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Controlling Your Health Data, Finding Cures Together
Episode

Craig Lipset, Advisor and Founder at Clinical Innovation Partners

Controlling Your Health Data, Finding Cures Together

In this episode, we are privileged to host a recognized leader in innovation, clinical research, and medicine development. Craig Lipset is the Advisor and Founder at Clinical Innovation Partners and in this interview, he discusses how he looks for opportunities beyond the four walls of the office and how he helps teams and individuals challenge their strategies. He shares his insights on how to be unique as an organization, merging both data and patient-centricity to support research and transformation, decentralized trials, advantages of creating a master protocol, creating a digital twin, and more. This is a stimulating conversation you’ll truly enjoy, so tune in!

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Controlling Your Health Data, Finding Cures Together

About Craig Lipset

Craig 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. He was the head of Clinical Innovation and Venture Partner at Pfizer, on the Founding Operations Committee for Transliterate Biopharma and Founding Management Teams for two successful startup ventures, – Perceptive Informatics and AppNexus Therapeutics. He is a thought leader, advocate, educator, speaker, mentor, and innovator. 

Controlling Your Health Data, Finding Cures Together with Craig Lipset, Advisor and Founder at Clinical Innovation Partners: Audio automatically transcribed by Sonix

Controlling Your Health Data, Finding Cures Together with Craig Lipset, Advisor and Founder at Clinical Innovation Partners: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

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Saul Marquez:
Hey everyone, Saul Marquez here, and welcome back to the Outcomes Rockets. Today, I have the privilege of hosting Craig Lipset on the podcast. Craig is a recognized leader at the forefront of innovation and clinical research and medicine development. He’s 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 Transliterate Biopharma and Founding Management Teams for two successful startup ventures, Perceptive Informatics and AppNexus Therapeutics. During that time, Craig design and launched multiple industry firsts from the first fully remote virtual clinical trial for a new medicine to the first returning of results and data to research participants. So he is a forward thinker and really a thought leader in health care. And so I’m just really privileged to have him be with us today. Craig, I’m excited for our conversation today.

Craig Lipset:
Saul, I am psyched to be here. And I am sorry I gave so many polysyllabic words. I got to make that more simple and thanks for having me. It’s great to be here.

Saul Marquez:
Oh, my gosh. Yeah. It’s a pleasure to have you here. And so, you know, you’ve done some really cool work and really kind of broad verticals within health care, which is what I really love about your experience. And so talk to us before we dive into the specifics. Talk to us about what inspires your work in health care.

Craig Lipset:
Saul the easy answer, of course, is to say, patients. I get inspired by patients and I do engage with communities of patients, if not every day than multiple times a week. But honestly, the rocket fuel for me is around getting new cures and treatment options. I love to fix things. And there are so many things left to be fixed here. But I think over the last two years, I’ve also found incredible inspiration through strangers that I connect with on social media in a positive way. And so it’s those occasional direct messages or messages through LinkedIn that drop into my inbox from people I don’t know that are sharing a story or sharing something they’re doing that just fires me up. It’s completely inspired.

Saul Marquez:
And you’ve really spent a good amount of time in the innovation space and, you know, thinking creatively. And a lot of that comes from that cross-pollination of meeting these people that you’ve never even met before and having those conversations that potentially you never would have had. And so talk to us a little bit about what you do and sort of what’s at the center of how it adds value to the health care ecosystem.

Craig Lipset:
When I used to be at Pfizer, I used to live this life of one foot in and one foot out. One foot in to make sure I knew where the challenges were and what was keeping people awake at night. But to your point, that one foot out so that I always had that engagement outside of the company, outside of their four walls, looking for those different opportunities and looking is more than just going on Google or even just going to a conference. It’s talking to people and being able to hear their ideas and hear their inspiration in this. For me today, where I add value is largely in helping smart people to go faster and farther. I work with teams and help them tune and challenge their strategies. And quite honestly, I, I take that inspiration seriously. Like this adding of value to the work that others are doing is great, but adding value to the work that strangers are doing, being able to take advantage of different social platforms and get information democratized and into the hands of anybody who’s interested in listening. I think to me is like this indirect value stream that anybody can contribute to. I think it’s probably one of the most exciting opportunities that have been unleashed in recent years is looking at social beyond the noise of the social dilemma. And it’s interesting how with all the angst of social media today you don’t see angst about LinkedIn. It’s kind of been able to remain able to deliver again its promise.

Saul Marquez:
Yeah, that’s a really interesting point. And, you know, these inputs matter. And so how do you decide, you know, where you get your I guess your input from is your focus. So, for example, medicine, innovation. I mean, you spent a lot of time doing that and you still spend a lot of time doing that. You know, how do you put together a plan to actually bring some of the ideas forward that that could be valuable to your team?

Craig Lipset:
It’s a great question. Right. And so where do these inputs come from? From for people? I certainly spend and I’ve always thrived on spending so much of my time just consuming whatever information and streams I could that I trusted in, some of them might hit my inbox and they could hit anyone’s inbox through different trusted streams. But I think it’s so important that we all need to get out of these out of our echo chambers and look for those streams from adjacent areas, whether it’s trends that are happening in clinical research or looking more broadly at trends in health care or looking even more broadly than that at just the trends in our everyday world as great opportunities and signals. I’ll give an example of what I mean there. Right now, there’s so much energy and passion around decentralized trials, shifting location, and people ask me all the time, well, where is this field headed? What’s kind of the future direction? But my feeling is we all see that future direction right now in our everyday lives. Everything we’re doing right now is hybrid. It’s how our kids are going to school.

Craig Lipset:
It’s how we’re taking business meetings. It’s how we’re going grocery shopping. And so take that inspiration from what we’re seeing every day around us because the people participating in our trials are not subjects the way we’ve thought of them for years. They’re our neighbors. They are family. They’re our friends. It’s the same. They’re us. And so their expectations and experiences aren’t substantially different from all of ours. In all of us are expecting more flexibility in how we engage in the world going forward. I want to go back to an office someday. I want to go regularly back to the supermarket. But some of the digital and virtual options that have emerged are good. And we all want to find the balance that’s right for us at that level of choice and optionality. And so my takeaway there is looking for these signals of the future, looking for these trends not just in crazy corners of the world or having to hide out in the lobby of MIT or Stanford trying to listen to a conversation. But because these signals in our everyday lives.

Saul Marquez:
Yeah, you know, that’s well said. That’s well said. And I do think about this. This everything is hybrid now idea and you’re spot on. And why wouldn’t we let our day-to-day infuse what we’re doing in our innovation practices, whether it be pharma, med device, or health I.T.? It’s certainly a great idea to help get our inspiration going from day to day because it’s there. You just have to open up your eyes.

Craig Lipset:
You know, when I was working on projects at Pfizer, like the remote trial or some of our other initiatives, I took inspiration from my own journey as a patient. And I had been traveling a journey as a patient with a rare pulmonary condition for a few years before then. But we all have journeys as patients or as caregivers. Most of us were born in a hospital and will probably die in one and will be a patient multiple times in between and certainly caregivers as well. And so how do we better draw on those experiences? Whether it’s our experiences as consumers in the everyday world or it’s the experiences we all share as patients at various points in our lives?

Saul Marquez:
Yeah, Craig, one of the things that I totally agree, you know, we always want to get to different or unique. And that’s one of the questions we ask here. And so as a thought leader in the space, you know, I’ll ask it this way. What is it that folks, I guess what’s the best way to approach whether it be their business model or a process like so that you’re not just different for different sake, but you’re different in a valuable way? Talk to us about that and your approach there.

Craig Lipset:
Large complex organizations increasingly have teams that are focused on looking for that, for that next great thing. They don’t want to miss out on some opportunity out there and they want to be first or near first or towards the front of the line at the very least. But that importance in staying grounded and where there are true research in our case, research challenges or whatever that organization is, that we’re staying rooted to address those actual challenges. And this is such a hard challenge organizationally for many. If I have my business owners who are the closest to the challenges, if they have to own innovation in that space, it’s hard for them. It’s hard for them to see big and expansive and to look beyond our walls. But if I lean too hard the other way and I have ring-fenced, isolated innovation teams that can run off and do whatever they want, well, they’re not necessarily connected back to the business. They’re not necessarily going to bring back the confidence that they’re really solving a specific challenge or just making change happen for the sake of change. So I think for many organizations, it’s this careful balance, this dance between staying close in the line to business challenges while also being able to be expansive and to look beyond. And I think that’s really hard for individuals.

Saul Marquez:
Also, it really is it’s a challenge, and I know you’ve done kind of the Pfizer leader role and you’ve done work outside as an individual influencer. And so it’s great to hear your feedback there and what a lot of us could be doing in the realm of thinking outside of the box while keeping that business running because both of them are really important. And so, Craig, as you think about all the work that you do across the different hats that you wear, you know, your adviser and founder at Clinical Innovation Partners, you’re the co-chair at Decentralized Trials and Research Alliance. And on top of that, you’re a professor of Health Informatics. You wear a lot of hats. And so what’s exciting for you? What do you think? There’s something that we should be thinking about today that maybe we’re not.

Craig Lipset:
I think that today there are two really exciting trends. We see a lot in conferences and articles and even in the priorities for many life sciences companies. Certainly a tremendous enthusiasm around patient-centricity and a tremendous enthusiasm around data science and real-world data. And I think that we run the risk right now of these two worlds pulling in opposite directions. As we’re excited about using people’s data, are we doing that in a way that’s inclusive and transparent and clear to the individuals whose data we’re making use of? And so one of the great opportunities in front of us right now is for people to seize that and to pull these two threads back together. How do we empower people with access to their own personal data and give them the tools not only to access their data but the tools to share their data and trusted ways in transparent ways to support research? Nine out of 10 people when surveyed are willing to share their data to support research. And we see that numbers stand up, whether it’s the highly engaged communities of patients like me or the everyday patients that the Makowski group surveys, or the patients with children with serious conditions at Boston Children’s Hospital. I think this opportunity to advocate for and advance solutions for patients, for data-enabled and given that trusted tool and that trusted environment to share their data, to support research, is going to be transformational and it’s going to pull these two trends around patient-centricity and data science is back together.

Saul Marquez:
That’s really interesting. And so as it relates to trials then, Craig, I mean, what’s something that you’re seeing that is promising for the future? What are you excited about there?

Craig Lipset:
Well, certainly there’s incredible adoption happening right now over the last year to solutions that were needed for trial continuity, shifting how we think about monitoring for studies, shifting location, using digital tools, new processes. None of that had to be invented in the year 2020. It all existed before. It just hadn’t been embraced. It was looked at as risky rather than what it is today, a risk mitigation strategy in an unpredictable environment. And so the exciting thing today right now has been to watch organizations consume these opportunities, embrace them and commit in terms of adoption. But we have to have something beyond this horizon. I can’t sit here and say, Saul, the future is telemedicine and clinical trials. That’s not the future. That was our past. That was our future. Now it’s our present. That was a very bad time travel statement, but I think your audience hopefully followed that to me. Where the future is going is we’ve seen the opportunities with master protocols, we’ve seen the opportunities for coordination and how we do research. In fact, recently Janet Woodcock from the FDA spoke on this point when reflecting on where did the learnings come from during the pandemic, during COVID around the therapeutics that we were looking at? Well, in the US, we had a thousand flowers blooming where every investigator wanted to run their own COVID trial. All of them were underpowered and most of them yield very little learning. Whereas in Europe you had these coordinated Mastrov protocols and some of this was already planned for the World Health Organization had a pandemic master of protocol ready to go. If your audience isn’t familiar with a master protocol, instead of having an individual study written created, databases pulled together, site networks pulled together just to look at one drug for one medical condition, a master protocol creates shared sustaining infrastructure.

Craig Lipset:
It lets us test multiple drugs under one protocol framework, one network of sites, one protocol, one data management plan. And when we operate that way, just radically better efficiency and the opportunity to help patients get randomized to the arm, that makes the most sense for them. I’ll give one example. Where this thinking could have helped us last year, we were all anxiously watching these first two vaccine trials from Pfizer and Moderna, and the two protocols are nearly identical. They’re written for the same population. They’re looking at the same endpoints. They started within a couple of weeks of each other and they ended within a couple of weeks of each other. And both of them had patients being randomized one to one to either get the vaccine or to be in a control arm with a placebo. Each of these studies enrolled 20000 some odd people in the US alone just to receive a control arm rather than envisioning what a master protocol could look like, where two vaccines can be tested and have one control arm and a more coordinated way, it makes sense. It just takes some planning and some coordination and is willing to collaborate. But we’re seeing it. We see it in oncology right now. We see it in breast cancer research. We see it in lung cancer research. And I think we’re going to see much more of this in other disease areas.

Saul Marquez:
Yeah, it is exciting. And, you know, I actually I had an interview call it a month ago where a gentleman from Metadata was on and they have their arm. It’s called ACORN. And he was talking to us about how for the control placebo arm they successfully ran with a data set. So there weren’t even patients. It was a data set and they were able to get two FDA approvals off of this data set. That’s unbelievable. I mean, like, I was just floored when I heard about that. And now you’re, again, talking about hybrids, right? Because that’s not going to be the lane that everybody travels down. It might have its applications. So now what you’re offering is exciting, too, because with this master protocol is what you call that, right? That’s right. You’re able to why didn’t that happen between Pfizer and Madrona? You know, I didn’t even think about it, but I don’t.

Craig Lipset:
Look, sometimes these things take a little more time upfront for planning, but maybe it moves the finish line closer on the other side. But it’s hard to see that right. If there’s a little bit more time that’s needed upfront for the first patient. That’s a hard sell inside of a lot of organizations. But this shift around the control arm, I really think that over the next three to five years, the number of studies that are randomizing one to one and an active to have control is just going to become a legacy. You mentioned control term alternatives. And today, so actually some of the control arm alternatives date back to translocate and some work that actually even the team at Pfizer had done around just using the control arm patients from one sponsor study. And so if one sponsor has created a control arm and these are the patients that didn’t receive any intervention from Pfizer or somebody else, can that data be reused for someone else to study? And so you saw that with Trancelerate and you saw that with the meditators core platform. And then you started to see with the availability of real-world data, how might we create new control arms using electronic health record data for patients? It’s great. It’s more contemporary than a control arm. It’s not quite as structured and clean, but it has its advantages. And now we’re even starting to see this third generation. Well, there’s sort of a two-way generation, which is can I engage with patient communities and invite patients to share their real-world data to create control arms? The advantage there is, instead of using just aggregated to identify data if I’m going through a person with their permission, I can get a biospecimen, I can get PROs, I can get other data that maybe I couldn’t get if this was just pulling from an aggregated data set.

Craig Lipset:
But I think the last crunch that we’re seeing now is this notion of digital twins. And can we take the patients in our active arm and create a digital twin for each one of them with your digital twin will be your own control in the trial. And this idea of digital twins wasn’t invented by pharma. It’s been used for years in aeronautics, in the automotive industry. You take an engine and you use enough sensors on it so you can create a digital version of it, that you can monitor everything about it as if that engine was in front of you. And now we’re the engines with enough sensors and data around us that you can construct a digital version of me and have that digital version of maybe the control arm and let me get the intervention. So there are really some amazing opportunities right now that are emerging to really start to mark the end of at least one to one randomization. We may need some randomization to address bias, but do we need it to be one-to-one going forward?

Saul Marquez:
That’s really fascinating. The digital twin idea, and then there are the organs on a chip, right? I mean, that’s a whole other thing, like is that a form of a digital twin of the organ?

Craig Lipset:
In some ways it is. And you know, the things you’re describing Saul are Why words matter because I was talking earlier about decentralized trials and sometimes we’ll see in jargon and headlines virtual trials into the FDA, to many regulators, the term virtual trials in their mind means a study that doesn’t have people being enrolled in both treatment arms. The things that you’re talking about here, whether it controls arm alternatives or organs on a chip, are virtualizing a lot of the research study experience. And, you know, we need to make sure we have the right words for these verses. And that’s why I use this long term of decentralized versus something that’s more catchy, like virtual because virtual means something else and its own, like a pool of awesome new solutions getting created.

Saul Marquez:
That’s fascinating. Wow. Well, this is exciting stuff, Craig. I mean, just to think about where we’re going and despite all the challenges that COVID has given us, the leaps that we’ve made in this very short time, the willingness of regulators and companies to try new things, it’s certainly exciting. So we appreciate the insights that you’ve shared today. You know, as you think about where really kind of what we should be thinking about. Give us a closing thought. What should we be thinking about here? And then the best place where people could get in touch with you if they want to continue the conversation.

Craig Lipset:
A year ago, the industry’s reputation was about as low as it had ever been in terms of the public perception and trust of pharmaceutical companies and in pharmaceutical research. And yet here we are in February of 2021 right now is we’re having this conversation and it is over double in some of the published reports in terms of public sentiment that is favorable towards pharma today. There’s an incredible opportunity here, and there’s an incredibly easy path to slipping backward. The opportunity for us is around transparency to maintain trust. And so I was setting this up a little bit before, as we’re talking about how we use people’s data. There is a huge amount of angst in the community, especially among the younger generation, about how their data is used or misused. They’re smart, they’re savvy, they’re aware, and they know when their data is being taken from them and used in a certain way that is inconsistent with their wishes and they will reject that. And so when we’re doing work for good, that’s positive. Using people’s data, we should celebrate it. We should be fully transparent and make people as aware as they want to be because it’s good. And if we’re using people’s data in a way that we don’t think we should be transparent, that we should stop using their data in that way, it’s a great litmus test for all of us to make sure that we’re doing right with people’s data. And if we aren’t willing to be transparent, then we shouldn’t be touching it. I think to me, this is one of the great crossroads for our ecosystem, for our industry right now. It’s the way that we will continue to try to earn the trust that has been restored over this pandemic. Stay in touch with me. I am on LinkedIn and Twitter mostly. And Saul now it is hovering around Clubhouse. But I’m on LinkedIn and Twitter. It’s just my name, Craig Lipset. It’s the same on one clubhouse if you’re also experimenting there.

Saul Marquez:
Love, Craig. Hey, this is great. You’re always staying on top of the new stuff, so I appreciate you sharing those.

Craig Lipset:
Saul, I didn’t say you’re going to find me on TikTok. It’s a private account.

Saul Marquez:
This has been fun. I certainly appreciate the insights you’ve shared and the conversations have been stimulating and a lot of fun. And I’m sure it’s been the same for the listener. So thanks again for spending time with us.

Craig Lipset:
Thanks for sharing stories here. Thanks, Saul.

Saul Marquez:
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Things You’ll Learn

  • Looking is more than just going on Google or even just going to a conference. It’s talking to people and being able to hear their ideas and hear their inspiration.
  • Get out of these out of our echo chambers and look for those streams from adjacent areas, whether it’s trends that are happening in clinical research or looking more broadly at trends in health care or looking even more broadly than that at just the trends in our everyday world as great opportunities and signals.
  • Instead of having an individual study written created, databases pulled together, site networks pulled together just to look at one drug for one medical condition, a master protocol creates shared sustaining infrastructure.
  • The opportunity for us is around transparency to maintain trust.
  • There is a huge amount of angst in the community, especially among the younger generation, about how their data is used or misused. We should be fully transparent and make people as aware as they want to be. And if we’re using people’s data in a way that we don’t think we should be transparent, that we should stop using their data in that way.

 

Resources

Email: craig@lipset.com

LinkedIn https://www.linkedin.com/in/lipset/

Twitter: @CraigLipset

LinkedIn: https://www.linkedin.com/company/clinicalinnovation/