It is nearly impossible to find anyone in the United States whose life has not been touched in some way by cancer. Flatiron Health wants to change that.
The healthcare technology company’s OncoCloud software—an EMR management system—helps doctors manage patients and their practices. But the company also structures and standardizes anonymized information from the EMRs (in compliance with HIPAA) to give researchers and clinicians access to a broader spectrum of clinical data to help accelerate research and improve treatment options.
To date, approximately 2,600 clinicians and administrators are using the technology at about 260 cancer centers. Flatiron also provides data sets and insights to three academic centers and about fifteen life science companies.
Flatiron’s general counsel, Marc Berger, joined operations in early 2016. He was drawn to the company’s primary core value—to solve problems that matter—and its mission to improve cancer treatments and research. But he was also compelled by his own fascination with how technology affects all aspects of everyday life.
“Technology has changed how we shop, communicate, and access entertainment,” Berger says. “Besides having a mission that I wanted to be part of, Flatiron offers the potential to disrupt the healthcare industry in tremendously beneficial ways.”
When he arrived, the company was doubling its headcount annually. Raising awareness of the types of issues that the legal function could assist with was among his first objectives. To accomplish this, he developed a formal onboarding process that provides documented policies and procedures regarding codes of conduct, compliance obligations, how to execute contracts, how to work with vendors, and other essential guidelines.
Because he was the company’s only in-house lawyer at the time, Berger was also negotiating contracts and partnerships and collaborating on business development initiatives. As timing would have it, he had to close the company’s largest contract to date in his first few weeks on the job. The contract had been a year in the making and would create an even larger footprint for the company in the oncology space.
“We work collaboratively, but there was tremendous pressure for me to establish trust and credibility internally and with the client, all while explaining the nuances of data rights regarding patient information, service-level commitments, and how we stay compliant with all the applicable regulations,” he says. “I was definitely facing trial by fire.”
High-Level Partnerships
Adding the clout of Google Ventures as an investor in 2012 was just the beginning for Flatiron Health. In the spring of 2016, it signed a research collaboration agreement with the Food and Drug Administration to determine how deidentified, HIPPA-compliant patient data captured outside of clinical trials can provide new insights into the safety and effectiveness of emerging anticancer therapies. Part of this initiative will investigate using immunotherapies in patients with advanced nonsmall-cell lung cancer.
Since then, the legal department has grown to include Allison Canton, who specializes in healthcare transactions and regulatory issues; a chief privacy officer; and David Lindemeyer, a specialist who assists with contract negotiations. The company has already received HITRUST’s CSF certification for protecting and ensuring the quality of its technology.
When it was founded in 2012, one of Flatiron’s first backers was Google Ventures, which also led the company’s Series B funding round in 2014. In addition to the importance of that name recognition and financial backing, Google Ventures has provided critical support in areas such as branding, design, and business strategy.
Flatiron also stays in close contact with the Food and Drug Administration and the National Institutes of Health, which enables the company to stay current with all existing and evolving compliance requirements and to educate the agencies on the reliability, safety, and efficacy of its processes. This includes, for example, spotlight projects in which Flatiron provides clients with data tailored to specific types of patients, cancers, and drugs. Those data sets can then be used to help identify treatments or combinations of treatments that are producing better outcomes. These relationships have even led to Flatiron partnering with the FDA to investigate certain types of therapies.
As the company grows, one of Berger’s priorities is to preserve the start-up culture that attracted him and many others to work there. He’s quick to point out that that means much more than open work spaces, casual dress codes, and free daily catered lunches.
“As general counsel, I’m largely responsible for ensuring we adhere to all the necessary rules and regulations of our industry,” he says. “But I also want to be sure not to create an environment that is too bureaucratic and stifles the culture that makes this such a great place to work. We’re not working on self-driving cars or a hotel-booking system. Everyone here is dedicated to making a real difference in the lives of people with cancer.”
To illustrate, he recounts a group of cancer survivors who came to a company-wide meeting to share their stories. Their points of view helped further clarify the impact that Flatiron’s contributions to immunotherapy, genomic research, and other emerging treatments can have.
Berger says the personal nature of that experience made them want to work even harder and gave even more meaning to one of the company’s other priorities: “put the interests of patients first in everything you do.”
Ed Zimmerman, Peter Ehrenberg, Eric Weiner, Nick Mehler, Julie Werner, and the Tech Group at Lowenstein Sandler LLP congratulate our friend and client, Marc Berger.
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