In oncology biotech, legal teams sit at the center of efforts to advance science within complex regulatory and policy frameworks. At Exelixis, General Counsel Brenda Hefti, J.D., PhD embodies that role, aligning legal strategy together with scientific innovation and business goals. She helps deliver therapies to patients while guiding the company through litigation, IP strategy, regulatory hurdles, and shifting government policy, anchoring Exelixis’s approach at the intersection of law and science.
From science to strategy
Exelixis, a publicly traded biopharmaceutical company headquartered in Alameda, California, has spent over 30 years developing cancer therapies. The company introduced its first U.S. Food and Drug Administration (FDA)-approved drug, COMETRIQ® (cabozantinib), in 2012 after nearly two decades of research. That therapy now drives revenue and research investment. Recent filings show the cabozantinib franchise, marketed in the United States as CABOMETYX® and COMETRIQ, generates over $2 billion in annual global revenue and supports an expanding oncology pipeline.
Brenda leads the Legal and Compliance teams, guiding Exelixis’ scientific and commercial work. In addition to these functions, her responsibilities also cover government affairs and quality assurance. She handles everything from policy discussions to product launches and patent litigation. “My role is to identify risks, help leadership understand their impact and find solutions that fit our goals,” she says.
Brenda began her career in neuroscience, originally planning on academic research, but later chose a different path. After completing her PhD and a short post-doc, Brenda moved from academia to public policy. A fellowship in Washington, DC, led her to the National Institutes of Health, where she worked first in scientific policy and then in technology transfer, managing patents and licensing for research discoveries. That experience sparked her interest in biotech law. “I really enjoyed that work and wanted to continue it,” she shares.
Brenda later attended law school at the University of California Law San Francisco (UCSF), and then joined Wilson Sonsini, counselling small public and private biotech companies in corporate and transactional matters. She next moved to the UCSF, where she negotiated research collaborations and partnerships with biotech and pharmaceutical companies. That experience led her to Exelixis.
Rising through challenges
Brenda joined Exelixis more than ten years ago to negotiate clinical trial and research contracts. Shortly after, a key trial failed, triggering significant staff reductions and leaving the legal department with just two people. “I was one of the people retained,” she remembers. “From there, I
took on many responsibilities.” Over the years that followed, she built the intellectual property and transactional teams. Exelixis formalised her promotion to General Counsel in 2025.
Today, Brenda guides the legal side of product development, commercialization, partnerships and litigation. Much of her work focuses on Exelixis’ oncology portfolio and the systems required to deliver treatments safely and effectively. Cabozantinib remains central to that strategy. With annual income from net product revenue and royalties, Exelixis reinvests a significant portion in re-search on new therapies and next-generation cancer treatments.
Next in the pipeline is zanzalintinib, a novel oral kinase inhibitor currently being developed for the treatment of advanced solid tumors, including colorectal cancer (CRC), kidney cancer, neuroendocrine tumors, and meningioma. “We recently submitted our first New Drug Application for zanzalintinib, which is intended as a treatment option for patients with late-stage CRC,” Brenda explains. The FDA accepted the New Drug Application for zanzalintinib with atezolizumab in February 2026, based on data from the phase 3 STELLAR-303 pivotal trial showing statistically significant improvements in overall survival versus regorafenib in pretreated patients with CRC. The agency set a Prescription Drug User Fee Act target action date of December 3, 2026, marking a key milestone in Exelixis’ pipeline as it awaits a decision that could expand treatment options for this high-need population.
Navigating law and policy
Preparing for potential FDA approval brings unique legal responsibilities, including regulatory re-view, promotional planning, sales training, safety reporting and compliance oversight. At the same time, Brenda’s team monitors health policy changes that directly affect biotech companies, such as drug pricing reforms and FDA regulatory updates. “I was recently in Washington, DC, meeting with policymakers about FDA changes, drug pricing and other issues that affect us,” she adds.
Those policy debates create intense pressure for biotechnology companies whose revenue de-pends on a limited number of products. Drug pricing programs, negotiation frameworks and re-imbursement rules directly impact the resources companies have to reinvest in discovery and clinical development. For organizations built around a single commercial product, certain policy changes can have far-reaching consequences for long-term pipeline planning and investment decisions.
Litigation adds another dimension to the legal landscape. Since 2019, Exelixis has defended patents covering its commercial product under the Hatch-Waxman framework, which allows generic manufacturers to challenge an innovator company’s patents after a set period following a drug’s launch. In these cases, the company has protected its intellectual property and may negotiate agreements governing when generics may enter the market, balancing the need to maintain exclusivity with the realities of eventual competition. The experience has reshaped Brenda’s patent strategy. “You learn how strong patents are in litigation,” she observes. “Seeing how they are challenged and why patents survive teaches you how to prosecute them more effectively.”
Her team also manages partnerships worldwide to develop new oncology therapies. These arrangements involve detailed negotiations about intellectual property, data rights, regulatory responsibilities, and development plans. “You know you have a good agreement when everyone is fine with it, and eager to get started, but each party feels they needed to offer compromises to get it done,” Brenda observes. That balance reflects a fair allocation of risk and reward among partners.
Within the company, Brenda focuses on integrating legal thinking into business decisions as early as possible. She encourages teams to involve legal counsel during research and development, not just at late-stage milestones. “If Legal develops a reputation as the ‘Department of No,’ teams will hesitate to include us in early discussions,” she points out. Instead, she positions Legal as a partner that supports innovation and is solution-oriented while setting guardrails to protect patients, the company, and its stakeholders.
She starts each engagement by understanding the business goal behind a proposal, then works backward to propose solutions that account for regulatory, contractual, and litigation risk. “If I understand what the company wants, we can usually find a path forward while managing risk,” Brenda explains. That mindset helps her team support ambitious science and corporate goals while maintaining a strong compliance culture.
The work demands decisions amid uncertainty, as facts shift and data remains incomplete. As responsibilities expand, legal leaders must make judgments without perfect information. “As you move into senior roles, you must be comfortable making decisions with enough facts, but often without all the facts,” she notes. For Brenda, that means drawing on her scientific training, legal expertise, long experience, and understanding of Exelixis’ risk tolerance.
Brenda’s approach shapes collaboration with the executive team and Board, contributing legal expertise in research, resource allocation, partnerships and risk. The goal: deliver new therapies for patients with cancer by providing practical, risk-based legal guidance throughout the drug development process. She sees legal as an essential function for guiding Exelixis amid scientific, regulatory and policy uncertainty.
