A Conversation With Alum Lowell Schiller, Chief Legal and Regulatory Officer at Aetion

Leveraging his past government experience and considerable legal talent, Lowell Schiller found an ideally situated career opportunity with Aetion, a leading healthcare technology company in the field of real-world evidence (RWE), which is evidence generated from healthcare data collected from all types of sources outside of clinical trials. The company helps developers, purchasers, and regulators of medical products use RWE to analyze safety, effectiveness, and value.

“There is a lot of interest in real-world evidence right now,” says Schiller, who joined Aetion in 2020. He notes that COVID-19 in particular has highlighted the need to be able to derive valid and rapid insights about the use of medical products in real-world settings.

He says it is important for developers, purchasers, and regulators to analyze data using scientifically valid methods that can support high-stake decisions. “Where Aetion has led the industry is by infusing science into its technology platform to create a scalable way to generate evidence that is strong enough to support a regulatory decision about whether a product is safe or effective for a certain use.”

In his new role, Schiller oversees the legal and regulatory functions of Aetion, which include compliance, corporate quality, and policy. He also regularly helps customers work through regulatory questions about the use of RWE and data.

“We have done a lot of work involving regulatory submissions, and we understand what regulators are looking for,” he says. “It’s important to apply appropriate statistical methods in a transparent way and to be able to do so across multiple data sources.”

Of his varied projects with the company, he counts his involvement with the launch of the RWE Alliance, an industry coalition founded by Aetion and four other leading real-world data and analytics organizations, as particularly rewarding. “The reception to the RWE Alliance has been tremendous,” he says of the coalition, which advances the use of RWE in regulatory decision-making. “It’s been very gratifying to get this endeavor up off the ground and have a group of innovative companies that are able to bring expertise to policy conversations in this space.”

Before joining Aetion, Schiller held several senior leadership positions at the U.S. Food and Drug Administration (FDA) from 2017 to 2020. He most recently served as the Principal Associate Commissioner for Policy, in which he led the FDA’s Office of Policy and the development of regulations and guidance agency-wide. He also provided leadership on high-profile issues across the FDA’s jurisdiction. At the start of the COVID-19 outbreak, Schiller and his colleagues “worked around the clock to stand up policy frameworks that would support FDA and regulated entities during the pandemic.”

Schiller also served as the senior counselor to the Commissioner of Food and Drugs, and as the FDA’s acting chief counsel, stepping in for Becky Wood, who is a current partner at Sidley and at the time was a former colleague of his at Sidley. Wood rejoined the firm in 2018 and now serves on Sidley’s Global Life Sciences Leadership Council and leads the firm’s Washington, D.C. FDA and Healthcare group. In addition to Wood, Schiller had the opportunity to work with a number of other Sidley alumni at the FDA. “Working through tough problems with an incredibly talented group of people was one of the great joys of service,” he says.

Prior to his time at the FDA, Schiller spent two years on the Senate Committee on Health, Education, Labor, and Pensions, where he conducted congressional investigations and oversight and processed Senate-confirmed nominations to public health agencies. He also worked on the 21st Century Cures Act — a major piece of legislation that accelerated biomedical innovation.

“Looking back on my time on the Hill,” recalls Schiller “one thing that jumps out is how smart and dedicated the staff are. They are the people who drive so much of what happens in D.C. It’s kind of amazing how much talent is in that group.”

Schiller joined Sidley in 2007 and spent eight years as a litigation associate in the firm’s Supreme Court and Appellate practice — a group he describes as “second to none.” Working out of the firm’s office in Washington, D.C., he concentrated on appeals and dispositive motions and represented life sciences companies in matters touching on FDA policies and regulation. He developed a particular affinity for research and writing successful briefs in state and federal courts.

“Sidley made me a better communicator,” says Schiller. “More than anything else, writing memos and briefs, and doing it over and over again, really trained me on how to take a complex issue, distill it, and find a way to communicate it in plain language. It’s a skill that will serve you well — wherever you are and whatever you do.”

Beyond the challenging assignments, he says he relished every opportunity to work alongside the group’s highly regarded and accomplished litigators, including partners Carter Phillips and Peter Keisler. “What drew me to Sidley was the people. The firm has some of the best and brightest lawyers anywhere. Being able to practice at the highest level, with colleagues who are kind and respectful, wasn’t something to pass up.”

He credits these same colleagues for supporting him as he contemplated leaving the firm for a role in government service. “My mentors were more than happy to talk about my opportunities outside of the firm. I encourage every lawyer who is thinking about taking that jump to make use of Sidley’s professional development efforts and network of experienced alumni.”

Nowadays, when not juggling his various work responsibilities and the daily stressors of pandemic living, Schiller enjoys being home with his wife and children. “I will say that one silver lining of the pandemic has been the chance to spend more time with my family,” he says. “I’m very thankful for our health and for every lunch that I have with my kids.”

Published September 2021

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