publication date: Jul. 10, 2020

In Brief

Theoret, Beaver, Kim, Amiri-Kordestani named to new positions at FDA

Marc Theoret, Julia Beaver, Tamy Kim and Laleh Amiri-Kordestani were named to new positions at FDA.

Theoret was named deputy director of the Oncology Center of Excellence. At FDA, Theoret has served as medical officer in the Division of Biologic Oncology Products and then in the Division of Oncology Products 2.  He served as the clinical team leader of the Melanoma-Sarcoma team, DOP2, from 2013 to 2017. He was also associate director of immunotherapeutics in the Office of Hematology and Oncology Products, and acting associate director of immuno-oncology therapeutics in the OCE. He was most recently the acting deputy office director, and co-led the re-organization of OHOP to the Office of Oncologic Diseases. In these roles, Theoret has led the reviews of breakthrough therapies, new molecular entities, and novel biologics. Theoret has contributed to regulatory, scientific, and policy efforts in cancer therapeutic development, in particular immuno-oncology therapeutics. He remains engaged in clinical research at the NCI Genitourinary Malignancies Branch.

Beaver was named chief of  medical oncology in the OCE. Beaver has been director of the Division of Oncology 1 since 2017. As DO1 division director she has supervised the review of multiple applications across gynecologic cancers, genitourinary cancers, palliative care, and breast cancers. Under her leadership, DO1 led the first approvals for supplements and new molecular entities under the OCE programs of real-time oncology review, project orbis, assessment aid, and point-counterpoint. Prior to serving as division director, she was breast cancer team leader and then supervisory associate division director. She has authored FDA guidances for industry, including guidances related to expansion of eligibility criteria, male breast cancer, placebos and blinding, and metastasis-free survival. Beaver … Continue reading Theoret, Beaver, Kim, Amiri-Kordestani named to new positions at FDA

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