Jim Kastenmayer – Viela Bio
Imagine strolling through a park splashed with the greens, yellows and reds of trees, grass and flowers. The gravel or woodchips crunch underfoot as you enjoy exercise, sunshine and good health.
And suddenly, you can’t see well or have trouble walking.
It could be an attack of a terrifying and debilitating condition called neuromyelitis optica spectrum disorder, where your own immune system barrages your optic nerves, spinal cord and brain stem.
Viela Bio, a biotech company in Gaithersburg, Maryland, has developed a medicine to treat NMOSD.
The new medicine was approved by the U.S. Food and Drug Administration in June 2020. It’s a major milestone for the company, which is dedicated to discovering, developing and commercializing novel, life-changing medicines for patients with a wide range of autoimmune and severe inflammatory diseases.
Because inebilizumab, the antibody in Viela Bio’s new medicine, was shown to reduce the risk of NMOSD relapses without concomitant use of steroids (which can cause significant side effects), it’s a significant breakthrough, according to the company’s first general counsel, Jim Kastenmayer.
And Kastenmayer would know. He’s not just an attorney—he also has a Ph.D. in biochemistry, cell and molecular biology—and he says the potential of treatments like this, and his understanding of them, bring a vibrancy to his work that is never far from the surface.
“Viela has a team very experienced in the discovery, development, and commercialization of medicines, but many of us have taken on new areas of responsibility and are doing some things for the first time,” Kastenmayer says. “I’m surrounded by other people who are learning, who I’m learning from, and who are committed to doing well and growing as they do.”
Viela Bio was founded with assets spun out of pharmaceutical giant AstraZeneca, both human and molecular. Inebilizumab is its lead asset, and there’s a pipeline of clinical and pre-clinical innovative molecules focused on shared critical biological pathways of autoimmune diseases, Kastenmayer says.
He was pleased to discover how well the company’s external legal team at Mintz Levin had positioned Viela Bio for welcoming its first general counsel after shepherding the company through its recent IPO. And while he has a deep appreciation for the science, Kastenmayer’s been very busy setting the stage for Viela Bio’s emergence on the market.
As Viela Bio onboards and deploys its sales, medical, and market access professionals, it enters a highly regulated industry, he explains. So Kastenmayer is creating the compliance program to ensure the company’s field activities meet requirements guarding against fraud and abuse.
And because Viela Bio just became publicly traded, Kastenmayer helped file its first disclosures with the U.S. Securities and Exchange Commission. As company secretary, he’s also supporting the board of directors, noting their increased interest in the company’s progress in bringing its first medicine to patients.
The company is researching whether Inebilizumab works in additional diseases, and Kastenmayer’s team is in charge of protecting IP arising from those studies, as well as IP from development and manufacturing and the other assets in Viela Bio’s pipeline.
“We pride ourselves on being a small and nimble biotech,” though one with global ambitions, Kastenmayer says.
Kastenmayer has participated in meetings with commercial partners in Asia, has worked to establish European Viela corporate entities, and looks forward to potential approvals of Inebilizumab outside the U.S. in the coming years.
Of treatises and treatments
Kastenmayer say he’s long been fascinated by the intersection of law, business and science, and his work of late has blended them in ways he could not have imagined.
After an itinerant childhood in an army family, he earned his Bachelor’s in biology at the University of Virginia. His Ph.D. in biochemistry, cell and molecular biology, is from Michigan State University, where he was also a postdoctoral fellow.
“I was already intrigued with patent law, so I took and passed the patent bar during this time,” Kastenmayer says.
He joined the National Cancer Institute as a postdoctoral fellow and later became a technology transfer fellow at the National Institutes of Health. He also began law school in the evening and eventually earned his J.D. from Georgetown University Law Center.
While in school, he went to work as a student associate at the law firm of Finnegan Henderson, gaining a deep knowledge of patent prosecution and litigation. He recalls the firm as a great place to work on cutting edge IP issues with a team of some of the most experienced lawyers in the field, but the pace Kastenmayer set for himself was exhausting.
“Although rewarding, it was tough working during the day and going to school in the evening,” he says. “It was probably the only thing where I thought if ‘I had to do this again, I wonder if I would have done it differently.’”
After earning his J.D., Kastenmayer became a patent attorney at the firm, and subsequently entered the biotech field as IP counsel at MedImmune, where he spent honed his in-house skills as a patent attorney for several potential medicines.
He next joined AstraZeneca as a senior patent director, reuniting him with the lawyer who had headed the IP team at MedImmune, and who continued to have a major positive impact on Kastenmayer’s development as a lawyer. The move eventually brought a big shift in his career when he was asked to assume a general legal role, taking on contract litigation and advising commercial teams.
This experience opened up new areas of the law and business, giving him an opportunity to work with a highly skilled team of Williams & Connolly lawyers on a contract litigation. While surprised at how much he enjoyed working with and learning from the in-house legal team on a variety of issues, taking on new challenges does fit a pattern.
“Generally, I find I am interested in just about everything, and really enjoy working with smart, inquisitive people who are dedicated to bringing potentially life-changing medicines to patients and who are energized by new challenges” Kastenmayer says. “Viela Bio is full of people like that.”
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