Advertise on podcast: People Always, Patients Sometimes

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

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

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

Pharmacy companies are an important part for Spencer Health Solutions, and pharmacists are an integral part of fulfilling our mission to serve patients in their homes. Hi, I'm Tom Rhodes, CEO, Spencer Health Solutions. We have had the opportunity to bring patient pharmaceutical and digital health thought leaders to previous podcasts. However, today we're speaking with our first pharmacist, digital health advocate and analyst, Timothy Aungst, also known as the digital apothecary. He joins our host Janet Kennedy for an insightful conversation and a call to action to the pharmacy industry on the People Always, Patients Sometimes podcast.   Janet Kennedy: (00:45) Welcome to People Always, Patients Sometimes. I'm very excited that today's guest is Timothy Aungst, the digital apothecary. He is an associate professor of pharmacy practice and also a clinical pharmacist. Timothy, welcome to the podcast.   Timothy Aungst: (01:03) Thank you, Janet, I'm really excited to be here today to talk about, you know, all this stuff that's been going on.   Janet Kennedy: (01:08) It's been a crazy couple of years and that's one of the things that I wanted to talk to you about. I found you because I read your primer, "Digital Health Primer for Pharmacists." You published it in February of 2019. At that time you wrote, "after being involved in the digital health space for almost a decade, I can say with complete sincerity, that the topic is still relatively out of the realm of the general pharmacy profession grasp." Okay. You put a challenge out there. 10 years you've been involved in digital health and you're saying pharmacy is still not up to speed. Would you say that that's true two years later?   Timothy Aungst: (01:52) Yes. I still would stand by that. I would argue that we have seen entrepreneurship within the pharmacy profession gravitate towards digital health at large, but I would also conversely say that as a profession for pharmacists, we have not really actually actively engaged in this area. We still lack a large number of educational roles and trying to get people aware of the space. There is a lack of discussion around it. Most of our public organizations that provide guidance on what our next steps for the profession don't really think about it in, I think it's for that reason, I still would say the gap is there. Now that is changing. I would say that there has been a semi call to action amongst several pharmacy organizations, whether it's say PHA, ACP and several others who are now trying to get the profession up to speed on what digital health is.   Timothy Aungst: (02:44) And that's been a big focus of mine serving as so-called subject matter expert or key opinion leader to help get information out there regarding the topic. But very, at this time it's quite topical just because we are not actively highly engaged with it. I would probably say we're maybe like two or three years behind other healthcare professions, such as the medical community. The American medical association has an active digital health component that they've been pushing, I would say probably for about two or three years at this point, have reports coming out, organizations associated with it. And I think pharmacists have to play catch up to that. And depending on key stakeholders at this current time that may or may not go fast or may go slow. And that's one thing I'm actively keeping my eye on.   Janet Kennedy: (03:27) Well, I'm curious about whether pharmacists or the pharmacy is even included in some of this digital health development.   Timothy Aungst: (03:36) I'm always a person who would've actually separate the two. The pharmacist and the pharmacy, I think are no longer synonymous organizations. You don't need a pharmacy to have a pharmacist. I think it's going to be what we see in the 2020s or 2030s at this point. I think those two things will actually diverge and that will just come down to logistics and also some legal p

What happens to a person who finds out they have a rare disease? When you're diagnosed with a condition that affects one in a thousand or one in ten thousand, where do you turn to find information, help, and support? Recognizing the need for that resource, a team of dedicated individuals on Rare Revolution, a magazine dedicated to spotlighting the rare disease community. Their goal is to bring about a dramatic and wide reaching change in conditions and attitudes for the rare disease community. We are honored to bring Rebecca Stewart, CEO of Rare Revolution Magazine, to the podcast. Her conversation with our host, Janet Kennedy, truly reflects our philosophy - People Always, Patients Sometimes.   Janet Kennedy: (00:50) Welcome to People Always, Patients Sometimes. Today we're really taking a patient perspective and we're taking a unique look at patients who really need some attention right now, and those are the patients that reflect the rare disease community. With me is the CEO and founder of Rare Revolution Magazine, Rebecca Stewart, and we're going to be talking about the thousands of patients who may not be getting the attention they deserve and need - those with rare disease. Rebecca, welcome to the podcast.   Rebecca Stewart: (01:24) Thank you very much for having me Janet. It's a pleasure to be here.   Janet Kennedy: (01:27) I would like to think that we really are having a Rare Revolution, but is yours a call to action or a reflection of what's actually happening in the rare disease community?   Rebecca Stewart: (01:39) So to give you some context, there are over 7,000 known rare diseases, which affect globally 350 million people. So we're the biggest, rare community that there is. It's a huge number of patients, but of course, individually, each individual disease affects a small number. But globally it's a huge health crisis.   Janet Kennedy: (02:05) How about how the community is being served? Is this something where individual patients are truly having to learn how to advocate for themselves, or are they growing together as a community to speak and support each other?   Rebecca Stewart: (02:20) I think there's both. So, as a community, the rare disease community have both really good individual disease communities, mostly. Of course, there are those rare diseases that are so rare that there aren't support groups, there aren't patient communities. And so those people find themselves really quite isolated. And then collectively the rare disease community comes together to really help influence policy, to help influence healthcare, to help push for things like interest in orphan diseases, from pharmaceutical companies and research, and to support each other because individually, the individual nuances of each rare disease, whilst those might be very different, collectively people with rare diseases tend to have very similar problems; that's access to expertise, access to healthcare, education, meaningful employment, social services. These are all shared problems. And so they can really support each other across disease. So, you know, really disease, agnostic support as well as the absolutely amazing job that individual support charities and organizations provide on a specific disease level.   Janet Kennedy: (03:34) So what is the Rare Revolution Magazine role in all of this? What is your mission and how do you become involved in this community?   Rebecca Stewart: (03:43) In 2012, my sister, who's also my co-founder, and I actually began a disease-specific support group called Teddington Trust, which is to support families affected by the ultra rare disease Xeroderma Pigmentosum. And through that, what we found was a real gap in our ability to raise meaningful awareness for the work that we did and for the condition and that it was done in a way that we felt was sensitively dealt with and valuable to us as an organization and a community. And we thought, well, we can't be the only peo

Decentralized trials are here to stay, says Dr. Isaac Rodriguez-Chavez, our podcast guests today. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are delighted to have Isaac join the podcast to discuss decentralized clinical trials and why pharma companies should embrace digital technology for the benefits of patients. A former FDA officer who was instrumental in the review and approval of digital health technology in clinical trials, Dr. Rodriguez-Chavez is now the Senior Vice President for Scientific and Clinical Affairs and Head of Strategy for Decentralized Clinical Trials for Icon. I hope you enjoy this conversation with our team member, Janet Kennedy, on the People Always, Patient Sometimes podcast.   Janet Kennedy: (00:46) I can't tell you how thrilled I am to have finally landed Isaac Rodriguez-Chavez as a guest on the People Always, Patient Sometimes podcast. He is an industry leader that is someone that everyone listens to, and it's really exciting to have him here today. He is formerly the FDA officer focusing on clinical research methodology, regulatory compliance, and medical policy development, and recently joined the private sector as the Senior Vice President of Scientific and Clinical Affairs, Head of Global Center of Excellence, DCT Strategy for PRA Health Sciences. So he's got a foot in both camps and it's going to be a very exciting conversation. Isaac, welcome to the podcast!   Isaac Rodriguez-Chavez: (01:30) Thank you, Janet for having me and all the listeners, I am delighted to be here with all of you, sharing some thoughts on information that is really, I hope, pertinent for all of us.   Janet Kennedy: (01:43) You have been very active as an FDA member and as a member of the PRA Health Sciences in promoting and discussing decentralized clinical trials, and it's time is now. However, for the one listener who might not realize who you are, I'd love to explore a little bit of your background, what work you did with the FDA, and then what made you decide to come over to the private sector. So can you tell me a little bit about your background and how you came to be where you are today?   Isaac Rodriguez-Chavez: (02:14) Absolutely. I'd be happy to do so. The FDA, I was a senior officer for clinical developing medical policy and working internally. Also leading a program on decentralized clinical trials and supporting the modernization of clinical trials in general, including the implementation of digital health technologies in modern clinical investigations. The FDA is an amazing place. And my colleagues there are really wonderful, friends more than colleagues, because the work that we do really matters and impacts the entire nation. Essentially, I was a professional consulting internally and externally on decentralized clinical trials implementation of decentralized clinical trials. I believe in the modernization of clinical research. So I am a basic scientist by training with specialties in immunology and biology, but I became a clinical scientist also by training and experience over 20 plus years ago, conducting clinical trials, doing clinical research, being a sponsor, being the auditor, being essentially in multiple capacities, engage in investigations.   Isaac Rodriguez-Chavez: (03:32) So for me, my passion is really what I discover is the direct impact on the patients and their lives, and clinical research, along with the infectious diseases, which is at the end of the generic or the bigger umbrella where my expertise lands, are the things that I like and I enjoy doing. Direct impact to patients and their lives in clinical investigations, with novel products and in infectious diseases and even in vaccines, which are also a love of my life. And that's what I did at the FDA. And then I transitioned to PRA Health Sciences to lead the strategy of a newly created global center of excellence for decentralized trials. The idea really for me was about to transition from the regu

Understanding the patient journey is an important part of clinical trial development. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. On today's podcast, we welcome Shazia Ahmad, Senior Director of Patient and Physician Services at UBC. She is a thought leader in the space of patient communities and supporting the patient throughout the clinical trial process. I hope you enjoy this conversation on People Always, Patient Sometimes.   Janet Kennedy: (00:31) Hi I'm Janet Kennedy and I am your host for People Always, Patient Sometimes, a production of Spencer Health Solutions. I am really looking forward to a conversation today with thought-leader Shazia Ahmad. She is the Senior Director of Patient and Physician Services at UBC. Welcome to People Always, Patient Sometimes, Shazia!   Shazia Ahmad: (00:52) Thank you Janet! Thanks so much for having me today.   Janet Kennedy: (00:54) I've been trying to track you down for a conversation for actually a number of years, and I'm so glad I finally captured you today.   Shazia Ahmad: (01:03) Yes, absolutely! So excited to be on.   Janet Kennedy: (01:06) Well, I want to be talking to you a lot about the work that you do specifically as a director of patient and physician services; but first I think we need to set the stage. Can you tell me a little bit about UBC?   Shazia Ahmad: (01:18) UBC was founded in 2003 by industry experts with a passion for innovation and a commitment to working with pharmaceutical and biotech organizations in proving the safety, efficacy, and value of pharmaceutical medicine products. UBC is a leading provider of pharmaceutical support services, and we partner with life science companies to make medicine and medical products safer and more accessible.   Janet Kennedy: (01:46) Now, would you consider U B C to be a C R O?   Shazia Ahmad: (01:51) I would say we're CRO, but we really are proud to kind of stand out as a service provider, I would say.   Janet Kennedy: (01:59) Okay. Well tell me a little bit about what that means to be directing patient and physician services.   Shazia Ahmad: (02:05) At UBC, I have the honor of leading a team called patient and physician services. And what that is, is we're involved in supporting biotech and pharmaceutical sponsors in different services around patient recruitment, engagement, compliance, retention. We offer different services around making sure that we engage patients early on in research to ensure that the sponsor captures everything they need to, to really understand the patient journey and the development of whether it's the protocol design, developing the right strategies for recruitment retention. We're also able to integrate capabilities and services around awareness campaigns, where we use social media, digital outreach, and traditional advertising. A lot of programs that we do work on now at UBC involve the rare disease space. And I think Janet, that's where you and I really connected most over the last few years; a lot of the rare disease work that I lead. So we're able to also integrate different capabilities to really work with patient advocacy groups and really involve them early on in the launch of our programs to ensure that we're not just getting the patient voice by making sure that we work with the patient advocacy group as a partner, and really we work as a bridge to the sponsor with the patient advocacy group to ensure that we have the right strategies in place to support recruitment and retention for our program.   Janet Kennedy: (03:41) So are you actually bringing in these advocacy groups so early that they're participating in evaluating or contributing to the protocol design?   Shazia Ahmad: (03:49) Exactly. Exactly.   Janet Kennedy: (03:51) Well, that's kind of exciting. I'm curious - what sort of feedback have you seen coming from these groups that actually made the sponsors rethink how they had written a protocol?   Shazia Ahmad: (04

Huntington's disease is a rare genetic condition that impacts over 30,000 people in the U S and 200,000 worldwide. It is a neurological disorder that impacts movement mood and the thinking process. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. On this episode of our podcast, we ask patient advocate BJ Viau, co-founder of the Huntington's Disease Youth Organization, to join us in a conversation about patient advocacy on People Always, Patients Sometimes.   Janet Kennedy: (00:35) Hi, my name is Janet Kennedy, and I am your host for People Always, Patients Sometimes, a production of Spencer Health Solutions. I'm really looking forward to a conversation today with BJ Viau. BJ is passionate about positively changing the lives of people impacted by rare conditions. He has a history of working to support patient advocacy and rare disease non-profits by holding grassroots fundraisers. BJ also helped create an international nonprofit for Huntington's disease, the HD Youth Organization, or HDO. He has an MBA and has been working in the pharmaceutical industry for over a decade. Currently he's the Director of Patient Advocacy at Horizon Therapeutics. Welcome to People Always, Patients Sometimes BJ.   BJ Viau: (01:20) Hey Janet, thanks for having me. Excited to be here, look forward to a conversation.   Janet Kennedy: (01:24) Absolutely. Well, I think one of the things I'm most interested in learning about right now is what is Huntington's disease and how does it impact young people?   BJ Viau: (01:35) Yeah, I mean, it could be a 20 hour answer, but essentially broken down, Huntington's is a rare genetic disorder impacting about 40,000 individuals across the United States. It's a neurological disorder that unfortunately takes over one's ability to do anything and everything in life. Most commonly described the combination between more common conditions like ALS, Alzheimer's, and Parkinson's all wrapped into one. How it affects young people is typically symptom onset starts for individuals later in life, probably in their thirties or forties, although it can vary. Although that's not technically a young person, where it starts to affect the young person is it's their parents. So you start to see decline in your parents, they lose their jobs, they lose their ability to function. Young people end up having to be caregivers for their parents. And what some might say the worst part about Huntington's is its autosomal dominant genetics, so every child of a parent who has Huntington's has a 50% chance of also getting Huntington's disease later in their own lives. So it's a little bit of looking in the mirror and wondering, am I going to have this future of my parents, or am I going to have a future of no Huntington's? And that's a really emotional decision that young people have to make.   Janet Kennedy: (02:50) Now you mentioned it's genetic. So does that mean you can take a little test and find out, or do you have the sword of Damocles hanging your head your whole life?   BJ Viau: (03:00) Yeah, take a little test. It sounds very simple and easy. Essentially it is. It's a blood test or saliva test that will provide you pretty much, if you will have Huntington's or if you will not have Huntington's. But even though it's simple, it's got huge social, emotional, psychological kind of bucket that comes with such a simple task.   Janet Kennedy: (03:22) I'm curious about the fact that you're focusing on young people. Is this to help prepare them for a future of thinking through how does Huntington's going to affect them, or is this actually helping them deal with their parents?   BJ Viau: (03:38) Yeah, a little bit of both. 15 years ago, when we were kind of dreaming up the Huntington's Disease Youth Organization A few of us young people were attending conferences and all the sessions and all the meetings were really focused for our parents, and there wasn't much support or education for us young people. In f

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 organization

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

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

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