Leadership Team

Counsel to the Company

Phoebe Mounts, J.D., Ph.D.

FDA and Regulatory Counsel to the Company

Phoebe Mounts is a partner at the law firm of Morgan Lewis. She assists clients with special protocol assessments, clinical trial agreements, informed consent forms, and interactions with Institutional Review Boards. She also provides good clinical practice (GCP) training and audits clinical trial sites in preparation for FDA review. Dr. Mounts helps clients address privacy matters related to clinical trial data, and guides them through the implementation of the Safe Harbor certification program. Additionally, she assists clients appealing decisions by the agency’s review divisions, and responding to allegations of scientific integrity of research and development programs. Dr. Mounts’ experience includes securing reclassification of a medical device and, in 2005, she received an FDA award “for outstanding teamwork and leveraging of public and private resources to support the timely down-classification of hepatitis A serological assays.” She also is an active participant in the Food and Drug Law Institute/FDA In-House Training Program. Prior to joining Morgan Lewis, Dr. Mounts was a faculty member of The Johns Hopkins University School of Public Health for 16 years, and was elected to the Delta Omega Honorary Society in Public Health. She has published more than 45 articles in the areas of molecular biology and infectious diseases. Dr. Mounts received a B.S. and M.S. from the University of Pittsburgh, a Ph.D. from the University of Edinburgh, Scotland, a PD.F. from Johns Hopkins University and a J.D. from the Georgetown University Law Center.

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