JCO PO authors Lauren C. Leiman and Dr. Emma Alme share insights into their JCO PO article, “Recommendations for the Equitable and Widespread Implementation of Liquid Biopsy for Cancer Care”. Host Dr. Rafeh Naqash and guests discusses increasing access to liquid biopsy for cancer, reviewing the barriers and examining the proposed solutions.

TRANSCRIPT

Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, Social Media Editor for JCO Precision Oncology and Assistant Professor of Medicine at the OU Health Stephenson Cancer Center at the University of Oklahoma.

Today, we are excited to be joined by Lauren Leiman, Executive Director of BloodPAC, and Dr. Emma Alme, Public Policy Director at Guardant Health. They are both authors of the JCO Precision Oncology article titled "Recommendations for the Equitable and Widespread Implementation of Liquid Biopsy for Cancer Care."

Our guest disclosures will be linked in the transcript.

For the sake of this conversation, we will refer to each other using our first names. So, Lauren and Emma, welcome to the podcast and thank you for joining us today.

Lauren Leiman: Thank you for having us.

Dr. Emma Alme: Thank you so much.

Dr. Rafeh Naqash: So, this article is an opinion piece that addresses something that is emerging and current and tries to connect it to something that is futuristic also and hopefully, will address a lot of different needs relevant to patients with cancer. For starters, since our audience is pretty diverse, could you tell us what the BloodPAC is? Since the article is somewhat a combined piece from different stakeholders, could you explain what this BloodPAC Consortium is as an entity and what is its role for this BloodPAC?

Lauren Leiman: Sure, this is Lauren Leiman. The BloodPAC was formed almost seven years ago as an initial commitment to the White House Cancer Moonshot back in 2016. I was the head of external partnerships and had this idea with a colleague of mine, Dr. Jerry Lee: Could you accelerate the development and approval of liquid biopsy assays for cancer patient benefit if you were able to create some standards and frameworks for the field broadly, and also if you could aggregate data to support those standards and frameworks? So, we brought together about 20 different organizations across pharmaceutical companies, diagnostic partners, foundations funding in the space, government agencies, all to think through can we create these frameworks, are we willing to submit data. We were extremely successful in that first round, and by the end of 2016, we were able to have our first data deposit into- we built a BloodPAC Data Commons, which is housed in Chicago and was created by Dr. Bob Grossman up there.

In 2017, when it became clear that the last administration was not going to continue the White House Cancer Moonshot, we became an independent non-profit 501(c)(3). And we have grown substantially since that time from those original 20 different organizations to about 66 different organizations today, across all those areas again, including today, payers, which is very exciting. And we have added on to our mission statement one word that we will discuss today, which is very exciting, which is “accessibility”. After our five-year anniversary and even slightly before then, we decided that we really feel that we have been able to contribute, as a community, to accelerating the development and approval of these tests. But, in actuality if we don't get them into patients' hands, what is the point of all of our hard work? So, we added the word "accessibility." Today, we have these 66 different organizations that collaborate, essentially, to compete. They’re pulling together projects and deliverables in about ten different working group areas to contribute products to the liquid biopsy community to help accelerate those three things.

Dr. Rafeh Naqash: Thank you for explaining that. That seems like a very important initiative.

Now, when you say that you’re contributing data, does it mean that different companies and entities are contributing patient-level data so that you can pool that and assess what is the utilization, what is the utility, what is the payer-related aspects, coverage aspects. Is that all part of the initiative?

Lauren Leiman: It is. We started with the idea, which is kind of scary, I think, for a lot of different companies: Are you willing to submit your protocols essentially, pre-analytical data? I think, much to the FDA's surprise, I was kind of, “Of course, everyone should be willing to do this, they should absolutely do this, it’ll be really exciting. Why wouldn’t they?” And I think others were a little skeptical that these companies who are highly competitive including Emma's company, Guardant, would be willing to contribute data. And in fact, Guardant is probably one of the first ones, first two at the table to actually submit their data which was just extremely exciting. And the data was around mostly protocols and pre-analytical variables, what tube types are you using? As we moved on, our pharmaceutical partners did submit full clinical trials with deidentified patient data, which was extremely exciting.

Today, our Data Commons sits in two different areas or visibilities for our members. One is membership-only data that only our members can see, so have been been contributed by them potentially sometimes for certain projects we’re working on. And then we also have an open segment of our Data Commons that’s open to the public, that includes published data and studies that anyone can take a look at and see. Our goal is to continue to open up all of our data over time, so that anyone can take a look at it. We are, I think, the leading liquid biopsy repository.

As we move into the future though, I think because we are mostly an organization that has pharmaceutical companies and diagnostic partners, we are company driven, aggregating large sums of research data is not necessarily their goal. And so to try to identify an area of mutually beneficial interests for everyone, I do think that over the next year or two, you’ll see a potential shift or pivot in the use of Data Commons to where the industry is today which is probably, hopefully a little bit more coverage focused. How do we pivot from being a source of aggregated research to a source of identifying and approving the value of liquid biopsy to the full community? And again, that’s for the full spectrum all the way through payers and the coverage of these tests, which I do think would add a tremendous amount of value to everyone on the life cycle of this industry but would also add a tremendous amount of value for access in getting these tests into patients’ hands.

Dr. Rafeh Naqash: Of course, you importantly covered a bunch of different concepts. One is data democratization, which is extremely important in the current day and age for different people in the public domain if they have access to data, they can do a lot of interesting and important things and add to the overall understanding of what we know or don't know in this space of liquid biopsy utilization. And then, of course, the aspect of disparities and coverage assessments.

Now, going to Emma, for the sake of our listeners, some of them are trainees, and many of them are oncologists, perhaps many are patients. What is the current landscape for liquid biopsies? Where do we use them, and what are the general approaches and principles of where things stand?

Dr. Emma Alme: That's a great question, and it really spans the cancer care continuum. And I think the space where it's most established is in the advanced cancer stage for therapy selection. So that's where we actually have some even FDA approved assays for liquid biopsy, with Guardant 360 test being one of them. It's comprehensive genomic profiling to identify actionable biomarkers to get patients on targeted therapy. So that's where it's really been integral to precision medicine. And we're seeing an increase in utilization of liquid biopsy as the technology becomes more established. It's not just in cases where tissue is insufficient now. Most recently, we've seen NCCN guidelines and non-small cell lung cancer change for concurrent testing for liquid biopsies. So that's been an exciting trend in adoption.

And then as you move across the cancer care continuum, there's residual disease monitoring and response, where we can actually use ctDNA to look at a patient's response to therapy, even after surgery - is there still ctDNA there? Instead of just having imaging as an option, we can actually look sooner to see how the patient is responding and if there is still cancer present. So that's a really exciting place where we're seeing growth in liquid biopsy. And then moving even earlier, before a patient even has cancer, there's a tremendous opportunity for liquid biopsy in early cancer detection. I think that's something that has been previously discussed on this podcast and we see it a lot in popular media. But it's not just for multi-cancer, we have the opportunity for single cancer as well liquid biopsy tests in cancer screening.

That's a really exciting space, really thinking about the accessibility of these tests. Because a lot of cancer screening modalities today are hard for a lot of patients to access. And it requires going to a medical facility. So if the first step is a blood test, that really opens that up to communities that traditionally have been left out of screening. So I think there's a huge opportunity there, not just when we’re thinking about screening for cancers that don't have screening modalities currently, but also screening for those that do, where maybe a first non-invasive step can really open the door to patients who don’t have access.

So it's a long answer to say that, really, it's across the entire cancer care continuum. We see a lot of opportunity here for liquid biopsy to be a way to advance the field but also increase access for patients who have been left out of precision medicine.

Dr. Rafeh Naqash: I think access is definitely the focus here. And I can give you my example. So I do early phase drug development and I do a lot of research in liquid biopsies and ctDNA monitoring. In the center of care, I treat people with lung cancer also and there have been instances, probably about a year or a year and a half back, where a patient could not come to the clinic. The clinic wasn’t done and on my to-do list for that individual patient, I put in ctDNA testing just to remind me when I see the patient, to get it done. But the patient didn't make it to the clinic. Surprisingly enough, mobile phlebotomy was available. And later I came to know that this is something that can be done and provided to the patient at their home and you can still get the same results, which was very surprising in a good way. And it did help in making some treatment decisions for some patients who, sometimes in a state like Oklahoma, which is where I am based, we have a significant rural population and people drive six hours for some of our trials, especially the early phase trials. And then if you tell them, “Well, if you don't make this appointment, XYZ cannot get done,” it doesn't necessarily change things for them. So something of this sort definitely helps.

Now, going to Lauren, I noticed this interesting sentence in the article, "fork in the road," where you describe, based on the current practices and policies, in the direction that we're going in, we can either increase or deepen the divide and disparities or decrease it. Could you tell us a little bit more about what currently exists on the disparity side and how do you see us narrowing that gap in the near future and implementing something that is equitable?

Lauren Leiman: What's exciting about this paper is I think as we are talking about trying to condense this discussion down to something that’s really digestible for everyone in the community, there are six barriers that we’ve identified. And I also should start by saying the working group that we have within BloodPAC that wrote this paper is intended to look at two different areas. One is that broadly, liquid biopsy still isn't available for the majority of the population domestically here in the US so that’s a problem. In addition, it's clearly not available in underserved areas, and that's an even deeper divide. So we're kind of at this fork in the road because it's not broadly accessible to the majority of patients today. And so we have this moment in time where we're able to make a decision to bring everyone along with us, which is very exciting but also will take a lot of work. And these six barriers that the paper identifies, I think are very clearly articulated. They are: lack of uncertainty around test performance, the lack of familiarity with this technology, inconsistent payer coverage is an issue, mistrust of the medical establishment - especially in underserved areas, fear of discrimination in seeking this kind of technology, and the difficulty with terminology.

I think that the whole liquid biopsy community has a role to play in addressing these six areas. I think that BloodPAC, in particular, as a consortium and a collaborative process for 66 different organizations that work in the field, we have a role to play, most certainly in helping to address specifically some of these areas. We have working groups that specifically address reimbursement and policy, so that would obviously fall into payer coverage of these tests. We have working groups creating lexicons both in the molecular residual disease area, as well as our multi-cancer early detection areas. So creating terminology and lexicons that are consistent across the entire community and also digestible for patients, which is really important. And so mitigating these barriers is going to be a collaborative process across all stakeholders in the liquid biopsy field. And I think BloodPAC is uniquely positioned to address many of these because of our diverse stakeholders and membership, which is exciting. But I do think that this is the perfect moment in time now to start addressing these challenges, and we shouldn't wait much longer, as we think through how we can bring everyone along with us and make sure we're not leaving anyone behind.

Dr. Rafeh Naqash: As this entity or consortium, as you call it BloodPAC, has moved forward, this is a question for both of you, Emma and Lauren. Emma, I guess you can start. How were things five years back? What are some of the things that you have been able to achieve, and where do you potentially see the next five years?

Dr. Emma Alme: I think we have made a lot of strides on the coverage side when it comes to advanced cancer testing for liquid biopsy. By no means are we there by any stretch of imagination, but we're starting to see some coverage adoption, which does make a huge difference because at the end of the day, that’s so important to ensure equitable access. Especially when we're talking about a technology that has the potential to close some of the barriers in precision medicine because of the fact that you don’t need access to some of the medical facilities, as you pointed out earlier, rural patients don’t have access to. Because transportation is not necessarily a barrier here the way it is for some for some of these other treatment aspects. But if you don’t have consistent pay or coverage, that’s a place where you’re really going to see drop off in terms of patients not getting equitable care and not getting standard of care as liquid biopsy enters into that realm.

The increase we've seen in private payers adopting coverage, the way we see Medicare coverage for advanced cancer liquid biopsy, is encouraging. We've seen states adopt legislation to require coverage of biomarker testing, that’s passed in 15 states now, thanks to the work of the American Cancer Society and a broad coalition of stakeholders. I think that’s beginning to make a difference, but we have a long road to go. We still, on the MRD side, that’s just emerging. And so one space where we have some recommendations on this is continued evidence generation - continue to gather that clinical utility data that will support payer adoption increasing on the advanced cancer side, but then moving across that cancer care continuum to those other types of liquid biopsy tests. I think that’s hugely important and there’s a role for BloodPAC to play in that as well, especially in making sure that we bring everyone to the table to have these conversations on what is the evidence that, we need to generate, what should that look like, what are the standards to ensure that everyone feels confident in these tests. That’s one area that we’re really excited to see.

And I also think another space is on the diversity in clinical trials. It's so important to make sure that when we are bringing these tests to market, the data that we gather to support that is representative of all patients who can benefit. It is so important to make sure that the tests work, but also to build confidence in all of the people who are going to get these tests and feel like, “Okay. I know that this test works for patients that look like me, too.” And so that is something that at Guardant we are working really hard on. We read out our clinical trial, ECLIPSE, for our blood based test screening for colorectal cancer a little over a year ago, and we were really happy to be able to say that our trial was representative of the US population, particularly for Black Americans, where colorectal cancer incidence is increasing, 30% to 40% higher rates of mortality, in Black patients than White patients for CRC. So it’s especially important to make sure that the population is representative in the clinical trial of the patients who will benefit.

And I think we are seeing companies increasingly realize their responsibility in that space and it’s something that we can all really prioritize moving forward with things like making sure transportation is accessible to patients, making sure that clinical trial materials are accessible, culturally sensitive in a broad set of languages. There are a lot of different activities. You have mentioned mobile phlebotomy earlier, that can be incorporated into trials working with community centers and not just academic medical centers to ensure that the trials are taking place close to where patients live and work. This is a tractable problem and I think we’ve made a lot of headway in the five years. But looking to the future, there's still a lot more we can do together to ensure that work continues.

Dr. Rafeh Naqash: All excellent points. And I completely agree with you. Bringing the trial to the patient is more important and likely to lead to better outcomes than the patient driving six hours to a facility to come on for trial.

So, the question for Lauren that I have from a physician or scientist standpoint, is what gets covered or does not get covered is not necessarily that I know about in my daily clinic of 15-20 patients. What is the difference between different states having different coverage policies for something like this? If it's the same payer in state A and the same payer in state B, why is the coverage policy in state B different from that in state A? And what are some of the things we can do locally and at a national level to help bridge some of these disparities and gaps?

Lauren Leiman: I'm going to hand that question over to Emma. This is her bread and butter.

Dr. Emma Alme: That is such a great question, and I wish I had a more satisfactory answer for you. The reality is that when it comes to diagnostics, coverage is really a patchwork, compared to when we think about drugs whether it’s FDA approved, we expect to be covered. With diagnostics, it's really up to the insurer. And I keep going back to the advanced cancer space because that’s where we see the broadest coverage because it has been around the longest. But we see broad coverage from Medicare for these types of tests. But, for private payers, it's really a patchwork. We see a lot of payers only just starting to cover these tests, maybe where there's a CDX indication with an FDA-approved drug we see it, but not more broadly for tumor profiling. Especially not for the larger, more expensive comprehensive genomic profiling panels that are more expensive. I think you can extrapolate the obvious reasons why that might be. But, as this is being moving into NCCN guidelines, we see very slow adoption by some private payers.

And you touched on the legislation in different states. This coalition on American Cancer Society has been spearheading is trying to pass state-level legislation that will align coverage with a strong, robust set of evidence, and that’s an FDA-approved companion diagnostic indication, medicare coverage, whether it's an NCD National Coverage Determination, a Local Coverage Determination, or National Clinical Practice Guidelines like NCCN, so really a robust set of evidence. And so this is resonating with state legislators across the country where we are seeing that take off in 15 states. But the political climate is different in different states so there are differences in terms of which state will adopt this, some of the differences are in language that they put into this. But even now that these are passing, we're seeing differential implementation, some plans are not necessarily reading this legislation and saying, “Okay, I have to cover all the tests that Medicare covers.” They are thinking that maybe they have some agency to put on other medical necessity criteria. So I think there’s a lot that will play out on the individual state level to see how this nets out. But it’s really kind of how different insurance companies and plans are interpreting these mandates, are interpreting guidelines, etc.

But you touched on the differences between the states and one of the things that has actually been shown in data from the precision medicine coalition is that even when you change insurance coverage for one individual plan, it doesn’t necessarily translate into adoption in the direct correlation that you would expect. And part of that is because it’s such a patchwork and it’s so chaotic. Providers don’t necessarily know for their patients which plan will cover, which one won’t. They’re very hesitant to subject their patients to out of pocket costs and so you get providers being reticent to order liquid biopsy just because of this coverage landscape. And so there really is that need not just to go step by step but get broader coverage for these patients across the board.

And so I think the long term vision is can we get to a change at the federal level. That’s hard compared to the state level. It’s a long road ahead. That’s why I started this with I don’t have a satisfactory answer. There is still a lot of chaos ahead even though we made some progress along the way.

Dr. Rafeh Naqash: I completely agree. Lots of things to do together. But, in my daily role as a physician or a scientist, I come across situations where a patient's situation was denied for liquid biopsy, then the company went and appealed or insurance doesn’t want to pay for it, and then they ask for peer-to-peer review, which is a lot of time and energy on the provider’s side, the physician's side, even for as simple as a CAT scan for cancer, let alone a liquid biopsy. I started thinking at that time, is there a scenario where if I were ordering a Guardant or a foundation or any liquid biopsy for that matter, can they not provide additional support where I don’t have to do a peer to peer and I can spend time and energy concentrating on the more important patient issues that are right in front of me, rather than having to wait for an insurance company to call me at a certain time of the day where I may or may not be available and then having to reschedule the call and spend another 30 minutes to them explaining. So I don’t know if you guys on the other side of the aisle also think about some of these issues, but could that be a scenario that could potentially be implemented in the near future?

Dr. Emma Alme: Yes, absolutely. This is something that we at Guardant think about a lot. One of the challenges is that, as a laboratory offering liquid biopsy, you are an ancillary provider, and so I think you touched on it, a lot of this role falls to you as the physician to secure prior authorization and to be the patient’s advocate. And not all plans – this is often true for Medicare Advantage – allow the laboratory to be the one to, for example, initiate prior authorization and provide the medical necessity information to make sure that that test is approved by the insurance company, and then to be the advocate for that patient in appeal process as you mentioned. And I think there is a lot of education that needs to happen among policymakers to make some tweaks to this process to ensure that the patient can have access, that the laboratory can be involved in the process where it makes sense, to smooth out this process.

And exactly right, I think you touched on a place where it is a huge burden for providers. There are places where the laboratory is best equipped to move the patient through that process and there's a lot of red tape that we can help overcome. And that's not specific to liquid biopsy. I think that's true across the diagnostics industry. But you're exactly right that it is another hurdle to access is if this is a process that has a lot of red tape. So I'm pleased to hear you think about this the same way.

Dr. Rafeh Naqash: I'm glad you guys are having those conversations, having conversations is the first important step to make a change in the near future.

If there's a patient listening out there and that patient has gotten a recent bill of $5,000 for liquid biopsy, what are some of the steps that you would like to highlight for them from a patient standpoint so that they can advocate for themselves? And should they talk to the physician in the company? Should they directly approach the company to not have that additional financial toxicity in situations where it may not be covered?

Lauren Leiman: I would 100% encourage those patients to please reach out to the company. I can only speak for Guardant but we have a patient access program. Our team calls any patient that's going to have more than $100 out of pocket because our goal at Guardant is to make sure that patients have access to the testing they need to inform their treatment and get the best possible care. I think we're all aligned across these companies across both- like we want to make sure that we are lowering the burden for cancer patients. There's already so much stress on these patients initiating treatment. They don't need to have the added stress of battling insurance. So we're here to help and no patient should be on their own in that space. So please tell your patients to reach out to the company in those instances, but I would hope that they would already have gotten outreach from the company in the first place.

Dr. Rafeh Naqash: I often discuss with some of my colleagues about the financial burden of cancer care, unfortunately, that people tend to have. And I remember this scenario a couple of months back where a patient of mine, when I sat down in the clinic room, they had this big, thick folder with them. And after I finished the discussion about what was going on with the cancer, they said, "Could you help figure this out?" And they opened this folder. It had so many bills, and one of the bills was obviously a liquid biopsy bill. And that was my understanding, too, that there is a lot of resources available to these people. And eventually things worked out. The company took the cost of whatever was not being covered by the insurance. But again, you touched upon an aspect in the article about educating the physicians, the providers. I think definitely a lot of work needs to be done there so that the patients can advocate for themselves and the healthcare providers can advocate for the patients, too, like having those checks and balances and those resources present and in the institutions where these people get cared for or knowing what's the right way to channelize these issues and to whom within the companies, so that all of this gets taken care within a timely period, so that the patient doesn't come back with the same issue six months later, “I still have this bill,” that even if it's being sent to the patient or their family by mistake, it does add a lot of psychological pressure.

So I think a lot of things potentially need to be done in that space, and hopefully you guys are still doing that and continue to do that, make progress in that space to help mitigate and alleviate some of that patient level burden, which is extremely crucial in their care.

Lauren Leiman: I think what's interesting about what we're looking at now is BloodPAC is thinking through these financial challenges, the coverage challenges for someone who's probably made it to an academic center to access these tests to begin with. And so to go back a little bit in the conversation, I think there still are challenges, which I'd love to hear more about from the experience of a clinician. But we have talked about, does mobile phlebotomy access everyone? Is it capable of providing access for everyone? I don't know. There's new technologies that we are looking at, like home blood collection. Most of the companies that we work with right now, they're not getting enough quantity. The quantity isn't there. But is that something that we should be pursuing? Because as you've already said, people drive six hours, and sometimes you can't make that drive. And sometimes a mobile phlebotomy lab is not able to get those six hours away. There’s a limit on how far they can go. That's a huge challenge.

I'm also fascinated by the idea that if you were to eliminate coverage as an issue, so if we were to say we're offering tests for free, is there still the educational barrier, the understanding barrier that we are not putting enough emphasis on? I don't know the answer to that question. I think there is a large element to that, though. And I think that when you say education, I have asked colleagues, "Okay, guys, who are we educating? Are we educating the clinician on specific tests? Are we educating the community health worker somewhere else outside of an academic center? Are we educating the patients themselves? Do they need to really understand exactly what this kind of futuristic technology is and what it can do for them?" Those are a lot of permutations of what if, what if, what if, what is the barrier? And so to take a step back, the reality is for that big bucket of individuals that I talked about at first, yes, coverage is going to be the primary barrier for them. But if you were to remove that barrier for some individuals, I think you still have a lot of challenges left ahead of you, which is essentially what the paper is saying. But I think that that is the really big question that I still have in my mind. If we can eliminate coverage, what's left and how do we address it?

Dr. Rafeh Naqash: To that point, I would like to add also- you pointed out educational barriers and there's definitely educational barriers on the provider side also, physicians, whether it's academic or community, that's a different discussion altogether. And this is not just one example, but this is an example that I'm giving because there's several other examples similar I've seen where somebody gets a liquid biopsy done in the community setting, or maybe even in an academic setting somewhere else. And somebody like me who deals with some of these results, I do a lot of precision medicine, I do a lot of genomics, but that's not everybody's interest or forte. That's not something that everybody's necessarily interested in or I try to read each and every detail in a report and understand implications, and not everybody necessarily thinks that that's the best utilization of their time. And I have identified a lot of patients that have been in the system within our state or outside our state where liquid biopsy two years back showed a certain potential germline mutation with a very high variant allele frequency and never got any germline testing. And then I see the patient and I start connecting the dots and the patient gets germline testing done - patients is positive, children are positive, children get XYZ procedures done as part of surveillance or mitigation strategies to prevent future cancers, which again, prevention is cure. At the end of the day, you catch something earlier, as we all know, higher chances for cure.

So I think that part of education, we still need to do a lot more on educating the providers, the physicians, or making it somewhat easy, like is there a way that, well, if you have a potential finding of a germline mutation, let's say on a report, instead of just mentioning the potential of germline mutations, maybe we can go to the next level and offer free germline testing and free genetic counseling and make sure that you communicate with that provider versus the responsibility being on the provider or the physician that, “Hey, did you read this carefully? Did you miss something? Did you not miss something?” This is something I have come across and we’re actually doing a project right now looking at some of that and analyzing the data and the percentage is pretty significant, and hopefully, if and when the results of that project are published, you will understand how much of a difference it actually can make in the lives of patients and their families to catch something early.

Dr. Emma Alme: I think you raise a really good point and your example of germline testing along with tumor profiling is a good example of the kinds of questions that we'll encounter as liquid biopsy moves across that cancer care continuum. So I think we do have to be thinking about what kind of education will we be giving to providers for how they integrate, for example, MRD liquid biopsy testing with standard of care imaging, what does that patient management process look like? On the early cancer screening side, what happens when you get a positive test for a patient? What does that diagnostic workup look like? Especially when there isn't necessarily a standard of care screening pathway- isn't a diagnostic pathway. Whose responsibility is that? There are so many outstanding questions through how we think about provider education across this board that really will take all stakeholders together to really formulate what this looks like.

I think you raise a really good point. Right now, I think we all have more questions than answers, but I think it's an important place for us all to be working really hard on right now, to ensure that this doesn't roll out in a way where there is confusion, especially where the providers offering liquid biopsy, maybe primary care physicians who aren't necessarily, as you said, going to be well versed in the literature on liquid biopsy, thinking about these tests report the way that you are right now. There's a lot of work to be done there.

Dr. Rafeh Naqash: Absolutely. It was a pleasure talking to both of you about the science, logistics, and payer aspects. A couple of quick minutes on both of you as individuals. I like to start with you, Lauren, can you tell me briefly, what's your background? How did that background connect to what you're doing today? And what else have you learned in this process?

Lauren Leiman: Sure. I am Lauren Leiman. I’m the Executive Director of BlooPAC. My backgrounds are primarily in communications and business and developing collaborations that are mutually beneficial for all participants. I have worked in finance. I've worked in Africa for many years for an economist and really decided during that time that health care and health initiatives were really what interests me and ended up working in a melanoma foundation for many, many years, developing interesting collaborations between academic institutions and funding formats, and took that to the White House for the first White House Cancer Moonshot as the Head of External Partnerships, and work towards identifying collaborations between different government agencies and different companies, as well as straight corporate commitments to the Cancer Moonshot, which was “a decade of progress in half the time”, the mission statement.

And having worked in melanoma for a while and working at the Moonshot, I'd heard about this liquid biopsy technology. It's out there and I thought it was pretty cool. I have melanoma in my family, and was like, wouldn't it be really interesting if you could get your blood drawn and just tell me if I have melanoma as opposed to kind of scanning my body every six months? And my colleague Jerry Lee, at the time kind of dropped a ream of paper on my desk and said, “Read this.” So I'm neither MD nor PhD, I’m a lowly MBA, who went home and read through everything and came back and said, “You don’t have a science problem. You have the collaboration problem, you need to work together, you need to share your data and share your information, which was kind of the birthplace I guess for BloodPAC - could we again, aggregate our data, bringing together these experts in the field to help accelerate the development and approval and accessibility of these technologies. That is my background.

Again, an interest in things, going back to Africa and the time I spent there, I'm heavily interested in underserved populations, not just domestically but globally. My hope is that eventually BloodPAC starts really engaging in how do we increase access for all to these really exciting new tests? I do receive, BloodPAC and I as the executive director, receive calls probably once a month from different startups around the world saying, “Good luck with all your $500 test. I want a $5 test, how are we going to get there?” Which you know, I think is the absolute goal for everyone. But slowly but surely, I think we are going to work towards increasing access for all not just domestically here and not just underserved populations here in the US, but hopefully locally as well.

Dr. Rafeh Naqash: Thank you, Lauren. Same question to you, Emma. Could you tell us about your background and how it led to your current work and some of the things you learned?

Dr. Emma Alme: Absolutely, my background began on the science side. I did a PhD in biochemistry at UCSF University of California, San Francisco. About halfway through my PhD, which I think is a realization many have, I discovered that I loved talking about science and thinking about science and reading about science, but it would be okay if I didn't have to pick up a pipette again. At the time, I was so invigorated by all of the research going on around me but realized that, similar to what Lauren said, it wasn't the science that was the barrier in a lot of cases of this research really reaching patients and changing their care. There were so many policy barriers that were standing in the way of that that I felt like I really wanted to help tackle and so I was fortunate in the fact that there are a lot of fellowships out there for PhDs in science to move into policy roles and serve as science advisors, so I did a smattering of those all around DC. I worked at the National Academy of Science. I worked at NIH and then I went to Congress, where I was a Health Policy Fellow for Anna Eshoo and got to interact with so many different companies in the biotech space and learn about all of their amazing technology, including liquid biopsy that folks were working on where there again, were so many barriers to adoption, where there were policy solutions, and I got really excited to work on that. It was the perfect nexus of my background and biochemistry and genetics and health policy.

And so the opportunity came up to work on policy for Guardant who was really thinking about those issues. And so I jumped at the chance to spend all of my time thinking about how do we increase access for patients? How do we make sure that this innovation actually gets into their hands through changes in coverage and reimbursement? And also thinking about most of the things that we've been talking about today - diversity in clinical trials, how we brought in education for patients and providers. So it's been a really exciting space to work in. It's been super fun to get to help the Guardant work with BloodPAC and I think it's an amazing group of collaborators that brings me a little bit back to my academic roots in terms of enjoying the kind of conversations that all these folks have together as we think about standards. That's been a really exciting place for me to sit in the health policy world combining all of that experience together.

Dr. Rafeh Naqash: Thank you so much. It looks like all of you within the BloodPAC and perhaps outside the BloodPAC are people driven by a common vision and mission and hopefully will succeed in all of those things that you're trying to achieve. Thank you for giving us the opportunity to talk to you guys and thank you for publishing in JCO Precision Oncology. Hopefully we'll see more of your work with regards to implementation and some of the next steps that you're taking and perhaps even the data for some of these studies that you're combining together, within JCO Precision Oncology in the near future.

Dr. Emma Alme: Thank you so much for having us.

Lauren Leiman: Thank you.

Dr. Rafeh Naqash: Thank you for listening to JCO Precision Oncology Conversations. Don’t forget to give us a rating or review and be sure to subscribe, so you never miss an episode. You can find all ASCO shows at asco.org/podcast.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guests’ statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Leiman COIs:
Stock and Other Ownership Interests:
Company: Illumina
Company: Eli lilly

Alme COIs:
Employment:
Company: Guardant Health
Stock and Other Ownership Interests:
Company: Guardant Health