Roche’s purchase of Flatiron Health will accelerate the development of real-world data suitable for supporting regulatory decisions, said Daniel O’Day, CEO of Roche Pharmaceuticals.
“They have very good coverage of cancer lives in the United States, but it’s roughly 30 percent, so they have the scale in terms of the number,” O’Day said. “As we know, in electronic medical records systems, up to 50 percent of the data is unstructured and uninterpretable in a digital format. The wealth of information that exists in that unstructured data is exceptionally important.
“So, they’ve been able to structure that data, make sense of it, and they’ve done it at scale and uniquely compared to other companies in the field.
“We really want to shape the field for the benefit of patients, and when we do that right and do that well, that will transform the way that we do our business in oncology, in terms of research and development, and the regulators, I think, will be able to achieve their objectives of getting transformational medicine and innovations to patients quicker and faster and more reliably.”
O’Day spoke with Matthew Ong, a reporter with The Cancer Letter.
Matthew Ong: With the acquisition, will Flatiron’s data now belong solely to Roche?
Daniel O’Day: I think this is a really important question. The answer is, of course, no. Our strategy and objective here is to bring two leaders in the field together. So, we’re a leader in cancer medicines and diagnostics and Flatiron is a leader in, obviously, health technology in cancer, and our objective here is to accelerate the Flatiron mission for the benefit of all stakeholders in the system.
We’re going to leverage this experience together to make sure that we are good partners with industry, with academia, with regulators, and most importantly, with providers and patients to make sure that we advance the field of care of oncology for everyone. I think this is a strategy that two leaders in the field can come together on, because we understand and we certainly hope that the entire cancer ecosystem will benefit here and, of course, we’ll benefit as well.
So, Flatiron will be able to share its data with third-party organizations?
DO: That’s correct. Yes, the answer is that the data will be available to the oncology community for sure, as it has in the past. So, basically no difference to the way that Flatiron operates today; we will keep Flatiron as an autonomous unit within the Roche Group.
We’ll certainly set up appropriate firewalls to make sure that data is protected from a patient perspective, a physician perspective, and other life sciences companies. This is something we have a lot of experience with; we do this today with Foundation Medicine, for instance, and we’ve done with other collaborators in the past. So, it’s something we believe very, very strongly that the data is for the benefit of the cancer and health care community.
How will Roche allow Flatiron to maintain autonomy over its community practice portfolio?
DO: Well, I think the good news is our interests are aligned and that’s why we feel very comfortable with the setup that provides that autonomy. In other words, our focus at Roche is to discover and develop transformational medicines in many disease states, but certainly in our leading disease area of cancer. The reason we’re able to do that is because we have a real focus on patients’ needs and the science, our ability to evolve the science.
Flatiron’s objective is, of course, to clearly improve the patient experience with the provider base and provide regulatory-quality real-world data that allows researchers, academics, industry to create insights from that data to make better decisions on new medicines and new interventions.
So, the objectives are all aligned and therefore creating autonomy within the Roche Group, we think, makes sense to make sure that Flatiron maintains its independent decision-making towards providers, towards other life science customers.
We’re confident that when that happens, Roche will also benefit as a leader in cancer medicine and our mission of developing transformational cancer medicines.
Would the Roche ownership in any way affect or change Flatiron’s ability to form new partnerships and collaborations?
DO: Absolutely not. We feel that our investment in Flatiron will only help accelerate their mission. In other words, being able to advance more quickly their product offerings to providers or their research base, or their information base to the researchers in the industry community. I mean, we feel we can accelerate that mission, make it even more attractive to the partners that they work with today. We plan to invest in this business and make it stronger and better.
Right, with a $2 billion price tag, you’re not going to let Flatiron wither on the vine.
DO: No, no, no.
What does Flatiron offer that other health tech companies do not?
DO: Well, I think that they’ve definitely differentiated themselves on their ability to both support the patient experience with their OncoEMR system—their electronic medical records system—and the practice and providers.
They also have done a terrific job of creating regulatory-grade, real-world data, and what I mean by that is really high quality data on aggregated patients’ experience that allows us to more deeply understand how cancer is evolving in groups of patients, and how we might, as significant investors in research and development on the medicine side, how we might better improve the patient experience, either by discovering more quickly a new medicine or accelerating the way we do clinical trials or finding ways to bring ways to bring those medicines to patients more effectively. So we think this is all very much core to their mission and how we would support it.
Could you share an example about meaningful use of Flatiron’s data that convinced you that the company is worth acquiring?
DO: Yes, we’ve been partners with Flatiron now for more than two years, really working on an opportunity to use their data to accelerate access to medicine. So, what I would say is, for instance, with one of our medicines called Alecensa, which is a medicine for a rare, but particularly difficult to treat lung cancer—I’m sure you’re aware of it.
Because of the effect of that medicine in clinical trials on patients, it was approved very quickly through the regulatory authorities, and in order to support the access of this medicine in different countries around the world, different countries wanted to see more data on how the control arm of the trial would be used, given their regimen in their country.
We were able to access the Flatiron database and give them confidence on how patients on the current standard-of-care medicine would perform, and then they were able to compare that to the way that Alecensa performed in a clinical trial.
It satisfied many questions that regulators and payers had in different countries to be able to support the quicker access of Alecensa for patients. We used this data in more than 20 countries around the world and it accelerated the access for patients by more than a year for this medicine in many of those countries.
I mean, it’s particularly great news for patients, because you of all people know how fast cancer development is going and we need to be able to keep up with robust databases that are seen by regulators and payers as highly validated and highly controlled, so that gives them the confidence that the patients are going to get the benefit on our new medicines that they expect them to get and therefore accelerate the access.
How is Flatiron positioned to set the standard for creating a data analytics infrastructure that can reliably generate regulatory-grade data?
DO: Well, I think they’re very well positioned for two reasons. Number one, they have very good coverage of cancer lives in the United States, but it’s roughly 30 percent, so they have the scale in terms of the number.
And secondly, what they’ve done very differently than other companies in this field is that they’ve structured the unstructured data. As we know, in electronic medical records systems, up to 50 percent of the data is unstructured and uninterpretable in a digital format. The wealth of information that exists in that unstructured data is exceptionally important.
So, they’ve been able to structure that data, make sense of it, and they’ve done it at scale and uniquely compared to other companies in the field. We’re very interested in partnering with leaders in the field and there’s no doubt to us that Flatiron is a leader in this field and significantly ahead of other companies, and we intend to invest to accelerate that into the future.
How will the nature of Roche’s work with Flatiron differ from your development efforts with other companies that you have a stake in or a collaboration with?
DO: Our objective is to work with different companies in the field and make sure we experiment with different technologies and when we, of course, identify a leader in the field, we increase our interest and our desire to invest in them.
That was certainly the case, first, with Foundation Medicine, a company that we had collaborations with and decided that they were leaders in their field of clinical genomic profiling and it’s been the same with Flatiron and, by the way, the intersection of those two companies—FMI having the depth of genomic sequencing on a particular point in time in a patient, and Flatiron following the patient journey in a very structured and methodical way, we think also can lead to some interesting insights.
But in addition to that, we at Roche will continue to partner with other collaborators and others that are either involved in data aggregation or analysis of that data, creating insights from that data through different types of technologies, like artificial intelligence or machine learning. We think this partnership strategy is going to enhance the overall area of personalized health care for Roche.
At the end of the day, we believe that the use of digital data and being able to analyze that data is going to transform the patient experience in terms of personalized health care, making sure that, in this very complex world of oncology, we’re always looking to get the right treatment to the right patient at the right time.
And so, this will been done through ownerships, like we have with Flatiron, and complemented by other partnerships that can add to the strong foundation.
Some observers have said that this acquisition is a way for Roche to assert leadership in this space as well as a pre-emptive move ahead of other health care and tech companies. What is your response?
DO: The good news for patients is there’s a lot of investment in this space, both on the innovation medicine side and also on harnessing Big Data in health care. All of that is good news for patients, so we welcome a lot of companies investing in this area, because at the end of the day, it’s going to move the field and it’s going to move the patient experience and patient benefit.
What is Roche hoping to achieve with Flatiron over the next year?
DO: Well, the milestones are to get the acquisition completed, first and foremost. So we believe in them and we believe in their mission, we want to do whatever we can to accelerate that mission to, as I said before, continue to honor that autonomy but accelerate the mission that they were on before.
The milestones will be driven by Flatiron, and by Nat [Turner, co-founder and CEO of Flatiron] and Zach [Weinberg, co-founder, president, and COO of Flatiron] and the team, and we’re going to sit down with them and say, “How can we get there faster? How can we potentially leverage relationships outside of the Roche Group or inside the Roche Group to accelerate their mission?” We’re very much looking forward to seeing where they want to go and supporting them in their investment and their journey.
How do you envision Flatiron to change the way Roche interacts with FDA?
DO: I think we’ve been great partners in working with FDA and with other regulatory authorities around the room, and I think we’re respected for our individual expertise in competency, but coming together in looking at, very importantly, things like virtual control arms for trials in the field of oncology or looking at real-world data endpoints that will allow us to use real-world data to demonstrate the effectiveness of our medicines in broader populations.
These are things that we have been collaborating with Flatiron on and working with Flatiron on and we’ll continue to. We really want to shape the field for the benefit of patients, and when we do that right and do that well, that will transform the way that we do our business in oncology, in terms of research and development, and the regulators, I think, will be able to achieve their objectives of getting transformational medicine and innovations to patients quicker and faster and more reliably.
Did we miss anything?
DO: I don’t think so. I think you asked the questions that allow me to articulate my enthusiasm in this acquisition and just the belief in what Flatiron has achieved so far. I think this is really an opportunity to really accelerate the efficient delivery of care to cancer patients and that’s we’re all about, and I think together, we’re going to do that even stronger and even better.
