Authorized by the 21st Century Cures Act, the OCE was established on January 19, 2017, to facilitate the development and clinical review of oncology products by uniting scientific experts across the FDA’s product centers to conduct expedited review of drugs, biologics, and devices.
Center Director: Richard Pazdur, MD
Deputy Center Director: Paul G. Kluetz, MD
Immunotherapeutics (Acting): Marc R. Theoret, MD
Regulatory Affairs: Tamy Kim PharmD
Pediatric Oncology: Gregory Reaman, MD
Medical Policy: Patricia Keegan, MD
Oncology Devices (Acting), also Chief Medical Officer, Office of Surgical and Infection Control Devices, CDRH: Dorian M. Korz, MD
Oncology In vitro Diagnostics (Acting), also Director of Personalized Medicine, CDRH: Wendy Rubinstein, MD, PhD
Cell and Gene Therapy, also Chief of Oncology Branch, CBER/OTAT: Ke Liu, MD, PhD
Neuro Oncology: Joohee Sul, MD
Research Strategy and Partnership: Julie Schneider, PhD
Global Regulatory Outreach: Dianne Spillman, BS
Communications: Kirsten Goldberg, MA
External Outreach and Engagement: Rea Blakey, BS
Education (Acting): Jennifer Gao, MD
Patient Outcomes (Acting): Vishal Bhatnagar, MD
How OCE Review Works With FDA Product Centers
Applicants submit applications to the product center they normally would, and those centers decide whether the product will be under an expedited program. For products selected, the OCE forms a Medical Oncology Review and Evaluation (MORE) team that includes a medical oncology specialist and specialists from the relevant product center.
The MORE team:
- Provides a unified clinical review to promote development of safe and effective oncology products.
- Builds on cross-center collaboration by providing input to selected INDs that are under expedited program.
- Implements common decision-making standards for Breakthrough Therapy and Fast Track designation for all oncology therapeutic products.
The completed clinical review is sent to the product center, which makes the final application approval determination, taking into account both clinical and non-clinical information.
FDA Product Centers Working With OCE
- Immediate Office
- Division of Oncology 1 (DO1)
- Division of Oncology 2 (DO2)
- Division of Oncology 3 (DO3)
- Division of Hematologic Malignancies 1 (DHM1)
- Division of Hematologic Malignancies 2 (DHM2)
- Division of Hematology Oncology Toxicology