Food and Drug Administration (FDA)

Interagency Oncology Task Force (IOTF)
Nanotechnology Characterization Laboratory (NCL)
Oncology Biomarker Qualification Initiative (OBQI)

Interagency Oncology Task Force (IOTF)

Established: 2003

The FDA/NCI Interagency Oncology Task Force (IOTF) was formed in May 2003, as a multi-part interagency effort to enhance the efficiency of clinical research and the scientific evaluation of new cancer medications. The goal of the IOTF is to leverage the expertise and capabilities of both agencies for the purpose of streamlining and accelerating the overall development of diagnostic, preventive, and therapeutic interventions for cancer.

Under this effort, the two agencies share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients. Theresa Mullin, Ph.D., Assistant Commissioner, Office of Planning, Office of Policy and Planning, FDA, and Anna Barker, Ph.D., Deputy Director for Strategic Scientific Initiatives, Office of the Director, NCI, serve as the Co-Chairs for the IOTF.

Since its formation, the membership of IOTF has collaboratively undertaken an analysis of the overall process for new oncology drugs and devices and identified several specific initiatives that are directed toward optimizing new oncology products development. The NCI is working to specifically gather and synthesize the scientific support needed by the FDA to address specific regulatory issues. The IOTF works through a series of issue-specific subcommittees.

For more information on the FDA/NCI Interagency Oncology Task Force (IOTF), click here.

Nanotechnology Characterization Laboratory (NCL)

Established: 2004

The Nanotechnology Characterization Laboratory (NCL) performs and standardizes the pre-clinical characterization of nanomaterials intended for cancer therapeutics and diagnostics developed by researchers from academia, government, and industry. The NCL serves as a national resource and knowledge base for cancer researchers, and facilitates the development and translation of nanoscale particles and devices for clinical applications.

FDA has developed a strong and standardized model for evaluating diagnostics, has a new integrated regulatory program for regulation of diagnostic devices (Office of in vitro Diagnostic Device Evaluation and Safety), and has begun to explore methods for evaluating multiplex technologies and for better incorporating new diagnostics into drug development when appropriate. While the agency has limited experience with nanotechnology, it has great interest in developing mechanisms for facilitated review and for ensuring rapid but science-based decision-making in regulation of this new technology.

NCI believes that the NCL's activities will markedly speed the development of nanotechnology-based products for cancer patients, reduce the risk of doing so, and encourage private-sector investment in this promising area of technology development. By achieving its goals the NCL will provide a comprehensive set of baseline characterization parameters that will enable cancer biologists, drug and diagnostic developers, and clinical oncologists to apply their tools to solving problems that most affect cancer patients. This work will also lay a scientific foundation that will enable the FDA to make sound decisions concerning the testing and approval of nanoscale cancer diagnostics, imaging agents, and therapeutics.

To achieve its mission, the NCL has established the following six objectives:

• Establish and standardize an analytical cascade for nanomaterial characterization
• Facilitate the clinical development and regulatory review of nanomaterials for cancer clinical trials
• Identify and characterize critical parameters related to nanomaterials’ absorption, distribution, metabolism, excretion and toxicity profiles of nanomaterials using animal models
• Examine the biological and functional characteristics of multi-component/combinatorial aspects of nanoscaled therapeutic, molecular and clinical diagnostics, and detection platforms
• Engage and facilitate academic and industrial-based knowledge sharing of nanomaterial performance data and behavior resulting from pre-clinical testing
• Interface with other nanotechnology efforts

For more information about the Nanotechnology Characterization Laboratory, please visit http://ncl.cancer.gov.

For more information about NCI’s funding of nanotechnology, click here.

Oncology Biomarker Qualification Initiative (OBQI)

Established: 2006

The Oncology Biomarker Qualification Initiative (OBQI) is an agreement between the Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Medicare & Medicaid Services (CMS) to collaborate on improving the development of cancer therapies and the outcomes for cancer patients through biomarker development and evaluation.

The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.

The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. OBQI will address questions such as how particular biomarkers can be used to:

• Assess after one or two treatments if a patient's tumor is responding to treatment
• Determine more definitively if a tumor is dying, even if it is not shrinking
• Identify which cancer patients are at high risk of their tumor coming back after therapy
• Determine if a patient's tumor is likely to respond at all to a specific treatment
• Efficiently evaluate whether an investigational therapy is effective for tumor treatment

For more information about the Oncology Biomarker Qualification Initiative, please click here.