Harmony Biosciences was founded in 2017 with the goal of providing new and novel options for rare and orphan diseases, with a focus on central nervous system disorders like narcolepsy. Though still in its infancy, the company’s investigational product is under review by the FDA, and it has the potential to bring a novel, first-in-class treatment option to people in the US living with narcolepsy. The fast pace of an emerging life sciences company is an ideal destination for Harmony’s general counsel and compliance officer Stephanie Wisdo, whose background enables her to bring a varied background and diverse perspective to her role at Harmony. Wisdo has done it all, from employment law to litigation. But it’s her seven years as a pharmacist that no doubt have given her a distinct advantage as in-house counsel at the biopharmaceutical company. As Harmony Biosciences matures, Wisdo tackles her dual role to help shape the emerging company’s processes and practices.
After spending seven years both in hospital and retail pharmacy roles, Wisdo says the transition to law came at a time when a transition made sense. “I had been in pharmacy since I started pharmacy school at eighteen, and now I was thirty and wondering what else was out there,” she says.
Such a dramatic pivot didn’t provide Wisdo with many role models to emulate, but it may have turned out to be for the best. “I didn’t know any lawyers when I started the process, and I really had no idea what I was getting myself into,” Wisdo says. Starting out in a new career, working long hours, and tackling junior-associate tasks was challenging. After a stint in employment law, Wisdo moved to a construction law firm where she gained more practical experience running her own cases. It also became clear to her that a career in litigation wasn’t where Wisdo wanted to wind up.
She left her role to devote her full attention to passing the patent bar exam. “Everyone said I was crazy to leave without a job, but to have any meaningful chance of passing the patent bar my first time, I needed to study all the time,” Wisdo says. That decision paid dividends, as Wisdo did pass the bar, and patent law opened up an entirely new set of experiences for her. That patent law experience has helped Wisdo with everything from negotiating contracts to understanding life cycle management. In addition, advising on IP matters is now one her of day-to-day duties, she says.
As both general counsel and compliance officer, Wisdo’s multitude of law and pharma skills are ideal for the number of roles she finds herself inhabiting on any given day. “It’s great to have a baseline understanding on a variety of issues,” Wisdo says. “It means that I’m able help when it comes to finding solutions, even when it’s from a pharmacy service or patient service perspective.”
“Staying up to date on the science of what’s happening in the market is helpful.”
Wisdo’s early years in hospital pharmacy still inform the way she approaches her legal role. “There was one pharmacist I worked with a lot, and whenever he worked, there was a line of nurses down the hallway coming to him with questions,” Wisdo says. “His personality and his approachability is what made everything work there.”
Wisdo learned that no matter what the occupation, be it a hospital pharmacist or in-house legal counsel, making people feel heard, understood, and appreciated often goes just as far as the advice itself. “I try to drop whatever I’m doing and to be approachable,” Wisdo says. “You have to make time for people.”
Wisdo’s credibility is further enhanced by the fact that she is still a registered pharmacist, staying current with continuing education requirements. “I think a lot of people who work in-house in pharmaceuticals only really learn about the medicines that their companies develop,” Wisdo says. “Staying up to date on the science of what’s happening in the market is helpful.”
Although Wisdo says there are more pharmacists-turned-
lawyers in law today, she says that those looking to duplicate her journey should be ready for anything. “Try not to go in with any preconceived notions of the job you will have,” Wisdo says of a continuingly difficult employment market for pharmacists, but lawyers even more so. “Just embrace that you have taken time to start a new career and see where it takes you.”
Emerging biotech companies face many challenges when launching a product in the US. Stephanie Wisdo brings years of experience helping emerging companies understand the legal and compliance landscape and help them build a sustainable compliance infrastructure from the beginning. KPMG’s partnering with Stephanie has also helped to operationalize the complex requirements of the government markets in the US.