A key priority of the Oncology Center of Excellence (OCE) is providing education, insight, and transparency on the role of the FDA in oncology product development.
The goal of Project Socrates is to build an educational network bridging the OCE and the public, focusing on regulatory policy and science.
Through partnerships with professional societies, the OCE hopes to extend the breadth of its educational outreach and engagement.
OCE Regulatory Science Webinars
In 2022, OCE is launching a new online regulatory science webinar lecture series, aimed at providing an overview of the OCE’s role in oncology product development. This page will be updated periodically with new topics:
Episode 1: FDA’s role in Oncology Product Development
Episode 2: Oncology Trial Design Considerations
FDA-AACR Educational Oncology Fellowship
In 2020, the OCE established a new FDA-AACR Oncology Educational Fellowship, developed in collaboration with AACR. Launching in October of 2020,the OCE will welcome approximately 20 fellows with an MD, MD/PhD, PhD, and DO background to a series of virtual educational sessions on topics in oncology drug development. More information is available on AACR's website and in the AACR Cancer Research Catalyst guest post.
FDA-ASCO Hematology and Oncology Workshop
The FDA-ASCO Hematology and Oncology Fellows’ Day Workshop welcomed approximately 50 fellows to a virtual session on October 30, 2020 to learn about the FDA’s role in oncology product development. Through case discussions based on recently approved oncology products, the workshop discussed considerations around investigational new drug (IND) applications, expedited pathways, expanded access, and licensing applications, to name a few.
Project Livin’ Label
Oncology product labels contain essential information needed for the safe and effective use of the product, such as indication, dosing, dose modifications, and much more. However, many are unfamiliar with the product labels, what information is contained in it, and how to use it. In collaboration with AACR, the OCE is launching Project Livin’ Label to foster broader understanding of oncology product labels and increase awareness of recent FDA oncology product approvals. Using oncology product labeling as a roadmap, the FDA’s Oncology Center of Excellence (OCE) will guide discussions on the backstory of the product, featuring an FDA reviewer, a clinical trial investigator, a patient, and the company as discussants. Continuing medical education (CME) credit will be offered through AACR and available to those who watch the episodes and review the associated product label. Project Livin’ Label episodes can be found here.
Interagency Oncology Task Force Fellowship
The Interagency Oncology Task Force Fellowship is a partnership of the NCI, the NIH, the FDA, and the Department of Health and Human Services (HHS). The program offers four tracks, with track 1 designed for medical hematology/oncology fellows, track 2 for board certified medical oncologists, track 3 for postdoctoral research fellows, and track 4 for those interested in cancer prevention research. Fellows in Track 1 spend a year in the OCE to learn about oncology drug development and are involved in longitudinal research projects. From 2019-2020, the OCE welcomed 2 clinical fellows in Track 1 for a year-long fellowship, and OCE is currently hosting 1 fellow for 2020-2021.
Icons in Oncology Distinguished Lecture Series
The OCE established the Icons in Oncology Distinguished Lecture Series in 2020 to invite esteemed oncologist and scientists to provide a historical perspective of how cancer research, clinical trials, and cancer therapies have evolved over the past few decades. The OCE welcomed Dr. Bruce Chabner on March 2, 2020, and Dr. Norman Wolmark on November 2, 2020, and looks forward to welcoming additional speakers in 2021.
The ASCO Post: OCE Insights
OCE Insights is an occasional column in The ASCO Post that focuses on regulatory policy and science. Topics have focused on Project Socrates, Patient-Centered Initiatives at the FDA, Project Facilitate, with all articles available here.
OCE Summer Scholars
The OCE Summer Scholars Program is designed to expose high school students from underrepresented and underserved communities to oncology drug development. The program also provides mentorship and career guidance. From 2017-2019, the OCE Summer Scholar students spent six weeks at the FDA campus, with a curriculum that included visits to the National Institutes of Health (NIH), pharmaceutical companies, local universities, and cancer advocacy groups. In 2020, the OCE welcomed approximately 70 Summer Scholars for a three-week virtual program.
The OCE remains dedicated and committed to the many educational initiatives and outreach efforts, both those that have already been established and those that will be launching in the future. As we look ahead to 2025, Project Socrates will continue to strengthen its ongoing collaborations and continue to build new ones. We look forward to sharing these exciting updates with you as they happen.
To contact Project Socrates, tweet us at @FDAOncology.