Who We Are - Oncology Center of Excellence
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.
Oncology Center of Excellence (OCE) Leadership
Center Director: Richard Pazdur, MD
Deputy Center Director: Paul G. Kluetz, MD
Deputy Center Director: Marc R. Theoret, MD
Director for Regulatory Affairs and Regulatory Policy: Tamy Kim, PharmD
Director, Oncology Program Operations: Sherwin Sapasap, MS, MBA, MHA
OCE Associate Directors
Biomarkers and Precision Oncology: Reena Philip, PhD
Cardio-Oncology: Laleh Amiri-Kordestani, MD
Cell and Gene Therapy: vacant
Communications: Kirsten Goldberg, MA
Education: Jennifer Gao, MD
External Outreach and Engagement: Rea Blakey, BS
Global Clinical Sciences: Angelo de Claro, MD
Global Regulatory Outreach: Dianne Spillman, BS
Oncology Devices: Dorian M. Korz, MD
Oncology in Older Adults and Special Populations: Harpreet Singh, MD
Oncology In vitro Diagnostics: vacant
Oncology Labeling: William Pierce, PharmD, MPH, BCPS
Patient Outcomes: Vishal Bhatnagar, MD
Pediatric Oncology and Rare Cancers: Martha Donoghue, MD
Pharmacoepidemiology and Oncology RWE: Donna Rivera, PharmD, MS
Project Renewal Clinical Director: Sundeep Agrawal, MD
Safety: Abhilasha Nair, MD
Science & Policy to Address Disparities: Lola Fashoyin-Aje, MD, MPH
Strategy and Partnership: Julie Schneider, PhD
Tissue Agnostic Drug Development: Steven Lemery, MD
How Oncology Center of Excellence (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
CDER Office of Oncologic Diseases
- 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
Center for Devices and Radiological Health