, and not numbers.   Brian Loew: (19:44) Right. Absolutely.   Janet Kennedy: (19:45) Alrighty. Well, I can't thank you enough for joining me on People Always, Patients Sometimes to share the story of Inspire, and I will definitely look forward to getting the link to the study that we will post, even if it's after we publish on the podcast, because I'm very excited to hear how that turns out.   Brian Loew: (20:06) Thank you, Janet. I really enjoyed talking with you.   Janet Kennedy: (20:08) Thank you very much for being here, Brian.

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Today we have invited Jake LaPorte co-founder and global head of The BIOME by Novartis to return for a second conversation on the People Always, Patients Sometimes podcast. On the previous episode, Jake spoke about The BIOME by Novartis and digital health innovation in clinical trials today, Jake shares his thoughts with our host Janet Kennedy on COVID-19 innovation, digital health, and more. I hope you enjoy their conversation on People Always, Patient Sometimes. Janet Kennedy (00:36): Hi, my name's Janet Kennedy and I am your host for People Always, Patients Sometimes, a production of Spencer Health Solutions. Today we have invited Jake LaPorte to join us again for part two of a podcast episode, where we are discussing The BIOME by Novartis as well as patient centricity in clinical trials. Jake, welcome back to the podcast. Jake LaPorte (00:57): Thank you, Janet. It's great to be back. Janet Kennedy (01:00): So for the folks that might not have caught the previous episode, can you give us your elevator pitch on what The BIOME project is? Jake LaPorte (01:08): I'll do my best. So the thesis behind The BIOME is that Novartis has made a big commitment to become a company powered by data and digital, but yet we're not digitally native. So we almost always rely on an external partner to some extent, to help us build digital solutions. And we recognize we need to get a lot better at partnering with companies in the digital and tech ecosystems. And so The BIOME was developed to break down the natural friction that exists between a large multinational pharmaceutical company and the data and tech ecosystems and help us partner with those companies more effectively to develop digital health solutions that have an impact on patient's lives. Janet Kennedy (01:54): You know, there are a lot - like a lot - of digital tools out there. How do you even sift through and figure out who is a good potential partner? Jake LaPorte (02:04): Yeah, that's a great question, Janet. And that's frankly, what our process is all about, to be honest, because what is not often acknowledged in digital health is there's a scarcity of evidence that is available to understand whether a specific digital solution is going to be scalable if that's even feasible. And that it's going to have a meaningful impact if it is scaled. And so The BIOME is really an evidence generating mechanism so that we can make better more data-driven decisions about how we allocate our resources within Novartis to make sure that we're allocating more resources to those things that are more likely to be successful and have an impact on patient's lives. So for instance, we're doing a lot of work to figure out how we can sift through this complex ecosystem more effectively and more systematically to even surface the right partners. We're doing a lot of work to think about how then we onboard those partners more quickly and how we do what I call healthy proof of concept work with them. So we're really thinking about what are the real meaningful hypotheses, the questions that we really need to answer so that we can get more comfortable, that we need to put more resource behind certain companies and solutions in order to scale them a lot of that discipline. And I think this is true of most of the industry did not exist in the digital space. And frankly, it was a paradox, right? Because we have a very healthy innovation management process when it comes to developing medicines, we certainly just don't plunk a tremendous amount of resource into medicines that haven't gone through certain stages of trials. And we certainly know about our portfolio of trials and allocating resources to those ones that have gone through certain milestones, like stage one, stage two and stage three of clinical trials. However, we weren't doing that as systematically with our digital solutions and The BIOME is really that innovation management process. That's helping us do that with external partners. Janet Kennedy (04:13): All right. So one of the pushbacks that so many young new startups get is how many clinical trials have you done? Well, you know, none because we need you to try us take a risk believe in us. Is that something that's hard to overcome internally? Jake LaPorte (04:33): There are still challenges because there are so many solutions that exist out there. It's impossible for Novartis to make a bet on every company from the very get-go and be the ones that are really sponsoring their initial work. We're trying to make as best decisions as possible. So we spread our bets. So there are some that are kind of very early on companies and we have to do our best to figure out if we believe in what they're doing without the evidence behind them. And that fits well into what we're trying to achieve. And we make a bet on them. There certainly are companies that we do that with there's others, where frankly, we might need to see a little bit more evidence behind them before we make a bigger bet. And so it's a balance that we need to strike as much as we would like to try to support everyone in the very early stages, it's just not feasible for us to do that. Janet Kennedy (05:24): Digital is a pretty broad word. So when you're talking digital, are you literally talking about apps, platforms, medical devices? What kind of things are you looking at? Jake LaPorte (05:35): So for us, we take a fairly loose definition of digital. It could be any and all of those things. Distinctively we don't play in an area where we're partnering with conventional biotechnology partners to, for instance, co-develop assets or license, an asset from them. That's a clear place that we play, but any where there is data to be generated or devices to be tinkered with. I think that's a natural area where the bio model that we developed can be very effective. Janet Kennedy (06:11): Before we jump into the bigger conversation, can you remind folks how they can find out more about The BIOME? Jake LaPorte (06:17): Sure. They could probably Google Novartis BIOME, and we have a page that will give you a little bit more information about what The BIOME is, give you links to some of the leadership team, and you can always feel free to reach out to me or others to get more information. Janet Kennedy (06:36): Alright. And we will include a link to that in the show notes. Jake LaPorte (06:39): Perfect. Janet Kennedy (06:40): So Jake, one of the things that I was very curious about is the sea change that has happened and we're golly, nine months into a COVID process. How has The BIOME changed from this time last year? Jake LaPorte (06:57): It's been a meaningful change, not so much to the operating model that we developed, because we think that's a good one for us to facilitate digital innovation and meaningful partnerships to create digital solutions that have an impact. But certainly when you factor in COVID-19, which is first and foremost, a human tragedy, it's also certainly surfaced some of the challenges of the healthcare ecosystem. And we have really focused on helping develop solutions that solve some of the challenges presented by COVID-19. So for instance, we have a big initiative as a company on helping to think about developing telemedicine solutions that improve the continuity of care for folks that now cannot necessarily set up regular doctor's appointments, right? So there's a whole second level issue occurring in healthcare, which is that people that normally should be going to the doctor and getting diagnosed with other diseases, simply aren't going to the doctor or their physician as much and are suffering from diseases that they normally wouldn't have suffered from. So how do we help patients and physicians connect more effectively? So we're working a lot on solutions like that, making them scalable and effective and providing more convenience to patients and physicians that are challenged in this new era. We're also re-diverting some of our resources to focus on specific COVID 19 challenges that have been posed by certain government. So for instance, we have a BIOME in the UK located in London and they work with the NHS and the NHS has defined some specific challenges that they wanted to try and solve. And so our entire innovation program that we have in the UK this year was diverted to helping solve some of the challenges that the NHS has presented. So I think COVID-19 has given us a new problem set if you will, to focus on. And it certainly accelerated a lot of people to really think about how to use digital solutions creatively to overcome some of these challenges. Janet Kennedy (09:20): Well, I think that's really exciting because in many cases we think about pharma as being the big engine. That's only rolling forward at a certain pace and suddenly the flywheel of COVID-19 has accelerated that. And I think it might be really exciting to be working in a company to know that this is not a solution five years down the road. We're solving something today. Jake LaPorte (09:45): Yeah, certainly. I think again, although it's first and foremost, a human tragedy, it's sad that this is the catalyst behind some of this digital transformation. I think the solutions that are being developed are solving some more fundamental challenges in healthcare that will have longer term benefits after we get to a better place with COVID-19. Janet Kennedy (10:05): I agree. Totally. And I think telemedicine, which has been in development for over 20 years is finally seeing its day. Do you see any other type of digital health solutions that we're going to be treating more as an everyday use that might not have been accelerated so quickly? Jake LaPorte (10:25): Yes, certainly the biggie out there is telemedicine, as you already alluded to Janet. But I think that frankly opens up a platform for a lot of other digital solutions to be incorporated into a telemedicine backbone. I think as telemedicine gets more widely adopted it's, there will be ecosystems of digital devices that collected data that can be used in a telemedicine forum to make better more data-driven decisions by a physician remotely. I think you'll see these ecosystems of devices spring up that are expressly designed to fit within telemedicine scenarios. So almost like a virtual checkup room, for instance, that the doctor can use to deliver care more effectively. And in remote scenarios, I think we'll also see more creative ways to do digital clinical trials. For instance, I think we'll be using data more often as telemedicine kind of increases. So does the data that's being collected. And as the data improves that we have on patients, the smarter we can be around developing hypotheses for clinical trials that make them more honed and more focused on answering the questions we need to answer and nothing more than that. So I think we'll see trials get more effective. So I think there will be a number of knock on effects that we'll see as this increase happens. Janet Kennedy (11:55): Do you see personalized medicine becoming something much more central to our healthcare system? Jake LaPorte (12:01): Certainly over time. You know, I think there'll be a certain amount of catalytic event that happens through COVID-19 with personalized medicine. But I think that will generally occur over time with more development. One of the things with personalized medicine is that we've often looked at what we've can do on the molecular level with the evolution of Omix. And we've seen that as a flagship for what we're going to be able to do with personalized medicine, but the conversation is often not focused on the other part of personalized medicine. What we really need is that really well, curated longitudinal data set of healthcare outcomes across a population that allows us to really link up what it means on the molecular level, to what it means for healthcare outcomes. And I think once we start getting these more curated longitudinal healthcare outcomes, datasets, possibly through digital technologies and starting to make those links back to the Omix, we'll be able to make greater strides in personalized medicine. So I'm very optimistic about the future of personalized medicine. I don't know if COVID 19 per se is going to accelerate a lot of that right now. Janet Kennedy (13:17): Alright, now understand that I'm speaking to a PhD in chemistry, which is not the degree that I have. So I'm going to ask a little bit of a 101 level question here. When you talk about getting more data, are you looking at beyond adherence and persistence? This is really digging a little bit deeper and how can patients be involved in providing that kind of information? Jake LaPorte (13:41): So if I relate it back to the question posed around personalized medicine, I think, again, this is something where the healthcare community could really come together and make great strides in how we advance personalized medicine. So personalized medicine has been a concept that's been around almost since we started the human genome project, right? The aspiration of course, is that we can deliver therapeutics and interventions that are personalized to a person's genetic makeup. But what we've realized over time is that we need more information to really interpret different gene sequences that people have and be able to better predict what that actually means for their health and how they will actually experience a particular therapeutic or intervention. And then more over, we have to also incorporate environmental effects that those people experience because different environmental effects obviously have different impacts on patient's health. So therefore the grand challenge, I think in personal health is to create a large dataset across a wide population of folks that is able to basically detail what their health care experience and outcomes have been over a long period of time, as well as their genetic makeup and their proteomic signatures and sequences to them be able to make that Rosetta stone translation, if you will, between certain sequences of DNA that might exist with one person and not the other, certain protein expressions at one person as versus the other, certain environmental effects that a person experiences versus the other, and then say, Oh, this is what that means in terms of how their health care and their outcomes have been. Right. And so this is where actually patients can make a tremendous contribution, right? And the amazing thing about it is there's long been this concern about privacy, right, privacy, around the types of data people are sharing. And that is a very big concern and people are very right to have that. But now with the advent of some of these newer technology paradigms, like blockchain technology, and distributed ledgers, there now becomes an opportunity for patients to own their data, their healthcare data, and share what they want when they want with whom they want and revoke access when they want. And not only that, it then becomes possible for this learning technique machine learning technique called federated learning, which allows you to kind of anonymously sample data from patients that may be on part of a distributed ledger and not have to take a lot of their personal healthcare information, but just take the information they've generated health and therefore anonymize that, and still be as effective in developing new, more sophisticated algorithms. So again, this is more of a grand challenge, but I think it's something that the community is the answer is how do we develop technology platforms that allow patients to be involved in contributing data throughout their lifetime, in a safe and effective way where they're recognized for their contribution, right? Cause that's another piece of it. They need to be recognized for the contribution that they're making, but it allows us to advance medicine and ultimately get better at treating people. Janet Kennedy (17:14): In the rare disease community - and I am not familiar with everything you all are developing - but are you working in rare diseases at all? Jake LaPorte (17:21): So we don't have a big focus on rare diseases per se. I think what you'll find is we work in rare diseases in a targeted way, and it's more platform driven. Like we have a cell and gene therapy business unit. And so one of our major products that we just got approved last year is Zolgensma, which is a gene therapy to treat spinal muscular atrophy - SMA - it's miracle, right? Because if you are able to get a treatment to a patient within a certain amount of time, it pretty much cures them from a disease where they would definitely die. So we work in rare disease, but we don't have like a rare disease business unit per se. Janet Kennedy (18:02): So one of the things that we're hearing from people who have COVID-19 is there long-term health concerns that may be a result, whether it's heart impact on lungs, et cetera. So co-morbidities become a much more important part of understanding how the data works together and then it gets really complex. So are you finding in The BIOME or in the industry at large, this awareness of the importance of pulling together very disparate pieces of data to try and understand health issues? Jake LaPorte (18:34): Yeah, so I think this conversation is starting to become more prominent throughout the entire healthcare sector. The understanding that we need to be able to have more datasets, talk to each other and be joined together in order to power things like machine learning and AI, right. We often talk a lot about the promise of AI and machine learning in healthcare. And it turns out that one of the biggest barriers to seeing more impact from this very impressive technology paradigm is just being able to have the structured datasets to train these algorithms. And so I think there's more recognition that number one, the healthcare data that we do have tends to be very fragmented and incomplete and that we need to as a community come together and be able to do something about that. So what that means is we need to come together and develop data standards and an ontology, which is basically a language or a way to relate data sets together in order to join datasets that we already have. And then in the future, we need to think about ways in order to collect data more effectively to sort of power some of these powerful technology paradigms like AI and ML. Janet Kennedy (19:54): And I think as you said earlier, digital health literacy is essential. Helping patients understand that their data is really needed to help themselves and others. Jake LaPorte (20:05): That's exactly right. It really boils down to ultimately increasing digital literacy, but also developing solutions that make sense, right? So I think we need to be very focused on the patient, what their problem is, how do we solve that problem and how do we protect their privacy? And then how do we communicate that to them to help them understand that that's what we're trying to do. Janet Kennedy (20:30): Well, and that's what should always be right? Focused on the patient for the patient, because that's what we're trying to do. Jake LaPorte (20:36): Exactly. Janet Kennedy (20:37): Well, Jake, what a fascinating conversation. And I appreciate your spending the extra time to do a part two episode of our conversation. I appreciate your being here very much. Jake LaPorte (20:48): My pleasure, it was fantastic conversation for me and I hope you and the audience enjoys it. And again, if there is any questions about the bio that folks want to follow up, please feel free to do so. Janet Kennedy (20:58): Thank you for downloading this episode of People Always, Patients Sometimes if you enjoyed our conversation, a review and a rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions.

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Our podcast People Always, Patients Sometimes was created to feature innovators, disruptors, and patients driving new ways of doing things in clinical trials. Little do we know that the coronavirus would escalate the need for transformation and demonstrate which organizations were prepared to move ahead more quickly. Today we've invited Jake LaPorte, co-founder and global head of The BIOME by Novartis. Jake has spoken on the topic of digital innovation and health tech startups, and impacting patient's lives. We enjoyed our conversation with Jake so much that we have a second episode with him on the schedule. Join us for this episode of People Always, Patients Sometimes as we listen to Jake's insights on The BIOME by Novartis in digital health and clinical trial innovation. Janet Kennedy (00:52): Hi, my name is Janet Kennedy and I am your host for People Always, Patients Sometimes, a production of Spencer Health Solutions. Today we have invited Jake LaPorte to join us. He founded and leads The BIOME by Novartis, also known as Novartis BIOME, the company's first ever externally branded innovation lab. The BIOME has garnered global recognition for supporting innovative tech and digital health companies and connecting them to Novartis's vast network of expertise and resources to accelerate solutions that improve and extend patients' lives. I really love that and I can't wait to find out more about it. Jake, welcome to the podcast. Jake LaPorte (01:32): Thank you so much, Janet, for having me. I appreciate it. Janet Kennedy (01:35): You know, you've had a very interesting back from before you got to Novartis. So do you mind bringing us up to speed and telling us how you ended up where you are? Jake LaPorte (01:43): I started off my career as a scientist. I was actually an organic chemist. I did a little bit of medicinal chemistry, but early on, I sort of learned that while I loved talking about and learning about science, I didn't necessarily love the bench work. So after graduate school, in order to get a different experience and try to figure out what I wanted to do with the rest of my life, I joined a global consulting firm, McKinsey and company, but there I focus primarily on the pharmaceutical industry and even within the pharmaceutical industry, primarily on R and D. And I got really obsessed with trying to make a contribution to what was starting to be discovered at the time as the R and D productivity problem, right in pharma. And now obviously there was data suggesting that we were on an unsustainable path and I generally believe in bringing technology and science to society to improve human health. So I want to make a contribution to solve the RD productivity problem. During my time at McKinsey, I sort of learned a tremendous amount, but at some point I got tired of kind of talking about it and wanting to try to do something about it. So that led me on a journey to work at a global CRO called PPD with one of the clients that I had at McKinsey. Her name is Kristine Bigaven. She was the chief medical officer at PPD at the time. We learned a tremendous amount from her. She ultimately was hired at, into Novartis to lead a big part of their global drug development organization. And I followed her there to Novartis, to lead digital strategy and innovation for our global drug development organization. And then ultimately then created The BIOME within that. And now we're trying to grow The BIOME into an enterprise wide solution for all of Novartis. So that's, that's sort of my snapshot of my journey to where I'm at today. Janet Kennedy (03:33): Okay. So I want to talk about the good old days of 2017 and digital development. What did that mean in 2017? Jake LaPorte (03:44): Digital development meant to us, which was the name of my organization was really thinking about how to harness these digital technologies and solutions that were starting to arise and incorporate them into future clinical trial paradigms that made them that made clinical trial is a better experience for patients and the healthcare providers that were participating in our trials and frankly, as well as to make them more efficient and effective and faster so that we could more effectively develop our portfolio of medicines just to make a concrete, right. We were looking at paradigms like decentralized trials, for instance. And how do we bring those about in a scaled way into our portfolio? We were looking at things like digital end points and evidence, and how do we incorporate digital technologies to capture new information in trials to make the development of our medicines more effective. Janet Kennedy (04:41): And tell me a little bit about the sense of urgency then versus now, was it something that like this was on our five-year plan or were you really trying to focus on things that, how can we get some tests going sooner? Jake LaPorte (04:55): So I'm sort of where we're at today. Obviously we've had a huge catalyst in this area also known as COVID 19, which has obviously challenged the conventional way to do clinical trials pretty significantly. So I think the urgency to do something in this area is unparalleled now compared to where were at 2017. However, we, you know, as Novartis, we had a pretty aggressive schedule to transform the way we did trials back in 2017. And it was more about how do we do some of these digital solutions at scale versus continuing to do them in pilots. But of course the urgency, now that folks have to transform as a matched, due to this new challenge in health. Janet Kennedy (05:42): Now, when you were looking at digital platforms in 2017, 2018, even early 2019, were you looking at things that you would absorb within your ecosystem or were these more partnership opportunities? Jake LaPorte (05:58): So I think most of the time, what we were looking at is for partnership opportunities. So many of these solutions and digital, and by the way, I think this also applies to the broader part of the enterprise are not things that are naturally owned by a specific pharmaceutical company, because most of the time for digital solutions to be meaningful, they need to be adopted at scale within the healthcare sector, right? Which necessarily requires that multiple pharmaceutical companies are using these things as a standard that multiple healthcare systems are using these things as a standard. So oftentimes that almost suggests that there's a partnership that needs to happen. Janet Kennedy (06:40): So what made you decide that the work you were doing in general needed this big investment of time and effort and physical location in creating The BIOME. Jake LaPorte (06:53): What it ultimately came down to is a little bit of what I said before that that partnerships are often so critical to building meaningful digital solutions that solve complex healthcare problems. And if you really reflect on where we're at as an industry, the pharmaceutical industry is not digitally native, but obviously we need to transform. And so we almost always require a partner to some extent, to help us build a digital solution. The complication is that we have just never, as an industry, built a capability to partner with the external digital health ecosystem effectively. And so there tends to be these barriers or this friction that naturally exists between a major multinational pharmaceutical company and the digital health and tech ecosystems. And The BIOME is really a focus on how do we break down those barriers and allow our internal teams to more fluently partner. And co-create with the digital health and tech ecosystems. That's really what The BIOME is about. We knew we needed to get better at partnering and that's what The BIOME is focused on. Janet Kennedy (08:03): So I'm really envisioning here, you have the big giant pharma company, and then you've got the fly by the seat of their pants startup. Those don't seem like they would mesh very well? Jake LaPorte (08:14): Perhaps not, but in a lot of instances, if you partner with younger companies that are maturing in the right ways, they can bring about beautiful solutions that can really have an impact on healthcare, but it's the key, the devil's in the details. How do you partner with them in the right way? A lot of the expectation tends to be that that partners are going to come with a fully baked solution that can easily be plugged in to an environment and deployed at scale. In the reality, what we found is that you need to be able to be committed and make an investment in these companies to really adapt their solution and help them co-create their solution so that it can be adapted into our, the context of the pharmaceutical industry. So let me give you an example of what I mean by that, that we've come out with publicly. And we talked about right, is a BIOME project that we did in support of our global health organization. And they had already launched an initiative to increase access to medicines for sickle cell disease patients in Sub-Saharan Africa. What we did is we helped them find a technology that by the way existed in Portland, Oregon, with this company called Hemex Health, that would allow them to identify patients in Sub-Saharan Africa, more effectively, diagnose them more effectively, and therefore allow them to get medicines to these patients more effectively. But that of course required that we make an investment in this company. They weren't for instance, approved by the FDA in Ghana, which is where we were launching this initiative. So we put some regulatory resources around this company to accelerate the regulatory approval onto the Ghana market to allow them to participate in this initiative. And now they're involved in this initiative and hopefully through this partnership, we're going to be able to get more medicines to the patients that need them faster with regards to sickle cell disease. So again, when you partner and you think about how to partner in an effective way, it can really, really increase your ability to extend and improve patient's lives. Janet Kennedy (10:28): And in that example, it really sounds like you were utilizing skillsets, experience, existing departments within Novartis to help advance. So you were giving really a helping hand to a company who maybe didn't have that deep experience or capabilities. Does that sound right? Jake LaPorte (10:44): Yes. That's a fantastic observation, Janet. That's exactly right. And I think that you can extend that to a more general Axiom that as a pharmaceutical company, you need to think about the complimentary resources and expertise that you have, that you can bring to bear and how to connect that effectively to the partners that you're working with and be able to make that investment in them in order to co-create solutions that are really going to have an impact. Janet Kennedy (11:10): Alright now, I want to talk about culture and mindset a little bit. Yes. We've been talking about digital for a long time. How long has telehealth been in the market, 20 years? And we are just now due to, COVID seeing this exponentially explode. Well, it's about time, but too bad. It took a global pandemic to change our mindset in working with a large company that has, I'm using my little air quotes here, always done it that way before, have you had to work with your internal existing team about helping them be more flexible in their mindset and think about not solving the one problem, but solving the multiple problems, looking for the multiple right answers. Has that been a challenge? Jake LaPorte (11:54): So culture and mindset are so fundamental to any kind of transformation that one undergoes, whether it's a digital transformation or some other transformation we've placed a big emphasis in Novartis on the appropriate cultural transformation that we need to undergo in order to successfully transform into a company that's driven by data and digital. We thought a lot about that. We're making a lot of investments in that space. In fact, we have a whole learning organization that is focused on how we upskill our organization with regards to digital skillsets and a mindset, right. That needs to be accompanied with that. When you say it's a challenge, I think, yes, it is a challenge. It's more of a journey that we need to go on. We see it as a journey that we're on in order to up-skill and change the mindset of all of our associates within Novartis to embrace data and digital, and be able to think about how to take smart risks with how they implement digital solutions to really improve the way they do their work. Janet Kennedy (13:04): What about the speed of drug development? And maybe that's an oxymoron right there versus digital tools. Digital is advancing at exponential rates and yet protocol design isn't there yet. Where does digital come into play? Are you trying to work at it from the very base level, or is there a way even with an existing protocol, you can find ways to bring digital tools in? Jake LaPorte (13:29): I think it kind of requires both approaches really Janet. So I think there's ways right now that you can have an impact on the way you design trials from a conventional standpoint, by being able to bring in more meaningful datasets and really think about, and challenge how you did design inclusion, exclusion criteria, right? To make your trial more amenable to a broader population without sacrificing the scientific objectives you have, and the questions that you need to answer that certainly can be done today. I think going forward, there's an opportunity to reimagine how one, for instance, designs a trial, and frankly how one acquires the data needed to answer their scientific questions. There's been discussion in the community around some people call them digital twins, other people roughly allude to the same concept as in silico trials and our ability to acquire more sophisticated information, either through just tapping into existing populations, without them being in a trial, for instance, like in real-world evidence or even using new systems like organoids that can replicate the functionality of complex human systems will only grow over time. And you can start to imagine where some of the stuff we do in trials today with human patients will not need to be done in the future because that data can be acquired by different means. Janet Kennedy (15:01): So using simulation technology? Jake LaPorte (15:03): For instance, yes. So you can imagine we'll get more sophisticated over time with how we acquire and our ability to acquire real world evidence, and then how to translate that into meaningful ways in which we can simulate pieces of a trial or pieces of a development program. So it doesn't burden the ecosystem as much. And we're starting to see this happen already. This happens already with virtual control arms, for instance, and people have been applying this successfully in the oncology space already, right? So not having to stand up an entire control arm for studies can reduce the burden on the healthcare sector in a pretty significant way. Janet Kennedy (15:46): I'm curious about the 'I don't know what I don't know' issue. Are you finding that your data scientists are coming to you saying, man, wouldn't it be nice if we knew this next level of information and let's go find a digital platform that's building that, or are you finding that the digital folks are coming to you with, "Hey, but if you had this kind of information, you could do even more with it?" Jake LaPorte (16:11): Yeah. I think there's always a tension, right? I think it kind of happens both ways in different scenarios. I think there's what we try to do is we try to work with our business teams to understand what their challenges are and the questions they're trying to answer and try to take more of our activity based off of solving those challenges. But there's always that dynamic as you alluded to, you don't know what you don't know. So we also make an investment in trying to understand what is happening in the digital health and tech ecosystems and make our associates within Novartis, more aware of what's going on so that they're able to have a better understanding of how those new things could be applied to how they work. It happens in both directions I would say. Janet Kennedy (16:59): Are you finding that patients are embracing digital and I'm thinking more specifically of more mature patients that aren't necessarily still smartphone enabled, et cetera, et cetera. How does that impact some of the decisions you're making? And again, you mentioned going to Ghana where I actually imagined cell phone adoption is relatively good because it serves as the primary computer for those that have it. But I'm curious about the disparity between the patient's ability to utilize digital tools. Jake LaPorte (17:31): Yeah. So this brings up a fantastic point that I think the overall sector needs to think more about, and that's building digital literacy across the entire population in order for us to use these healthcare technologies more effectively. And that not only includes patients by the way, but it also includes healthcare providers. So how do we build that literacy? How do we build into the natural way in which people experience their lives and practice medicine, that ability to really select the right tools for them that work that makes sense for their lives. You can almost think about it as an analogy of how do you build the app store for digital health solutions, right? Because that's a great analogy where it's very customer centric. You go in with a particular need, you're able to search the solution set pretty quickly. You're able to download and try a solution. If that doesn't work, you're able to kind of find another solution. And so how do we get to that point? It's a tougher question, obviously in healthcare and as an entire sector, including the payers and providers, as well as pharma, I think we need to think more about how do we build this literacy within different populations. You mentioned Ghana, for instance, as a perfect example, there is a huge adoption of cell phones, but they're not necessarily state of the art smartphone. So you have to think about building digital solutions that work on more basic flip phones, for instance, and think about there, there that there might be different partners that are needed to build those solutions. And in fact, we have a very good partner called Dimagi, who thinks a lot about how to build data architecture and solutions that allow people to capture healthcare data on a more basic cell phone so that you can really take advantage of the technology that exists in an area. Thinking about that in a meaningful way is important. Thinking about how to increase the digital literacy within populations that are older, that may not have kind of grown up with technology is important. So all of these things factor into how we increase the impact of digital health. And frankly, that I think boils down to culture and mindset shift, not only within companies, but within the broader population as well. Janet Kennedy (19:51): So who has that responsibility then? Drives from pharma primary care providers from the patients themselves advocating? Jake LaPorte (19:59): I think we need to find a way to work together as a community to bear that responsibility. I think it's a shared responsibility amongst everyone that participates in healthcare. I think it's a responsibility of the payers. It's a responsibility of the healthcare professionals and the providers and the organizations that focus on them. It's a responsibility of pharma, for sure. It's a responsibility of patients and patient advocacy groups to be thinking about that. And the only thing I can say, and I hope people could take away from this podcast is if we can find more ways to work together as a community to advance digital health, I think we'll all be better off for it. Janet Kennedy (20:41): Well, I couldn't agree more. Let's focus back on The BIOME for instance, if I'm a digital health startup and I was involved in startup weekend for health a few times in the Raleigh Durham area. Very exciting. Sometimes people came in with ideas that they felt very strongly about and they just needed tech teams to help them develop them. Others were just throwing spaghetti up on the wall, but ended up with something kind of solid. When you have people come into The BIOME, are they literally coming into a working space? Jake LaPorte (21:11): In some cases they can be, but we actually are trying to really think about models, which really are accessible to everyone and anyone in the world, because really what The BIOME focuses on is how do we help companies, external partners work with our internal teams to build solutions. And so a lot of that work can frankly be done virtually. And a lot of the support that we give companies can be done virtually. We certainly have physical locations and certainly companies that are local to our physical locations can take advantage of them to the extent that they want to or need to. But the nature of us focusing on digital technologies suggests that there's certainly a lot that can be done virtually as well. And so we're adapting our model to take that into account. One thing that you asked about was how do companies really engage and get involved with Novartis and the Novartis BIOME? And we certainly recognize as a company that the journey for an external partner to find the right people within Novartis to support them and match what they're trying to do can be chaotic. We're on a journey as a company to make that faster and more effective and a better experience for our external partners. And one of the things that we're developing actually frankly, has been developed already is called the Novartis digital brain. The easiest way to explain is it's a partner relationship management platform so much like customer relationship management. We want to have a way to track all the interactions we're having with our external partners, for the purposes of trying to understand how we match the right internal teams with the right external partners. Ultimately, we want to open this platform up so that it's accessible to any external partner in the world that can update and manage their profile on the Novartis digital brain. And tell us all of the great things that they're doing potentially within Novartis or outside of Novartis and help us match them to a team in Novartis. That's trying to do something where their solution makes sense to be matched to, and therefore kind of cut through all of the arduous process of trying to knock on 20 different doors and figure out the right person to work with within a large complex organization. Janet Kennedy (23:42): Well, that's exciting. Is it by invitation only right now, or how do companies get to your attention? Get to the platform? Jake LaPorte (23:50): We don't have the module yet where external companies can access the Novartis digital brain. It's definitely on our product roadmap right now. We're building profiles of all the companies we already work with through a combination of third-party external databases like tech crunch or health Excel, as well as internal inputs into those profiles that have been already developed through teams that are working with these partners. But over time we have the aspiration of inviting partners onto this platform, and it's not going to be something that's exclusive where we only invite a select few people. We, again, we really want to democratize access to this platform as a way to cultivate the best relationships with our external partners and match them to the right scenarios in order to work with teams and develop solutions that make sense. Janet Kennedy (24:40): Okay. So right now it's still door knocking for some folks, but you are systematizing and organizing companies you are currently in partnership with. Jake LaPorte (24:49): Yeah, that's right. I mean, we're on a journey. So certainly I don't want to give the impression that we solved all of these problems in The BIOME yet we're on a journey. And frankly, we always like to talk to external partners and understand the challenges that they're having. As we really seek to build out our services and products, we eat our own dog food, if you will. And that we're trying to really become more customer centric and get feedback from our external partners and therefore use that feedback to inform the next series of products that we develop. But we're definitely on a journey. Janet Kennedy (25:25): Alright. Well, I know that we'll have your contact information in the show notes of this podcast episode. So I'm sure you don't mind if people reach out to you via LinkedIn and get to know you there. Jake LaPorte (25:35): I do not mind. No. Janet Kennedy (25:37): Well, I can't thank you enough for being here. We have a lot more to talk about. So I give the audience a heads up that there's going to be a part two conversation, when we talk more specifically about COVID-19 and the acceleration of digital trial initiatives. So for now, Jake, thank you so much for joining me and I thank everyone for downloading this episode of People Always, Patients Sometimes. If you enjoyed the conversation, a review and rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions. Thanks again, Jake. Jake LaPorte (26:09): Thank you. It was a pleasure being here and I look forward to part two.

Tom Rhoads (00:02): Welcome to "People Always, Patients Sometimes." I'm Tom Rhoads, CEO of Spencer health solutions. Our podcast is focused on many of the thought leaders and executives that are calling for change in how we design and run clinical trials. This episode is the second in a series of interviews with patient advocates, influencers, and organizations dedicated to putting the focus in healthcare where it belongs, on the patient. Our mission at Spencer health solutions is to ensure that patients are at the center of everything we do. So we are pleased to introduce Carly Flumer to the podcast. She was a young adult survivor of thyroid cancer and author and a health data scientist. I know you will enjoy her conversation with Janet Kennedy on "People Always, Patients Sometimes." Janet Kennedy (00:51): The people always patients sometimes podcast is about the change agents in healthcare who are focused on patient experience, patient engagement, or disrupting the process of clinical trials to become more patient centric. Our guest today is Carly Flumer. She's a patient advocate, a data geek, a change agent, and one of Spencer's voices of disruption. If you have not read our ebook yet, in which Carly's comments are featured, look for a link in the show note. Welcome to "People Always, Patients Sometimes", Carly! Carly Flumer (01:22): Hi, thank you so much for having me. Janet Kennedy (01:25): I have been. So looking forward to talking to you, because while you provided a great insight to our voices of disruption ebook, we really didn't have a chance to have a conversation at the time. So now I'd like to get to know more about you. Carly Flumer (01:40): Wonderful. What questions do you have? Janet Kennedy (01:43): Let's start with, we invited you here because you have a very active patient advocacy focus in your life, and it is not everything you do, but it is an important part of who you are and what motivates you. So can you tell me a little bit about how that all came about? Carly Flumer (02:01): Sure. I was diagnosed with thyroid cancer in 2017 when I was 27 years old. So I was considered an adolescent and young adults or an AYA patient. And those are very few and far between, it feels like to me, in terms of where age lies on the cancer spectrum I feel like there are a lot of younger patients and then there are, are a lot of older patients, but we really don't hear much about AYA's, which are considered between 18 and 39. And so I wanted to get my story out there and I figured out the best way to do that was to become a patient advocate and to write, which is one of my passions. And so I have been writing about my story and my perspectives in healthcare from a patient perspective, and then from a perspective of somebody who works in healthcare. So it's kind of, two-fold where I can share it from in front of the doctor while also behind the scenes. And so I think if that gives me a unique look into all of the nuances of healthcare and how it can be changed to make better out patient outcomes. Janet Kennedy (03:11): How long was your cancer journey and where are you today? Carly Flumer (03:15): So I was diagnosed the second week of January of that year. And I was in treatment until the end of November of that year. So almost a full year. I am in remission at the moment. The magical words that every cancer patients want to hear is no evidence of disease. I have not reached that status and I may never reach that status, but I was told that I was in remission and I'm checked every so often to make sure that I remain in remission and I don't relapse. Janet Kennedy (03:52): Well, I think that's one of the huge challenges with cancer is while you might beat it, that's not necessarily a forever thing. Carly Flumer (04:02): Exactly. It's something that is always on the mind of every cancer patient, because it's so different for everybody. You hear that no patient is the same, but also no cancer is the same either. Whether it's considered the good cancer, which is what thyroid cancer is considered, or whether it's a cancer, that's more serious, but it's an ongoing thing. It's something that we all think about in the back of our minds. So just something to be cognizant about always, Janet Kennedy (04:34): And is getting thyroid cancer at such a young age, pretty unusual? Carly Flumer (04:39): I would say yes, yes and no. It is on the rise in terms of how many cases are discovered. But I have found, I guess, through my research and through my advocacy work, that it is more common among females. And I would say the majority of the women who I have found in support groups, they're in a wide age range. So from the early teens up to, I would say, you know, 60's - 70's, we are all over the place in terms of age. But the majority of patients I have found are women. Janet Kennedy (05:12): Let me ask you something about your advocacy as every cancer might be different. I imagine every patient advocate would give themselves a unique job description. So what exactly does your advocacy encompass? Carly Flumer (05:27): From my own perspective, my goals are to impact health literacy, patient education, oncology research, and patient provider communication, to create a better health outcomes in the oncology space. That's what my work, that's what my writing involves around those specific topics. But then my job, I wouldn't say it's necessarily advocacy work, but it's certainly within the oncology space is where I receive protocols from cancer centers across the United States for clinical trials. And it's written in this language that no patient could understand. What I do is I translate that information into language that patients can understand. And so that information goes onto website clinicaltrials.gov, which is where patients go to find clinical trials. Should they be interested in enrolling? And so it does kind of encompass that advocacy piece, where I am making that language clearer for patients in order for them to make the best health decisions for themselves. But it's more on the scientific ground, more so than I would say most advocacy jobs are. Janet Kennedy (06:44): So this is something that's a higher level information than webMD per se, but also making that scientific language very accessible. Carly Flumer (06:53): Right. Janet Kennedy (06:54): So how did you end up writing for clinical trials.gov? Carly Flumer (06:59): Well, the way our process works is we receive the protocol and we have a program that we use for our job and we abstract certain parts of the protocol that the patient is going to be most interested in, such as what are the objectives of the trial, meaning what are the researchers looking to do? What is going to be happening? What type of treatment are you going to be receiving? Whether it be chemotherapy, immunotherapy, radiation therapy, what have you, and for how long, what are the outcomes? What are the researchers looking to gain from this experience and what are they looking for patients to experiences, outcomes, including quality of life, survival, things like that. Eligibility of course, is a huge one to make sure that you are eligible to enroll and then things such as biomarkers, which are confusing at first to understand and I still get confused by them sometimes. But those are really key and understanding how a cancer can progress or how our cancer is found. But that's another topic with genomics. So yeah, that's the type of information that I am looking for in these protocols in order to translate that for, for patients so that they can understand what these clinical trials are going to be about. And if they want to enroll this as the information that they need to know in order to participate. Janet Kennedy (08:29): And this is through your work as a scientific data analyst for the National Cancer Institute? Carly Flumer (08:35): That's correct. So I contract with a company outside of the government and we work with the NCI and then these clinical trial protocols are coming from cancer centers across the United States. Janet Kennedy (08:49): You have experience with a clinical trial, do you not? Carly Flumer (08:53): I do. I feel like thyroid cancer is very rare in terms of clinical trials. I very rarely see them in my work and I'm not sure if it's because thyroid cancer has such a great survival rate, but there are variants of thyroid cancer that are more serious, such as medullary, which are the trials mainly revolve around that type. The trial that I participated in was a quality of life trial. And those, I feel like are so important. We see a lot of trials that are focused on treatment and prevention, but then those trials that focus on quality of life and how patients really are doing, whether they're in treatment or after treatment are so important. This one focused on the quality of life of thyroid cancer patients, which I loved because thyroid cancer is considered the good cancer, you don't really consider what can happen with patients who live without a thyroid. And I didn't know what a thyroid was when I was diagnosed with this type of cancer and, and, you know, any bodily function that you can think of the, I feel like the thyroid has a part in playing. And so living without one has really impacted my quality of life in ways that I wouldn't have thought of and ways that were not really described to me when I was diagnosed. And so really focusing on the, on the quality of life of these patients with this type of cancer, I thought it was really important to open the eyes of researchers and pharma and other advocates as to what living with thyroid cancer is really like, as opposed to what the media or, or other organizations or other doctors have termed it as they've termed it as the cancer you would want to get if you were diagnosed. And that is absolutely not true. And so I really appreciated the trial that I was a part of. Janet Kennedy (10:47): I think it's insane that somebody would even use the two words good and cancer in the same phrase. It's an oxymoron that makes no sense whatsoever. Carly Flumer (10:56): Absolutely. Yeah. Janet Kennedy (10:58): What, what exactly were they testing? Were you getting surveys on just how you felt? Was this anything related to a drug specifically, or was it more about surveys and feedback about how your daily life was going? Carly Flumer (11:12): So it was mainly a questionnaire about how daily life was going, the symptoms or the side effects that I experienced. I feel like I have not felt them, or I didn't feel them until after my thyroid was gone because when I was diagnosed, I didn't have any symptoms at the time. And the biomarker and the lab levels that are measured for thyroid were completely normal for me. And so now without a thyroid, I am feeling more tired. My temperature, my body temperature fluctuates a lot. My mood is altered, hair loss. So different things like that, that I wouldn't thought about have started happening as a result. And so I don't think that those are really talked about when a patient is diagnosed, you know, because the majority of treatments for thyroid cancer is removal. And then for some patients who have, metastases including myself as a form of oral radiation, I feel like that encompasses the majority of treatments. And so it feels kind of like it's a one and done thing as opposed to other cancers where they go through chemotherapy and radiation therapy, which may have significantly more harsher side effects. And so when you think about it, outsiders may think, Oh, well, you know, they just had a surgery or quality of life. Must've not been too impacted, but when you're really losing a small gland, a small organ that helps you function on a daily basis, it really does impact how you live. And so I don't have a thyroid. And so I take a medication to replace those hormones that I've lost. However, the medication dosage, which is prescribed by my endocrinologist is based on a bunch of different factors. So it's based on my lab values. And it's also based on how I feel during the past few months or so, it's kind of strange to have a dosage based on that kind of information. It's kind of like a playing with numbers game. I was told that, you know, when the beginning, when they choose the specific dose of what patients mainly take is called Synthroid, when they choose that dosage, when you first come out of treatment, it's really a guess based on your lifestyle, your gender, your age, your weight. And then it's just an up and down system based on how your lab results go over time and how you're feeling over time. So it can take many years to find the dose that's right for the specific patient. And I don't think most people realize that I've been on the same dose for a while now, but that could change at any time, which is why I am checked all the time to get back to your original question. I think focusing on how patients are doing after this type of diagnosis is, is very important because you don't realize how much cancer can impact you, even if the treatment seems simple. Janet Kennedy (14:32): Absolutely. I mean, you've been impacted for the rest of your life. This is something that was part of your daily regimen that you have to deal with. One of the things I hear from patients who have participated in clinical trials or a concern about participating is they've kind of feel like a number, that's great, I'm here, but I don't ever get any feedback about how that turned out was my participation valuable. What if it didn't work? So do you know what happened to the feedback that you gave them in this clinical trial and how it was applied, or are you also in the dark? Carly Flumer (15:10): I am also in the dark with my work. I received the consent forms as well, which are given to patients. And that's more of a lay friendly language based protocol, if you will. That, it's basically what I am doing with my work, but it's physically handed to patients as a form, if you will, which they have to sign saying, I understand what I'm going to be going through with this trial. So the consent forms, I think the majority of them do say, well, I know the results of my research and the majority of them do say no. And I do think that is very frustrating to know whether or not this has affected you, especially if this is a more intense trial, you want to know if something worked or not, or if something was found, because I mean, you are not just a number in this trial. This is your life that's being impacted. And so I think patients do have the right to know what happened in this trial. How did my role in it play a part and creating a greater impact for future patients? Janet Kennedy (16:19): Absolutely because even a trial that does not result in a successful drug launch still has a lot of important learnings. And generally speaking, it tends not to be so much about the drug efficacy. It's about getting enough patients engaged in the trial for a long enough time that they get truly valuable statistical data. Carly Flumer (16:40): Right. The other thing about that is that I feel like health literacy is such an important aspect in clinical trials as well. And I think one of the reasons why clinical trial enrollment is so low nowadays is because patients are not understanding the information that is given to them. And if they don't understand it, then they're not going to want to enroll. And then if these clinical trials, they cost millions of dollars to put on, they end up falling through because they can't get patients. And clinical trials are the way to new drug development and new drug development is how we create better treatments, which is how we create better outcomes. So it's like a rolling ball of catastrophes. If you will, that if something doesn't happen in the beginning, then it just keeps falling through towards the very end where you really cannot find treatments that will create these better outcomes for patients. If you can't get the patients in the door in the first place. And I think one of the nuances that is impacting that is health literacy and just clinical trials being available in general. I feel like most patients don't have, or they don't hear clinical trials as an option. Patients are, I feel like they're given very limited choices when it comes to treatment. But my view is that patients should be given options based on a variety of factors, including their culture, their lifestyle, their financing, because clinical trials can cost a lot of money and just taking into account who the patient really is as a person, rather than seeing them as just a plus one. And that clinical trial, you really have to take into account who they are and their life, because this is their life that they're entering into a trial. It's you don't really hear about how patients are feeling as they go through a trial. You just hear about the results sometimes, maybe even not, not even that. And so I would be really interested in hearing other patients and how they experienced clinical trials and what it was like for them. And how did, how do they even get started? How did they learn about it? Do they hear about it from a doctor? Did they have to be their own advocate and research it for themselves? Were they able to understand the language and what made them want to enroll things like that? Janet Kennedy (19:17): My next question actually pulls that thought together and the situation that we're dealing with right now, which of course is, is COVID-19, and we will be for awhile. As a patient advocate, you are very savvy in social media, you've got your ear to the ground and you're hearing a lot of things. And I have been hearing mixed messages about COVID's response to the awareness of clinical trials. One thing that if there is a good side to COVID, it has been making people aware of the disparity in communities of color or chronic disease and how they're not involved in clinical trials. I think it has raised the opportunity for people to be more aware that they could be participating in clinical trials. Certainly people who have experienced COVID and are providing plasma. So the awareness level to me feels very high. And initially I think there was research that said people were more interested in participating in a clinical trial, but then just a few weeks ago, I saw another survey that said, Nope, no, they were concerned. So your ear to the ground, what are you hearing from the patient communities? Or are you already talking to folks who are pretty much on the advocate scale so they would be engaged anyway? Carly Flumer (20:35): Well, in my work, I have seen many clinical trials that are COVID related come through, and I cannot remember if they were specifically focused on people with health disparities, but I do think that that is incredibly true and important. I think COVID has opened up everybody's eyes into the downfalls of healthcare that need to be worked on including health disparities, where people in rural areas have a harder time getting testing, or they have a harder time finding clinical trials because they don't live near a hospital. And how there are populations such as the African-American community who are affected more because of COVID-19. I feel like that could be the same with cancer it's just talked about more. I think COVID has really opened the healthcare's eyes as if it were a person too, I guess, just everything that is wrong with healthcare and how it can be fixed because healthcare is an ongoing process. It's something that will never end and that's something that can always be improved, but I think COVID has really amped it up. And it's really forcing all aspects of healthcare to really focus on what can we do to make patients better, I guess, at an increased rate, but also focusing on the patient outcomes as well. Janet Kennedy (22:06): I think that's a thoughtful and excellent answer. And I hope as well that we are going to see the tide turn from the standpoint of supporting more communities that are disadvantaged and not getting involved in clinical trials, as well as just raising awareness of it. And I think that also goes back to your point about the importance of health literacy and plain language in what we're trying to share with people. Yes, exactly. Well, I would like to thank you very much for being with me today and to everyone listening. Thank you for hearing this fascinating interview with Carly Flumer on the "People Always, Patients Sometimes" podcast. We look forward to hearing your thoughts about the episode. You can tweet us @Spencerhealth, or just send me an email. [email protected]. Carly, thanks for being here today. Carly Flumer (22:57): Thank you so much. It was a blast.  

Tom Rhoads (00:03): Welcome to "People Always, Patients Sometimes". I'm Tom Rhodes, CEO of Spencer Health Solutions. Our podcast is focused on many of the thought leaders and executives that are calling for change and how we design and run clinical trials. We have also had patient advocates on the program like Jen Horonjeff, of the Savvy Cooperative, Pam Gavin of NORD and Barby Ingle of the International Pain Foundation. Our mission at Spencer Health Solutions is to ensure that patients are at the center of everything we do. So we are pleased to kick off a series of interviews with more patient advocates, influencers, and organizations that are focused on bringing the patient experience to the forefront of the conversation in healthcare. Kicking off our series is a conversation with Lilly Stairs and leading patient advocate advisor and founder of Patient Authentic. I know you'll find her conversation with Janet Kennedy, as interesting as I did. Janet Kennedy (01:01): "People Always, Patients Sometimes" podcast is about the change agents in healthcare who are focused on patient experience, patient engagement, or disrupting the process of clinical trials to be more patient-centric. Our guest today certainly fits that bill. Lilly Stairs is a nationally recognized patient advocate, speaker, author, and innovator. She has recently founded a new company, Patient Authentic, which I look forward to hearing more about on "People Always, Patients Sometimes." Welcome to the podcast. Lilly! Lilly Stairs (01:33): Thanks so much for having me, Janet. It's always a pleasure to connect with you. Janet Kennedy (01:38): I think entrepreneurship is a big challenge and as a patient advocate where you're already facing a series of your own personal challenges, as well as challenges in the workforce. Wow. What made you think about starting your own company? Lilly Stairs (01:55): Well, Janet, I will also say that I didn't plan to start a company the year that we ended up with a worldwide pandemic, but here we are to add that challenge to the list too. But yeah, I've always had an entrepreneurial spirit. From a very young age, I was always creative and started choreographing for a kids' theater program and took the helm there. And then in high school, I started an anti-bullying program that ended up touring around our local schools in Massachusetts. When I got to college that is when I started my patient advocacy work. And because I was diagnosed with a few different auto-immune diseases I started a campaign to raise awareness about people who were living with auto-immune diseases. There are an estimated 50 million Americans who are living with auto-immune diseases. It was called the 50 cents for 50 million. I have spent most of my career in health tech startups. It just felt right to jump in and take the plunge and make a bet on myself and start Patient Authentic. Janet Kennedy (03:17): I imagine your first 30 days you were feeling pretty euphoric and then February came and you probably started to be a little nervous. So COVID, how has that impacted your life and impacted your work? Lilly Stairs (03:31): Well, I think it's really, and I don't think this is an exaggeration, it's turned my life and everyone's lives upside down. And I, as somebody who is considered high risk because I am immunocompromised due to the medication that I am on, which depresses my immune system to treat my auto-immune diseases is certainly scary and carries a lot of weight. I am fortunate that from a work perspective, all of us in healthcare, I think have been quite busy, which is important. We've stayed busy trying to do what we can to support patients. And so from a work perspective, all has been really good. It's just that we've got a lot of COVID focused projects now. And then from a personal perspective, I think that honestly, it's been hard because it's isolating and I think a lot of people are feeling that, and there's always the fear that people are not taking it seriously enough, especially as someone who is high risk. Janet Kennedy (04:30): I understand totally what your experience is. Like my two nieces are in New York City who works at Trader Joe's and unfortunately, the misapprehensions and the willful lack of understanding is really frightening for them. One of them actually did get COVID, was fortunate that it felt like the flu, and got over it, but then found out later she had definitely had it. It has changed everything in our lives. So I'm curious as a patient advocate, and I know you are talking to patients constantly, what is the general mood among the folks that you're talking to? Are they finding that this is an incredibly scary time or are they finding that even the discussion of "at-risk" is raising awareness and making people a little more sensitive or empathetic to folks who have challenges? Lilly Stairs (05:27): Well, I have to say, I think it's a mix. And I would say generally speaking patient communities across their pubic areas have certainly been vocal about concerns that people are not taking COVID seriously enough. And I think that there are some really baseline things that everybody could be doing, like wearing a mask that would put a lot of those fears at ease. I will say warranted fears because for some contracting COVID is really a death sentence when you are somebody who's high risk. I'll be honest in saying that for me personally, I live in balance. I live in breathe and balance. That's how I operate. And for me, I've been cautiously optimistic and I'm cautious in living my life. So I don't just sit at home. I will go out, I wear a mask, but I'll go do outdoor dining in Boston. We have some awesome outdoor dining and, you know, see friends at a socially distant level because I think what we're seeing with this pandemic is a mental health pandemic kicking in because so many people are struggling with the isolation and the loneliness. So I try to weigh that out. And I think that a lot of other people in the community do that too. And it's really just about finding that mix of being safe and taking care of yourself. Janet Kennedy (06:50): I agree very wise words. Now let's back up a little bit and talk about Patient Authentic. I don't know what your company is doing. So tell me a little bit about it. Lilly Stairs (07:01): Absolutely. Well, you know, Janet, I think that I'm still learning what my company is doing and I don't know if I should be saying that, but here we are. Because I think it's evolved so much since I started in January. And a lot of that is largely because of COVID, but also because I've just ended up in places I didn't expect. And so the way that I like to talk about Patient Authentic is that it is a hybrid of healthcare marketing and patient advocacy. So all of my work is grounded in developing patient-centric deliverables alongside patients. And I'll talk to you about a few projects I'm working on just to give you a flavor of what it is that I'm doing at Patient Authentic. So I am leading patient advocacy for a health tech company and that's Clara Health, which is in the clinical trials space. Lilly Stairs (07:50): And I know that Spencer does quite a bit of work there too. I am developing and running a social media campaign with oncology patient influencers to promote a nutritional supplement, which helps to aid in the healing of mouth sores that have been developed from chemo and radiation. So out of that, we've developed the hashtag #MoreThanASore campaign, which is all about how sores are so much more than just a sore and they really impact the quality of life. And so there's the marketing in me coming out through that campaign. And then, you know, I'm working with some patient advocacy groups as well. So I'm building a masterclass to help train patients from across therapeutic areas and how they can be effective advocates on a policy level. So on Capitol Hill and at FDA advisory committees. Finally, I'm also supporting the development of a COVID-19 resource hub for the transplant patient community. My projects span across therapeutic areas and they are focused, at the heart of them, they are working with patients to create something, Janet Kennedy (08:56): Oh, that's excellent. Now, is this a single consultancy? Or do you have other patient advocates that you will bring in to support some of these projects? Lilly Stairs (09:04): Primarily it's a single consultancy, but I do often bring in patients who are paid because patients should always be paid to support the work. Janet Kennedy (09:14): I totally agree. Well, let's talk a little bit about some of the work that you've done in the past and hopefully in the future related to clinical trials, have you ever participated in a clinical trial as a patient? Lilly Stairs (09:29): I participated in a study that was through my gastroenterologist for my Crohn's disease. And it happened right when I was in the office and it was quick as could be. My gastro said, "Hey, I'm working on this study. We're trying to measure the levels in the liver because the liver is often impacted by treatments." And so I agreed to do it. And it happened all in the same office visit. It was the most convenient clinical trial experience I've ever had. Did the informed consent, all there. Probably happened in 20 minutes Janet Kennedy (10:08): Now from a standpoint of your work as a patient advocate and being around the clinical trial space and helping support companies and organizations that are involved in clinical trials. I want you to put your hat on as a patient advocate. If you were to point out one or two things that are really kind of a roadblock for patients in participating successfully in a clinical trial, regardless of whether the clinical trial is a success, what do you think are the challenges that patients face that the pharma companies, CROs and physicians that are involved in research need to be thinking more about? Lilly Stairs (10:48): I'm just going to pick two - there's a lot. And so two is tough for me to do, but I will do it. I still think that awareness and myth-busting. As much as we talk about it in our community, I think that in the professionals and the clinical trial space, we talk a lot about this, but we aren't reaching the right people. It's still a huge issue. There's still so much misunderstanding about clinical trials and risk associated with them. And am I going to get the placebo? So many questions that really plague the everyday patient when we think about clinical trials. And so I think we have a lot more work to do there. And part of the solution to me is that we need to have more people working together to raise awareness and to get into communities. And so we can't be all working in silos because we continue to work in silos. Lilly Stairs (11:45): We need to work together. That's one piece. The other big barrier that I have seen is honestly, the travel and the distance piece. There are a lot of patients who actually do want to participate in clinical trials, but they are restricted because it is too far for them to travel. And they can't either, you know, financially afford it because the trial is not going to cover the cost of travel, or it's just, it's a distance thing. And they are not well enough to travel. And I can point to through my work with all of the different companies I've worked with, I can point to so many patients from across therapeutic areas that have had this experience. Lilly Stairs (12:28): So I was recently speaking with a woman who was in a breast cancer trial. First of all, her physician didn't even bring up clinical trials to her, which is a problem in and of itself. She did the research on her own and she ended up traveling from the East coast to the West coast for a clinical trial. And she had to do a GoFundMe so that she could raise the money. And she ended up having to drop out of the trial because the GoFundMe only got her so far. So we have patients who are willing to participate in trials, but we're not making it convenient for them. I would say that we need to branch out outside of some of these research hospitals. We also need to, if we can't do that, build money into the budget to help the patients get there in a comfortable manner. Janet Kennedy (13:14): So is the challenge that a lot of the research hospitals are in major metro areas, and if you don't live in New York or Boston or Atlanta or Los Angeles, you're going to miss out on an opportunity. Lilly Stairs (13:26): Yes. Precisely. Janet Kennedy (13:29): All right. Well, what would solve some of those problems? Lilly Stairs (13:33): Again, travel, being able to provide stipends for travel and not just like a $25 Uber, if somebody lives out of state, but they're really willing to participate in the trial. What can you do to facilitate accommodations, to cover the flight, to cover the hotel room? Because I'll tell you something working in the recruitment space, you're going to spend a lot more money trying to recruit patients that are nearby. Versus if you just foot the bill for flying someone out, getting them a hotel room who's eager and willing to participate. So that's one piece. And then also, I think we need to be raising more awareness within some of these community hospitals too so that physicians within community hospitals can refer out to some of the major research institutions. Because again, this is where the awareness piece comes in. There's a lack of awareness and understanding about trials. So patients don't even know they exist in the first place. Janet Kennedy (14:31): So raising awareness is a real key. Now, how are patients finding out about things? They suddenly find out they have a disease and they're just going online and doing a search and then whatever pops up pops up. Lilly Stairs (14:44): I think that online is of course a huge space. I mean, I would guess I, I won't put a statistic because I'm sure I won't be accurate, but everyone's going to Google. Everyone goes to Doctor Google. And I think that the patient advocacy organizations play a role. But I will say that we are seeing patient influencers or individual advocates are becoming more and more prominent in being the trusted go-to resource for sort of your everyday patient. So these are the patients who are sharing their stories on Instagram and TicTok now and Twitter, and they have blogs. They're on YouTube. That's where patients are going because they're able to get that sort of one-to-one support and really hear from somebody who understands them. So I've been trying to really push companies, pharmaceutical companies, biotech companies, CROs, to engage not only with the patient advocacy organizations but also with some of these patient influencers and advocates who are out there and working to fight the good fight and raise awareness. Janet Kennedy (15:49): You know, a few years ago, patient advocates were not that seen, were not that present. And I think as social media has become really an essential part of our lives, patients are realizing that there's real power there. However, there's also the challenge of my gosh, you have a chronic illness, or you have a disease that is very debilitating and social media in many ways, demands that you're up, that you are being positive, that you're being optimistic. How would you balance being someone with a chronic illness or a disease that really makes you feel bad? And these social platforms that sort of demand a much more upbeat presentation of yourself. Lilly Stairs (16:34): That's a great question. And I think it's something that's so many advocates struggle with because when you become a patient advocate and you make the decision to share your story, you're often the type of person who wants to do better and to help others, right? You're out there because you want to support other people and help them not feel like they're alone. And that can become emotionally demanding and physically demanding. Even when, especially when you are going through it in the auto-immune space, what we would call it a flare. So when you are really not well and your disease is under control. And so it's a matter of learning to say no, and to set boundaries. And so I've seen a lot of patients artfully do this, where they say, you know what, I'm turning off the comments on my Instagram because I cannot be every single person's support system. I can put this out into the world and I can try to help them, but I can't possibly respond to every single person because it's too taxing on me. And you know, some maybe sometimes you have your comments on maybe sometimes you have it off, but it's little changes and tweaks like that to help ensure that you're taking care of yourself while you're taking care of others. Janet Kennedy (17:41): I know you mentioned earlier that you're actually doing a course for patient advocates on how to use social media. There are so many platforms now, how are you focusing their energy? When I coach about social media, my advice is you can't do it all. So pick a few and do it well. But I do see some patient advocates with a lot of social platforms going on at the same time. Lilly Stairs (18:06): Oh yeah. It's hard to do. I agree with you, Janet, that picking one or two and focusing on those and making them really great is also my piece of advice. It also feels less overwhelming. I was just giving a keynote at the One Rare young adult's virtual summit. It was their first annual one. Rarer is an amazing organization run by Jen McNary. And so I highly recommend checking them out. It's a rare disease organization for young adults, but we were talking about career planning and how you build your brand as an advocate. And again, one of my key pieces of advice was to pick one platform so that you don't get overwhelmed. And so that you are not emotionally and physically drained and also pick some platforms to have that are private, that is just for you and your friends. I'm really active on Twitter professionally, but I have my Instagram private and closed so that I can just feel comfortable sharing what I want to share there and not feel like I always have to be on. Janet Kennedy (19:05): It is a huge challenge in social media and one that demands the ongoing feeding of the beast. However, do you think you can take a break from social and come back and not lose your audience? Lilly Stairs (19:18): Oh, 100%. Absolutely. If you need to take a hiatus, you can. And I think that what's interesting is that especially in the patient community, people are very forgiving of that because they know exactly what you're going through. And so they understand that it can be really taxing to have to be on all the time and they'll miss you while you're gone, but they'll be just thrilled that you've come back, Janet Kennedy (19:41): Circling back to Patient Authentic and what you had originally intended to be before COVID came. Where did you think that the company was going to take you and what were you hoping to accomplish? Lilly Stairs (19:54): Honestly, what I wanted to do, is still there. And that is to build and work on meaningful projects that support the patient community and make you move the needle in healthcare. And so I am doing that. It's just a bit of a different one than I thought. Because of my background in marketing, I always envisioned that every single thing I worked on was going to be super campaign driven. And now I find that I'm doing a little bit of strategy here, a little bit of project management, a little bit of advocacy engagement. So if anything, it's really more fitting for me because I tend to be the type of person who loves to work on a lot of different things at once. It's very rewarding for me to be able to leverage a lot of my different skills to help better the community. The opportunity to work, not only health tech and biotech and pharma, but also to work with some of these patient advocacy organizations who are really at the ground level fighting the good fight. Janet Kennedy (20:59): Oh, well, that's a great note to end on. So Lilly, tell people how they can find you. Lilly Stairs (21:04): Yes. So you can find a, learn more about Patient Authentic at www.patientauthentic.com. You can find me on Twitter @LillyStairs. You can find Patient Authentic on Instagram @PatientAuthentic. Janet Kennedy (21:24): That's excellent. Well, I can't thank you enough for being here, Lilly and I look forward to hearing more about some of the new programs and projects you're going to be involved in, in 2021. Lilly Stairs (21:35): Thanks for having me, Janet. Janet Kennedy (21:38): Thank you for listening to our interview with Lilly Stairs, founder of Patient Authentic on the "People Always, Patients Sometimes" podcast. We look forward to hearing your thoughts about the episode. You can tweet us @spencerhealth or send me an email at [email protected].

The National Organization of Rare Disorders has been helping patients, caregivers, organizations, researchers, and Clinicians for almost 40 years. Introduction by Tom Rhoads (00:02): There are over 300 million people living with one or more of over 6,000 identified, rare diseases around the world. A disease defined as rare in Europe affects fewer than one in 2000 people. Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Hi, I'm Tom Rhodes, CEO of Spencer Health Solutions. We are honored to have a special guest from the rare disease community on the "People Always, Patients Sometimes" podcast. Pamela Gavin is a Chief Strategy Officer for the National Organization for Rare Disorders. NORD has been educating, supporting, advocating, and building a community for the rare disease community for over 38 years. I know you'll enjoy learning more about NORD on the "People Always, Patients Sometimes" podcast. Janet Kennedy (00:56): Hi, my name is Janet Kennedy and I am your host for "People Always, Patients Sometimes," a production of Spencer Health Solutions. We have invited Pamela Gavin, Chief Strategy Officer of NORD, the National Organization for Rare Disorders to join our podcast. Patients with rare disorders often are overlooked by clinical research and drug developers, or have histories of misdiagnoses. Now that Coronavirus is impacting the globe and awareness of the fragility of persons with rare diseases is triggering teachable moments for all of us. Let's dive in! Welcome to "People Always, Patients Sometimes," Pam!   Pamela Gavin (01:33): Thank you, Janet. Great to speak with you today. Janet Kennedy (01:36): I am so fascinated by your organization. I had no idea that literally there were hundreds and hundreds of rare diseases that you all are tracking and cataloging through your organization. Pamela Gavin (01:49): Yes, it's an amazing, exciting time within the field of rare diseases. We have over 7,000 known, identified rare diseases in the world today. And so NORD as patient advocacy organization supports all of them and the work that we do. Janet Kennedy (02:08): Can you tell me a little bit more about NORD itself and how it's structured? Is this an organization that provides information to people or are you proactive in helping resolve and learn and educate people about the diseases? Pamela Gavin (02:24): So we do some of both of those things and an organization established by patients and caregivers and advocates over 37 years ago, for some of the very things that you mentioned in starting your podcast introduction. And that is to advocate for improvements in it, interest in job development, device development, medical care, and services for people with rare conditions because very little was being done in the field. It was very hard to make it work economically for companies and researchers to study rare diseases because the patient populations were so small, but people were suffering tremendously. Pamela Gavin (03:04): So the community, the patient advocates got together and pushed for legislation that ultimately led to the Orphan Drug Act being passed in 1983. And that legislation established financial incentives for those to do research and study and develop products for people with rare conditions, the majority of which even today still live with a disease for which there are no FDA approved treatments. So we advocate for change. We advocate for people living with rare conditions to have access to proper diagnosis, treatment, and care so that they can live their very best life. We advocate for an environment that promotes research and innovation and fairness and equity across the entire community. As part of that advocacy work to promote access to that which is necessary for people to live their best life. We also do a lot of education to collaborate with organizations across the rare disease spectrum. Many of which are members of NORD, other advocacy organizations to educate people, clinicians about rare diseases. We also educate advocates so that they could advocate on their own behalf. Janet Kennedy (04:23): I'm thinking back to when you were founded 37 years ago, and there's no internet there. So I can't imagine how hard it must have been for patients with a rare disease to find other patients with rare disease. It must have been like living in a cave to feel so alone and to feel like they're so unique that nobody cared about them. Pamela Gavin (04:48): They could live their whole lives without meeting somebody with the same condition. You're absolutely right. Janet, the isolation is just an incredible challenge for people to live with such a burden. I can speak personally from my own family's experience, having grown up part of my professional career without the internet, certainly the beginning of it. And now knowing not only that we have the internet, but all the amazing tools to connect people together, to communicate with one another, to bridge people across many, many boundaries across the world. So there still is isolation today, but it wasn't seemingly hard to connect to people. I can remember the first time we saw a newspaper article where there was a story about somebody with a rare genetic condition that was similar to what my nephew had. And it was as if that piece of paper that photograph trying to connect to that community. It was so impactful and so meaningful. Now we don't have to fax things over a fax machine or try to find a phone number by looking in a yellow pages or white pages or calling institutions and calling and calling and calling until you found someone who may know somebody, a family, you sit at your computer or on your cell phone and start searching. Janet Kennedy (06:10): And sometimes you're looking across States across the country, across the globe to find other people with similar conditions. Pamela Gavin (06:18): Absolutely, absolutely. And we work with organizations like ours across the globe. It's a privilege and an honor to represent the rare disease patient and caregiver community. As we try to unite ourselves across the globe. Janet Kennedy (06:35): Let me ask you a question about your organization. It is made up of other organizations that support a very specific rare disease for instance, but do you also support individuals for whom there is no support organization? Pamela Gavin (06:52): That's exactly right. NORD represents all rare diseases that are known. So we work in collaboration with organizations that exist for those diseases that are known. And then if there is no organizational representation, NORD tries its best to fill that gap and representing those communities as well. Janet Kennedy (07:12): Before we move on to discussion of patients and clinical trials, I'd love to know a little bit more about your history and how did you end up at NORD? Pamela Gavin (07:21): It certainly was not a planned professional path. I started my career working in healthcare. I at first wanted to be a clinician. I wanted to be a physician and ended up finding myself, getting involved in healthcare information systems, technology really fascinated by the opportunity to leverage technology, to improve healthcare delivery, healthcare decision making, and the experience for patients so that they had better outcomes. And I was intrigued by the impact that technology could have disruptive in a positive way to empower clinicians, to make better decisions, to have better information, better tools, equipped to do their job better. And so that's really where I started to focus. I ultimately found myself evolving into an advocacy role because of personal experiences. I had members of my family to be involved in medical errors. So I got involved in advocacy for improvements in patient safety and clinical care safety. Pamela Gavin (08:32): And then that led to getting involved in rare diseases. My brother's first son, my nephew, Trevor was born with metachromatic leukodystrophy. Although we didn't know it right away, they took some time for it to be diagnosed. And this is right when the internet was really beginning to be used predominantly for academic and for business to business purposes. So to your point about isolation, I saw that firsthand. We're a pretty close family. And so we all supported my brother and my sister in law through this journey. But one of the first organizations that they were introduced to once they finally got this devastating diagnosis, the disease for which there was no cure and was going to take my nephew over very over a period of time was the national organization for rare disorders. And I remember what it meant to be able to talk to somebody that knew something about what was taking place in our lives. Pamela Gavin (09:31): And NORD connected my brother and sister law in particular to medical information and to clinicians and researchers that were working in the field. So even though there was no treatment or cure and the outcome was going to be inevitably devastating to know that there were people working on, it provided some comfort. So that's how I was first introduced to NORD many, many years later, an opportunity to join the organization came about where I was really marrying my work in healthcare information technology and data and supporting improvements in clinical outcomes. Marrying that with my rare disease experience, I feel very privileged to have this opportunity to work in this space, representing the community and helping to make a difference for those who today live with a rare disease or love or care for someone with a rare condition in the US. Janet Kennedy (10:35): I think that's such an important thing is to have passion for the work you do. And in your case, it's well, really a job. You can never leave, but it sounds like it's a job that also sustains you. Pamela Gavin (10:49): Thank you for describing it that way. I think you are spot on. It is one I could never leave. If I were to ever be working someplace other than NORD, I'd still be passionately connected to the community and concerned about its wellbeing and progress. I could meet anyone with a rare disease or connected to a rare disease, and it doesn't have to be metachromatic leukodystrophy. And I feel connected to that person or persons, but I do feel lucky. I feel very lucky to be able to do this work. Janet Kennedy (11:19): Tell me a little bit about your role as the strategy leader for the organization. What does that mean? And one of my side questions is - you're supposed to be involved in strategy, which should be three, five, 10-year plans. And suddenly COVID-19 comes around. Did your strategy get blown out of the water? And you're having to rethink a lot of things? Pamela Gavin (11:39): So as Chief strategy officer at NORD, I have the privilege to work with members of the community, our board of directors, our scientific and medical advisory committee, our other committees, as well as our staff, other stakeholders that we collaborate with to as you said, look to the future to ensure that we are planning for and evolving and changing to meet the needs of the community in the future from the patient and caregiver perspective. Clearly COVID-19 has had a dramatic impact on the entire community and, and the organizations that operate in this space, including NORD. We are still looking out for the future, but we certainly had to deliver a lot of immediate resources to address the needs of the community, where we could, where it made sense for us to do so around education resources, to help people financially get over hurdles that were completely unexpected. I certainly don't have to tell you that this is a virus of epic proportions, not really anything we could prepare for. Pamela Gavin (12:52): And so we had to stop some of our earlier work in the beginning of 2020 on strategic planning and divert some of those resources to rapid response programs for our member organizations to help raise money to seed money. So they could stay afloat webinars where we brought clinical scientific experts, psychologists, psychiatrists, geneticists, telemedicine, experts, you name it, a variety of people into our community. Through webinars. We did some surveys early on to try to understand what people were thinking of, where they were being impacted. And then some of our existing programs where we help patients logistically get to clinical trials. Some of those were impacted early on. So we definitely put a pause on some of our and immediate quarter, one quarter, two work to ensure that we could pivot quickly to meet the needs of the community because they were hurting. Janet Kennedy (13:53): Based on what we've all seen in social media, it seems as though there are people who really don't understand the terms, high-risk immunocompromised, people who are at risk in regard to reacting to COVID and the persistence of some people to not understand the importance of wearing a mask and implications for this particular population is really rather astounding to me. Has NORD been challenged to help educate the folks who are not really aware of how large this community is and how serious the implications are of not wearing a mask during COVID? Pamela Gavin (14:35): We certainly, you know, work to promote the guidelines that have been put out by the government and promoting, for example, the CDC guidelines and wearing a mask. And we have been promoting our member organizations who have doing that, especially those diseases for which patients are immunocompromised, but it's been a challenge not uniformly across the country, but it's definitely been a challenge nor has had staff working remotely before. COVID-19 clearly all our staff are working remotely. Now we have offices in the Connecticut area, New York area. So we were early on involved in the first epicenter. So we saw the impact and participated in adopting the guidelines. So we were able to promote those best practices by virtue of the fact that they were supported by the federal government, as well as the local state governments, where we actually had offices. So we saw it firsthand. We have an office in the Boston area, not too far from where you probably heard about the Biogen conference. Pamela Gavin (15:47): And so we were very sensitive to what was happening early on in the country around COVID-19 and some of the early epicenters. So I think we were tuned to it from the very beginning and we've promoted the use of masks. You know, we have staff with rare conditions. We have loved ones with that are immunocompromised, some of which are rare and some of which are not rare. So we promote from within and from personal knowledge and experience, but it's concerning to the entire community that this is not something that is necessarily has been adopted across the country as early on, as we would have liked. Janet Kennedy (16:25): Let's pivot for a second. I'd like to talk to you about NORDs involvement in clinical trials. Do you actually have any kind of funding for programs or are you more about facilitating the conversations that could start clinical trial discovery? Pamela Gavin (16:42): Much of our work tends to be early on in that we raise money for researchers who are looking for seed grants to get them from one phase to the other potentially, or get some of their work over a hump. Our seed grants are about $50,000. So not nearly enough to operate large, expensive clinical trials. We also provide resources and tools and support to help patient organizations who want to establish natural history studies. And those may lead to clinical trials or may help inform the design of clinical trials. So we're very much involved in the peripheral activities or the early supporting activities that may lead to clinical trials. But with clinical trials themselves often conducted by industry stakeholders. We will work with them and CROs to help operationalize trials by working on the logistics side. So to help reduce the burden to patients and families, we will help them with their travel arrangements. We will help them with their costs associated with their participation in the child. And we'll also work to help promote trials and inform people of trials to help with trial recruitment. We're doing a lot in that ecosystem if you will, but we don't conduct the clinical trials ourselves. Janet Kennedy (18:09): I would imagine it'd be very difficult for you to pick one rare disease to focus on. Pamela Gavin (18:16): Yes, they care about them all. That would be a hard decision that's like saying I love one child more than the other, picking a favorite child. Janet Kennedy (18:30): Within your organization do you have the opportunity for patients to actually talk to each other? Do you have a platform for them to engage anonymously or otherwise with people of a similar disorder? Pamela Gavin (18:43): We did have a platform called rare connect that we worked with our colleagues in Europe. Over time, that platform, it was hard for us to participate and continue to support it financially and the different languages and folks tended to gravitate to the more commercial robust platforms like Facebook. So a lot of the direct communication amongst patients are with platforms like that. We'll connect people in other ways to augment that we have meant that by bringing people together around perhaps their educational needs, where we have a patient and caregiver annual forum, and this year it's virtual, it's called living rare living stronger forum, where we bring patients and caregivers, family members together, and they could be a various backgrounds, different diseases represented. Pamela Gavin (19:41): Some of them may be strong policy advocates. Some of them may be, have different areas of interest, but we bring them together. We also bring together clinicians that are providing educational opportunities. They bring their experiences and really trying to provide resources so that people can feel stronger, more empowered to live a better life, and have more successful opportunities to engage in the community, share their experiences, develop friendships, relationships with people. And we were doing this by bringing people physically together and we rotate around the country a different place each year. So we were supposed to be in Cleveland this past year, this past may and said, we're going to do it virtually in a couple of weeks in July. And we're going to go back to Cleveland next year. And we end our event with an annual award ceremony where we, and this has been part of NORD's history since I can't remember over 25 years, where we bring researchers, academics, patients, patient advocates, organizations, members of industry, government, federal, state policymakers, together to celebrate the successes of the previous year. So we will do it virtually this year. And we'll go back to Cleveland and the Rock and Roll Hall of Fame next year. Janet Kennedy (21:12): Oh, well, rock on. That's all I can say. Well, Pam, I can't tell you how important I think your work is and how proud I am of the whole organization. The amount of services and activities, information that you all have is really quite astounding. And let me ask you this. If somebody wanted to be more engaged, whether they are an individual person or they represent an organization, is there a place for them at NORD? Pamela Gavin (21:43): Absolutely. At both of those levels, there is, there's always a place there's so much opportunity, so much to do so much positive energy and opportunity to bridge gaps that exist in the community. And we'll find something for everyone to get involved in. So they shouldn't hesitate to reach out to us. Our website has forums where people can submit questions, comments, requests, or they could call our main number, which will route you to the right department program or project within the NORD. Janet Kennedy (22:15): That's excellent. All right. We'll be sure to have the links to the website and your social media properties in the show notes. So I encourage everybody to please check that out so you can find the links to both Pamela as well as all the organization social media platforms, Pam, I thank you so much for being here for "People Always, Patients Sometimes." It was a great pleasure to talk with you. Pamela Gavin (22:40): It's been my pleasure. Thank you, Janet. Safe and healthy. Connect with Pamela and NORD LinkedIn Website Twitter NORDpod (NORD's own podcast hosted by Matthew Zachary Facebook Instagram

Introduction by Tom Rhoads, CEO Spencer Health Solutions (00:03): This past January, I had the pleasure to speak at the open innovation and health event at the JP Morgan healthcare conference. The event was sponsored by Mount Sinai Innovation, Ogilvy Consulting and Humble Ventures. Our panel discussed the consumerization of healthcare delivery, which was led by Ritesh Patel, Chief Digital Officer of Health at Ogilvy Consulting. Ritesh is an amazing thought leader in the digital health space and has been kind enough to accept our invitation, to be a guest on our podcast. And frankly provide is timely healthcare insights who could have known then the dramatic changes we've experienced over the last six months in healthcare. Simply remarkable. I hope you enjoy this conversation between Ritesh Patel and our senior digital brand manager, Janet Kennedy on the "People Always, Patients Sometimes" podcast. Janet Kennedy (00:52): Welcome to people, always patient, sometimes a podcast production of Spencer Health Solutions. Healthcare has come to a crossroads and it's time to start listening to new ideas. That challenge are always done it that way, thinking we hope you enjoy our conversations with the disruptors, the innovators and the transformers in clinical trials in healthcare. My name is Janet Kennedy and with me today is Ritesh Patel. He's the chief digital officer for health at Ogilvy Consulting. Welcome to the podcast, Ritesh. Ritesh Patel (01:22): Thank you, Janet. Thanks for having me. I hope you're having a good morning. Janet Kennedy (01:26): Everything is going great here a little bit rainy, but uh, I'm very happy to have that. Ritesh Patel (01:31): Absolutely. Janet Kennedy (01:33): We've had a chance to run into each other. A number of times in social also engaging in the digital medicine society, which I find the Slack channel to be very, very engaging and very full of exciting people wanting to do new things. Ritesh Patel (01:49): Yeah. You know, I was funny when, when I first became a member and got invited to be a member of it, I thought, Hmm, that's an interesting way of engaging with your membership using Slack, but I'll tell you what you're absolutely right. It's a fantastic tool. And a lot of other member or societies should really look at that because the engagement level is fantastic. There's so many ideas being exchanged, people, helping each other announcements being made. I think it's a really smart move by the Dime Society to do that. So I'm very impressed. Janet Kennedy (02:23): I have used Slack for a couple of other organizations and companies that I've been in. And I constantly am surprised when people are like, Oh, just text me. You know, it's a conversation that just gets lost. It's very hard to have a group text with anybody and not drive folks crazy. And you are pushed by text, whereas Slack, you can engage with at your own pace and at your own level. So I don't know why they would prefer that, but I love the way Slack has enabled me for instance, to meet and engage with folks. And in our case to reengage after podcast interview over four years ago. Ritesh Patel (03:02): I know. We use Slack as a collaboration tool for Ogilvy Consulting for many years now. With the youngsters that we have coming in from universities, they're used to that. They're not used to us old fogies using email and mainly email. So it was interesting for me, and eye opening society would use it the way that are using it. It's very well done. Janet Kennedy (03:26): Well, I think the other interesting thing about the Digital Medicine Society is you don't join as your brand or company. You join as a person and everybody in essence is equal because it's only $50 to join. And it's an individual membership and you may or may not be speaking on behalf of your company. If you want to innovate, you can come in there and be part of the conversation. Ritesh Patel (03:47): Yeah, exactly. Exactly. I love it. Open Innovation in Health Pop Up on Sunday 12 Jan 2020 in San Francisco, CA, USA. Janet Kennedy (03:50): Well, let me ask a little bit about Ogilvy Consulting for the folks who don't mind for the folks who don't know. Do you mind giving folks a little elevator pitch on what Ogilvy Consulting is? Ritesh Patel (04:01): Certainly. About seven years ago, we noticed that the big consulting companies like Accenture and Deloitte are getting into the creative agency space and buying up agencies. I think Accenture Interactive is huge now because they've acquired so many interactive digital agencies. And so we, as Ogilvy, with our deep 75-year heritage of advertising decided to get into the consulting world. We wanted to make sure we could claim an area because of the brand Ogilvy to help our clients with. And it's really around brand customer experience and positioning in this new digital world that you're living in. So three years ago, it was all about digital transformation. And what we would do is say, well, that's all good. You're transforming your business, but how does your brand fit into that? How are customers experiencing your brand or your products or your service in that digital world, you may be transforming internally, but there is an impact that it has on the revenue that's being generated. Ritesh Patel (05:02): So that's what we focus on. We have a, quite a large group of folks around the world 400 or so that do that for big brands, as well as healthcare where I sort of read on the digital health practice is what can we do from that perspective, if you're a pharma company or a health system or a payer or a medical device company, we're doing a lot of work in that area that way. Janet Kennedy (05:26): And I understand that the work you do is also very collaborative. It isn't Ogilvy coming in to do strategy and we'll do all these other pieces for you. What you're actually doing is basically "cat herding". Ritesh Patel (05:39): You know, a lot of the times one client we're working with a global pharma company where we're creating a digital business framework, et cetera. We then work with, you know, I think they have you name it. They have McKinsey in there, Cognizant in there, Wipro in there, Accenture in there 80 in there. And then on the agency side, they have 13 different agencies they work with. And we're the Switzerland in the middle of that basically works with the business units to create all these things. And then we educate the agencies and the partners to say, this is how we need to operationalize this. So we're very much focused on what is that you're trying to achieve, how will it get achieved? And then who are the players we can help you get there. And that's not necessarily Ogilvy on the sign. Janet Kennedy (06:25): I'm curious about brand with a pharma company because some people may know a drug name better than they know the pharma company when drugs are being designed. And they're going through the naming process and the logo design process. Do they take a lead from the corporate branding or did they view each of these drugs as independent brands? Ritesh Patel (06:47): Well, I don't know if you know, it's a little secret here in the U S that there's only two companies that have the market for naming drugs, that they split between them 50/50, and it's all around the product. It's never around the parents. It's never around, it's a Pfizer products or Novartis products or a Merck product. It's all around the molecule and the medicine. And there's some taxonomy that's been created as a gentleman's agreement between the two organizations that they adhere to and the scientists adhere to. But, you know, I think Inventive owned one of those companies back when I used to work for Inventive that did that naming and they actually, they were based in Raleigh. Actually, if I'm not mistaken, I have to look them up. Now my brain is as melted around all that, but I think most cases, they look at it from the product, never the parents. Janet Kennedy (07:38): That is absolutely fascinating. And I learned my something new today. So I definitely want to find out more about that. That's awesome. Well, I know one of the things Ogilvy Consulting has been doing is some big thought leadership programs from an in-person program at the JP Morgan pre event, where my CEO, Tom Rhodes, was able to participate to a whole series of webinars that you've been doing. Tell me a little bit about how you go about selecting what you're going to be talking about and what are you getting out of these webinars, Ritesh Patel (08:12): I'll take those industries. So the first one is sort of how do we select we select based on what's happening. There's not a sort of a global annual content calendar we create. It really is around what is the interest in? And do we have enough thought leader capability or partners or people we know we can reach out to, to pull that together. And so recently you've seen an uptake on the webinar simply because we're seeing a huge amount of interest from our clients on the topics that we've covered so far. The first one we did was around the open data walls. You know, CMS announced the open data rules and interoperability rules that people like Epic were fighting for a bit and the President signed them into law not too long ago. So there was a huge amount of interest from a lot of our clients. What does that do for me? And what's the impact on my business? We thought it'd be good to bring some people together who knew about that stuff so they can get into the nitty gritty of it a little bit. So that was then, and similarly, the next one was around virtual trials, huge amounts of interest in virtual decentralized trials because clinical trials have come to a bit of a grinding halt since the pandemic. And so what can we do? I was getting frustrated because I was attending a number of these, whether it was all about the technologies, it really wasn't about how do you do this and what are the pitfalls like, really, if you're going to go do this, it's not just a matter of putting some remote patient monitoring tools in the patient's hands and digitizing the investigator. There's a huge amount of change that has to occur. So we brought some people together who are doing that at the cliff face, like Moe, from Boehringer and Craig from Pfizer, or formally from Pfizer to impart their knowledge about what you need to think about. If you're going to go down this route. And the same thing, patient centricity, we've been hearing the worst patient centricity from our healthcare pharma clients for 10 years. Now, everybody says the words, but what really does it mean? And how are you going to actually make it happen? And with the pandemic, everybody's even amplified the patient centricity verbiage, but nobody's really doing anything about it by things like, including patients in the trial design or including patients and figuring out how you can engage in a trial or how you discover a trial, or what do you do if you want to enroll in one or whatever. The rare disease community has figured it out a little bit, but in general, they haven't. Ritesh Patel (10:41): So we said, you know what? Let's bring some people together around that. So that's how we sort of have been putting them together this year. And then on the, on the popup side, it really is around innovation. We wanted to, one of the biggest issues I have is when I call people to see how, if I can help the word Ogilvy qualitate in their mind an ad agency, we really needed to reposition Ogilvy Consulting in the marketplace, particularly within the healthcare environment, as the consulting organization that can help you think through these hard problems from a digital perspective. So that's how we started doing those innovation popups. And it's really around positioning, Ogilvy Consulting as the guys to come to. If you're really thinking about some of these challenging things, we can certainly help you there. Janet Kennedy (11:25): Well, I definitely think that Coronavirus has accelerated a lot of conversations regarding decentralized trials. And I'm curious to know in hosting all of these webinars and having a chance to listen to all of these thought leaders, do you think digital health and innovation are really going to change clinical trials? Ritesh Patel (11:47): Yes. With a caveat, the caveat is how do you get the IRB on board? Because they are a gatekeeper and increasingly the ones that say no to most of these things. Number one, number two is how are you convincing the sponsors who are led primarily by the CRO to do this as well because the CROs have a view and a difference of opinion on how things need to be done because there's revenue involved there, right? You always have to look at the money, follow the money. Here's why I think it'll change. The pandemic has forced a fundamental change in the way we consume healthcare anyway. In a recent study from cancer, 70% of the doctors that they interviewed, I think it was about three, 400 of them in the U S C 30 to 50% of their practice being completely tele-health after the pandemic is over. Ritesh Patel (12:43): So what has been adopted as a way of working in the interim is becoming normal going forward. And if that's the case, then I'm going to start looking at other ways that I can apply this technology and these ways of working into what I do. And so a lot of these doctors are also primary investigators. So they're going to start asking, well, hell if I can see a patient using telehealth, why can't I see a patient on a clinical trial using the same technologies. And I'm already starting to hear some of those rumblings from a few investigators that we're working with. So I think this force digital for the pandemic is going to change and create new norms that a percentage of the population will expect. And therefore that will drive the innovation within clinical trials. Janet Kennedy (13:32): I think that's an interesting point because you were talking about innovation at the convenience of the investigator. And I think one of the things that the patients have been saying all along, but with Coronavirus, they can finally say, 'no, I'm not leaving my house. You have to figure out how to get to me if you want me to participate'. So I think we've seen a sea change in that patients were requesting asking demanding, but they were just a smaller part of the equation. And now we have clinical trials with no patients because people won't come here. I've got to figure out how to accommodate them. Ritesh Patel (14:10): And the sponsors have to, right. We are talking about billions of dollars at stake here. So if an investigator, if she uses to do it, it's incumbent on the CRO or the sponsor, or whoever's running that trial to figure out a way to either change the investigation or figure out a way to give the investigator the tools and the capabilities to do all of these technologies that we're talking about now have been around for five years. The pandemic has forced the use of them. And I think that's the biggest thing here. That's the mindset change and it's personalize the box suffocation of our lives. You know, there are taboo subjects that never were spoken about. I remember working on Cialis in 2012, I think. And you know, it was the, what they call the doorknob conversation that the man had with the call with the doctor. Oh, by the way, I've got a little problem as they're leaving the office along comes hymns and Romans, and now it's perfectly acceptable to go to a website, talk to a doctor via video, get a prescription. And it arrives in a box every three weeks. So these new norms, and now that we've gone through pandemic and we're used to having Instacart deliver our food to us Uber deliver our takeout to Doordash and GrubHub doing the same thing, Amazon doing the same thing, Hey, this stuff actually works. I press a button and things are over at my door. So why can't I apply it to healthcare? Janet Kennedy (15:37): That makes so much sense. Well, I'm curious where you think if you wanted to make impact and get your innovation into a clinical trial, would you be talking to pharma people or would you be really working the CRO route? Ritesh Patel (15:53): It's an ecosystem, I think. The sponsors have a responsibility to make sure that the trial is successful, obviously because there's revenue at the end of it or bring you a new product to market, right? A lot of us struggling because their business model is not conducive to the new world that we're living in the business model was a army of people managing this thing for you, making sure the CRS were trained, making sure the investigators were set up when the site was done. Even the feasibility study work, right? There's enough data out there today that you can create a dashboard around, say, you're doing a trial for a new diabetes thing. You can take the care set data, which is five years or eight years up to date have Medicare or Medicaid data overlay with IQVIA data and some other data. And you can find the referral patterns between hospitals and the investigators within those areas. Ritesh Patel (16:46): And also the patient population within a two mile radius of that facility. You don't need an army of people going around doing that. Feasibility has to change as well. So there are processes that are embedded in the CRO, particularly the bigger ones, that need to change as well. And then the third area is around the investigators and the IRB. The IRB is particularly the one. Those independent review boards. It depends on the digital acumen of the person reviewing. We all proposal as to whether you're going to get it done or not. So really need to educate those people and engage with them and show them that the EKG that's handheld, that the patient is using that's FDA approved device is as good as the patient going into the office and having a nurse do the EKG. Janet Kennedy (17:36): Now, the other thing too, is the ability to get the information much more frequently. If your patients who are having to come in every week, well, that's a huge burden for the patient. If you were only seeing the patient once a month, that's a long time between datasets. If you're not gathering information digitally. Ritesh Patel (17:52): I believe there are certain trials where you can do this completely remotely today, where you have the ability for a patient to use a device in their home to be able to report data. And it's not the eCOA, forget the eCOA is actual real data, right? So the EKG, for example, the cardio mobile product from AliveCor is a six and a 12 lead as good as any EKG you will find in any academic center. So I think the lower end product is on sale for $89, right in Walmart. So you can get an $89 product as a sponsor, give it to a patient and you can collect the data on a daily basis. You can do it on an hourly basis if you wanted, and then have the patient come in once a month, you can do the same thing with a bunch of other tool sets. Ritesh Patel (18:40): Now, Propeller just got approved for the AstraZeneca. I think it's AstraZeneca is inhaler product, where they are now going to collect the data for every squeeze of that inhaler for the patient. So why can't we apply that to a COPD trial? Right? So I think there are some places where we have to sit through and things that journey through and say, where's the application of data collection or connectivity with the patient. And then instead of saying, I'll get you an Uber because you don't have a car or we'll figure out a way to pay for your journey on public transport. Well, his $89 kit go do it yourself and we'll collect it every morning and every evening as you use it. Janet Kennedy (19:22): Just a really relatively easy solution that pays for itself in minimal amount of time. When you just add up the Uber trips or the however else, things are being funded. Ritesh Patel (19:33): It's not that hard to find the money for something like this. I mean, look, what is the cost of a trial these days? Do you have any idea, roughly? Do you take a product like a COPD product, right? The trials gotta be at least a couple of hundred million dollars by the time you're done. Right? So if you're going to get 10,000 patients times, 200 bucks, not that much money for the trial to be successful, the problem is the collectors of the end point data. It's like researchers in an agency, the researchers in an ad agency, I used to using four tools. If you come across and say, here's a new digital tool that can give you 600 mums at scale on an app that can tell you instantly within 10 minutes, what they think of your product, they're looking at you like you're from Mars. It's not possible. It's not research. It's not statistically viable. Who's going to do the tabulations, how aren't going to know, which is... All of the questions come up of the traditional way of doing things. And we have the same issue with the people who manage the end points of the data collection. A lot of them say, well, you know, the investigator nurse didn't actually check it. How do we know it was not them, really, could they give it to their child in the house? All of those things come up. Janet Kennedy (20:50): Absolutely. Well, I think we're going to have a conversation that's going to happen multiple times over the coming months and years regarding digital health innovation and clinical trials, because it is, I hope as exciting for those folks in pharma, as it is for those of us working with pharma, there are so many opportunities to do a better and more efficient and more cost efficient job in clinical trials. By engaging with digital health. Ritesh Patel (21:20): I'm even more optimistic because I've seen how R&D has embraced AI already for discovery. And I think that step has been taken and the culture within the sponsors to use AI and AI capabilities for drug discovery will bleed over into trials fairly quickly I think. Janet Kennedy (21:40): Awesome. Well, Ritesh, I cannot thank you enough for being a guest on People Always, Patients Sometimes it is always a pleasure to talk to you. And I think this is a conversation we should have on a regular basis because the innovation that's going on in pharma and in healthcare is one that's literally changing every day. Ritesh Patel (22:00): I'm thankful to you and happy to be a part of the conversation anytime you need Janet. It's always a pleasure to speak to you. Janet Kennedy (22:07): Thank you so much. Ritesh Patel (22:08): Thanks. Have a great day. Connect with Ritesh Patel Twitter LinkedIn

Tom Rhoads: The patient perspective is an integral part of how we at Spencer Health Solutions approach our work from UX and human factors testing and designing Spencer all the way through our customer interactions. We always look at how the patient evaluates their experience with our system. In this episode of our podcast, we asked chronic pain patient advocate Barby Ingle, founder of the International Pain Foundation, to share her perspective on improving clinical trials. I know you enjoy this episode of "People Always, Patients Sometimes". Janet Kennedy (00:37): Hi, my name's Janet Kennedy and I'm your host for "People Always, Patients Sometimes", a production of Spencer Health Solutions. I am really looking forward to my conversation today with Barby Ingle. Barby is a bestselling author, a reality live-streaming personality, she lives with reflex sympathetic dystrophy, Migralepsy, endometriosis, and other pain disorders. Not a surprise. Barby is also a chronic pain educator, a patient advocate, and president of the International Pain Foundation. I am very, very excited to have Barby here today and also because she is an avid user of social media to share her story. Barby, welcome to People Always, Patient Sometimes. Barby Ingle (01:21): Thank you so much Janet for having me. I'm so glad to be with your audience today. Janet Kennedy (01:26): You know, we talked to a lot of different people in pharma, in health care and clinical research, and I have spoken with some other patients, but I have to say in reading your bio and the things that you're dealing with, while the title of our podcast is people always patients, sometimes I have to think that sometimes it feels like a flip for you, that it's really patient. Always people sometimes. Yeah. Well, I think I'm both all the time. Is it a situation where you literally can never not think about what you're feeling? Barby Ingle (02:02): I absolutely have to pay attention. I have to plan and be prepared, and luckily before I was chronically sick, I was already organized, so I definitely used the skills that I learned in cheerleading, including organization and responsibility in dealing with the healthcare challenges that I'm faced with every day. For sure. Janet Kennedy (02:22): Now, have your challenges come as a result of your adult life, or is this something you dealt with even as a teen or preteen? Barby Ingle (02:30): I was actually pretty healthy growing up and when I was 26 I developed endometriosis. And then at 29, I developed reflex sympathetic dystrophy, RSD for short, and really endometriosis was something I got through really quickly. You know, it was like, Oh, this didn't work. These shots didn't work. What's the next thing? A laparoscopy. Okay. That made my insides very mad and the spread. And then the final thing was a hysterectomy and I was like, take it out. I'm done. I can't take this. I got past it and I thought if I could pass that I could get through anything. And then I got hit with RSD and secondary conditions after a minor car accident, which triggered it. It's actually an autoimmune disease, but it was triggered by an automobile accident and that changed my life forever. That eight seconds. Janet Kennedy (03:26): Wow. Okay. I'm going to take a moment and really think about that eight seconds. And your life has changed forever. So what does that mean day to day? How are you impacted by RSD? Barby Ingle (03:38): So prior to the impact, I was in my vehicle, a small vehicle, and I was hit by a 16 passenger van. I saw the van coming, I saw him in my rearview mirror and I twisted my body and the van impacted my car and I blacked out after that. I went to court and he testified, he said he had never, he didn't see me and he never took his foot off the gas. So after he hit me, so from that moment I started having burning fire pain. It was in my face, neck, and shoulder area. But it was so overwhelming with my thoughts, with my actions. I was, I went from being a collegiate cheer coach at a division 1A university to, I still was trying to keep coaching, but my coaching suffered, my team suffered. Barby Ingle (04:26): We were in the top five in the country rankings for cheerleading. And you know, I really was living my best life and that eight seconds that it took for this accident to happen, everything changed. And I went from well to being bed-bound for the next six months or so. I tried to continue to work and I would go to practice and I at practice would lay down on the floor and have our team doctors taking care of me. Instead of taking care of my student-athletes. I would go back to my office and lock the door and sleep because I was in so much pain, but I also was quite fatigued maybe just from having that much pain. If I turned my head to the right, I would pass out. Just literally everything in my life changed. I was married for 10 years. It's my first marriage. Barby Ingle (05:15): Did not survive the auto accident. I couldn't explain why they told me I had whiplash, but yet I had this burning fire pain. I started going from doctor to doctor to figure out what was wrong. I went to chiropractors, physical therapy, anything and everything that was suggested. I tried and then what? Oh goodness. Then I ended up over a three year period moving from Washington state down to Arizona per doctor's instructions. They said I would get better care here. I ended up seeing 43 doctors in a three year period. And finally, that 43rd doctor stopped and he had me bring in, at that time all of my medical records, which took three, three-inch binders. I'm now on binder nine of medical records. And before he even came in to meet me or see me or anything, he went through every single record from all 42 providers before him from all the different specialties. Barby Ingle (06:12): And he came in and said, I think I know what's wrong but I'm not sure and I want to run a test. And I said, well tell me about the test and I'm going to go home and study about it. And that was the first time I advocated for myself instead of just listening to and doing what the doctors told me, I stopped and said, you know, I want to go research on my own. And I and I took a week to research and talk to other patients that had had this procedure and decided to do the test and went in seven days later had the test done and I was tested positive for RSD, which is now known as central pain syndrome. Janet Kennedy (06:50): And what, is this a situation where you have to be medicated all the time? Is there a different kind of physical therapy that works for you? Barby Ingle (06:59): I'm allergic to Oxycontin so I didn't know how I would do with other opioid medications for pain. So I also didn't want to be like out of my mind so much mentally foggy cause I was already mentally foggy from the RSD symptoms. So I tried to do other treatments, but I was on pain medication for a lot of that time. Although I was on a lot lower dose and strength than many of my friends are. I supplemented it with radio frequency ablations as well as nerve box. And I even tried epidural steroid injections. I tried physical therapies. I went through a whole bunch of different, I've done three clinical trials, two medications and also a medical device and I still actually am using the medical device that I did throughout the trial and there's actually a book written and I have another family member who has the same condition as I do and he actually uses the same medical device that I used and we're both in this book that has come out about the device. Janet Kennedy (08:11): You went from literally suffering every day needing multiple physicians, changing your life totally moving to a new area. Finally got a diagnosis. You got some things maybe a little more manageable? Barby Ingle (08:24): Yes, so I was in the accident on September 26th, 2002 and I finally started doing all of these treatments and trying all of these options. I ended up in a wheelchair. I went from being face, neck, and shoulder; through surgeries, I didn't need I had a rib removed. The doctor made a mistake on that and ended up damaging my right lung and just one thing after the next went bad, I ended up in a wheelchair and bed bound to the right side of my body. My hand was curled up, my foot curled up and really just was trying to maintain being alive. In 2009 I finally went through infusion therapy in seven days in ICU infusion. I went in in a wheelchair in seven days later I walked out, I teeter-tottered out cause my legs were quite a bit atrophied and my whole body was. Barby Ingle (09:18): But I was able to walk out on my own and I was so proud of that moment. I had to come in and out of remission since December 2009 and I still have a scooter that I use when needed, but I am managing much better now that I have a good group of treatments that are working for me. Janet Kennedy (09:39): So help me understand how you made the transition from being focused on your own health to helping other patients deal with their issues. Barby Ingle (09:50): I advocate for myself first and then I joined a local support group and realized that I had a lot to offer to the group because of everything I had been through, but I didn't quite get what I needed out of it. So I reached out to a larger organization for RSD and said, you know, I'd like to be a mentor to mentor other patients. Barby Ingle (10:15): And I took on mentoring three patients, one of whom is still to this day, my best friend, and we keep in touch almost daily and it worked out. But I started by mentoring other patients and just being someone that they could talk to and someone that I could talk to and growing that into - I started to get asked to speak at events, at other people's support groups at different conferences and things that are happening in the pink community at large, not just for my disease specifically. And in sharing my story, it just really opened up a whole new Avenue of reach of people that didn't know what this is somewhat, you don't know that you need it until you're in the midst of it. And sometimes when you get into a situation where you're challenged, it's hard to see all the tools that are around you. Barby Ingle (11:09): So I kind of found them slowly moving through my own story and I said I have to help other people. No one should go through what I went through. Janet Kennedy (11:18): So I'm curious, how do we refer to chronic pain? Is it a disease? Barby Ingle (11:22): Well, chronic pain is actually now in the ICD 11 a diagnosis in and of itself. You can be diagnosed with chronic pain as an ICD code and insurance covers different treatments and things that are pertaining to that code. So it actually is a disease in itself or it can be secondary to another condition. Janet Kennedy (11:41): Well Barby, tell me about the International Pain Foundation. What is that organization? The International Pain Foundation started back in 2006 and that was just when my advocacy was starting and it was started in my honor by family members, but it soon grew to something that's much bigger, which at first it was called the power of pain foundation because I believe that pain made me a better person and more patient. Barby Ingle (12:08): And that's the message that I was spreading. My family every year would pick a charity project going into a nursing home or serving food at a homeless shelter that we could do as a family, and that year the family said, look, if Barby had this much trouble there, have to be other patients out there having trouble, so let's do something that will help them. And it's grown from just a small family organization in my honor to me actually running it and now it's an international organization with people from all over the world submitting articles, submitting quilt project pieces and crafts and education and all kinds of awareness opportunities. It really has grown from this little small family idea and project into this global network. Janet Kennedy (12:59): Oh, that's awesome. Because I think that's what patients have really demonstrated to the industry is that they will find their solutions. They will find their networks, they will join together with peer groups and solve their own problems if you won't solve them for me. Barby Ingle (13:17): Absolutely. Sometimes I wonder and now I work with pharmaceutical companies to help with clinical trials and help people become aware of those clinical trials that are going on. But before it was involved in, I didn't quite understand the clinical trial process. I would wonder why are they not listening to the patient's voice? And I think over the last few years the pharmaceutical industry has made a special effort to pay attention to what the patient voices and have patients and caregivers on their advisory boards for a clinical trial. Getting it set up and getting it organized and all the way through to the end when the results are produced or their item medication came to market or I've been involved with trials that actually didn't make it to market, but I've seen that whole entire process and been a part of it and was one of those patient voices in that process. Janet Kennedy (14:13): Tell me a little bit about your experience as a patient in a clinical trial. You don't have to name names, but I'm more curious about what did you feel was done well and what do you feel may be missed the mark as far as considering the "patient first" perspective? Barby Ingle (14:29): There's so many things. The biggest, thing is the disparity. Clinical trials should mirror the patients that will be the end-user and so many times clinical trials miss that mark and they want people in their trial who will do well on the medication, but it doesn't necessarily serve the population. For instance, we know that people that are African American or black will have sickle cell disease more often than somebody who's white, but less black people will participate in the clinical trials so when they come up with a solution that could be viable for sickle cell, it hasn't been tried on the actual population. That's the majority population for that disease or condition. So I think that's one of the things is the disparity. Also, a lot of people are limited from being a part of the clinical trials because they don't have transportation or access to the trials themselves. Barby Ingle (15:33): They're usually held in the bigger cities and that has a certain population and income level and education level. So you get less of the smaller town, rural patient population. Being a part of those clinical trials? Janet Kennedy (15:49): Well, I think from your experience too, you probably weren't solo-ambulatory, so you needed someone's help. So that's two people. Barby Ingle (15:58): Yes. And that's what I meant by transportation because I have a seizure disorder. My seizures disorder didn't start until 2014 but I had migraines right after my auto accident, but I wasn't able to drive for many years because when I twisted my head to the right, I would pass out while to change lanes, you need to be able to look and see what's next to you. So I didn't drive a lot. So I do, I rely on my caregiver and now I have a seizure disorder. Barby Ingle (16:28): So I drive even less. But if he wasn't able to take me and have a vehicle to put my scooter in or my wheelchair in, then I wouldn't be able to go. I did try to take a taxi once to a doctor's appointment and it was $126 to go less than 20 miles. Wow. And my husband now. I was able to find love in the midst of all of that pain and chaos and he's the most amazing caregiver ever. He said, you know, I will take off work for $126 like this is ridiculous. Never, ever, ever take a taxi again. We just had to find ways around it and work out a better way, but if you don't have somebody that can do that or their job doesn't let them off, then getting to the appointments can be quite a challenge to participate in the clinical trial. Janet Kennedy (17:20): Barby, you're very savvy out there in the wide world, following social media, following the innovations that are happening. Do you see any improvements for patients with all of the digital health technology that's being developed? Barby Ingle (17:34): Absolutely. I think that some of the clinical trials are coming on board and they're allowing patients to do the trials from home. They're sending them kits where they can do the monitoring from home and it can work on an app on their phone and report the results to the researchers and or their providers. If the researchers find something, they can report it back to the patient's provider to get immediate care. So we're starting to see some of those types of trials come into fruition and I think this year especially telehealth has exploded and hopefully the clinical trial process follows that same path and works in telehealth into their system so that patients that are more rural can get involved in the clinical trial so that the trials can mirror better the types of patients that are the end-user of that product. Janet Kennedy (18:32): Well, that is exactly what we hope at Spencer health solutions as well. Our Spencer device allows for medication delivery also allows for patient engagement via asking questions after someone has taken their med delivery and there's a telehealth feature and can even tie into biometric devices. So there are a lot of options there to hopefully make it easier for in-home clinical trials. Before I go, I want to know a little bit more about the Ken and Barby Show. Tell me what this is. I don't think I've ever spoken to a reality TV star. So I want to know what this program is and how it got started. Barby Ingle (19:11): Yes. So I've been on multiple television stations, like game show network and TLC and WB, CBS, ABC, NBC. But my husband, Ken and I were "Ken and Barby", and we participate in the Ken and Barby Show. It is a show that is lighthearted. It covers our adventures together and raises awareness, but not necessarily in an upfront, in your face kind of way. So we talk about different conditions and things that I'm personally going through with my health or Ken as a caregiver, some of the challenges that he's faced. But it's also, we found ourselves because of the advocacy work in quite some interesting positions and situations and have been able to meet a lot of great people who have also use their platforms to raise awareness and spread the information that they need about their condition. So we're very funny together, very interactive with our viewers. Barby Ingle (20:11): Sometimes we play games, we give out prizes. We're on season nine some of our seasons. We've had sponsors this season that we're on right now. We decided to not have a sponsor for this season. It's just Ken and Barby raw all summer long and we just want to bring positivity into everybody's life and be cheerleaders of hope - or Ken calls himself a "Care Leader of Hope". We do that in a lighthearted, fun, positive way and it gets people's minds off of the pain, but we also have people that don't have chronic pain of any kind and they're tuning in and watching and we're reaching a larger audience than just our silo of patients and their caregivers. So we're actually planting seeds and we're hoping that when that person needs the information one day that they will remember some of the topics and things that we brought up during the show. Janet Kennedy (21:07): Oh, that sounds great. Well as people know who listened to the podcast, I will have links in the show notes that will take people to not just your social media profiles, but we'll make sure that we've got a link to a couple of your cool blog posts about clinical trials and of course to the Ken and Barby Show. Barby Ingle (21:24): Thank you so much. Janet Kennedy (21:25): Oh, Barby, thank you so much for being here and I really, really enjoyed having you as a guest on "People Always, Patients Sometimes", and really look forward to meeting you in real life when we get back into face to face situations. Barby Ingle (21:41): Awesome. I can't wait to meet you as well. Thank you so much, Janet. This has been a great time. Contact Barby Ingle Website LinkedIn Twitter: International Pain Foundation Twitter: Barby Ingle