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  1. 2023 OCE Annual Report

Professional Education and Resources

AR 2023 Professional Education Orange

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Project Socrates

Project Socrates is OCE's professional education and engagement effort. In 2023, the project launched a monthly newsletter, the OCE PULSE, for hematology/oncology fellows, early career faculty, and anyone interested in learning more about oncology drug development. 

Twenty-one new fellows are joining the fourth class of the FDA-AACR Oncology Educational Fellowship 2023-2024, including one fellow each from Chile and Canada. The fellowship spans eight sessions over the year and culminates in a mock Oncologic Drugs Advisory Committee.

The FDA-ASCO Hematology/Oncology Fellows Workshop is now in its ninth year, with nearly 80 participants attending in-person and virtually over each day-long workshop, held in the spring and fall each year.

OCE held its second annual FDA-ASH Collaboration: A Workshop on Regulatory Science in Hematology. Twenty hematology fellows and faculty joined for this two-day in-person educational program to learn more about regulatory science and hematology drug development.

During summer 2023, the OCE Summer Scholars Program welcomed approximately 90 high school students from across the US to a 6-week virtual learning program. Students learned about diverse career paths in oncology and presented their knowledge to the FDA oncology staff as their final summer project.

Two new episodes join the OCE Regulatory Science Online Lecture Series, discussing patient-focused drug development and real-world evidence.

New discussions on neoadjuvant nivolumab for non-small cell lung cancer and ivosidenib for patients with newly diagnosed acute myeloid leukemia are now available through Project Livin’ Label. Continuing medical education credit is offered free for watching the episodes and reviewing the product labeling.

The OCE Icons in Oncology Distinguished Lecture Series welcomed Drs. Karen Antman, George Demetri, and Margaret Tempero, who provided their personal perspectives of how the field of oncology, clinical trials, and drug development have evolved over time. 

The Office of Oncologic Diseases welcomed seven new clinical reviewers and analysts to the FDA oncology team, and Project Socrates held 28 classes as part of the OCE Curriculum to educate new reviewers on oncology regulatory policy and science. 

Project Facilitate

Project Facilitate is a comprehensive program designed to assist oncology healthcare professionals in submitting Expanded Access requests to the FDA. In addition to providing support via phone or email during business hours, Project Facilitate staff also reviews all CDER oncology single-patient expanded access applications.

In 2023, Project Facilitate staff handled 401 phone calls and 889 Expanded Access applications. Project Facilitate focused on improving internal outreach, coordinating with the clinical divisions to improve internal collaboration, and identifying important regulatory and clinical trends. External outreach was improved through panel discussion at the Friends of Cancer Research at the 2023 Annual Meeting and dialogue with New York University, University of Michigan, and individualized training sessions with institutions such as Seattle Children’s Hospital and institutions from the U.S. Department of Veterans Affairs.

Oncology Guidance

The OCE led the development of four new draft guidance documents and two final guidance documents for oncology drug development in 2023. See all current oncology guidance documents at OCE Guidance Documents.

Draft Guidance:

Final Guidance:

OCE Publications and Approval Announcements

The OCE’s strong support for publications by FDA oncology/hematology staff continued in 2023, resulting in 89 articles in scientific journals.

OCE’s Communications Team works with FDA clinical reviewers to issue approval announcements for some oncology/malignant hematology approvals; 45 of these were posted in 2023.


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