This article was originally published on LinkedIn.
It’s that time of year again, and I’m feeling a little shocked at the realization that a whole year has passed since I started sharing my perceptions and observations of the oncology landscape through this forum. It’s been a year of change for me professionally – a new and exciting role, a new team and culture, a very different set of responsibilities – and a year of change for me personally, as my family and I have settled into a new home in a new city on the opposite side of the country.
I’ve been at the helm of Foundation Medicine for three months now and I can safely say that it’s been even more exciting and inspiring than I imagined. I’m surrounded by a smart, dynamic and innovative team of people, who have helped me understand the intricacies of our business as well as view the oncology landscape through a different lens.
Having spent the majority of my professional life in oncology, each role that I’ve had – from my time at Sarah Cannon to the different roles I played within Genentech and Roche – has given me a slightly different perspective of the environment. But this move has had perhaps the most powerful impact so far, because I’m now looking out at a landscape of biopharma companies as partners and not competitors and this opens up a wealth of opportunities to explore. This is another reason why I feel fortunate to join Foundation Medicine at what I think is a pivotal moment – not just for us as a company but for the field of precision medicine as a whole.
The possibilities and potential of our platforms and technology are no longer just future promises. Comprehensive genomic profiling (CGP) has become a fundamental part of the oncology research landscape and you only need to glance at the ASCO 2019 program to appreciate that. However, on the clinical side, there is still progress to be made to enable widespread global access to, and adoption of, testing for patients at diagnosis of late stage disease.
To me, this challenge mirrors the resistance still being felt today by those trying to shift the focus of our healthcare systems to prevention instead of cure, and in both cases the only thing that can accelerate uptake is expanded access and acceptance of the evidence.
When it comes to evidence, I strongly believe we are at tipping point. The evidence for the role CGP is firmly integrated in optimizing discovery and development research, and we’re shaping and advancing the science of precision medicine with our own research and that of our partners.
ASCO is my chance to better understand the priorities of existing and potential partners and what role Foundation Medicine can play in delivering molecular insights and data to help advance their pipeline molecules or better define the right populations for therapeutics already in the clinic.
It’s also about looking at the landscape as a whole and understanding where the science is heading, from emerging biomarkers to new therapeutic directions or cancer subtypes. This view allows us to identify and facilitate collaboration across industry and academia, to explore rational combinations, or maximize the utility of new biomarkers across tumor types and therapeutic areas.
But as I take a moment to reflect before the full force of ASCO hits, one thing is clear. To harness the full power of precision medicine we must aim for a future of partnership that goes beyond what is happening today. So for me, if ASCO 2018 was about complexity, ASCO 2019 has to be about collaboration if we are to truly live up to this year’s theme, “Caring for Every Patient, Learning from Every Patient”.
To identify compelling insights, to see patterns, to unlock the knowledge that grows with every person we treat and every clinical decision, we need to be able to see and analyze the whole picture from across the oncology landscape. We need volume…individuals, subgroups, populations, sites, regions, countries. We also need harmonization…a consistent approach to collection, validation, integration and access.
Is this an achievable or realistic goal? In my opinion, it’s not only achievable, it’s fundamental. What I find most exciting is that we’re now able to demonstrate that this goal is possible and that the possibilities it presents are worth striving for.
As a community we have long recognized that the combination of genomic information and real-world clinical data is where the biggest opportunities lie for the future of precision medicine. But, until recently, we weren’t able to demonstrate the value and validity of this kind of data in the real world.
This was our goal in partnering with Flatiron Health to create our clinico-genomic database (CGDB), a database that combines the genomic information from our FoundationCORE® database with Flatiron’s longitudinal, real-world clinical outcomes data. A study that validates our CGDB data as ‘research-grade’ was recently published in the Journal of the American Medical Association (JAMA); this represents a significant milestone in our precision medicine journey and is an example of one of those tipping points I spoke of before.
Why? Because the possibilities for such data to accelerate discovery and streamline clinical decision-making are endless. But more than that, alternative data sources are also becoming a necessity. As we continue to subdivide cancer into rarer subtypes with smaller patient populations, expensive and time-consuming clinical trials on their own are simply not viable if we are to maintain the progress seen in recent years.
In April, the breast cancer drug palbociclib became one of the first drugs to secure a new indication using regulatory-grade real-world data, when it was approved by the FDA for men with a certain breast cancer subtype. This approval was hugely welcome news for the small number of men living with the disease, who until now had not benefitted from the large-scale clinical trials that have driven progress in the treatment of women with breast cancer.
This example represents the acceptance of real-world data as a potential part of regulatory decision-making and I’m certain that in years to come, this will be seen as a turning point for precision medicine in oncology.
So, as we approach ASCO, a priority for me is exploring how we can build on these successes and continue to forge partnerships that harness real-world data to fuel progress in oncology. This is so critical because the future of precision medicine is not just about learning from every patient to create real-world data to inform research and regulatory decision-making, that really is only half of the story. It’s about working towards a future where clinicians have access to these datasets at point of care to help guide and inform clinical decision making. This has to be the ultimate endgame if we are to maximize the value of precision medicine and translate that to what really matters – our ability to continually improve patient outcomes in cancer.
ASCO itself is a testament to what collaboration can achieve so what better place is there to start finding answers to these questions. I’d also welcome your insights and I look forward to sharing what I’ve learned at ASCO with you when we come out the other side.