Lynda Nguyen – Regeneron Pharmaceuticals, Inc.
For those immersed in the life sciences, it can be hard to contain enthusiasm when a potential game-changing therapy goes through the pipeline after years of research and no guarantee of return on investment. But that’s when Lynda Nguyen must be especially vigilant, appropriately advising her colleagues at Regeneron Pharmaceuticals to avoid claims that can’t be fully supported by evidence.
“One of my most important jobs is to ensure that any external facing materials that describe our medications comply with all applicable laws and regulations concerning pharmaceutical products,” she explains. “Our statements concerning our medicines must be truthful, accurate and not misleading.”
As Regeneron’s executive director and assistant general counsel for global products, Nguyen has got to be a stickler for compliance as the company commercializes medications in therapeutic areas, including immunology and inflammation, and infectious diseases such as Ebola and COVID-19, and now tests an investigational medicine with the potential to reverse a genetic condition that causes loss of hearing.
She pores through the details of every press release and website update. The same goes for labeling documents that must be submitted to the U.S. Food and Drug Administration and other ex-U.S. regulatory authorities. Because Regeneron also partners with another large pharmaceutical company for overseas commercialization of one of the company’s’ blockbuster medications for various inflammatory-related conditions, Nguyen also reviews promotional materials for compliance with local laws and regulations in foreign jurisdictions.
It’s all part of her evolving role in the Regeneron legal department since July 2015. While Nguyen also possesses an extensive background in the practice of law that pre-dates Regeneron, there was a time when she might have continued enhancing the life sciences from the laboratory. That proved too confining.
“Just being in the lab was not the life I wanted,” Nguyen tells Vanguard from Regeneron headquarters in New York’s Westchester County in December. “I fell in love with the law, and as a strategic and social person, this role offers me the best scientific excellence and collaboration with my colleagues.”
Strangers in a strange land
How she became the success she is today makes for an uplifting and compelling story: in 1975, the Vietnamese-born, then 2-year-old Nguyen was brought to the United States as Saigon was falling to communist forces. Her two older brothers had to be left with relatives in the war-torn country, although they did reunite with their family four years later in Council Bluffs, Iowa, where the Lutheran Church sponsored refugees. Having been a colonel in the South Vietnamese army, Nguyen’s father toiled in a cornfield while her mother worked janitorial jobs at a hospital.
“We had nothing except unconditional love, a safe home, meals on the table and encouragement to study,” Nguyen recalls. “That’s where I got my drive to get out there.”
Life continued to improve, with her father learning English and studying engineering at night school, and in 1979, taking the family to California’s Bay Area, where IBM had offered him a job. Still, money remained tight, and for Nguyen to pursue her fascination with science, she had to take out loans and apply for scholarships and grants to attend the University of California, Davis, where she majored in biological and biomedical sciences, graduating in 1995.
And as to how that interest arose?
“We’re all made up of molecules, cells and chemicals,” she says. “I loved figuring out and understanding all the processes that make us living, walking and breathing biological specimens.”
As an undergrad, Nguyen understood it well enough to have scholarly papers published in two prestigious, peer-reviewed journals: Science and Proceedings of the National Academy of Sciences (PNAS). She went on to earn a full scholarship to Northwestern University, where she earned a doctorate in molecular biology and genetics.
Before becoming too immersed in lab work, Nguyen met a patent attorney and learned how she could combine science with law. Her stellar academic performance got her another scholarship, this time to the University of San Francisco School of Law, where she graduated with an emphasis in intellectual property and was also certified as a patent prosecutor by the U.S. Patent and Trademark Office.
IP law and her scientific credentials prepared her for patent litigation, which she did from 2004 to 2015 at the New York City office of Jones Day, then one of the few firms with a full-service intellectual property practice and subject matter expertise that included electronics, telecommunications and pharmaceuticals. Nguyen, of course, focused on the latter and eventually had an opportunity to join Regeneron’s in-house legal team. Regeneron’s headquarters near New York City and the company’s growing IP portfolio made for a good match.
At Regeneron, Nguyen spent her first five-and-a-half years in dispute resolution and putting protocols in place for the company to commercialize its drugs without litigation issues. Before she joined the company, Regeneron and its alliance partner had been sued by another company, claiming the companies infringed on its patents for a cholesterol medicine.
Nguyen was the lead in-house counsel on this case, liaising with scientists and the executive team to gather information, develop the court record and prepare for their depositions and trial testimonies. After many twists and turns through the lower halls of justice, the case finally reached the U.S. Supreme Court, which unanimously invalidated the asserted patents in May 2023. With Nguyen’s responsibilities having shifted from litigation to commercialization, she can take satisfaction in knowing that she played a crucial role in helping develop the evidentiary record used in the successful defense.
“Our medicines are discovered in-house, which is amazing,” she says. “I get to meet the scientists and get their insights. It’s unique in that perspective and a big part of what sets us apart from others in this space.”
Nguyen also appreciates the progressive corporate culture of Regeneron, a company led by two physician-scientists, Leonard Schleifer and George Yancopoulos, who co-founded it in 1988. The company’s mantra is “Doing Well by Doing Good” in action every day, and there’s a focus on elevating talent of all backgrounds at the company. Nguyen reports to a female Senior Vice President and oversees two female lawyers.
“I’m privileged to work with such talented women,” Nguyen says. “Especially in the legal and scientific community. It’s really a wonderful thing.”
Another young lady might eventually make her mark in the life sciences. Nguyen and her husband are raising a 15-year-old daughter who, without any parental prodding, aspires to be a doctor. That would enhance what Nguyen describes as the epitome of the American dream.
It’s a dream being fulfilled despite long odds. Nguyen’s memories of her family escaping Vietnam can be cloudy, but they came into focus upon her arrival and upbringing in the Midwest. Her father died in 2013, but her mother is alive and reasonably well in the Bay Area. Her family is doing well—one brother makes videos that appear on NBA jumbotrons, while her husband is an aspiring novelist and recovering lawyer.
Nguyen would like for other immigrant families to share in this American dream and empathizes with those downtrodden newcomers trying to get a foothold in a new land.
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