Khelin N. Aiken
Biography
Khelin Aiken is a partner in the Transactional Practice and Healthcare & Life Sciences team, based in the Firm's Washington, DC office. Khelin practices in the area of US Food and Drug Administration regulatory and compliance law. She draws on her deep understanding of the US Food, Drug & Cosmetic Act, the US Public Health Service Act, and their implementing regulations, along with her prior FDA experience, to help clients develop and achieve their strategic business objectives.
Prior to re-joining Baker McKenzie, Khelin served as Senior Counsel, US Commercial Programs at Johnson & Johnson, where she advised on complex commercial strategies for multi-billion-dollar US pharmaceutical portfolios, designing and executing commercially innovative programs built to withstand regulatory and enforcement scrutiny, and helped business teams manage fraud and abuse, False Claims Act, Anti-Kickback Statute, and related regulatory risks.
She also served as Assistant General Counsel – Regulatory, Global Life Sciences and Pharma at Philip Morris International, guiding the growth of its subsidiary, Vectura Fertin Pharma, into a B2C organization across consumer health, cannabinoid, NRT and inhalation therapy product categories. In that role, she advised on advertising, compliance, product classification, post-marketing requirements, clinical studies, health authority inspection preparation, regulatory submissions, M&A diligence, product launch processes, and quality and clinical development operations.
Khelin also previously served as regulatory counsel at the FDA in the Center for Drug Evaluation and Research, in both the Office of Regulatory Policy and in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff.
Practice Focus
Khelin’s practice bridges transactional dealmaking and FDA regulatory strategy, advising life sciences clients on major deals alongside the regulatory risk that shapes them. Her practice spans the product life cycle, from therapeutic product development plans, clinical trials, and marketing applications for prescription drugs, including biologics and generics, to the acquisitions, development and collaboration agreements, divestitures, and spinoffs that follow.
Clients seek Khelin’s counsel on developing innovative strategies for FDA regulatory approval, compliance with FD&C Act regulatory requirements for investigational and marketed products including current good manufacturing practices (cGMPs), promotion and marketing, supply chain and quality issues. Khelin regularly advises large, mid-size and emerging life sciences clients on a variety of transactional issues including acquisitions, development and collaboration agreements, divestitures, spin-offs, clinical trials and related agreements, data coordinating center agreements, steering committee charters, and steering committee member agreements. She counsels pharmaceutical and consumer product companies on cannabis and cannabis-derived product development and marketing plans. She also regularly advises clients on the development and implementation of corporate compliance and ethics programs.
Representative Legal Matters
- Co-led global regulatory counsel for Johnson and Johnson’s USD 15 billion Consumer Health Business spin-off, guiding healthcare licensing and regulatory submissions.
- US regulatory counsel for AbbVie’s USD 50 billion acquisition of Allergan, guiding product labeling, packaging, and registration strategy.
- Counseled multinational biotech companies on compliance with PhRMA Code, AdvaMed Code of Ethics, Anti-Kickback statute, False Claims Act, and Physician Payments "Sunshine" Act.
- Advised global pharmaceutical firms on digital health and combination products development strategies, including FDA submission, approval planning, and post-market compliance.
- Advised life sciences and healthcare clients on AKS, FCA, OIG guidelines and opinions, clinical trial reporting, licensing requirements, Sunshine Act/transparency laws, privacy laws, product liability, and industry standards.
- Advised research university on designing and implementing a research partnership focused on collaborations with pharmaceutical companies and contract research organizations to advance medical discoveries in the rare disease space.*
- Represented national life sciences support services company in pre-litigation breach of contract negotiations and resolution.*
- Counseled research university client on FDA pharmacy compounding, Drug Quality and Security Act (DQSA), Drug Supply Chain Security Act (DSCSA) and Risk Evaluation and Mitigation Strategy (REMS) program compliance.*
- Counseled Ecommerce firm on structuring an online market and brick-and-mortar retail for distribution of products containing CBD.*
- Drafted and negotiated a complex data coordinating center agreement, steering committee charter, and steering committee member agreements on behalf of a global biopharmaceutical company.*
- Advised and counseled health system client on fertility center quality improvement and quality assurance program.*
- Counseled drug manufacturer and technology developers on FDA product development strategy and post-market compliance issues related to innovative digital health, combination product and mobile applications.*
- Advised pharmaceutical and dietary supplement firms on FDA labeling and advertising issues.*
- Advised global pharmaceutical manufacturer on the application of the FD&C Act’s import for export provision and provide guidance on requirements for future import for export shipments.*
*Matters handled prior to joining Baker McKenzie
Professional Honors
- Executive Leadership Program, PMI, 2023-2024
- Chambers 2023 - Healthcare: Pharmaceutical/Medical Products Regulatory - Up and Coming
- Chambers USA 2022 Healthcare: Pharmaceutical/medical products Band 4
- Law 360 - 2022 Life Sciences Rising Star
- LMG Life Sciences 2020 Regulatory Firm to Watch, Winner
- LMG Life Sciences 2020 Regulatory US Rising Star, Finalist
- Fellow, Leadership Council on Legal Diversity, 2020
- Honoree, Hampton University Forty Under 40
- FDA Practice to Watch, LMG Life Sciences Award, 2020
- FDA ORP Recognition of Excellence Award, 2017, 2018
Admissions
- District of Columbia~United States (2014)
- Virginia~United States (2010)
Education
- George Washington University Law School (JD) (2010)
- Hampton University (BS) (2007)
Languages
- English