The US Food and Drug Administration is taking bioinformatics seriously. In addition to its gene expression database efforts (see story, p. 1), a recently announced interagency collaboration with the National Cancer Institute will bring the FDA face-to-face with even more bioinformatics data.
Under the joint program, the two agencies plan to share knowledge and resources to speed the development of new cancer drugs. “Molecularly targeted drugs and other novel agents offer great promise, but they also present new challenges that require more collaboration between those involved in their discovery and development,” said Andrew von Eschenbach, NCI director.
Information sharing will be the key to this collaboration, which will require the creation of a cancer bioinformatics infrastructure. The shared platform will be broad in scope, with the mission of improving data collection, integration, and analysis for preclinical, preapproval, as well as post-approval research for cancer therapies.
An Oncology Task Force made up of senior staff from both agencies will oversee the details of the collaboration. The task force will address the details of the bioinformatics infrastructure “over the next several months,” according to an NCI spokeswoman. The FDA declined to comment on the project.
According to the NCI spokeswoman, NCI’s existing bioinformatics infrastructure, which includes the caCORE and caBIO modules, “will serve as a key component of our collaboration with the FDA.”
The two agencies have previously established a working relationship regarding data standards, particularly on common international biomedical standards like Health Level 7 (HL7) and the Clinical Data Interchange Standards Consortium (CDISC). “NCI will map its existing caCORE elements to these standards where they differ and work with the FDA and standards bodies to extend their coverage when required to address cancer research elements not already present within the existing standards,” the NCI spokeswoman said.
In addition to the existing informatics tools and standards, “new messaging standards for adverse event reporting” will be developed as part of the joint project.
“If science is applied across the continuum of discovery, development, and delivery, safe, more efficacious drugs will be available to patients faster. Bioinformatics is an important part of that science,” said the spokeswoman.