Bridging Care Delivery with Clinical Research

Craig Serra, head, commercial solutions, partnerships, Flatiron Health

In this Q&A with Applied Clinical Trials' sister publication, Pharmaceutical Executive, Craig Serra, head of commercial solutions and partnerships within the clinical research business unit at Flatiron Health, discusses the strategy behind Flatiron Health, the role of data for pharma company success, the focus on bridging care delivery with clinical research to unburden sites and patients, and more.

Pharm Exec: Flatiron Health was founded in 2012 and became a fully independent affiliate of the Roche Group in 2018. How does Roche interact with Flatiron Health?

Serra: Flatiron Health was acquired by Roche Holdings in 2018. We are an independent affiliate of the Roche Group and remain a separate legal entity. This autonomy essentially underpins our work with so many different companies—licensed life science companies, pharma companies, community cancer practices, academic medical centers, regulators, and advocacy groups. Our confidentiality obligations, which are posted on our website, outline that we keep and manage our client information completely independently from Roche.

Pharm Exec: How does the move into the clinical research business build upon Flatiron Health’s foundations?

Serra: Our move into the clinical research space was a natural progression for Flatiron. We leverage our knowledge of traditional patient care, real-world data, and interoperable technology to inform study design and enable faster, more efficient clinical research. Flatiron has been known predominantly for selling an oncology-specific EHR to community practices across the US and curating a quality standard for real-world evidence. And that’s still true today. Our ability to help advance how the industry conducts clinical research also stems from our very deep oncology and hematology expertise and world-renowned physicians, some of which are actually still seeing patients. We also work with a very large network of community cancer sites and several academic sites.

Our company’s vision is to reimagine the infrastructure of cancer care. We see huge pain points in different areas of that infrastructure that if we solved, it would also eliminate the largest pain points in clinical research.

We want to utilize the assets from all the pieces of the business. And you start to realize we could use real-world data for something other than strictly within real-world evidence. We can use those data, and we have a number of use cases that we're solving for, to apply to protocol optimization, site selection, and patient matching. We can fundamentally use these high-quality data to de-risk a clinical development program and increase the probability of success both scientifically and operationally.

The insights we can derive from these data result in far better protocols, higher quality sites used, and much more representative study participants of the population affected by a particular type of cancer. This means shorter timelines for a study, a program, or a submission, and we can easily see time-to-market ROI.

The function that I have the pleasure of forming and leading is focused on the commercial world, including business development, clinical research partnerships, product marketing, and alliance partnerships with a very select group of clinical research orgaizations (CROs) and tech partners. We listen, educate, share, and, frankly, drive lightbulb moments for our clients. Coming from more than 20 years in pharma, I love the ability to eliminate the asymmetry that exists in the clinical research ecosystem by being honest and credible. (Hopefully, both are true after 20 years!)

Pharm Exec: For pharmaceutical executives, who are not heads of clinical development, what do you think they need to understand most about clinical trials?

Serra: I want to start with the people component. The reality is that people involved in running clinical trials—by a sponsor, CRO, or a site or tech company, across this entire universe of stakeholders—are good people. It's like the old cliche of not letting one bad apple spoil the bunch. There's always some kind of exception, but not once in 20 years have I come across people that aren't trying to do the best they can within their own capabilities.

Continuing on the people front, it has to be known that the humans that are participating in a clinical trial are volunteers and it is not some sort of forced scenario. For most in the oncology and hematology world, it is life and death, and anything forced is that cancer itself is forcing them into a trial for a shot at a longer life.

Operationally, the executives need to know that clinical trials are expensive and take time for many good reasons. Not that there aren’t a lot of really bad reasons, but a primary driver is that quality evidence is hard to get. Another is that our science has become much more advanced, and low-hanging scientific fruit just doesn't exist anymore. So, scientifically, we need to get more and more evidence of sublime quality that is more compelling and differentiating versus competitors. And, of course, we can help with that.

Pharm Exec: How is Flatiron Health’s work impacting the field of oncology?

Serra: Quite simply, we want to learn from every cancer patient and we want to bring care and research closer and closer together. There continue to be less appealing studies using the same sites that have underperformed for nearly half of my life—and that’s saying something. We’ve made huge investments to do that and that extends to me, having been affected by cancer in most ways no one should ever be—and that makes this very personal.

Pharm Exec: You’ve worked at many large pharma organizations. What leadership or cultural qualities do you think make for a successful pharma company?

Serra: First, I want to acknowledge that we have quite the perpetual operational juxtaposition in our broader healthcare industry, where a letter of medical necessity created with generative AI for a $3 million gene therapy would then be faxed to someone. We’re in an amazingly complex space and so I think the focus needs to be on people and to give them a chance to succeed using their strengths. That is, after all, why they are hired, right? If you're a leader, be an exceptional leader. If you're a bad leader, be a good leader. And if you are a really bad leader, get out of there. A lot of people need to try something and hypothesis test and pivot. And if we gave people more chances like that, I think we'd see much better outcomes. It doesn't require innovation hubs or grandiose schemes; it just requires people to have the autonomy and the trust that they can explore and see what works and what doesn’t. Companies in 2023 aren’t the stoic behemoths of 70 years ago; they are dynamic, fluid, and should embrace the freedom to explore.

We also need clear decision-making. Having 50 people think the others are responsible for a decision is just as bad as two people thinking the other is responsible. So, make sure that it is crystal clear who makes a decision, when they need to make it, what inputs are required for a decision, and so on. That gives so much clarity to a workforce.

Lastly, make sure people are rewarded. We’ve seen recent chatter about ‘quiet quitting’ and other concepts that revolve around why we don’t have people staying at companies for four decades and then retiring. Whether it is someone focused on transformation or someone trying to deliver the portfolio today, have a reward system for driving towards success, thoughtful risk-taking, and drawing outside the lines.