Ariane M. Horn: Navigating the Regulatory Labyrinth to Save Lives

Emily was a “child destined to die,” according to doctors at Children’s Hospital of Pennsylvania. Diagnosed at five years old with acute lymphoblastic leukemia, she had failed all conventional treatments, leaving her parents hoping for a miracle.

“Everything Ariane does helps patients get access to life-saving therapies.”

– Lynn Robson  

They found one in a drug that was ultimately licensed by Novartis, and today, Emily is healthy and cancerfree, providing a success story for her family and physicians— and for lawyers who work behind the scenes, helping bring life-saving treatments to market.

Cornell Law School alum Ariane Schreiber Horn, A.B. ‘91, J.D. ‘96, is undaunted by the labyrinth of regulations that govern access to medications. “Every day, I’m talking to companies about rare diseases, orphan drugs, new treatments for cancer, and pharmaceuticals that can have a profound impact on patients,” says Horn, partner in the Washington, D.C., office of Arnold & Porter Kaye Scholer. “I get to advocate for the patients, n and it’s great to play even a small part in something that can transform and save lives.”

“Producing a drug that is safe and effective is only part of the story in the pharmaceutical industry,” says Viktoriya Bisker, global legal head of hematology and cell & gene at Novartis. “The other part is ensuring the right patients get the right medication at the right time. Cellular therapy [like the drug that helped Emily] is cutting-edge and a one-time potentially curative treatment. The regulatory space wasn’t designed for this type of drug. There was no framework in place, and that’s where we needed Ariane.”

“Everything Ariane does helps patients get access to lifesaving therapies,” says Lynn Robson, vice president and associate general counsel of market access for United Therapeutics. “She stands out in her understanding of the players, from both business and legal perspectives, in the market access ecosystem. Ariane’s contract drafting is second to none, and her breadth and depth of experience give her an edge when it comes to helping companies manage risk while accomplishing business goals.”

Horn did not foresee this career path when she entered Cornell Law School. In fact, she took two years off after graduating in 1991 with a bachelor’s degree in history from Cornell and headed to Washington, D.C., to be a Congressional intern and then staffer.

She loved the energy of the city and loved watching the political process. “I wanted to pressure-test law school and not just do it because it was the family business,” says Horn, whose parents and paternal grandparents were lawyers. “My mother went to law school when I was six years old. During her first year, she’d come home from school and tell me the fact patterns from her torts class. I was a six-year-old who knew what torts were!”

Horn returned to Cornell, focusing on litigation in her law classes. (“I grew up in the era of L.A. Law and was a theatre kid in high school!”) But she discovered she really didn’t like conflict and the adversarial nature of litigation. “When I interview Cornell law students, I often tell them that they have to try on a lot of coats before they find the one that fits just right,” says Horn. She says at most law schools, there’s not a clear path to the kind of regulatory practice she has now. But she’s very detail-oriented, loves building arguments, and always wanted to use the law “to do something worthwhile.”

She found a perfect match in the pharmaceutical industry: “I want to believe in the client and what they are doing, and I want to help them do what they need to do compliantly and avoid litigation.” She also sought the kind of job that would allow her to balance career and motherhood. She found that at Schering-Plough, which subsequently merged with Merck & Co. “I learned how to be a counselor, how to work with a team on a common goal, how to build something truly meaningful together. I found my right coat.”

While at Schering-Plough and Merck, she learned the value of great outside legal counsel working with a team at Arnold & Porter that included Jeff Handwerker, who ultimately recruited Horn to her current position. “I watched Ariane in-house as she spoke to a business executive and explained the complexity of the law as it related to business goals,” says Handwerker, a partner at Arnold & Porter. “It was a message he did not want to hear, but she did it so deftly, he understood it and respected it. I could tell that Ariane had what it takes to be successful.”

Recently, Horn was named a 2023 BTI Client Service All- Star, based on interviews with 350 top legal decision makers at organizations with at least $700 million in revenue. “Ariane puts herself in the shoes of the in-house counsel. She can relate to business clients in the complex pharmaceutical space, playing the inside role with an outside perspective,” says Handwerker. “There is not a single person in any outside firm who can do that. Ariane is also incredibly hard-working, practical, and smart, and her writing is crisp and clear.”

All qualities necessary to help bring a drug to patients, especially when the regulatory hurdles are high. In the case of the therapy that saved the life of Emily, there were multiple issues from the very beginning. Patients would need to stay near a hospital for several weeks after treatment, and that’s costly—how could they be financially supported with travel assistance or lodging or meals without violating the law? “For more than two years, we engaged with government regulators, answering their questions, demonstrating value to the patient every step along the way,” says Horn. “I was educating and advocating. What my clients are doing is simply amazing. I am just helping them achieve their goals in compliance with the law.”

“Ariane has truly mastered the advisory opinion work with the OIG and forged a roadmap for others,” says Handwerker, talking about Horn’s work with the Office of the Inspector General for the Department of Health and Human Services. “She is great at framing an argument in the way the OIG will appreciate, and then backs it up in her presentation. She understands how to take another point of view and fit it into an argument that makes sense. In this work, Ariane is on the front line of helping companies that are making the drugs that save lives.”

“We had solid legal arguments and we also had to make solid ethical arguments,” says Bisker. For Bisker, it was especially sweet to have Horn by her side. Bisker had received her law degree and a master’s in bioethics at the University of Pennsylvania, where scientists developed the compound that led to the Novartis drug used by Emily. Years later, the two women worked together to apply what was once just a life-saving idea to actually saving a life.

In being able to navigate through the maze of ever-evolving regulations, Ariane Horn is carrying on in the tradition of her namesake. “My mother wanted my name to pay tribute to my Greek heritage,” says Horn. Ariane is a tribute to Ariadne, a figure in Greek mythology who was deified after helping Theseus find his way out of a seemingly unnavigable labyrinth.

Little did Ariane’s mother know that the child who was learning fact patterns at age six would grow up to be one of the nation’s leading experts in presenting compelling arguments that save lives. “Sometimes you have to work for years to get through the regulatory process,” says Horn, “but at the end of the day, it’s very rewarding.”

~ Eileen Korey