Karen Gally

Karen Gally is a former General Counsel with more than 30 years of experience advising companies and their leaders on legal, regulatory, compliance, governance, and commercial matters, with deep experience in the pharmaceutical and life sciences industries. Known for providing practical, business-focused advice, Karen starts by understanding a company’s business objectives, then gives clear, achievable guidance that weighs legal risk alongside the commercial and operational realities of complex, highly regulated environments.

Karen draws on this combination of business judgment, executive leadership, and legal experience to provide solutions-oriented counsel to her clients. Her experience and current practice include:

• Advising executive leadership on corporate governance, enterprise risk, compliance strategy, policy development, and other organizational matters requiring General Counsel-level judgment
• Leading enterprise efforts on the responsible adoption and governance of artificial intelligence and other emerging technologies
• Advising on all aspects of research and clinical development to support regulatory approval by the relevant governing body (U.S. Food and Drug Administration, European Medicines Agency, and other regulators), including human subject research, Clinical Research Organization arrangements, investigator agreements, country-specific requirements, data security and privacy, and bridge and other early access programs for study patients
• Partnering on product commercialization, including compliant pre-launch activities, patient support and access programs, specialty pharmacy contracting, launch programs such as nurse education campaigns, promotional and medical material review, and compliant interactions among sales, marketing, medical, market access, and other corporate functions
• Supporting acquisitions, integrations, joint ventures, and co-promotion arrangements, including the legal and compliance issues that follow
• Serving as Corporate Secretary, including managing the Board and committee operations, recruiting and onboarding new Directors, and conducting Board skills and competency evaluations
• Guiding high-stakes government and regulatory matters, including subpoena response, investigations, strategy for interactions with federal and state agencies (e.g., the U.S. Department of Justice (DOJ) and the Department of Health and Human Services Office of Inspector General (OIG)), negotiating settlement agreements and Corporate Integrity Agreements (CIAs)
• Leading responses to FDA Notices of Violation (Untitled Letters and Warning Letters) concerning manufacturing and promotional materials
• Conducting and coordinating internal investigations
• Partnering on enterprise strategy for end of product life and loss of exclusivity.
• Supporting FDA inspections and responses to findings
• Advising on the formation and operation of a corporate philanthropic foundation
• Building and leading a sophisticated and efficient legal function, including organizational design, practice-group structure, hiring and mentoring, succession planning, outside counsel management, and legal operations

Before joining Outside General Counsel, Karen spent more than two decades with Otsuka America Pharmaceuticals, most recently as Vice President, General Counsel & Corporate Secretary. She joined Otsuka when its U.S. legal team was small and helped build the function as the company grew into a significant global pharmaceutical business. A trusted adviser to senior executives and cross-functional business leaders, she advised across the pharmaceutical product lifecycle, from clinical development through commercialization to loss of exclusivity. Her work also included complex commercial transactions (including co-promotes, acquisitions, and integrations), corporate governance, high-stakes government investigations and enforcement matters, organizational change, and enterprise risk. She also led legal department strategy, organizational design, talent development, outside counsel management, legal operations, and the responsible adoption of new technologies, including AI.

Earlier, Karen spent seven years as an associate in the National Health Law Practice at Epstein Becker & Green. She advised a diverse base of health care clients on regulatory and compliance matters, designed and managed compliance programs, and represented clients in government investigations, from subpoena response through settlement agreements with the DOJ and corporate integrity agreements with OIG.

Living outside Washington, DC, Karen and her husband enjoy the city’s cultural offerings, including the Smithsonian museums. She especially enjoys live music, comedy, and sporting events, and also looks for opportunities to combine those events with travel to new places. She also enjoys spending time with their two adult sons, who live nearby, and is currently in training for her comprehensive Pilates teacher certification.