The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.
"The purpose of this MOU is to engage in scientific and programmatic collaborations in clinical proteogenomics cancer research, such as statistical experimental design, instrument/technology validation, informatics, biological sample preparation, diagnostics, discovery, and validation of biomarkers for cancer development, treatment, and response," the text of the agreement says.
Proteogenomics is the field of research where the study of proteins and genomes intersects.
The collaboration will also see both agencies working together on bioinformatics and data analysis/integration, diagnostic assay development, discovery, and validation of surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.
The agreement will benefit FDA by extending outreach to device manufacturers early in the development process, as well as clinicians and drug manufacturers who are utilizing proteogenomics in development programs.
"This will enhance FDA's knowledge and technical expertise in proteogenomics as it is applied to medical devices and oncology drug development, and will facilitate the review of such medical devices and therapies when they are submitted to FDA," the text says.
Cooperative activities may include:
- Developing guidelines on "necessary requirements for data submission and analysis for proteogenomic data repositories that is mutually beneficial to the NCI and the FDA. These requirements will be intended to meet the needs of the NCI for the purposes of technology assessment and standardization, validation, and experimental reproducibility and the needs of the FDA for the purposes of diagnostic and drug submissions";
- developing joint educational materials on the most current standards and practices for proteogenomic technologies and applications;
- forming NCI, FDA, academic, industry and other partnerships to improve proteogenomics standard operating procedures and data policies;
- mutual use of facilities, software, algorithms and data repositories, as well as through the exchange of agency personnel, expertise and data or publications.
The MOU will also facilitate the sharing of non-public information, which FDA and NCI said will be appropriate and in accordance with applicable law.
The director of NCI's Office of Cancer Clinical Proteomics Research, the director of the FDA's Office of In Vitro Diagnostics and the director of FDA’s new Oncology Center of Excellence or their designees will be the primary representatives to coordinate the cooperative activities.
MEMORANDUM OF UNDERSTANDING: CLINICAL PROTEOGENOMICS CANCER RESEARCH