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
Chief of Medical Oncology: Julia Beaver, MD
Director for Regulatory Affairs and Regulatory Policy: Tamy Kim, PharmD
Director, Oncology Program Operations: Sherwin Sapasap, MS, MBA, MHA
Clinical Director Project Renewal (Acting): Sundeep Agrawal, MD
Oncology Center of Excellence Associate Directors:
Biomarkers and Precision Oncology: Reena Philip, PhD
Cell and Gene Therapy (Acting): Adnan Jaigirdar, MD
Communications: Kirsten Goldberg, MA
Education: Jennifer Gao, MD
External Outreach and Engagement: Rea Blakey, BS
Global Clinical Sciences (Acting): Angelo de Claro, MD
Global Regulatory Outreach: Dianne Spillman, BS
Oncology Devices (Acting): Dorian M. Korz, MD
Oncology Labeling: William Pierce, PharmD, MPH, BCPS
Oncology In vitro Diagnostics: Wendy Rubinstein, MD, PhD
Oncology in Older Adults and Special Populations (Acting): Harpreet Singh, MD
Patient Outcomes: Vishal Bhatnagar, MD
Pediatric Oncology: Gregory Reaman, MD
Pediatric and Rare Cancer Drug Development (Acting): Martha Donoghue, MD
Pharmacoepidemiology and Oncology RWE: Donna Rivera, PharmD, MS
Safety (Acting): Abhilasha Nair, MD
Science & Policy to Address Disparities (Acting): Lola Fashoyin-Aje, MD, MPH
Strategy and Partnership: Julie Schneider, PhD
Tissue Agnostic Drug Development (Acting): 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
- 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