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Cancer Researchers Team Up with FDA for a Workshop Aimed at Speeding Cancer Drug Development

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Duke Health News 919-660-1306

DURHAM, N.C. -- As the head of developmental therapeutics at
the University of Alabama – Birmingham's Children's Hospital of
Alabama, Todd Cooper's goal is to create drugs that can help
children fight leukemia more effectively. But Cooper knows it
can take 12 to 15 years, on average, to get a drug from the
scientific bench, where it is initially discovered, to the
bedside, where it can help a patient. Last year, he attended
the Accelerating Anticancer Agent Development and Validation
Workshop to participate in open discussions with
representatives from the Food and Drug Administration and the
pharmaceutical industry, as well as other investigators like
himself, to try to fathom ways to make this process move
faster.

"I found it interesting to learn more about the factors the
FDA considers when evaluating a drug for approval," said
Cooper, D.O., a pediatric hematologist/ oncologist. "I think
the workshop is useful from all perspectives because it helps
us understand one another and work together more
effectively."

The two-day workshop, which brings together about 100
early-career cancer scientists from the United States and
abroad with their more seasoned counterparts from the federal
government, industry, academia and consumer groups, will take
place June 20-22, 2007, at the Bethesda North Marriott Hotel
and Conference Center in Bethesda, Md.

Participants in the workshop include the Duke Comprehensive
Cancer Center, Duke Clinical Research Institute, FDA, National
Cancer Institute, American Association for Cancer Research,
American Society of Clinical Oncology, National Institutes of
Health and Friends of Cancer Research.

"The process of bringing drugs from the bench to the bedside
is complex, and some of the very best scientists don't
necessarily have the tools or the training to effectively move
drugs through the approval process," said H. Kim Lyerly, M.D.,
director of the Duke Comprehensive Cancer Center and chairman
and sponsor of the workshop. "Our hope is that this workshop
will provide some of those tools."

Researchers will arrive at the workshop with at least one
idea in hand. In small groups, they will present their ideas to
industry and government representatives and then they will
discuss potential obstacles to the approval process and how to
overcome them.

"I came to the meeting last year with a letter I had drafted
to a drug company, with the goal of getting approval to use
that company's drug in my trial," said A. Craig Lockhart, M.D.,
a gastrointestinal cancer specialist from Vanderbilt University
Medical Center. "I reviewed it with an industry representative
and he pointed out some issues that might hold up the
process."

Armed with the knowledge he garnered at the meeting,
Lockhart returned to Vanderbilt, revised his letter of intent,
and ultimately secured approval to begin his trial.

Dozens of new anticancer agents are discovered each year,
but many never reach patients because of the complex process of
drug testing and development that must ensue, Lyerly said.

"Scientists don't know all they need to about the regulatory
processes that lead to drug approval, and this workshop is
designed to address that," he said.

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