Maarika L. Kimbrell

During her tenure at the FDA, Maarika held a number of positions in the agency’s Center for Drug Evaluation and Research as well as the Commissioner’s Office. Maarika co-founded, established, and most recently led the Office of New Drug Policy, where she provided strategic advice and guidance on a wide range of regulatory and policy issues impacting drug and biologic products (including biosimilars) across their lifecycles, from early drug development, clinical trials, the drug review process, and approval standards and related expedited programs to development incentives such as exclusivities and vouchers, post-market regulation, withdrawals, and related user fee programs.

During the COVID-19 public health emergency, Maarika further assisted in the development and execution of policies implementing the agency’s emergency use authorities, including the development and establishment of the Coronavirus Treatment Acceleration Program.

Maarika also served as deputy chief of staff to former FDA Commissioner Scott Gottlieb, advising on policy matters involving drug products, drug pricing, and access, among other responsibilities. In connection with several earlier positions at the agency, Maarika focused on policy and regulatory issues surrounding the development and regulation of generic drugs in the Office of Generic Drug Policy.

Prior to joining the FDA, Maarika spent many years in private practice advising companies in the life sciences industry regarding the development, manufacture, and marketing of small molecule, biologic, and device products across their lifecycles. She focused on structuring and negotiating complex commercial transactions, including intellectual property–focused license and collaboration agreements and mergers and acquisitions, and conducted related due diligence and analysis.