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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 - For hematologist/oncologist trainees, early career faculty, bench and translational scientists, and post-doctoral fellows. 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. More information: AACR Cancer Research Catalyst.

FDA-OCE-ASA Oncology Educational Fellowship - For statistics and biostatistics graduate students and post-doctoral fellows, similar structure to the FDA-AACR fellowship.

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, held every fall. 

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.
 


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.

Dr Armitage

 

Dr. James Armitage

Jan. 29, 2024

Recording Link

Dr Demetri

Dr. George Demetri

June 12, 2023

Recording Link

Dr. Tempora

Dr. Margaret Tempero

April 24, 2023

Recording Link

Dr. Paul Bunn Registration

Dr. Paul Bunn

November 21, 2022

Recording Link

ICONS Hortobogyi

Dr. Gabriel N. Hortobagyi

September 26, 2022

Recording Link

ICONS Dr Karp

Dr. Judith Karp

July 19, 2021

Recording Link

ICON Dr Piccart

Dr. Martine Piccart

April 26, 2021

Recording Link

 

Connect With Us!

Twitter: FDAOncology • Email: FDAOncology@fda.hhs.gov

 

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