In Episode 2 of Innovations in Cancer, we speak with Lauren Leiman, executive director at BloodPAC, the Blood Profiling Atlas in Cancer (BloodPAC) Consortium, launched October 2017, to accelerate the development and validation of liquid biopsy assays to improve the outcomes of patients with cancer.

Lauren discusses the collaborative infrastructure that enables sharing of information between stakeholders in industry, academia, and regulatory agencies with the goal to standardize liquid biopsies to improve outcomes for patients.


Interviewer:  What is BloodPAC?

Lauren: BloodPAC is a consortium of about 35 different organizations made up of academic, industry partners, government agencies, foundations who are all focused on accelerating the development and approval of liquid biopsy technology through the aggregation of data. 

Interviewer: How did BloodPAC evolve and what do you think is the magic behind this broad consortium of academic, industry and government altogether?

Lauren: BloodPAC evolved when we were working at the White House Cancer Moonshot. I was the Head of External Partnerships. I’d spent time working in the melanoma field and really was interested in understanding what happened in the liquid biopsy space. How could we take some blood and decide whether or not you had melanoma in your dermatologist office.

There was a lot of progress in the science, but there really wasn't a lot of progress in the collaborative space and the question that I put out there to the group was, well if we were able to come together, aggregate data, hopefully create some standards, would people be willing to share their data and would we be able to accelerate the development and work with the FDA to kind of accelerate the approval of the technology. Spent time actually bringing a group of about 17 organizations together to discuss whether they felt that was actually possible, spent time with the FDA thinking through what is this, something that actually be interested in work pursuing with us and the answer was yes, go ahead and do it.

You know, I think they kind of laughed originally at me and said, you know sure, good luck with that—try to get people to share their information and I kinda naively said, okay, let's do this and went out. This was in 2016 while you're still at the White House and brought together a group of ultimately 20 different organizations to draft a White House Cancer Moonshot commitment to share their data, to create a data commons where you could look through and manipulate data and try to achieve a decade of progress in half the time.

That project known which became known as BloodPAC ---Blood Profiling Atlas and Cancer, was created and we received our first trainload of data, if you will, by December 2nd, and then when we actually left the White House, decided that we should really become our own independent organization. In late February 2017, we became an independent organization known as BloodPAC and I will say I think to answer the second part of your question, why do I think it works? 

My feeling is very much on the broader scale not just thinking about liquid biopsy, but that collaborations always improve outcomes for patients. If you’re able to really bring people together to share goals and create a project that's mutually beneficial, you will absolutely be able to accelerate and achieve your goals in a much faster timeline. I think that our agency partners agree with that …after kind of using BloodPAC as a demonstration project.  

My vision and goal is obviously to expand this out to other areas, but for right now, being able to walk—hand in hand—as I like to say with the FDA, with CAP, with the NCI, alongside our foundation, academic, pharma, diagnostic partners, to step-by-step say are we all on the same page. This is all going to be beneficial for each of us. How can we each contribute and get to the next level together has really worked well for the group and we've made a huge number of strides I think in a very short period of time, two years so far.

INTERVIEWER:  That’s amazing. I remember those early days in BloodPAC. I was probably one of the skeptics where I've never seen industry willing to share data and collaborate with their competitors and also I think we were in an industry were always massively scared of dialoguing with the FDA outside of very specific context because of worries of downstream. What do you think was the key thing that that drove that? I mean was this about the executive branch saying, you know, it's your duty to do this and work together or is there some other piece that really brought these competitors together?

Lauren: I think the beauty of BloodPAC and there's two incredible things that aligned here. 1) The White House Cancer Moonshot was a tremendous catalyst to say everyone should be contributing. Everyone should be doing their part. You need to be doing this for the benefit of the community as a whole. That only gets you so far in my opinion really. We can all make an announcement. It works really great on October 17th and a fact sheet to say we're all contributing data, but then once you've fulfilled that obligation then what, what next?

 People tend to think I filled my obligation and I did my part but what we were able to do with BloodPAC is really identify a need for the community in that liquid biopsy community as a whole, identify ways to make the project mutually beneficial for both the community and the FDA and other regulators. For the companies themselves, for the foundations that were fighting very hard for their patients to get new technology into physician’s hands to help them, for the academics trying to kind of understand new discoveries. And for the whole- all stakeholders as a whole— we were able to kind of find that sweet spot that create a project that would really be able to sustain through a five-year period and address all the needs, whether it was understanding variables, preanalytical variables, developing standards around analytic variables, understanding what payers are looking for and even understanding how to disseminate the technology in a kind of organized, really cohesive fashion to the physicians in the future, the nurses in the future, the patient's understanding in the future as well. And how do we take that trajectory from being a really long drawn out process and again condense it down to a five-year period?

We aligned everyone's interest and said this is a project we're looking to work on. How can we do it together faster and I think being able to identify what that was and ultimately create BloodPAC. Turn it in from a - here's the catalyst at the White House kind of asking you to do something good to- wow, this is actually going to be beneficial to all of us as a whole if we’re able to pursue this in the longer term.

Interviewer: With that important catalyst and now you've created this network where you know, you're finding commonalities of desires between all the stakeholders, which I think in cancer is very clear. Do we need more catalysts? Do you foresee obstacles in the future where we go back to kind of being silos in our different spaces or do you think now that it's kicked off and that we have this team going forward, we're going to continue to have progress and get away from the silo mentality and continue to be collaborative.

Lauren: I think there's a couple things 1) I think the group we've coordinated at BloodPAC are a group of extraordinary individuals and I never want to minimize that-- individuals such as yourself and Epic have contributed a tremendous amount in the drive and your pursuit of really helping patients is seen in all of the leaders of the organization. So I think that number one, we've assembled an incredible group of individuals who are determined to make this work.

2)  I think we are proving, day by day, that there is a benefit to companies who are competitive with one another—academics were competitive with one another to really work together to increase their potential and their ability to achieve more in a shorter period of time. That said, I don't want to act as if there aren’t complications in working together. I think it's a daily challenge and really something that I take a lot of my time to kind of work on with our partners.

How do you alleviate concerns for different companies who say just that? Well, if I do this then I'm giving the competitive advantage to XY and Z and I think they're always hesitations from companies as you’re doing well, as you start growing. Do I really still need to be part of a group like this? And again, I think it comes back to demonstrating that the success we've had, the individuals who have been working the project and has seen success we had. We've had agencies like the FDA that have continued to say, you know, we really appreciate the work together that you guys have accomplished as opposed to visiting with each one of you.

I do think that as we grow and as we achieve more as a consortium, the potential to continue to the option, the opportunities for us to find intersecting areas of interest that aren't in the pre-competitive space do start to narrow potentially may start to narrow but I think as the liquid biopsy field continues to grow that also then starts to expand out again.

Interviewer: Yeah. What I think of this collaboration - we have academics and physicians, we have foundations and government bodies—both regulators and peer groups that are starting to come on board. We have drug manufacturers, diagnostics, nurses now even start to join. The one thing I'm missing is patients, but where did the patients come in and are there things that you see active organization with patients? And what role do they have other than obviously being the beneficiaries of all this work to BloodPAC and do you see a time in the future where we are involved more.

Lauren: We have had several patient groups actually join BloodPAC meetings and attend. The feedback that we've received from them, which is actually I think good feedback for the menu diagnostic manufacturers to take in and really start to digest has been said that this is a very complex field.

I think they've shown up at our meetings and thought ‘This is going to be like any other meeting where drug companies are trying to tell me what drugs I should be,’ you know, getting patients to kind of pursue being on the clinical trial and the answer is you know, they leave our meetings thinking: Oh my gosh, this is actually exceptionally difficult for me to wrap my head around. I don't really know where this starts. I don't know where it ends. I don't know how to educate my patients about this.

We've had patient advocacy groups. So patient advocacy groups who advocate for advocates’ right who are saying I don't even know where to start with my advocates. How do I tell my advocates what to do? It was actually brought up by one of our groups very early on in the second quarter of 2017. Has anyone stopped for a second to say, how are we suggesting? You know, we promote these products to the public and promote to physicians and some of our physicians said this isn't a problem. We all know how to use it. And one of our other members very calmly said,  “You work at a really prestigious academic institution. Of course, you know how to use this. What if you're living in a rural area and you're an oncologist and you don't really know how to use this technology or you get a report back and you say I don't really know what to do with this report?” It’s absolutely going to be imperative that patients understand this technology and know when to ask for it potentially, you know how to work with their oncologists, but it is much more complex than I think initially anticipated.

My vision is that were able to gather together nursing societies, physicians, patient advocates, the advocates themselves and say I love to come up with a comprehensive plan on how to educate all of these groups together about the potential for liquid biopsy and what it can do for them. What it can't do right now, what it can do potentially in the future and the incredible work that BloodPAC is doing with all of those companies to actually help them help patients.  I still I don't think it's too early. Even though they kind of got a little scared off I think in the beginning my feeling is it's never too early to start the dialogue and I'm glad they've been a part of the initial conversations over the past two years.

I hope now that ONS has joined BloodPAC as a member. We're going to start having other groups follow behind them and say, oh I really kind of get it now and yes, this is something we should start being involved in today and not waiting three years down the road to become involved and you kind of have a shorter time period to explain what it is we're trying to do.

Interviewer: So what are you excited about? Used to get an opportunity to see new drugs, new technologies, you know, this collaborative experience of people who are all leaders in their field, what excites you in terms of what you're seeing about innovations and getting patients better healthcare?

Lauren: What excites me, I really do think that using BloodPAC as the demonstration project and being able to show the health care community as a whole that people and companies can indeed come together and work collaboratively to benefit patients has been incredible. You know, I think you're smiling right now across from me— that it's really been astonishing to watch, you know companies really say this is not just going to benefit me because  it should benefit them. Companies should absolutely benefit from working in the consortium like BloodPAC.  That said, it should also benefit the community as a whole. It should benefit patients directly. We should be able to get them these tests into their hands faster as a result of this consortium. What I'm excited about is, how do you use it? I keep using this term BloodPAC as a demonstration project to take into other fields?

No matter what, whether it's in creating new drugs, creating new technology and diagnostics, whatever it may be, how do you bring together groups using the similar model and say we're going to use this, you know outline in framework that BloodPAC is already created and set up, we're going to bring everyone together. We're going to take what we're trying to achieve to our regulatory bodies, to our payers and say this is what we proposed. This is what we're all trying to achieve collectively, and we really do believe that if we can create some standards—gather some data around this we can actually move faster and together as a whole group. I believe we've accomplished that already with BloodPAC. I think we will continue to do that and move forward and I really truly believe this model can be used in other areas, and I'm looking forward that anyone out there who wants to take up a project similar to this in other areas would love to work with them and find ways to promote creating other similar consortium because the feedback we've received from everyone within BloodPAC was a member is that they've benefited tremendously from being part of this group and for patients. I think we're moving forward faster than we would have had everyone walked alone.

Interviewer:  I'm going to go back to question I forgot to ask earlier, which is when you're looking at blood what are the key analytes, who is involved in BloodPAC? We know the different analytes that are there in the blood but I assume this is primarily focused on cancer. What can you say about what's included into the scope of BloodPAC?

Lauren:  So we are an incredibly inclusive organization and have included all analytes we have in our data commons where we aggregated our initial data sets data around CTCs(circulating tumor cells), ctDNA (circulating tumor DNA), DNA exosomes, RNA. We have data around multiple disease types too. We have not been exclusive around the data we've actually requested from our members. We are always in search of new members and I would say always happy to receive data in all areas. We have started to work primarily in ctDNA and in CTCs by design primarily because of the influence of the FDA and others who have said, “What is the low-hanging fruit?” Where can we move fastest and that's guided our trajectory.  I want to bring it back to how we were created. We were a White House Cancer Moonshot project commitment originally and so the idea was a decade of progress and half the time--the initial concept was what can we do really quickly? What can we achieve and accomplish in the short time period?

I do believe that you know, what our end product will be is going to be a data commons that will be around in perpetuity. And then that data commons will be analyzed in all areas of liquid biopsy and will be publicly available to everyone in the future. So the goal is to start continuing to collect data, continue to run projects around in all areas of liquid biopsy and spend these five years focusing on achieving, creating some standards that we can together as a group and creating a kind of critical mass of data for the community as a whole to kick off the data comments.

Interviewer: Anything else you want to add?

Lauren:  The company should get the credit deserved.  The Cancer Moonshot…it was the catalyst. It brought everyone together to make a commitment to say we're going to commit to you know, contributing data to a data commons. That's where the end of commitment started and where it ended. And once everyone fulfilled that commitment, that was the end and I really believe that all of the companies and the organizations that came together after that initial commitment to say we want to pursue creating our own organization deserve a lot of credit and in the foresight to know this is a really important project that we should really create ourselves. Without the funding of the government, without any other support, all members contributed their own dollars to get BloodPAC off the ground to start moving as an independent organization. So, it's not run by anyone else other than itself and I really do think it's an extraordinary vision for the leadership of BloodPAC who started off really early and the members who joined, continue to join, understand that. There’s a misconception that we are either run by dividing cancer initiative, which we are not. Or that we’re run and funded by the federal government, which we are not. We actually don't take any funding from the NCI right now.

Interviewer: So as an independent organization and obviously we don't know what the next political landscape is going to look like and obviously with Biden running again, do you see the executive branch at some point coming back in and taking interest in this and if they did, let's just say they did, how do you think they would work with BloodPAC or do you think it will remain independent?

Lauren: I think it's actually probably important for BloodPAC to remain independent. There's a few ways to answer that question 1) We right now have a spectacular relationship as we did during the White House Cancer Moonshot with the federal government. So we work very closely with the NCI, the FDA, the DOD.

It’s great to be able to say we are an independent organization coming to you to collaborate with you as opposed to being a government agency. It’s nice that we can all be independent, have our own agendas and our own needs, take them as a large group of stakeholders together and figure out what's best for the field in general. I like that I can get independence—has worked really well for us. But we've also been able to balance under both administration's working well together. My hope and my vision and I anticipate that wouldn't change it with whoever you know, whatever the next administration is, and I think it's important to stay independent.  The funding portion from the NCI. We have remained independent from them and not taking funds from them and I think we demonstrate two things: 1) We are an excellent example of how a privately funded data commons can interoperate with a publicly-funded data commons. We are fully interoperable with other data commons such as the GDC which makes us unique and interesting for people on the data. We need a field and it also allows us to build trust within our members because we don't have to release our data on a strict timeline yet. Our vision is to absolutely make the data commons and it will be publicly accessible data commons at the end of the project into the five years, but for right now, we're able to gather data from our members and really have deep discussions essentially privately among our members, without the concern of having to release data on the strict timeline.

If we were to take funding from the NCI, that would potentially change.

Perfect. Thank you