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Steven Lemery named acting associate director of Tissue Agnostic Drug Development at FDA’s OCE

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Steven Lemery was named acting associate director of Tissue Agnostic Drug Development within FDA’s Oncology Center of Excellence.

Lemery will continue as division director for the Division of Oncology 3.

Lemery joined FDA in 2006 as a clinical reviewer in the Division of Biological Oncology Products, which ultimately re-organized into the Division of Oncology Products 2. He served as team lead on the Gastrointestinal Malignancies team in the Division of Oncology Products 2 where he supervised the review of multiple original and supplemental applications.

Subsequently, he assumed the role of the supervisory associate division director in DOP2, primarily leading activities for the melanoma/sarcoma and pediatrics/rare malignancies teams.

More recently, he has assumed the role of acting director of DO3 and is a member of the Medical Policy and Program Review Council. In various roles, he has contributed to Office- and OCE-led regulatory or policy initiatives. These have included both biosimilar development and tissue agnostic development.

In his new role in the OCE, Lemery will focus on scientific and policy efforts related to tissue agnostic drug development and lead outreach and education in this topic.

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