Precision oncology leads to customization of healthcare, with medical decisions, practices and products being tailored to each individual patient with cancer. In oncology drug, biologic, and device development, more precise targeting of a product to an individual’s genomic, proteomic, metabolomic make-up will likely lead to more effective and less toxic anti-cancer therapies.
The Oncology Center of Excellence (OCE), charged with integrating the expertise of the product centers to advance care for patients with cancer, is uniquely situated to develop the methodologies to advance Precision Oncology. The focus of the Precision Oncology Program will be to coordinate and integrate efforts across the centers to:
- Educate FDA staff on the state of the science and cutting-edge research in precision oncology,
- Interface with the public and key external stakeholders and educate the public regarding FDA’s role in the advancement of precision oncology, and
- Catalyze regulatory science research and development to apply new methodologies to deliver the promise of precision oncology for new and better drugs, diagnostics, and biologics to reduce the burden of cancer.