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  1. Oncology Center of Excellence

Project Socrates

An Educational Network for Oncology Product Development

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Project Socrates

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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, Project Socrates hopes to extend OCE's breadth of educational outreach and engagement.


Fellowship Programs and Workshops

FDA-AACR Oncology Educational Fellowship - An 8-month series of educational sessions on topics in oncology drug development, culminating with Project ODAC Odyssey, where fellows participate in a mock Oncologic Drugs Advisory Committee. Applications now being accepted for the 2023-2024 class. More information: AACR Cancer Research Catalyst.

FDA-ASCO Hematology and Oncology Fellows Day Workshop - A daylong workshop that provides U.S. trainees with an introduction to the FDA and the oncology drug and device regulatory process. Details on scheduled workshops and upcoming application cycles will be shared with training programs as they are available.

FDA-ASH Collaboration: A Workshop on Regulatory Science in Hematology – A two-day workshop for hematology/oncology fellows, physicians, and researchers. The next workshop is scheduled for October 10-11, 2023, at ASH Headquarters in Washington, DC.

Interagency Oncology Task Force Fellowship - A partnership of the FDA and the National Cancer Institute, offering tracks for medical hematology/oncology fellows (track 1), board certified medical oncologists (track 2), postdoctoral research fellows (track 3), and cancer prevention research (track 4). Fellows in track 1 spend 6 months to 2 years in the OCE to learn about oncology drug development and conduct research projects.
 
OCE Summer Scholars Program – A six-week virtual learning program to expose high school students from underrepresented and underserved communities to oncology drug development, as well as providing mentorship and career guidance.
 


On-Demand Learning

OCE Regulatory Science Online Lecture Series – Each episode provides an overview of the OCE's role in oncology product development.

Project Livin’ Label – A collaboration with AACR to foster greater understanding of oncology product labeling and increase awareness of recent FDA oncology product approvals. Moderated discussions bring together FDA clinical reviewers, a clinical trial investigator, a patient, an oncology nurse, an oncology pharmacist, and a company representative. Continuing medical education (CME) credit through AACR, ONS, and HOPA is available to those who watch the episodes.

OCE Insights – An occasional column in The ASCO Post written by OCE subject-matter experts and highlighting a variety of topics in regulatory policy and science. 

OCE PULSE: OCE Oncology News – A monthly newsletter for oncology/hematology fellows and fellowship program directors. Click to subscribe.

EMA and HMA Pilot Educational Program Oncology – A series of recorded webinars covering basic principles of regulation of human medicines in the EU and basic regulatory aspects relevant to oncology.


FDA Staff Development

The OCE Curriculum - A regular series of educational lectures by FDA and OCE program and project leadership.

Icons in Oncology Distinguished Lecture Series – OCE invites esteemed oncologists to provide their personal perspective to the FDA’s staff of how cancer research, clinical trials, and cancer therapies have evolved over the past few decades. Two lectures are linked below.

Icons in Oncology Tempero

Dr. Margaret Tempero, April 24, 2023

Recording Link