Educating the next generation of oncology leaders and the public about the role of the FDA in oncology drug development is one of the key priorities of the Oncology Center of Excellence. Through education and outreach, Project Socrates aims to provide insight into the FDA’s role in oncology drug development and the multidisciplinary and team-based approach the FDA takes in this process.
OCE Scientific Exchange
The OCE Scientific Exchange Program, begun in 2017, offers trainees in medical hematology and/or oncology, radiation oncology, and pediatric oncology an opportunity to spend 4-8 weeks at the FDA. The fellows are paired with a mentor in their disease area of interest and interact with experts across the OCE, the Center for Drug Evaluation and Research (CDER), the Center for Biologic Evaluation and Research (CBER), and the Center for Devices and Radiologic Health (CDRH). With this in-depth experience at the OCE, fellows gain a better understanding of different types of FDA submissions, considerations in clinical trial design, role of biomarkers and patient-reported outcomes, and regulatory requirements, to name a few. This rotation is offered three times a year.
FDA-ASCO Hematology and Oncology Fellowship
The FDA-ASCO Hematology and Oncology Fellows’ Day Workshop welcomed 45 fellows to the FDA campus on November 5, 2019, for a day of learning about Investigational New Drug (IND) applications, expanded access and Project Facilitate, expedited programs, companion diagnostics, and real-world evidence. This workshop continues in its 3rd year with ASCO co-sponsorship and has been expanded to two days at the FDA. An additional half-day was organized in Chicago prior to the 2019 ASCO Annual Meeting.
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. Students spend six weeks at the FDA campus, with a curriculum that includes visits to the National Institutes of Health (NIH), pharmaceutical companies, local universities, and cancer advocacy groups.
The annual Accelerating Anticancer Agent Development and Validation Workshop, co-sponsored by the OCE and held each May in Bethesda, Maryland, is an interactive conference with leaders from academia, industry, government, and advocacy. In 2020, the workshop will offer two new tracks—one for international regulators and one for patient advocates.
Through the success of outreach and educational efforts, the OCE has noted greater interest from fellows and oncologists in joining the FDA. Fellows who are still in training frequently have a significant time lag between their FDA interview and their start date, often up to a year. Project Gateway began as an initiative to keep new FDA hires engaged during this time, inviting them to attend educational sessions at the FDA, public FDA workshops, meetings of the Oncologic Drugs Advisory Committee (ODAC), and many others.
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 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. The OCE currently has two NCI oncology fellows who are spending a year at the FDA to learn about oncology drug development and are involved in longitudinal research projects.
On November 1, 2019, the OCE welcomed more than 50 oncology fellows to White Oak for the inaugural Oncology 3D Educational Workshop. Based on the popularity and positive feedback from this pilot, the OCE plans to offer this workshop annually and is establishing additional fellowships focused on 1) translational oncology drug development, and 2) drug development and regulatory policy in hematologic malignancies.
To contact Project Socrates, email ProjectSocrates@fda.hhs.gov.