Khelin Aiken

Khelin N. Aiken

Partner
Baker & McKenzie LLP

Biography

Khelin Aiken practices in the area of US Food and Drug Administration regulatory and compliance law. She leverages her deep understanding of the US Food Drug & Cosmetic Act, US Public Health Service Act and their implementing regulations along with her prior experience at the US Food and Drug Administration (FDA) to help clients develop and achieve their strategic business objectives.

Khelin 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 focuses her practice on leading and counseling life sciences companies from product development through the product life cycle, with a particular focus on therapeutic product development plans and marketing applications for prescription drugs, including therapeutic biologics and generics. Khelin also advises clients on strategies for addressing critical regulatory matters, including inspection observations, untitled letters, warning letters, dispute resolution issues and advisory committee comments.

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, divestitures, collaborations, clinical trials and related agreements. She also counsels pharmaceutical and consumer product companies on cannabis and cannabis-derived product development and marketing plans.

Representative Legal Matters

Prior to joining the Firm, Khelin handled the following matters:

  • 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.

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