Cancer Researchers Team Up With FDA
Birmingham's Children's Hospital of Alabama 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.