Maria E. Pasquale – Incyte
When Incyte, a Wilmington, Delaware-based biopharmaceutical company, began developing a therapy using a newly discovered compound called ruxolitinib more than a decade ago, its scientists found its effectiveness in treating conditions including myelofibrosis, polycythemia vera and graft-versus-host disease. That led to the U.S. Food and Drug Administration approval using ruxolitinib orally as Jakafi to treat myelofibrosis in 2011.
Then, Incyte’s R&D teams proved ruxolitinib’s effectiveness as a cream in treating vitiligo, a chronic autoimmune disease that causes depigmentation leading to light spots and patches on skin.
It was a breakthrough—it’s estimated that vitiligo affects as much as 2 percent of the world’s population and as many as 2.9 million people in the U.S. may have it. Company researchers also discovered that ruxolitinib could be effective in treating atopic dermatitis—commonly known as eczema.
However, as Maria E. Pasquale says, Incyte couldn’t just begin selling ruxolitinib as a skin cream called Opzelura. It needed FDA approval and at the time, the company lacked the people and infrastructure needed to conduct advanced studies in dermatology and launch the drug upon approval.
“Incyte was focused on oncology but when the inflammation and autoimmunity data looked important, we chose to build an entirely new franchise,” says Pasquale, Incyte’s executive vice president and general counsel. “We needed a mindset that understood the scope of the investment. I like the entrepreneurial approach to creating a new franchise from scratch.”
Setting the structure
Incyte was established in 2002 by the merger of Incyte Genomics, which had been founded in Palo Alto, California, in 1991, with Incyte Pharmaceuticals.
The company currently operates globally with locations in North America, Europe and Asia. There are more than 800 research and clinical development employees among its staff of 2,500. Its portfolio has eight approved products, sold directly or licensed, used in oncology and for treating inflammation and autoimmune diseases. Incyte also has nearly 40 other therapies in its development pipeline.
As general counsel, Pasquale is responsible for managing the legal affairs including corporate governance, intellectual property and patent protection, business development, commercial and reimbursement considerations and manufacturing in the U.S. and globally.
To set up Incyte’s dermatology franchise, the company needed to find employees with the expertise needed to develop Opzelura. Pasquale and her team worked with the clinical team, supporting hundreds of clinical trials by ensuring data and patient information was protected, including photos showing how the drug improved the skin conditions.
“You need to be open minded about data and work with the people who know how to turn it into a clinical study with protocols with meaningful statistical endpoints,” Pasquale says.
Approval comes with responsibilities
Opzelura was approved by the FDA for use as a topical cream in patients 12 and older to treat certain types of eczema in September 2021 and to treat the most common form of vitiligo in July 2022.
FDA approval comes with its own regulatory requirements for bringing a new drug to market, Pasquale says. For instance, she and her team supported commercializing what Opzelura does without overstating its capabilities or understating potential side effects.
Legal and compliance efforts included helping Incyte have a successful launch and importantly, patient access to the drug. Pasquale and her team supported patient access by developing appropriate contracts allowing for minimal out-of-pocket spending.
Now that Opzelura has been approved for use in the European Union, she and her European legal team are working on distribution arrangements, expanded access agreements and supporting reimbursement negotiations.
“A lot of what we do is educate people from a legal and compliance perspective to empower good decisions,” Pasquale says. “I try to instill a culture where the legal and compliance teams are very accessible.”
Do the work
This was not the first time Pasquale supported setting up a dermatology franchise. She also did so at Celgene Corp., where she was the company’s first in-house counsel and held a variety of roles in 17 years, including global chief legal counsel, executive vice president and global chief compliance officer.
In fact, she hadn’t expected to leave Celgene when Incyte came calling in 2018. However, Pasquale was impressed by Incyte’s commitment to financing research—more than half of its revenues were spent researching serious diseases.
“As I learned more about Incyte, I became intrigued and I love supporting a company that’s in the growing stage,” Pasquale says. “I like creating a global footprint with a smaller workforce. It’s exciting to be a part of that kind of growth period.”
Pasquale also brings scientific expertise to her role. She says she grew up in the Bronx, New York, in a family that sometimes lacked means but placed a high value on education.
She earned her bachelor’s degree in biochemistry from the State University of New York at Stony Brook and she has endowed a summer research scholarship in her mother’s name for minority students.
While doing lab research after graduating, Pasquale became interested in patent and intellectual property law. She began attending Brooklyn Law School at night while working in research labs during the day.
Pasquale also keeps some practical career advice in mind no matter what her role may be.
“I think it’s important to be motivated but not overly focused on precisely what your career will look like in 15 years or you might close yourself off to possibilities that you never even knew existed,” Pasquale says. “I’m a nose to the grindstone-type person. I’m focused on our team and the work itself to appropriately fulfill the goals of the company. Figure out what interests you, do the best you can and prove your value. Good things will happen for you.”
View this feature in the Vanguard Summer II 2023 Edition here.
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