Khelin Aiken supports life sciences companies as they develop innovative products and bring them to market, with particular focus on therapeutic product development plans and marketing applications for prescription drugs, including therapeutic biologics and generics. She also advises on policies related to over-the-counter (OTC) drugs. Prior to joining McDermott, Khelin served as regulatory counsel at the Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research, first in the Office of Regulatory Policy, and most recently in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff.
Khelin’s time at the FDA makes her uniquely positioned to help clients develop the strategic regulatory approaches necessary to bring drugs to market, navigate citizen petitions and execute Rx to OTC switches, all while maintaining a competitive advantage.
Prior to joining McDermott, Khelin also served as an adjunct professor at The George Washington University School of Law.
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