Prior to joining the Firm, Mrs. Aiken served as a Regulatory Counsel at the FDA, in both the Office of Regulatory Policy and, most recently, the Office of New Drugs, with the Therapeutic Biologics and Biosimilars Staff. While at the FDA, she advised on the review of product development plans and marketing applications for New Drug Applications, Abbreviated New Drug Applications, and biosimilars. Mrs. Aiken also advised on policies related to over-the-counter (OTC) drugs. In her roles at the FDA, she consulted on procedures and methods related to the implementation and application of various regulations under the Federal Food, Drug, and Cosmetic Act and the Biologics Price Competition and Innovation Act.
“Khelin’s FDA background and insights will further strengthen our capabilities in the important life sciences and FDA sectors,” explained Kristian Werling, co-chair of McDermott’s Life Sciences Practice. “Our clients are operating in a constantly evolving regulatory landscape and require counsel who understand the FDA. Khelin’s FDA experience will bolster the already robust strategic regulatory advice our clients have come to expect and rely on from us.”
Mrs. Aiken’s arrival is part of McDermott’s ongoing commitment to both broaden and deepen its already comprehensive FDA client advisory offerings. As a member of the Firm’s FDA practice, she will leverage her previous FDA experience and insights to help life sciences clients develop strategic regulatory approaches for bringing products to market, navigate the citizen petition process, execute prescription to OTC switches, respond to post-approval Agency inquiries, effectively engage with the FDA, and address regulatory issues arising under the Hatch-Waxman Act.
“Khelin’s FDA experience across a variety of product-focused matters – along with developing the associated policy guidelines – will strengthen the strategic advice that McDermott’s FDA practice provides to clients every day,” explained the Firm’s FDA Practice co-chairs Vernessa Pollard and Veleka Peeples-Dyer. “With Khelin on board, the FDA team will be even better positioned to address the complex regulatory and compliance challenges facing companies in the dynamic marketplace.”
“McDermott’s Life Sciences and FDA practice groups have a track-record of advising clients on some of the industry’s most high-profile and transformative legal matters,” said Mrs. Aiken. “I’m thrilled to be joining a Firm with such a collaborative culture, and to have the opportunity to work with such outstanding lawyers as we work together to help clients achieve their goals.”
Mrs. Aiken received her JD from The George Washington University Law School and her BS from Hampton University.
McDermott’s global Life Sciences team helps fuel its clients’ missions, leveraging a purpose-built and dedicated group of lawyers with demonstrated strengths across intellectual property, regulatory, transactional, employment and litigation law. Combining industry leadership and personal passion – and leveraging the Firm’s deep health care experience – our lawyers are routinely listed as “Life Sciences Stars” by LMG Life Sciences. Additionally, our Life Sciences Intellectual Property team was ranked as a leading US practice in Life Sciences on Managing IP’s “2018 IP Stars” list.
The Firm’s Food and Drug Administration (FDA) practice helps guide clients through the complex regulatory and compliance landscape, providing counsel on the development, manufacture, marketing and promotion, and reimbursement of drugs, biologics, devices and other products regulated by the FDA. Led by a former FDA Associate Chief Counsel and a former senior executive in-house counsel to leading biopharmaceutical companies, our FDA regulatory lawyers offer deep industry experience, strategic legal advice, diverse perspectives and practical solutions that address the full scope of regulatory and compliance issues life sciences companies face.
McDermott Will & Emery partners with leaders around the world to fuel missions, knock down barriers and shape markets. With 20 locations on three continents, our team works seamlessly across practices, industries and geographies to deliver highly effective—and often unexpected—solutions that propel success. More than 1,100 lawyers strong, we bring our personal passion and legal prowess to bear in every matter for our clients and the people they serve.