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Zana Holley Dupee

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Practice Areas

Business Law: Business Contracts, Business Dissolution, Business Finance, Business Formation, Business Litigation, Franchising, Mergers & Acquisitions, Partnership & Shareholder Disputes

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Professional Experience

Fractional Biotech COO & General Counsel: Life Sciences BioPharma Company Clients; 2025 - Current; Support biotech companies in navigating complex regulatory, compliance, and operational challenges. My services encompass a wide range of regulatory, legal, compliance, and strategic functions, including: - Fractional CXO Services: Serve as a fractional General Counsel and Chief Operating Officer to guide companies through operational challenges, streamline processes, and enhance organizational effectiveness. - Legal Guidance: Provide expert legal advice on compliance with FDA regulations, intellectual property rights, contract negotiations, and corporate governance. I ensure that companies stay informed of legal developments and best practices. - Operational Strategy: Collaborate with executive teams to develop and implement efficient business strategies that align with organizational goals. I focus on optimizing operations, enhancing productivity, and driving growth. - Business Development: Negotiate technology licenses and sponsored research agreements to drive growth

Sr. Director, Legal: Solid Biosciences; 2022 - 2025; - Offered legal support on corporate, compliance, and regulatory matters; Drafted unanimous written consents (UWCs), documenting key approvals from Board of Directors; Drafted company policies to align with regulatory requirements; Collaborated with cross-functional teams to address governance-related issues; Updated and maintained data room for due diligence during financing activities, ensuring relevant documents were organized, accurate, and accessible. • Managed contracts team, which reviewed 1,000+ contracts annually. • As Privacy Officer, oversaw compliance with HIPAA and GDPR, safeguarding sensitive information, and implemented a best-in-class document retention system. • Partnered with Quality to craft compliance policies that better positioned the organization to respond to FDA inquiries. • Worked closely with Clinical Operations to facilitate the seamless execution of clinical trial agreements (CTAs) and preparation of informed consent forms (ICFs).

Sr. Director, Legal: AavantiBio; 2020 - 2022; As the first non-scientist full-time employee, I played a vital role in building the company during its rapid growth, scaling from 5 to 90 employees in 18 months. Working closely with the COO and General Counsel, establishing operational frameworks, and supporting a $107M Series A across multiple tranches. Key Responsibilities: - Corporate Governance: Offered legal support on corporate, compliance, and regulatory matters; Prepared and maintained minutes for Board of Directors meetings; Drafted and managed unanimous written consents (UWCs), documenting key approvals; Presented to executive team and Board of Directors; Developed and implemented company policies to align with regulatory requirements; Collaborated with cross-functional teams to address governance-related issues; Updated and maintained data room for due diligence during financing and M&A activities, ensuring that relevant documents were organized, accurate, and accessible to facilitate smooth transactions.

Contracting Officer: University of Florida Office of Research; 2014 - 2020; As a Contracting Officer in the UF Office of Research, I supported the College of Medicine and the College of Pharmacy by reviewing and approving research agreements and grants with corporate, non-profit, federal, and international sponsors. Key Responsibilities: - Research Agreements: Assisted researchers with the review and approval of research agreements and grants, ensuring compliance with institutional standards. - Scope of Work and Budget Review: Collaborated with Principal Investigators (PIs) and Department Administrators to assess the Scope of Work (SOW) and budgets for funded projects. - Export Control Compliance: Conducted preliminary Export Control reviews to ensure research fit within the Fundamental Research Exclusion, working with UF Compliance Officers to adhere to Export Administration Regulations (EAR) and International Traffic in Arms Regulations (ITAR). - Intellectual Property Negotiation: Partnered with the UF Innovate Tech Licensing office to negotiate IP