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Charles Ryan: Hello from the Milken Global Conference in 2021, we are here in Los Angeles. I'm delighted to be joined by Esther Krofah, who is the Executive Director of Faster Cures and the Center for Public Health at the Milken Institute, and she is based in Washington, DC. Thank you so much for joining me today, Esther. We have a lot that we could talk about. There's a lot going on, obviously in health right now that is important for our listeners. I want to talk, first of all, before we go anywhere, and hear about Faster Cures, the mission of Faster Cures, and your ongoing work.

Esther Krofah: Well, thank you so much for having me. It's a delight, I'm happy to talk about Faster Cures. As you know, it's been around for about 20 years, and it was created really across different disease conditions to bring together different stakeholders, to tackle huge problems. Many times in medical research, we have silos, the academic research institutions normally talk to themselves, the patient disease foundations, pharma companies, regulators, and the like. And so Faster Cures has been brought together so that all of these stakeholders can come together and talk about, what do we need to do to make biomedical research and innovation work faster and safely on behalf of patients. And that's what we do. We bring together all of these groups to tackle significant issues that are affecting the entire ecosystem and hope to identify solutions that we can implement going forward.

Charles Ryan: Is it mostly a policy advocacy function or a meeting function, sponsoring research function? Of all of those, sort of, how do you divide up the mission?

Esther Krofah: We do all of that. So maybe [inaudible] our website. We do a bit of all of that. We do research and publication, not necessarily bench research, of course, but mostly on policy issues. We work with policymakers directly, for example, 21st Century Cures. We worked very much behind the scenes helping to implement that piece of legislation. We also convene in small gatherings, but also in large ways. We found that the private conversation that's happening with multi-stakeholders, you are really able to get people to tell you the truth, for them to really identify what the issues and challenges are in a closed-door setting, where they know they're not necessarily going to be on the front page news, that allows us to get further progress. And of course, we have large meetings, large conferences because we want to elevate these issues on a national, on a public basis, so we do all of that.

Charles Ryan: Indeed Faster Cures is sort of the group organizing the health-related content here at Milken Global.

Esther Krofah: That's right. We've organized a lot of these sessions. Here we are, the fifth wave, some might even say, of COVID-19. And there's a lot for us to talk about this year at the global conference, particularly around lessons learned from the pandemic, which is extremely important to us as an organization, because again, our goal is Faster Cures. We saw that in the front row seats with the development of the vaccines in under 11 months, about 11 months or so. What can we do for other disease conditions? Can you imagine coming out of this pandemic where we are able to accelerate research for COVID-19, but we're not able to do that for all of these other disease conditions as well. So our goal is how can we start to document and articulate very precisely, what did we do that allowed us to get over the finish line so quickly?

How do we translate those learnings for the future, but we need to sustain that. So we wrote a paper we actually released in January. We interviewed about three dozen stakeholders from Dr. Anthony Fauci, Dr. Francis Collins, Dr. Janet Woodcock at FDA, patient organization leaders, industry, and the like, and we identified five primary areas of lessons learned. One was research and collaboration. I think we've talked a lot about that. There are probably two things people say about COVID-19. One, unprecedented. The second, collaboration. So we articulated, where were all those different areas where collaboration came together?

The second was accelerating medicines. A number of the vaccines that came over the finish line were based on platforms that we had already invested in for decades. So how do we do that for other platforms going forward? The third area was clinical trial innovation. And we talk about things like master protocols, I'm sure things that you've done a lot in your career, bringing together again, a number of different ways that we can very quickly study components, antivirals, antibodies, to see whether they work or they don't work for COVID-19.

The fourth, we talked about real-world data and evidence. And what do we mean by that going forward? How do we create a regulatory regime? How do we learn in real-time?  And the fifth and then we'll talk about this, is health equity. If anything has really come front and center during COVID 19, the issues of racial and ethnic disparities in this country have been incredibly laid bare, challenging, hard to confront, but certainly something we need to do going forward. So global conference, we are tackling these in a variety of different ways, not necessarily all five topics in one fell swoop, but certainly starting to dig into each of these.

Charles Ryan: That's a great framework. And let's, as we think about health equity, I'm struck by the question, has COVID improved situations around health equity or made them worse? I would think maybe there's an improvement because there is greater awareness. But I also think we've learned a lot about real problems we have in this country around scientific literacy, acceptance of clinical trial results, acceptance of scientific data by the populace. Where do you think we're going to land on that question?

Esther Krofah: I think what COVID laid bear is a silent epidemic that we faced, multi-generational, in fact. It's not new. It was not new before COVID-19. I do think it was a moment of time because perhaps a lot of us were all working from home, yet we were seeing frontline workers go out. We were cheering for the delivery workers, for the grocery store workers, and the like, while at the same time, they and their family members were disproportionately suffering the effects of COVID-19. So it was all laid bare. Of course, at the same time, the issues of the social justice movement and the George Floyd killing, all of that was really creating this level of awareness from the society as a whole, that if there is a silver lining, it is the fact that there is greater awareness.

The other silver lining, I will say, is the mobilization that we are beginning to see across all of healthcare to tackle health disparities. A number of initiatives are being stood up. All of that is very positive and we take it and look at it in our world in medical research, we also have a responsibility because we do see those inequities as well. On the medical research side, we do not see necessarily have the right level of representation in clinical trials and the health research workforce. When we think about what the patients that are coming from these disproportionate backgrounds are suffering from, many of them say, "Providers don't necessarily listen to us." "There's bias." Clinical trial opportunities are not even presented to them. And so certainly at NIH, Dr. Francis Collins created an initiative called, Unite to Tackle Structural Racism. Rochelle Walensky at CDC talked about, we need to identify and really create solutions for this epidemic of racism in our healthcare system. So we are actually using the right words to pinpoint the issue.

What I think is going to happen going forward is that a number of these initiatives are going to kick off, but we need to bring them all together. So for us at Faster Cures, where we are tackling it first, is around the issue of diversity in clinical trials. It's a multi-stakeholder effort. It's not going to be one solution. It's going to be a variety of solutions, and we all need to work together, whether you're sitting in an academic setting, whether you're a regulator, whether you are in an industry, whether you're a patient organization, all of us have a role to play.

There are really three areas where I hope we can make progress. One of the areas is really around general awareness and education and sustained funding in order to tackle them. The second area I think we need to focus on is greater coordination. I am very encouraged by all the different initiatives, but we need a quarterback. How do we move forward, if we don't have a plan? We need a plan and we need to be able to execute against that plan. The third area we need to focus on really is around, how do we ensure that we can sustain and create the right infrastructure that keeps this in place, well beyond the pandemic? That this is not just about a singular moment of time. We need that investment in community-based settings. We need to fund at the local level and empower the community-based organizations to really create an environment where we see the same level of outcomes, whether you're sitting in a community oncologist's setting, or whether you are at Dana Farber, we need to see equal outcomes for all patients.

Charles Ryan: You like me, sound like an optimist. And I think what you are doing is, what I hear you saying is, we're going through this terrible moment, but we are really going to use it as an opportunity to build a better infrastructure for clinical trials, a better awareness of health equity disparities, things like that. So the challenge is, what is step one? We can sit and talk about this and say, "Well, if I could do one thing to move the needle on this topic?" And I would say of health equity, what would it be? What would be the top three?

Esther Krofah: Well, I spent the vast majority of my career in policy, public policy. I worked at the state level, at the national level, so maybe I think about this from the top down. I think we need to establish national priorities. I think that's the first step. When I talked about that second area of coordination and national quarterback, I would actually say that is number one, in my mind. We need a national plan. We need someone that's responsible within HHS to carry this agenda forward. And we need the commitment and the funding in order to do so.

Charles Ryan: To be specific, a national plan for health equity-

Esther Krofah: Well, so in the context of diversity and clinical trials, that particular... Well health equity, we all have a role to play. That is going to be an ongoing issue, an ongoing set of challenges. And in fact, there is a task force that is thinking about this much broader, but specifically, when we were talking about diversity and clinical trials, I think we need a plan. We need to intentionally design, what is the clinical trial network that we want to see in this country, that allows more representation, more participation from diverse communities? And it cannot be so decentralized that in five years' time, we don't have the metrics to say, "Did we make progress?"

Charles Ryan: Right. Well, I can think of how we could work together on that question, because there are so many factors that drive into this such as just the level of awareness of an individual clinician, at all different community sites throughout the country. Some of them do not know about clinical trials, wouldn't know the first step of a clinical trial. I'm talking about cancer now. Some of them might be very interested, but their system doesn't give them the time. Some of them may be interested and maybe have the time, but the system doesn't give them the space. It boils down to things like that. And I've worked with networks trying to do clinical trials where I've gotten feedback, "We'd really like to participate in your trial, but we don't have the space for the files and our office can't afford them," and things like that. So finding out, doing a deep dive, and figuring out those issues and the barriers, some of them are not that significant. They just need to be identified as common and removed or adjusted to.

Esther Krofah: And I would also say that those exact same sentiments apply to the individual as well. I was never asked, I don't even know what a clinical trial is. All of those same things that the provider may say, the patients will also say. So there's a massive opportunity for education and awareness.

Charles Ryan: Right. Well, I applaud the work you are doing. It's great to get to know you a little bit better. And I look forward to working with you on some of these questions because I think we have the same long term outlook in mind, and of course the same level, maybe, I hope the same level of great optimism about the future of our country and the future of health in this country and what we can do to improve it.

Esther Krofah: Likewise, look forward to working with you.

Charles Ryan: All right, Esther, thank you so much.

Esther Krofah: Thank you.