Legal Departments of the Year, Product Counseling, Emerging Companies: Exelixis
For Exelixis' legal team, getting the launch of Cabometyx right was a high stakes endeavor, but the lawyers proved up to the challenge.
November 13, 2017 at 04:00 AM
3 minute read
For Exelixis Inc., there was a lot riding on Cabometyx. The launch of the drug marked a new opportunity for success after several lean years at the oncology-focused biotechnology company.
South San Francisco-based Exelixis in April 2016 obtained U.S. Food and Drug Administration approval for Cabometyx, a therapy for patients with an advanced form of kidney cancer whose disease progressed following prior treatment. And it fell to the company's commercial and compliance lawyers to counsel their business and medical counterparts, most of whom had recently joined Exelixis, about how to be both effective and compliant as they launched the drug in a highly competitive market.
To ensure compliance, the lawyers vetted the company's go-to-market strategy, materials and resources—from product descriptions to speaker programs to advisory boards. This business-legal partnership culminated with the company's presence in June 2016 at the annual meeting of the American Society of Clinical Oncology, a prominent conference in the field and the first chance Exelixis had to showcase Cabometyx.
“We can't do our work effectively unless we have a seat at the table and work closely with our commercial colleagues,” said Bethany Fox, Exelixis' senior director of commercial legal affairs and compliance. “In order to advise them, I need to know what they're doing.”
“In our highly regulated industry, the business side needs to understand that legal must be present and around and taking part in team meetings, and legal needs to understand what their plans are,” she added. “It's really a close partnership.”
The partnership and collaboration with legal and compliance is so strong at Exelixis that over the past year, business executives have grown comfortable coming to the lawyers whenever they have questions or concerns, said Pedro Sandoval, vice president and head of compliance at Exelixis.
“In most companies, compliance is seen as a policing function, but I wanted to make sure that compliance at Exelixis is viewed as a strategic business partner and that our business colleagues understand that we recognize the complexity and challenge of their day-to-day operations,” said Sandoval, adding that compliance's routine involvement even includes riding along with sales representatives.
In August, Exelixis submitted to the FDA a supplemental new drug application for Cabometyx as a treatment for first-line kidney cancer, or for patients who had not previously been treated for the disease.
“A year ago, we were building the plane as we were flying it,” Sandoval said. “When a drug is launched for a new indication, you have to bring in a whole host of different individuals to cover different activities and functions. When you grow fast, that also creates risk. It is our job to help manage that risk and keep the company doing the right thing.”
Despite how busy the company's lawyers have been this past year, both Fox and Sandoval said they're reminded of why they work so hard when patients come to Exelixis to share stories of how the company's drugs, including Cabometyx, have helped them get well.
“We might work hard, but hearing from the patients who have benefited from Cabometyx brings our efforts full circle and makes the job worthwhile,” Fox said.
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
NOT FOR REPRINT
© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllAttorney of the Year Finalist: Michael Rubin, Latham & Watkins
Attorney of the Year Winner: Kalpana Srinivasan, Susman Godfrey
Cooley Litigation Rainmaker Mike Rhodes Set to Retire: 'It's a Good Time to Hang It Up and Do Something Else'
Trending Stories
- 1The Law Firm Disrupted: Playing the Talent Game to Win
- 2A&O Shearman Adopts 3-Level Lockstep Pay Model Amid Shift to All-Equity Partnership
- 3Preparing Your Law Firm for 2025: Smart Ways to Embrace AI & Other Technologies
- 4BD Settles Thousands of Bard Hernia Mesh Lawsuits
- 5A RICO Surge Is Underway: Here's How the Allstate Push Might Play Out
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250