There is something to have in mind when you work in the clinical trial space: we all are patients at some point in our lives.
In this episode of Bite the Orange, we are happy to have Decentralized Trials & Research Alliance Co-Chair Craig Lipset on the show. As a patient with pulmonary sarcoidosis himself, Craig has let his experience influence his work in clinical trials around patient engagement and centricity, enabling access to their health data in the studies they participate in. Craig explains his condition, shares insights into some of his work inspired by his patient journey, and touches on sore points the clinical trial space faces regarding cost and innovation. He also speaks about what the Decentralized Trials & Research Alliance is and how anyone can learn about the initiatives in the organization.
Tune in and listen to Craig and what he has to say about improving the experience for patients in clinical trials!
FULL EPISODE
BTO_Craig Lipset: Audio automatically transcribed by Sonix
BTO_Craig Lipset: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Emmanuel Fombu:
Welcome to Bite the Orange. Through our conversations, we create a roadmap for the future of health with the most impactful leaders in the space. This is your host, Dr. Manny Fombu. Let's make the future of healthcare a reality together.
Emmanuel Fombu:
Hello, everyone, dear listeners, and thank you. Welcome to another episode of Bite Orange, where today we have a guest that I'm sure you all know already. He doesn't need much introduction, right? Craig is someone, Craig Lipset is joining us today in Bite the Orange, I think he fits the profile perfectly, you know, as someone that challenges the status quo in healthcare and is a huge advocate and everyone in the community, especially to be involved in clinical trials, or innovations, or in clinical trials, you certainly know, Craig, and someone I respect and look up to quite a bit that I'm very happy to have you today, Craig. So with that being said, thank you and welcome. Can you tell the audience about yourself in a few words?
Craig Lipset:
Manny, it is great to be here with you. I am a long-time friend and ally and glad to be a first-time guest here with you in Bite the Orange. For friends out there that I have not yet met, I am an individual who's focused on identifying and scaling innovative opportunities in clinical research and medicine development. Spent about a dozen years at Pfizer, where I was the head of clinical innovation, and at the time since leaving Pfizer, I've been busy as an advisor, as a board member with both for-profit and non-entities. I teach in health informatics at Rutgers University as an adjunct assistant professor, and I'm an advocate as a patient myself and a board member at the Foundation for Sarcoidosis Research. And so I've tried to spend my time today straddled across investors, pharma and biotech, medical centers and research sites, and innovators around solutions that we can scale to impact medicine development today.
Emmanuel Fombu:
Thanks for that background, Greg. I know anyone go to LinkedIn and look at your profiles, oh yeah, this is impressive profile, but what I would like to know, which I don't know at this point, we'll get to know together, is what got you interested in clinical operations, right? Like what? What is that, why? What drives you? I mean, it's an extra passion in all of us that gets us to be that passionate about. In my case is my grandmother, she had heart failure and she passed away about 15 years ago from this, and I saw what she went through it, and so I realized there's a lot of things that we could do to technology to improve quality of care for patients, so that's what drives me. So what's your why?
Craig Lipset:
You know, I originally came into this because I was fascinated by the cost and spend associated with drug development. When I looked at like the pharmacoeconomics around the cost and investment required just to get a single medicine all the way through, it seemed like a few different things to me. It seemed like an area that was great with opportunity to try to bring new solutions in, so it seemed like a fun convergence of innovations, right, that you can take innovative science coming out of the bench and blend it with innovative tech and approaches and try to impact that spend and cycle time. So that seemed really appealing to me because it felt like coming out of grad school, like that was a big, gnarly problem. But a lot of what influenced me during my time prior to Pfizer and during is my own journey as a patient. I mentioned in the, at the outset that I am a patient myself with pulmonary sarcoidosis. I'm very active in the sarcoidosis community as a board member and vice president for the Foundation for Sarcoidosis Research, and that journey of my own as a person navigating diagnosis, managing my personal health data, being spread across a web of different specialists and places where my data resided, and the appreciation that I needed to own and control my health data if I was going to see better care and better outcomes. I let that influence and guide a lot of my work at Pfizer. A lot of the design of the original remote trial, our work around patient engagement, and patient centricity are desired to enable people to access their own health data from the studies in which they participated. I led my own journey as a patient influence and shape a lot of my thinking in those areas.
Emmanuel Fombu:
And that's, for those people that don't know about pulmonary sarcoidosis. So, I mean, I don't want to just push it out because I didn't know that about you, right, and so a lot of times I'm glad I'm really in this piece, but I think to create awareness around it. So what is life like for you, Craig, with pulmonary sarcoidosis?
Craig Lipset:
So sarcoidosis is an immune-mediated inflammatory condition. It disproportionately affects the lungs, but can affect other systems. And when it's done with its course of granulomatous-induced inflammation, it will often leave behind scarring. And when you think about lungs that like to move in order to inhale and exhale, scar tissue is kind of detrimental to that process. And so for people like me with sarcoidosis, what that means is some reduced pulmonary function. It means a greater propensity to find oneself short of breath, going up a stair, a set of stairs. Or you might find me if I'm rambling on a podcast, I take an extra gasp of air along the way. There are, traditionally been very few treatment options in sarcoidosis. The mainstay were, was prednisone without even substantial data to back it up and very little else available. That started to change during the era of drugs like Infliximab and drugs like Enbrel and others, Rituximab and others that really started to show the power of monoclonal antibody treatments in other areas and other immune-mediated inflammatory conditions like rheumatoid arthritis to be repurposed here. Today, because of the work of the foundation and others, we're seeing a number of pharma and biotech companies start to identify sarcoidosis as a great area of unmet opportunities. I like to think of it as a very large, rare disease. It still means your rare disease criteria, but there is a substantial population and among that population, there are some who are responsive to steroids. About a third will have a self-limiting course of disease, but the remainder have an unmet medical condition that we believe can be addressed with modern science with so much learning around the inflammation cascade. I have to mention that I do not look like your typical person with sarcoidosis. Sarcoidosis disproportionately affects black women, and so there has always been an additional challenge and barrier there in making sure that people have good access to healthcare, that they can get through a diagnostic journey and find a diagnosis with sarcoidosis, given the challenges that so many have with access. I am a very privileged white male, right? I know my way around the healthcare system, and even for me it was a journey to try and find a good diagnosis.
Emmanuel Fombu:
And thanks for giving us those insights and thanks for sharing your personal story with us, Craig, and this doesn't just apply to sarcoidosis. I think you could take the same kind of story and this could be a journey that applies across the board in healthcare, right, and the challenges that patients face. And from what Craig just described here, like difficulty walking upstairs. So imagine designing a clinical study and patients have to get up and walk and drive distances to go to the research areas, right? Which brings us into decentralized clinical trials, something that I know you're very passionate about, right?
Craig Lipset:
Well, absolutely, and by the way, many you're absolutely right, though, that, you know, I have my journey. You have your journey. Your parents have their journeys, your loved ones have their journeys. All of us are patients that sometime in our life. I remember going to a conference years ago in Philly, I think at the time it was called E Patient Connections, a guy named Kevin Cruz used to run it, it was a very cool meeting, and I remember sitting in that room and somebody got on stage and said, How many people in this room are Pharma? How many people in this room are from this sector, from that sector? And then at the end, how many are patients? And a few people raise their hand, and I thought, nonsense. How are only two of you in this room patients, right? We refused to self-identify as more than one thing. And what we started to find even in my time at Pfizer, was what happens when people who are embedded in the organization are willing and able and feel safe and protected to self-identify also as a patient, as a person with a condition. We had one amazing colleague of mine at Pfizer who started to self-identify more internally as a breast cancer survivor and really started to bring more of that into her work. I think it would be really powerful, and I have great respect that many don't feel safe or comfortable in doing that, but I think for those of you who are able to bring your full self into your work, your journey, your experience as a patient, and be able to bring that into your mindset, as you were setting up, that really defined a lot of my thinking around decentralization and improving access.
Emmanuel Fombu:
Correct, and I think as more people identify, I actually refuse to use the word patient sometimes, right? Because, and I saw people that I do against it, like, oh, I'm a patient because I want to be called a patient. I think it's, based on individual, you just say whatever you want to call yourself, but I don't think being a patient is like instead of like a permanent condition in life, right? Like, I mean, your knee could hurt you. A patient for a knee patient, people buy Tylenol, acid reflux, whatever. So there's a whole thing, I'm saying that I'm not saying every disease is not some are more serious than others, yes, but I think that is a personal experience that everyone goes through. And if we put on that cap and understand where the patient is coming from, understand our journey, I think, to be more adoption of all these new solutions that we have, right, in general.
Craig Lipset:
It's sort of, break down some of that us and them kind of mindset when during, about three years ago I had the privilege of serving on a board for a PCORI spinoff group called PCRF, which was chaired by Rob Califf, now the commissioner of the FDA. PCRF, stood for the People-Centered Research Foundation, and it was very deliberate that this wasn't about patients, it was about people. And it's interesting when you're right, when we start to be a little more expansive in terms of our, the way we try to bundle and compartmentalize people. The patients we're talking about aren't, you know, three people in the back of the conference room, it's all of us, it's people.
Emmanuel Fombu:
Correct, and correct, discussing things that are on clinical trials, I know not, there are many people actually that work in industry like ourselves. I worked in industry, but they've never been involved in clinical research themselves, right? So I understand that whole process is like that back, that back-end piece, the dirty work, right? What happens in the back behind the scenes, right, that happens, right? It's a world in which we still use fax machines, it's a world in which like innovation is like, people have pilots who just kill pilots, right, for the sake of killing things, right, and the basic things that we do become my challenges. And so, tell me some of the archaic technologies or things that have happened in the clinical trial world today, like in today's world. I pick the first one is one for you, fax machines still exists in this world.
Craig Lipset:
Well, you know, that's an easy one for me to pick on today because a friend of mine has a great thread going on LinkedIn where his research site received a fax message with a very strangely worded invitation to participate in a research study. And, you know, he's looking at this and sharing it on LinkedIn with the heading of the company that sent me this, raised hundreds of millions of dollars at a multibillion-dollar valuation, and I got a fax today with this invitation. And I get it, like, well, clearly the company knew you had a fax, right? You must have promoted or advertised your fax number. I mean, they didn't just randomly find you via fax, but maybe they did, so it is fascinating. I mean, fortunately, the fax machine is not quite as popular as it once was. I mean, I remember when I was in graduate school, we used a platform called Data Fax, and that was like how we were scanning in our case report forms. We were so proud of ourselves at the time, right? That sites could handwrite their case report forms, put them on the fax machine, and we had an automated platform on the other end to consume those electronically. Obviously, I like to think we've come a long way. Maybe, maybe not, there are still plenty of places, though, that still use some very legacy approaches. I think one of the areas that's been really hard for us to digitize has been the consent, the electronic consent. In some places. Maybe it's because of signature issues in certain countries. In truth, though, I believe that one of the reasons why it took so long for us to digitize consent is there is no budget in a study, a clinical trial budget for informed consent. It is a piece of paper that you download from SharePoint, you modify a template in Word, and you email it off, and that's your budget for consent, $0. And when somebody would come along with a cool technology and say, Well, wait a minute, I can do this electronically, they say, well, does it cost more than zero? Because that's what I paid for today. And so it was all just viewed as incrementally more spend that wasn't in their study budgets, even though by digitizing and making this a digital process, we would reduce protocol deviations, we would reduce other types of monitoring findings associated with having people signing the wrong version or dates that might have been missing. All sorts of reasons why consent actually cost more than $0 when it's done on paper, but in the minds of people up front making decisions, it just looked like extra spend.
Emmanuel Fombu:
But you know, it was interesting about the consent piece. It is basically a consent that a patient says, I want to participate in the study or I understand what happened. So I, this happens all day. If you open a bank account, you apply for a credit card or line, and you can get a consent online and sign it and open an account. You can do consent, we do consent all the time electronically. But what is so different in the clinical trial space that becomes like another additional burden? It's just, it's a paper piece they automate and giving you a signature. We have Adobe, we have DocuSign, we have all these different things that exist today that we use on a daily basis. But why is so difficult in the clinical trial space?
Craig Lipset:
Well, I guess the one thing I would hope will be different here is we really do want somebody to be informed, you know, and the difference there is we click accept constantly in the course of our day, whether we're accepting a cookie and a browser or whether we're accepting the terms and conditions in order to download that software update or whatever it is, and God knows what you're giving away. I mean, more than God knows, right? We all know what we're giving away. We're giving away our data. We're giving away all sorts of information about ourselves with every one of those clicks. But the informed consent for research participation, there are risks that we need people to be aware of. In fact, if we have poorly consented people up front, we're going to lose them during the trial. They're going to drop out because they were not properly aware of what the study was really involving. Now, that's a great argument for moving from legalese language with a piece of paper on a clipboard under the pressure of doing this in the doctor's office and shifting to something electronic, using multimedia, using better ways to administer consent. Because an electronic consent has shown that we can improve knowledge retention over time among patients that go through that process. So to, back to your point, why is it so hard then, right when we're, clearly we've made this work in the financial sector and other highly regulated industries, why is this so hard? I think part of why it's so hard for us is, you know, there's two frames of reference for clinical trials. There's the view of, well, actually, I'd say there are three. There's the unit view of the research sponsor and CRO, and they're looking down on the perch at one protocol and they want all the systems to be controlled and predictable in data flow and their protocol. And then orthogonal to that, you have the research site and they're working on multiple protocols, they have their own systems and their own needs. And then you have the patient, they're just in one study, ideally should be in just one study at a time, their unit is just this one cell. And so you have this complicated matrix, right, where we're trying to push down study technologies at a site, at a study protocol level, and at the same time, the site is looking and saying, Oh my God, how many of these things are you going to shove at me for every protocol that I'm working on today?
Emmanuel Fombu:
Correct, and you just highlighted something that I didn't think about before, it comes, it's beyond just the idea of someone signing off. It's that opportunity to educate that patient, to make them understand what they're actually participating in, and it's not just a legal thing to sign up and go, You're taking something that you might put in your body that might affect you, right? And so the more people understand the likelihood they don't drop out of a study. So it's a great opportunity to educate as well.
Craig Lipset:
My friends out there that focus on this would be pinging me on LinkedIn if I don't say that clinical trial is a process, it is not a document or a signature. It is the process of making sure that the person is well-informed.
Emmanuel Fombu:
Correct, and so that's the reason why I think e-consents are important, and I think that's something that should be highlighted. It's not just, but I think people up front when the budget for the studies, the reason why they ignore e-consent because everyone thinks it's just oh, sign off, right? Because the mentality of people that they don't think that far in right, they don't think about retention and studies.
Craig Lipset:
They don't think, they think my study is going to be different. Why would I expect to have errors that need remediation? But when you talk to leaders in ClinOps, leaders in DevOps, all they need is that one study that was delayed at the back end and had all that extra cost associated with remediation efforts often attributed to simple things, signatures, dates, and versions on my consent, all of which I can make better controlled, better predictable, more transparent if I do this electronically upfront. When compared to the cost of remediation at the end of a study, e-consent is a bargain. It doesn't mean that our economic models for e-consent today are perfect. Very often it can still be pretty expensive on a study-by-study basis, but as larger organizations start to figure out how to do this at enterprise scale, the economics become much more manageable.
Emmanuel Fombu:
Excellent, and I don't think it'd be fair to end the conversation without talking about DTRA. I'm actually very proud of you and Amir and see what you guys have done in a short amount of time, right? So tell me more about DTRA, because in the last several years, I just started this, but it's a massive organization now. Everyone talks about DTRA now and you have an event you host every Friday as well, right? The TGIF is a cool name, I wish I stole that name from you before. So tell us about these cool things that you're working on.
Craig Lipset:
Manny, I'm happy to share. So Amir and I started to conspire on this need of a sustaining place for the challenges of decentralized research to be addressed together. We found that really smart and interesting people were gathering at conferences with a regular frequency, and we would do this at the CNS summit and at other venues, and we'd have great and interesting conversations, and very often we'd say, Wow, these are some things we could work on together, and then we'd all go our separate ways and reconvene in six, nine, twelve months at the next panel. And so that started to give rise to this belief that we needed a space for us to work together to address these challenges. And we started to scope that out prior to the pandemic. Certainly, when the lockdowns in the spring of 2020 started to hit, everybody became heads down internally, focused on, how do I sustain my protocol, my portfolio right now? But by the end of 2020, people had their house a little more under control and we were able to bring DTRA back to life. DTRA, the Decentralized Trials Research Alliance is a global nonprofit collaboration exclusively focused on supporting the adoption of decentralized research methods in interventional and in observational research. Our membership today comprises about 130 different organizations from your top pharma and biotech, your CROs, both the very large global incumbents and many of the mid-sized leading zeros, technology companies from as large as Microsoft and Amazon straight through to the clinical trial-focused leaders like Medidata and Vivan Oracle, straight through to your growth companies in this space like Science 37, Metabolic and so many others. We have site networks, we have government agencies like the VA, the FDA, all the ways trade through to the Ministry of Health in Israel, right? So from large to small, it's a very diverse ecosystem, including, I have to say, advocacy groups there as well. With those 130 members, we have a leadership council comprising those leaders, and I'm very happy, Manny, that I just learned this week that we will be welcoming you to that leadership council with your leadership position at Alira Health, one of our member organizations, so I am thrilled to be able to see you there, Manny.
Emmanuel Fombu:
I'm thrilled as well, and I think it's something that was needed. And I also like how you've leveraged this on LinkedIn as well. So you have a show, every discussion group, every Friday.
Craig Lipset:
We have a live event every Friday afternoon we used to do on Clubhouse, now we're trying it out on LinkedIn Live Audio, see how that works for folks every Friday, 12 to 1. We also have our annual meeting for DTRA taking place in November that people can learn more about at DTRA.org, and finally, also at DTRA.org, you'll learn about the work of our initiatives in the organization defined and led by our members. The very first initiative readout will be taking place this coming week, probably already happened right around the time this podcast drops. So be sure to follow DTRA on LinkedIn, on Twitter for updates, or check out the website to see more about this first initiative that is reading out and providing a deliverable for our community.
Emmanuel Fombu:
Thanks, thanks a lot, Craig. It was an honor and pleasure having you. I'm sure this is like the first time, this is not the last time that we are going to be having a chat on this. There's many topics and different directions we could go in, and I'm looking forward to working with your leadership council, DTRA, and you're doing a fantastic job and I believe strongly that together we could make the future healthcare reality. And so thanks a lot, but before I let you go, I would like you to recommend two people that you think we should talk to. What I'm trying to do with this podcast is to create a community and a movement that will support each other, and for those that believe in the movement of, to Bite the Orange to transform healthcare. And so I focus specifically on inviting guests recommended by other guests, right?
Craig Lipset:
All right, then. So first off, Manny, thank you for all that you're doing, both to bring great vision to this field, but also to keep these dialogues going and help continue to escalate great conversations and share them so broadly. Now, for two other folks to bring on to your program, I'm going to suggest first a gentleman named Brad Hightower. Brad is an investigator with very strong opinions, great to follow on LinkedIn, has his own podcast Note to File, but a very provocative voice in the field from a research side perspective. I think a second fabulous voice for you might be Jen Horonjeff from Savvy Co-op. Jen, also based here in New York, is the founder and CEO of Savvy, which is interesting because it's not only a public benefit corporation, it is a patient-owned cooperative, providing insights for all sorts of different organizations that want the patient voice and patient perspective.
Emmanuel Fombu:
Perfect, I know there's a lot more on that list. I just ask for two-piece and I'm sure those two recommend another two and it's all circle and community. So thanks a lot, Craig. It was great having you, and everyone, I'll have the contact info below the podcast with the show notes, and so you can always reach out. But like I said, it's not the first, it's the first, but not the last conversation we're going to have with Craig. So thanks a lot, Craig, and good luck with your show later today. I'll be there as well.
Craig Lipset:
Thanks, Manny. Talk to you soon.
Emmanuel Fombu:
... Take Care.
Emmanuel Fombu:
Thank you for listening to Bite the Orange. If you want to change healthcare with us, please contact us at info@emmanuelfombu.com, or you can visit us at EmmanuelFombu.com or BiteTheOrange.com. If you like this episode and want more information about us, you can also visit us at EmmanuelFombu.com.
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About CRAIG LIPSET:
Craig Lipset (he/him/his) leads at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Craig designed and launched multiple industry firsts -- from the first fully remote/virtual clinical trial for a new medicine to the first return of results and data to research participants.
He currently serves on the Board of Directors for the Decentralized Trials & Research Alliance (Co-Chair), Foundation for Sarcoidosis Research, and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.
Craig has received the red jacket 'hall of fame' recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List, and the AlleyWatch Who's Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.
Things You’ll Learn:
You can take recent innovative science and blend it with tech to impact the drug development spend and cycle time.
Pulmonary sarcoidosis is an immune-mediated inflammatory condition that mainly affects the lungs with granulomatous-induced inflammation, often leaving behind scarring and reduced pulmonary function.
Sarcoidosis disproportionately affects black women.
In the clinical trial space, digital consent has been hard to adopt as a printed informed consent costs almost $0.
Digitizing this process can reduce protocol deviations, and is not very expensive if done at an enterprise scale.
The DTRA, the Decentralized Trials Research Alliance, is a global nonprofit collaboration exclusively focused on supporting the adoption of decentralized research methods in interventional and observational research.
You can watch a weekly live event on the DTRA LinkedIn profile to learn more about their initiatives and updates on the work they are doing.