With 23 years of experience at the U.S. FDA, Brooke brings extensive expertise in regulatory compliance and policy to ELIQUENT. As Senior Vice President of Regulatory Compliance at ELIQUENT Life Sciences, Brooke applies this deep knowledge to support clients as they achieve regulatory and quality goals and provides strategic guidance on issues related to drug product manufacturing, quality, and regulatory compliance.

Brooke spent 11 years with the Office of Manufacturing Quality at FDA’s Center for Drug Evaluation and Research, where she held roles of increasing responsibility, including Senior Policy Advisor, Acting Team Lead and Branch Chief. She was responsible for reviewing both international and domestic cases, supporting regulatory and enforcement actions, and reviewing novel technologies as part of the Emerging Technology Program. Prior to joining CDER, Brooke spent 12 years with the Office of Inspections and Investigations (OII, formerly ORA), where she began her career as an Investigator and later advanced to serve as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, she continued leading domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor.

Brooke was as a member of FDA’s inspection training course advisory groups for 15 years where she was responsible for creating and delivering technical and inspectional technique training to OII investigators and analysts, and Center personnel. She also participated in numerous domestic and international outreach events, conferences and workshops, where she delivered speeches and served as a panelist.

Brooke is the recipient of multiple FDA group and honor awards for exceptional and superior work including international quality outreach, drug product contamination response, unapproved new drug enforcement, injunction and compliance, and drug shortages.