Marc Theoret MD

Oncology Center of Excellence (OCE)/FDA As Deputy Director, I made significant contributions in driving the strategic vision, managing operations, and coordinating efforts within the OCE. I led the regulatory review of drugs and biologics for hematological malignancies, melanoma, and tissue agnostic development, aligning with the cross-product center’s mission and also within the capacity of a leadership role in the Office of Oncologic Diseases, CDER. Additionally, I initiated and managed wide-ranging programs to enhance the development and review of innovative oncology therapeutics, including immuno-oncology therapeutics, novel trial designs, oncology endpoints, oncology safety, dosage optimization, and regulatory science initiatives.

Office of Hematology and Oncology Products (OHOP)/CDER I played a pivotal role in managing operations and driving organizational transformations. Led regulatory reviews of drugs and biologics for solid tumor and hematological malignancies.

OCE/FDA OHOP/CDER

OHOP/CDER

Division of Oncology Products 2/OHOP/CDER

Genitourinary Malignancies Branch Provided clinical care and other support of Phase 1 and Phase 2 clinical research protocols evaluating novel immunotherapeutics and small molecule therapeutics for prostate cancer and other solid tumor malignancies.

National Cancer Institute & National Naval Medical Center Bethesda, MD

Tumor Immunology Section Surgery Branch, NCI Bethesda, MD Conducted Phase 2 trials and translational science studies of adoptively transferred, genetically modified lymphocytes for the treatment of patients with melanoma and other solid tumor malignancies.

Internal Medicine Residency Program Boston, MA

ACS Certified