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Project Socrates

 

Project Socrates: OCE Educational Initiatives

Project Socrates Photo of Participants

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 (OCE). 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.

FDA-AACR Educational Oncology Fellowship

On June 1, 2020, the OCE established a new FDA-AACR Oncology Educational Fellowship, developed in collaboration with AACR. Launching in the fall of 2020, the OCE will welcome 10-15 MD, MD/PhD, or PhD clinicians and scientists to a series of educational sessions on topics in oncology drug development. More information in the MOU and application details forthcoming.

OCE Summer Scholars

Photo of 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. This summer, OCE is welcoming approximately 70 Summer Scholars for a three-week virtual program.

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. Fellows in Track 1 spend a year at the FDA to learn about oncology drug development and are involved in longitudinal research projects.

Project Gateway

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.

OCE Fellows Program

OCE Fellows Program Photo

The OCE Scientific Exchange Program, launched 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. (Currently on hold due to the COVID-19 pandemic)

FDA-ASCO Hematology and Oncology Fellowship

OCE Director Richard Pazdur, MD, takes a selfie with FDA-ASCO fellows.
OCE Director Richard Pazdur, MD, takes a selfie with FDA-ASCO fellows.

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. (Currently on hold due to the COVID-19 pandemic)

AAADV Workshop

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. (Currently on hold due to the COVID-19 pandemic)

Looking Ahead

Photo of OCE Participants

The OCE remains dedicated and committed to the many educational initiatives and outreach efforts, both those that have already been established and and those that will be launching in the future. Discussions are currently underway regarding new formats, such as virtual sessions and webinars, and more details will be provided as they become available.

To contact Project Socrates, email ProjectSocrates@fda.hhs.gov or tweet us at @FDAOncology.

 

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