Oncology Research and Development 2024
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Project Catalyst
In 2024, OCE’s Project Catalyst provided guidance and expanded the educational resources available to small pharmaceutical companies and academic life science incubators to support informed anticancer therapy development, including:
- New Bench-to-Bedside Chats: Three videos on guidance for phase 1 investigational drugs; pharmacology and dose optimization, and economically infeasible indication drug development.
- Organized webinar, “Regulatory Do’s and Don’ts: Tips from FDA,” with CDER, SBIA, and NIH-NCI SBIR, for companies involved in the SBIR CARES program, academic accelerators, and small start-up companies.
- Accelerator innovator discussion meetings with academic accelerator life science hubs on innovations in drugs, biologics, and devices, and planning for session at 2025 AACR Annual Meeting.
- Public-Private Consortium Development: Project Catalyst and the OCE Pediatric and Rare Tumors Program collaborated with the Foundation for the National Institutes of Health and the National Cancer Institute to discuss forming a public-private consortium to advance development of therapies for ultra-rare tumor indications. FNIH, FDA, and NIH, plans to hold public meetings with the scientific community, industry, and patient advocate groups on the proposed consortium in 2025.
- Participated in several conferences and working groups including AUTM Annual Meeting, FDA’s Rare Disease Day, AACR Annual Meeting, collaboration with CBER and the Parker Institute on a workshop with Friends of Cancer Research, and the NCI Innovative Molecular Analysis Technologies program annual meeting.
Project Catalyst welcomes questions regarding oncology drug development plans that are premature for a pre-IND submission, and values input regarding other efforts that would be useful to early-stage oncology drug development programs.
OCE Scientific Collaborative
The OCE Scientific Collaborative supports FDA oncology staff in intramural and extramural regulatory science research, focusing on applied research questions regarding challenges encountered in regulatory review.
2024 Program Highlights:
- Presented OCE Scientific Interest Areas at 2024 FDA BAA Day.
- Worked with the OCE Real World Evidence Program to establish Research Collaboration Agreements (under “Selected Currently Active Oncology RWE Collaborations”).
- Awarded two grants for ultra-rare cancers (FDA-FD-24-038), focusing on proteogenomics and genomic profiling of malignant phyllodes.
- Reorganized the OCE Publications web page by article type to encourage users to browse extramural and intramural research papers.
- Funded eight new applied research projects through the Centers of Excellence in Regulatory Science & Innovation and Broad Agency Announcement programs, covering:
- Liquid biopsy and tumor detection methods
- Statistical analysis techniques for clinical trials
- Real-world data analysis
- Novel therapeutic approaches in pediatric and rare cancers
Visit OCE-Funded Active Extramural Research Projects for further details on our funded projects.
Project SignifiCanT
OCE's Project SignifiCanT (Statistics in Cancer Trials) holds discussions with the Biopharmaceutical Section of the American Statistical Association, the LUNGevity Foundation, and other oncology stakeholders to further the design and analysis of cancer clinical trials with the goal to advance cancer therapies. Visit our web page for links to the latest publications.
We discussed six key topics in 2024 with multi-disciplinary experts:
- February 13: Interpretation of Results from Hierarchical Testing of Multiple Endpoints, Subgroups, Analyses Across Disease Settings in Cancer Clinical Trials.
- April 23: Statistical Design Considerations in Estimating Contribution of Each Sequential Treatment Effect to the Overall Effect of a Sequence of Treatments in Randomized Cancer Clinical Trials.
- June 11: Trial Considerations in Indolent Cancers with Overall Survival as a Safety Endpoint.
- July 16: Statistical Considerations in the Design of Randomized Pragmatic Cancer Trials.
- September 10: Tolerability Endpoint Considerations to Guide Dosage Optimization in Oncology Clinical Trials.
- November 19: Clinical Trial Design and Analyses Considerations in Evaluating Treatments for Ultra Rare Cancers. This session expanded upon prior Project SignifiCanT discussions on rare pediatric cancers.