The Missing Voice in AI Drug Development

In this episode of SCRS Talks, Jimmy Bechtel sits down with Donna Cryer, Chief Patient Officer at Cryer Health and active FDA patient advocate, to explore the critical difference between patient inclusion and patient leadership in drug development. Drawing on her own lifelong experience as a patient, Donna makes the case for why having patients in real positions of authority is not just a values statement but a strategic necessity, especially as AI becomes more embedded in every stage of the research process. From AI governance and model training to the risks of replacing human experience with simulated data, this conversation challenges the industry to stop treating patients as an afterthought and start building their perspectives into the foundation of how research gets done. 

Transcript

Jimmy Bechtel 0:00

Hello and welcome to SCRS Talks, provided by the Society for Clinical Research Sites. I'm Jimmy Bechtel, the chief site success officer with the Society, and today I'm joined by Donna Cryer. Donna is the chief patient officer with Cryer Health and an active FDA patient advocate here to give the patient perspective and insight into how artificial intelligence is being embedded into drug development, and how we need to make sure that we're considering patients along their journey as we do this. Donna, it's excellent to have you, and I'm really excited to get a- a patient perspective and a patient advocacy perspective in this very current and important topic. And before we jump into the conversation, I'd love for the audience to learn a little bit more about you.

Donna Cryer 0:45

Thank you so much for this opportunity. I really appreciate, to be here today and be talking with this audience in particular because if w- you know, if we don't have great clinical research, we won't have the treatments of tomorrow. And I am a person who was diagnosed at age 13 with inflammatory bowel disease, which developed into, an autoimmune liver disease that necessitated a transplant in my 20s. And just to keep things, updated and current, I've ventured into orthopedics in my more recent years. And so, really innovation, is not something that is theoretical or hypothetical to me. It is something that keeps me alive, keeps me functioning, enables me to advocate for others. And so making sure that, innovation in research are embedded with real people's experiences, the realities of conducting research with real people in real communities so that we come out with things that actually, you know, work for people and solve problems that matter is just such a passion for me

Jimmy Bechtel 2:00

That's amazing, Donna. Thank you, of course, for your contributions to, the work that we all do. It's, it's a noble cause, it's a challenging cause. so again, thank you for doing that. But I, I wanna talk about, something that I know you're, we'll say, passionate about, and that is drawing this clear line or distinction between patient inclusion and patient leadership. So can you talk to us about what that distinction looks a little bit like in practice, and where are some areas you see the industry really confusing those two terms?

Donna Cryer 2:32

So patient inclusion often looks like a clinical trial program and- materials and protocol that are all baked and developed, and then you sort of hand a brochure to patients or a patient advocacy organization to recruit for this trial. and so when patients look at this and say, "Well, most of our patient population doesn't actually qualify for this trial the way it's constructed. Look at these exclusion criteria." And they're like, "Well, there's nothing we can do. We're all the way, you know, down the line. It's sort of a take it or leave it." You know, that was the situation that we were too often facing years ago, and still, and still do. Patient leadership can come in several forms. for one, it can come as a boundary. when I was CEO of the Global Liver Institute, a patient advocacy organization that I founded in the hepatology space, it came to a point where I realized that I was going to have to do something different in my leadership and simply say that we would not promote or recruit for any trials that did not demonstrate that they had patients involved in meaningful ways earlier in the trial. And that could have been in helping to write the protocol. It could have been in helping to select and support the sites so that they would be in communities. It could have been in a variety of ways. So it wasn't, Something overly restrictive. It was something that was very achievable, for any company of goodwill and true intentions. And so that was helpful and that clarity was helpful to us certainly as an organization from just a go, no-go, standpoint, but it was also helpful, we later heard, to the champions for patient engagement and con- inclusion inside companies. they could point to us as the bad guys, saying, "Well, we, you know, it's not us pushing for this impossible thing. the patient advocacy organization said that this has to happen." And I, and I think that is a form of leadership. You know, Kathy Giusti, is a hero of mine for having come from her pharma background, of course, her business background, and then her patient experience and saying, "I'm literally going to create the new table and the new rules, and we're going to insist that if you want to work on the research that we're funding, you have to work in consortia. You have to share data." That there were new rules that were set by patients, on how research would be conducted. And, and so I think along that spectrum, from something as simple as a boundary to as complex as bringing the money and setting the table and setting the rules and creating the whole ecosystem around research in a particular space, Those are examples of what leadership can look like.

Jimmy Bechtel 5:42

Those are great examples, Donna. It's kind of this, boiling it down or maybe grossly oversimplifying it. It's really this concept of being reactive versus proactive, right? Inclusion is kind of the reactive, you know, we need to do this, we need to do that, we involve patients as an afterthought, or we enroll them in the trial after all the major impactful decisions have already been made. But what I heard you talk about, leadership really is involving them from the beginning or making sure that, they're included in some of that decision-making proc- pro- processes as well as pounding that drum, right, from the patient perspective and making sure you're not backing down or, or, not, really being part of those critical, junctures along the cl- the trial or m- medicine development, planning process.

Donna Cryer 6:34

You know, it's the difference between tokenism and- really building it into the operations of an organization. And that's when I saw a shift when companies would, report back that they had made the decision that within their organizations, a protocol could only go so far before it hit a point where it had to show how patients had been included, how patient input and insights had made changes in the work. otherwise it couldn't go forward. And if it, you know, so if they hadn't done that work, they would have to go back, work with patients. and I think that one of the most profound, definitions of, of patient engagement that I've ever heard, was it's not, or it is patient engagement if something's changed. and the inverse is it's not patient engagement if nothing has changed. I think that is the point when it comes into part of your business operations for how the trial is conducted and it can't go any further and people's, bonuses and, performance plans are all built around, how patients have been, embedded, into the work. That's when it's real

Jimmy Bechtel 7:44

It's excellent, Donna. And I know that AI is already making consequential, decisions, or it's already a becoming a major part of drug development. So can you walk us through, from your perspective, where that's happening today, and what the absence of patient input costs in terms of what, again, these decision-makings are happening?

Donna Cryer 8:07

I think that there are both pros and cons to, how AI is being used today, and certainly how it can be used, tomorrow. So we've seen, incredible shakeups in, in the pharma biopharma space of AI there are a lot fewer people, who are in, involved, and that is, un- unsettling and disruptive in, in a way that we still don't know the effects of. The other, we'll see if it's a pro or con, is the pace of research. So we see it at various stages in early drug discovery, being able to, go through and model more quickly. I think that's positive. We've seen, imaging, a space that I have worked a lot in, in diagnostics and imaging, becoming so much, more efficient and more accurate, in a way that, when we look at, for example, AI assisted, histopathology or looking at slides from liver biopsies or other biological samples that patients give, that they're donating to the medical system and to the c- clinical trial enterprise. And, you know, we had a situation before where there was so much inter and intra variability in the readers of these samples that i- it was a, a why are you doing it? It was disrespectful. I felt it was dishonoring what patients were giving. And now we have, several companies in the space, like PathAI, which I've been an advisor to, and others who are really making those samples matter and improving both the, Reducing the number of people who need to be involved in looking at those samples, and so decreasing the time that we can use that valuable information in drug discovery, and validation of both diagnostic tools and of medications. So I think that's an enormous, positive and a pro. so there, the speed of drug discovery and the, ability to look at, at drugs and samples and biorepositories in new ways, with new eyes if you will, using AI, is amazing and a huge benefit to patients. the cons I see are when Companies want to say, "Well, now we don't have to talk to patients. Now we don't have to use real people. Now we can just, you know, scrape data or, create, you know, a quote, unquote model patient and, just, do all of this in some type of simulation." And that, it- it ignores the richness and diversity of people's experiences. certainly in our very fractured healthcare system in the US, and when you look globally, there are other types of fractures and fragmentations and gaps that emerge in the actual delivery of care that, no AI can tell you. And so there's a risk of failure. There's a risk of putting something into a regulator, and the regulators are using AI, increasingly. th- but there's a risk of providing something that only works in the minds of a model, that only works in a simulation, that only works in, some hygienically clean, hypothetical world that you created without the realities of what people and patients go through. And so, what I have been supporting and, leading is, more patients involved in AI governance, in the training of AI models, in the, testing of assumptions. the, contributions into, the databases so that the, rich conversations that patients may be having in their, online communities or in other ways that aren't, embedded in, guidelines or publications or the other sources that are traditionally, used to train AI models, that there is some data policies that allow for patients and patient communities to add that to what AI is being trained on so that it better reflects the patient experience. And so I think that work with patients in partnership, as AI develops, and I think that's the same for physicians and other providers that need to be, involved in AI development very closely so that it reflects, clinical and, life reality, are really important to having AI as a tool that we use that optimizes human potential, which is never more important than in health, versus something that we are, dependent on and that fails us in the end.

Jimmy Bechtel 13:03

I think you really summed it up perfectly there, Donna, right at the end, 'cause that was kind of the sentiment that I was growing as you were talking, is really finding that balance between, you know, making the patient's life easier and, you know, maybe we have a few less painful, biopsies that we need to do as a set of patients, yet not dehumanizing the clinical trial process. I wanna talk about, what it means to be a chief patient officer and the authority that exists around that and I guess the what kind of, what that really needs to look like, and I guess what decisions that person that has that seat at the table should be able to influence

Donna Cryer 13:41

I first wanna give a shout-out to all my, global heads of patient engagement and advocacy or, you know, US heads of patient policy and government affairs. There, there are, you know, loads of titles, they give to, very talented people who are doing a variety of work that may or may not touch patients within companies. Someone recounted just yesterday to me a meeting on, patient access, and, they were three-quarters through their day and someone said, they had never actually used the word patient. it was about the other stakeholders. It was about business. It was about finance. It was about the market, but never touched on patients. So the first thing is that, there is no room, there is no time, there is no circumstance or situation that someone with my lived experience, or as I imagine, any chief patient officer coming into a situation where we do not have patients top of mind, where we would not inject patients into the conversation, or even look in the lead-up to such an event asking, are patients going to be included, involved in this meeting?" And not just as a story inspiring at the top, but really for their insights and perspectives throughout. Have we done patient insights work that we're bringing into this as well as real people in the room? how are we pulling this through and testing it with patients, after this day? So I think that first and foremost, the chief patient officer always asks the question, "Is the patient in the room, and how are patients meaningfully included?" And the second thing, is the authority So I have been, a patient, as the, you know, sort of youngest person in the room and at the end of the table and maybe I got to ask one question. it may or may not have happened. it could be an, just an apocryphal tale that, the executive director at the top of the table, passed a note down. And then when I opened the note it was like, "Be quiet." I may have had that experience early in my career to now being, on boards of hospitals and, other organizations. having been, you know, my name as a principal investigator of $42 million of research grants for, for PCORnet, for the, Patient-Centered Outcome Research Network, which was nine academic networks and two payer networks. And so, the difference is- The authority. The difference is, same insight. I might have asked the same question or had the same thought. But the authority to make the room stop and at least listen to that thought, to consider that and perhaps even be the person who is like well, we're gonna do this anyways, after, you know, we've considered it and I've had, other input." And so being a part of the C-suite of where, the buck stops, of where the decisions, both early in companies about what we're gonna invest in, what our portfolio will look like, what it may continue to look like if there are crises or bumps in the road, determining priorities, determining people, determining, strategy, adding, landscape views, being able to s- you know, see around corners from this perspective that I have even, you know, as a busy professional, And, you know, that grounding is very different from anybody else in the room. I remember a panel when, we were talking about the timelines and the timeframes. This was an investors conference for, a particular, diagnostic, gold standard, and I was the only one who actually had, experienced that test. I was the only one who had had it, who had had to go through it, who understood the cost of it in a human sense, and the cost for the caregiver as well, and the real timelines and the real timeframes, and the real investment and the financial implications, not just on the healthcare system, but on lost productivity, on, job trajectory, on childcare costs and costs, for a host of different things that were involved, in the taking of that test as just one example. And those are things that- no one else can bring to the table, combined with, legal and business, acumen to, to provide, a company, with a different perspective from the chief medical officer, or the chief finance officer. And if the whole mission of the organization, if the whole purpose of an organization is supposed to be to make medicines for people, to not have a representative, of the people, at the highest level seems very short-sighted. And frankly, as a, former federal prosecutor, I was like, that seems risky to me. and so that's what a chief patient officer does really at the core. It ultimately de-risks the environment and the decision-making for the entire organization and provides, insights into, unlocked, value for Potential, for, medications and diagnostics and devices that, are often just missed opportunities, throughout healthcare. Uh, so that's what a chief patient officer would, would bring to the table and, and do differently.

Jimmy Bechtel 19:20

Thank you, Donna. There's a lot to unpack there. But I think, you really hit it when you talked about how important it is from a strategic, right, this kind of from the top-down perspective to bring that patient voice in so that it really is, ingrained in everything that flows down from those decisions is really the most powerful part of that and, and where that starts. So I appreciate, you know, the emphasis on that perspective. But for our pharma and biotech organizations that want to maybe move in the direction of responsible artificial intelligence governance, from your, again, your perspective, where might they start and what does that sort of, progress in that space really look like?

Donna Cryer 20:03

I think it's even more important in the age of AI because, AI requires, you know, boards and C-suites to have, discernment, to have judgment, to understand what is, reality, versus a hallucination. And so if you don't have someone who's living that reality, as part of that decision-making, you're going to make mistakes. that is why, as we rely more and more on AI, and I, I do, um, in both my, you know, sort of everyday, operations as well as in increasingly in, utilizing my health data. And every patient advocate that I know and work with is working with AI, creating their own AI tools, none of which right now are, connected or have visibility, into the biopharma enterprise. So we're already, missing the boat on that. Um, so I, I think moving forward, having, patient leaders in C-suite roles, is increasingly important in AI because of their connections to reality And, and the connections to community, and the ability to help make strategic decisions and investments that are based on real opportunities and not hallucinations is going to be ever more important, and we have to do it faster. patients make the most urgent, moment to moment, daily decisions about, their health. And so we are the ones with the greatest ability and the greatest, alignment with biopharma choosing the right questions to answer, answering them most efficiently, and coming out with solutions, better, stronger, faster, to draw from, Six Million Dollar Man, terms. And we have the technology. we can rebuild this, healthcare, research enterprise. and we must do so with patients at the table in real leadership positions.

Jimmy Bechtel 22:14

I could not agree more, Donna. Thank you, for really, capping us off with that sentiment. I think it's an excellent place for us to end our conversation here. So I wanna thank you, again, for your contributions and the contributions of those that you work with, in a patient advocacy capacity. and thank you, of course, for your time with us here today.

Donna Cryer 22:33

Thank you.

Jimmy Bechtel 22:34

And for those of you listening, make sure that you check out other site-focused resources, like the podcasts like these, as well as other opportunities to hear from patients, sites, and other partners on our website, myscrs.org. Don't forget to check out Cryor Health and, and maybe learn a little bit more about Donna and her story. but for those of you listening, thanks for tuning in, and until next time.