In 2022, Project Socrates completed its third year, having continued many of its educational programs while also establishing new initiatives. These programs and initiatives complemented the goal of Project Socrates of building an educational network bridging the OCE and the public, focusing on regulatory policy and science.
Educational Initiatives for Oncology Professionals
Project Socrates’ partnerships with professional societies extended the OCE's breadth of educational outreach and engagement.
- FDA-AACR Oncology Educational Fellowship welcomed 20 new fellows to its 2022-2023 class in October 2022. The Fellowship spans eight sessions over a year and uses discussions of approved oncology drugs to highlight regulatory science topics.
- Project Livin’ Label currently has eight online episodes available, each discussing the backstory of the development and FDA approval of an oncology drug. In 2022, Project Livin’ Label welcomed the Oncology Nursing Society (ONS) and Hematology/Oncology Pharmacy Association (HOPA), as Project Livin’ Label continues to expand its scope by highlighting the perspectives of oncology nurses and pharmacists.
- FDA-ASCO Hematology-Oncology Fellows Workshop continued in its eighth year, with one half-day virtual session and one full-day hybrid session (with in-person attendees at the FDA White Oak campus); there were over 60 attendees at each workshop.
- With the American Society of Hematology, OCE welcomed 12 hematologists to the inaugural FDA-ASH Collaboration: A Workshop on Regulatory Science in Hematology, providing a solid foundation on hematology drug development.
- With the Society of Surgical Oncology, OCE participated in two FDA 101 for Surgical Oncologists webinars, providing an overview of FDA’s role in oncology drug and biologics development for surgical oncologists.
- The OCE Regulatory Science Online Lecture Series began in 2022 and produced four webinars, covering expedited pathways, INDs, oncology clinical trial design, and statistical considerations. The webinars include accompanying FAQs.
High School Summer Program
The OCE Summer Scholars Program welcomed 52 students to a six-week virtual learning experience in summer 2022 on cancer drug development and career opportunities in government, regulatory medicine, and cancer advocacy. The Summer Scholars Program began in 2017 as an in-person internship for up to 20 high-school students; it has since quadrupled in size and scope. Students from across the U.S. and abroad are now able to participate in this program.
On September 14, 2022, current and former Summer Scholars participated in an OCE Conversation on Cancer titled Cancer Moonshot in Action: Launching the Next Generation of Cancer Leaders.
Educational Initiatives for FDA Reviewers
The OCE Icons in Oncology Distinguished Lecture Series welcomed Dr. Dennis Slamon, Dr. Anna Meadows, Dr. Gabriel Hortobagyi, and Dr. Paul Bunn, each of whom provided personal and historical perspectives of how research, treatment paradigms, and clinical trials in their respective fields in oncology have evolved over time.
In 2022, the Icons in Oncology series was the first recurring OCE event approved for Continuing Education credits through the FDA CDER Office of Executive Programs, an accredited CE provider. This was coordinated by the OCE Continuing Education Program and Planning Committee, begun this past year by the Oncology Program Operations team.
In addition, Project Socrates held 34 classes as part of an internal OCE Curriculum to educate new reviewers on oncology regulatory policy and science. In 2022, the Office of Oncologic Diseases welcomed 30 new reviewers to FDA multi-disciplinary oncology review teams.