The influenza virus constantly mutates, leaving researchers at Seqirus, a top developer and manufacturer of influenza vaccines, in a constant race to keep up.
As associate general counsel at Seqirus, Shawn Gibbs is in the thick of it. Seqirus, a division of CSL Limited, battles influenza around the world, which means the company is constantly engaging with regulatory agencies. “Negotiating commercial agreements, compliance with regulations, litigation—they’re all part of the job,” Gibbs says. “You could say it’s a broad area.”
In the pharmaceutical industry, advertising often presents a unique legal challenge. “The United States is one of the few countries to allow direct-to-consumer advertising of prescription drugs,” Gibbs points out. “But the ads must be truthful, non-misleading, and based on the label approved by the FDA. You can’t avoid mention of safety risks observed in clinical trials.”
Unlike typical pharmaceuticals, the influenza vaccine has to be approved as a new formulation each season. As such, when a new influenza vaccine is approved, it generally must demonstrate non-inferiority to an existing influenza vaccine already on the market. “More and more with the influenza vaccine, we try to talk about how the vaccine performs after it is approved by the FDA,” Gibbs explains. “By collecting and analyzing real world data, we’re able to gain valuable insight on how a particular vaccine technology performs in the ‘real world.’”
“Having military experience gives you a perspective on how to deal with adversity. You learn how to stay the course whatever the task at hand.”
Early in life, Gibbs got a taste of what it’s like to be part of an organization tackling a huge challenge. He enlisted in the US Army, and for a time was stationed in Africa as part of Operation Support Hope, a military effort to provide assistance to refugees of the Rwandan civil war.
His military experience gave him skills he has relied on throughout his career. “It gives you a perspective on how to deal with adversity,” Gibbs explains. “You learn how to stay the course whatever the task at hand. And you absolutely learn about teamwork and organizational skills.”
Gibbs used his GI Bill benefits to help pay his tuition at the University of Iowa. After earning his undergraduate degree, he worked for a time at a local clinical research organization. That experience would influence the choices he made in his career path.
“It was my first experience with pharmaceutical trials,” he says. “They were working on a drug in phase four research. In law school, I harkened back to that period and realized I enjoyed the science in that kind of work.”
Most lawyers spend some time working for a law firm after graduating law school, even if they eventually choose to work in-house. Gibbs instead took a series of jobs working his way up at various life science corporations, including C. R. Bard Inc., GE Healthcare, Optimer Pharmaceuticals, and Nestle Nutrition North America.
Then he heard about Seqirus, then newly created spin-off after Novartis had sold its influenza vaccine to CSL Limited. “I was looking for new opportunities,” he recalls, “and this was a chance to work in a start-up environment.”
Advice for Recent Law School Grads
Shawn Gibbs shares words of advice for young lawyers interested in working in-house.
- “Don’t be afraid to go down unconventional paths. Most people who become in-house lawyers work for law firms first. I didn’t. Try betting on yourself.”
- “Don’t be afraid to take on new challenges and new areas of the law.”
- “Continue to build your skills.”
The flu is often regarded as a sickness that can keep one in bed for a week and causes little lasting damage. But that’s not really true. Influenza can be deadly for some, especially the very young and the elderly. Each year, the virus claims between 290,000 and 600,000 lives worldwide. The 1918 pandemic proved fatal for more than 50 million around the globe.
The crew at Seqirus is constantly faced with new challenges when it comes to the flu vaccine. “With influenza, you need a new vaccine every year, based on World Health Organization requirements,” Gibbs explains. “Next to the human immunodeficiency virus (HIV), influenza is the most active in terms of mutation.”
Seqirus is a global company, with manufacturing and R&D hubs across the US, Europe, and Australia, and a commercial presence in more than twenty countries. Though Gibbs is based in the US, he also provides legal advice for corporate operations in Argentina, Brazil, and Canada. He relies on a small but very effective team to help assess the laws in those countries. “I have an attorney who sits at our manufacturing site in North Carolina as well as a paralegal who attends law school,” he says. “I also have a contract counsel in Argentina, a very seasoned lawyer who assists with our needs in South America.”
What’s more, Gibbs sees some big changes for the industry on the horizon.
“There’s been a lot of effort to find a more effective influenza vaccine, and a recent Presidential Executive Order sets the stage for federal agencies to provide more funding,” he says. “From a regulatory standpoint, there’s opportunity to talk more about how a vaccine performs and in-house counsels need to stay abreast of the changing laws to effectively counsel their clients.”
Ballard Spahr is proud to partner with Shawn Gibbs and support Seqirus in its global fight against influenza, clearing the way so that clients like Seqirus can focus on what counts—their mission.
