Cancer Research and Regulatory Fellowships Announced
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NCI and FDA have announced the inception of the NCI-FDA
Research and Regulatory Review Fellowship program. The program’s
objective is to train a cadre of scientists in cancer research and research-related
regulatory review so that they can develop skills that bridge the two
disciplines and cultures.
The program is one of the initiatives of the NCI-FDA Interagency Oncology
Task Force (IOTF), created in 2003. IOTF’s purpose is to efficiently
move safe new oncology medical products from the laboratory to the clinic.
NCI-FDA fellows will learn to build awareness of regulatory requirements
into the early stages of medical product development and will devise
strategies to improve planning throughout the research and regulatory
review phases. They will also learn how to use state-of-the art
knowledge and technology in the design, conduct, and review of
clinical trials.
“NCI and FDA share the common goal of bringing safe and
effective products to cancer patients quickly and carefully,” said
NCI Director Dr. Andrew C. von Eschenbach. “This type of
partnership between science and regulation is vital, especially
given the rapidly advancing scientific environment.”
Acting FDA Commissioner Dr. Lester M. Crawford added, “This
cross-fertilization with NCI will be invaluable in helping FDA
prepare for the next wave of promising cancer-fighting agents.”
Dr. Jonathan Wiest, associate director for training and education
in NCI’s CCR, commenting on the importance of the new fellowship
programs, said, “We believe that physicians and scientists
who are trained in the regulatory process and also understand the
inner workings of NCI and FDA will be able to facilitate and improve
the development and approval process for drugs - especially
for chemotherapy.”
The NCI-FDA fellowships offer a unique career opportunity for
participating researchers to become well-positioned to facilitate
the new age of molecular medicine. New targeted therapies and diagnostic
products will demand new skills and processes that must be incorporated
into the research and regulatory system.
Program graduates will develop skills of value to academia, the
pharmaceutical industry, and government agencies, noted Dr. Wiest.
Through their training experiences, he continued, “the fellows
will gain the knowledge and skills to fill a void in the cancer
research enterprise and hasten the delivery of medical products
to patients using 21st century science.”
NCI-FDA fellowship programs are available in:
- Clinical Oncology Product Research/Review
- Clinical Oncology Product Research/Review for Board-Certified
Oncologists
- Oncology Product Research/Review
- Cancer Prevention
The fellowships last for 1 to 4 years, based on the training
program. Fellows will work closely with mentors representing senior-level
medical and scientific staff at NCI and FDA.
Fellowship candidates must have an M.D. and/or Ph.D., or an equivalent
degree. They must also be either a U.S. citizen or have permanent
residency status.
Additional information about the program, including application
deadlines, can be found at http://iotftraining.nci.nih.gov.
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