The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Julie A Schneider; Yutao Gong; Kirsten B Goldberg; Paul G Kluetz; Marc R Theoret; Laleh Amiri-Kordestani; Julia A Beaver; Lola Fashoyin-Aje; Nicole J Gormley; Adnan A Jaigirdar; Steven J Lemery; Pallavi S Mishra-Kalyani; Gregory H Reaman; Donna R Rivera; Wendy S Rubinstein; Harpreet Singh; Rajeshwari Sridhara; Richard Pazdur

doi:10.1158/1078-0432.CCR-20-4429

The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Clin Cancer Res. 2021 Oct 1;27(19):5161-5167. doi: 10.1158/1078-0432.CCR-20-4429.

Authors

Julie A Schneider¹, Yutao Gong¹, Kirsten B Goldberg¹, Paul G Kluetz^{1

2}, Marc R Theoret^{1

2}, Laleh Amiri-Kordestani², Julia A Beaver^{1

2}, Lola Fashoyin-Aje^{1

2}, Nicole J Gormley², Adnan A Jaigirdar^{1

3}, Steven J Lemery^{1

2}, Pallavi S Mishra-Kalyani⁴, Gregory H Reaman¹, Donna R Rivera¹, Wendy S Rubinstein^{1

5}, Harpreet Singh^{1

2}, Rajeshwari Sridhara¹, Richard Pazdur^{1

2}

Affiliations

¹ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
² Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
³ Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
⁴ Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
⁵ Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.

Abstract

The FDA Oncology Center of Excellence (OCE) is a leader within the agency in scientific outreach activities and regulatory science research. On the basis of analysis of scientific workshops, internal meetings, and publications, the OCE identified nine scientific priority areas and one cross-cutting area of high interest for collaboration with external researchers. This article describes the process for identifying these scientific interest areas and highlights funded and unfunded opportunities for external researchers to work with FDA staff on critical regulatory science challenges.

MeSH terms

Humans
Medical Oncology*
Research Report*

Grants and funding

FD999999/ImFDA/Intramural FDA HHS/United States