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FDA recently appointed Dr. Richard Pazdur to lead its newly established Office of Oncology Drug Products. He spoke with the NCI Cancer Bulletin about his plans for the new office.

What are some of the challenges for this newly established office?
The challenge is to coordinate activities within the FDA's centers as well as with the external community, including our stakeholders - patients, physicians, NCI, pharmaceutical companies, and biotechnology companies. Another challenge is to have consistency in the review of drugs and biological products. Uniform regulatory principles must be applied throughout the drug development process irrespective of the product.

FDA and NCI are already collaborating on several fronts, including the Interagency Oncology Task Force. How will this new office expand the partnership with NCI and other agencies?
One important assignment of the new office is to develop programs that will answer scientific and regulatory questions that impact drug development. Interactions with NCI, the academic community, patients, and sponsors are essential in developing these programs. These include ongoing discussions of regulatory endpoints for drug approval, a pediatric oncology advisory committee, and an evolving chemoprevention program that examines endpoints and safety of drugs that will enter chemoprevention trials. Other initiatives will examine alternative statistical approaches to clinical trial designs and review nonclinical requirements for entry of drugs and biological products into clinical trials.

In what areas are we most likely to see the next wave of significant advances in cancer therapeutics - diagnosis, treatment, or prevention?
All three. Advances in all three require a more basic and fundamental understanding of oncological diseases. True advances in treatment, prevention, and diagnosis will require a more complete understanding of the molecular pathways of disease - moving away from the conventional, historical approaches of histopathological diagnoses.

What is your vision of the future of the oncology drug development process?
Here again, the future of the drug development process will be linked with a more thorough understanding of the molecular basis of the disease. Molecular targets will need to be developed to provide a greater understanding of drugs. This will answer the question of why certain drugs work in particular diseases and also may provide more information about drug safety. The basic understanding will be essential not only for development of drugs in the advanced disease setting, but also in the prevention of oncology diseases.