Preparing for Pharma’s Next Big Legal Hurdle

Cinda Serianni knows—she built Gilead Science’s legal department from the ground up to keep the award-winning biopharmaceutical company growing and innovating

Gilead Sciences is making a mark in the biopharmaceutical world: the $25 billion company has more than eight thousand employees across six continents, working on developing innovative medicines for life-threatening illnesses like HIV/AIDS, liver disease, and cancer.

The organization hired Cinda Serianni in 2008 as its first—and for years, its only—in-house counsel and member of the leadership team for its Canadian affiliate. Advantage caught up with Serianni to hear what it’s like to jump from a large firm to a thirty-three-person office, growing with the affiliate as it expanded to over one hundred employees, and shaping the Gilead Canada legal department.

What were the challenges to being Gilead Canada’s first in-house counsel?
While difficult, it was an opportunity to come on board with a clean slate. That doesn’t happen very often. Were there challenges? Absolutely. I was a team of one. I came from a previous job where we had four lawyers, which offered an environment of collaboration.

To create that same sense of collaboration at Gilead Canada, I built a team of advisers. I got to know my colleagues in Foster City (Gilead’s California headquarters), as well as my outside counsel—both of whom I could call and bounce ideas off of—as well as other colleagues in the industry. It has been an immeasurable help to work with such a talented, hardworking, and conscientious group of colleagues, as well as an experienced general manager.

As the business grew, the issues became more complex, and I was required to prioritize and make use of external resources to survive.

“What we’ll see is more transparency. It’s making things more accessible to the public.”

How would you describe your management style?
First and foremost, I make the business the most important. I see myself as a business partner, contributing leadership beyond pure legal issues. However, as legal counsel, I have to be prepared to sometimes take unpopular positions, which is important when I am the business conduct lead. Today, I am fortunate to have a staff of two lawyers by my side. The priority I set for my staff remains being responsive to the needs of the business. I ensure that we’re connected through weekly one-on-ones and meet as a group twice a month. It’s important for our team to share what we are each working on to allow for collaboration.

What’s your approach to working in the pharmaceutical industry, which is so highly regulated?
How we do business is really important. Our primary focus is to ensure that we’re always acting in the best interest of patients and in compliance with laws, regulations, and industry rules, as well as our own code of ethics. At Gilead Canada, everyone owns the business conduct.

I challenge our employees to think of compliance as an effective business tool that is part of everything we do, and not an end in and of itself.

So shifting the perspective?
Exactly. Training is an important part of any compliance program. Because of the nature of this kind of training, I like to make it as interactive as possible. This year at our national business meeting, we used touch-point technology, video vignettes using real-world examples, and our own employees to make the training as relevant as possible. We use other learning formats, including e-learning modules that have an emphasis on engaging the learner.

Are there any differences working on the Canadian side of Gilead?
For the most part, the market is similar, and my colleagues to the south face many of the same issues we face here. The United States may be more formally regulated, but many of the same compliance practices have been adopted by Canadian pharmaceutical companies and Innovative Medicines Canada. Over time, I believe our environments will become much more similar.

Another critical difference is that Canadian pharmaceutical companies are prohibited from marketing prescription medications directly to consumers.

What are you working on right now that’s got you excited?
One program I’m proud of is our Gilead Canada Grants Program. I’m the chair of the committee, and last year we were fortunate to provide more than $1 million to charitable or not-for-profit organizations in support of initiatives that will improve healthcare for Canadians. We support academic or medical fellowships, community health initiatives, and patient education programs. Generally, our funding aligns with the therapeutic areas in which we work—like HIV/AIDS, liver disease, and oncology.

What does the future of the pharmaceutical industry look like from a legal point of view?
What we’ll see is more transparency. Health Canada has recently introduced a regulatory transparency and openness framework. It’s making things more accessible to the public: Health Canada introduced a searchable online database for drug and health products that will include consumer information for uses, safety warnings, and side effects. Health Canada also announced it would begin to post previously unavailable inspection information for drugs, medical devices, and other health products.

There’s also a movement toward greater transparency in the relationships between pharmaceutical companies and other stakeholders, such as physicians and other healthcare organizations. Gilead Canada has joined a number of other member companies of Innovative Medicines Canada, which will be implementing a voluntary framework to capture and report payments to healthcare professionals and organizations in an aggregated fashion. This kind of reporting is new for Canada.