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Lester M. Crawford, D.V.M., Ph.D. - National Cancer Advisory Board

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Announcement of
NCI and FDA Research and Regulatory Review
Fellowship Program
National Cancer Advisory Board

Remarks by
Lester M. Crawford, D.V.M., Ph.D.

Acting Commissioner of the FDA

February 16, 2005

Thank you Andy (Dr. Andrew von Eschenbach, Director, National Cancer Institute) for your kind introduction. It is a genuine pleasure to join you in announcing this first major program stemming from our two agencies’ collaboration in the Interagency Oncology Task Force (IOTF)

I want to commend the many senior staff from both agencies especially Dr. Janet Woodcock and Dr. Theresa Mullin of FDA and Dr. Anna Barker of NCI for the long hours devoted to this collaboration over the past two years. Staff from both agencies continue to work jointly in other major areas under the IOTF umbrella that will be crucial to fostering the new age of medical products to conquer cancer, including nanotechnology, surrogate markers of clinical benefit, and chemoprevention.

As Dr. von Eschenbach mentioned, FDA and NCI have distinctly separate missions but a common goal in the fight against cancer. NCI’s mission is one of basic and clinical research to foster discovery and development of new medical products and FDA’s mission is to assure the safety, efficacy, and quality of manufacturing of new medical products prior to marketing. In other words, part of FDA’s responsibility is to ensure that basic discoveries turn into new and better medical treatments.

We need to make the effort to create better tools for developing medical technologies, and our close collaboration with NCI through the IOTF is an important step in joining the mission of the two agencies to produce a seamless process for speeding new technologies to cancer patients. An important step, as Dr von Eschenbach has stated, in moving both agencies forward towards our common goal of improving the public health and eliminating cancer.

One of the most important tools of course, is a knowledge base that is built not just on ideas from biomedical research but on reliable insights into the pathway to marketed products for use in patients. During clinical testing, FDA scientists conduct ongoing reviews of emerging data on safety, efficacy, and product quality. FDA reviewers see the complete spectrum of successes and best practices during clinical trials, as well as the failures, slow downs, barriers, and missed opportunities. Because FDA is uniquely positioned to help identify the challenges to development and regulatory approval, we need to work with the larger scientific community on developing solutions.

The implementation of this Research and Regulatory Review Fellowship Program as a part of the collaboration of NCI and FDA in the IOTF is a critical first step in developing that all-important knowledge base.

There is no better way of learning about the problems inherent in developing innovative products than to participate actively in the regulatory review process.

Clinicians and scientists who are selected for these fellowships have a unique opportunity to spend from 1-3 years at the FDA, to work with, and be mentored by, experienced FDA reviewers and researchers. They will be able to watch product development programs succeed and fail and, in the process, to learn to recognize the characteristics of successful product development.

They will then be able to take this knowledge of regulatory requirements back to their home institutions and incorporate it into their research on new cancer treatments from the earliest stages thus enhancing the likelihood of success.

I can say on behalf of all the FDA mentors that we look forward to our close collaboration with NCI in this important training initiative, and believe that this investment will benefit the fellows, the partnered agencies, and the American public through more efficient use of public resources.

Thank You!