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New Drugs: Getting Them to Cancer Patients Faster

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Duke Health News 919-660-1306

DURHAM, N.C. -- David Lassiter knows he is running out of
options. The new drug Avastin is keeping him alive, staving off
his colorectal cancer that recurred three years ago. But
already the drug is showing signs of diminishing success. When
it stops working, there are no drugs on the market to keep his
cancer at bay.

"I'm not convinced the National Cancer Institute and the
Food and Drug Administration are effective at getting new drugs
to patients quickly," said Lassiter, a patient at the Duke
Comprehensive Cancer Center. "I know there is a need to balance
the risks versus the benefits, but we patients are less
concerned about the potential side effects than the fact that
the drugs may save our lives, which is the ultimate goal."

Currently, it takes 12 to 15 years and an estimated $1.5
billion from the time a drug is discovered until a safe and
effective product reaches the market, said H. Kim Lyerly, M.D.,
director of the Duke Comprehensive Cancer Center. The drug
development process hasn't kept pace with the rapid scientific
advances in cancer biology and genomics, but the problem isn't
solely a government regulatory issue, he said.

"We need to devise tangible solutions to accelerate drug
development so that cancer patients have access to safe and
effective drugs more quickly," Lyerly said. "The responsibility
doesn't rest with a single player -- academia, industry and
government are collectively responsible."

Lyerly has teamed with government, industry and cancer
groups to create an open forum for scientists and regulators to
discuss the testing and validation of new drugs, free of the
regulatory constraints that necessarily occur during official
drug approval process. In 2004, he organized what is now an
annual workshop with the FDA, the National Cancer Institute,
the American Association for Cancer Research and the American
Society of Clinical Oncology to train early-career scientists
how to effectively develop and validate new anticancer
drugs.

Contrary to assertions that the FDA closely guards its drug
approval guidelines, Lyerly said the agency has embraced the
opportunity to educate investigators on how to best approach
drug development and approval. The problem has been largely one
of communication, not privacy, he said. Scientists and
companies design clinical trials and test new drugs without
prior input from or collaboration with the FDA. When it comes
time to seek regulatory approval, scientists may lack critical
data that the FDA needs, sending the process back to the
testing phases.

"Some of the very best scientists don't necessarily have the
tools or the training to develop their drugs and move them
through the approval pipeline," Lyerly said. "With this
workshop, we're removing the barriers to constructive dialogue
by linking academic and industry scientists together with FDA
officials in a creative way to talk about new strategies for
accelerating drug discovery."

In the training workshop, "Accelerating Anticancer Agent
Development and Validation," seasoned cancer researchers from
industry, academia and government -- along with senior
representatives from consumer groups -- will share their
knowledge of drug development with early-career cancer
scientists from the United States and abroad. Workshop
participants will bring their data about a promising anticancer
agent or new therapeutic strategy. Senior scientists will
mentor participants as they design strategic plans for fully
developing and validating their anticancer agents.

Senior FDA officials will be among the more than 60 mentors
-- all volunteering their time -- who will help train
participants at this year's workshop, to be held May 17-19 in
North Bethesda, MD.

"In this era of targeted drug development, it is imperative
that there be an open dialogue among representatives of
industry, academia, and the FDA regarding ways to optimize the
development of these novel therapeutics with the ultimate goal
of enhancing treatment options for cancer patients," said Neil
Spector, M.D., director of Exploratory Medical
Sciences-Oncology at GlaxoSmithKline. "This workshop provides
an opportunity for researchers to obtain guidance in a much
less formal setting, where the discussion can be more open and
free of the constraints that might otherwise stymie the process
if delayed until a later stage."

The workshop's primary goal is to encourage what is known as
translational research -- transforming scientific discoveries
made in the laboratory into viable treatments for patients,
said Richard Pazdur, M.D., director of the FDA's Office of
Oncology Drug Products.

"The workshop allowed me to converse with regulatory experts
and better understand the requirements and expectations of the
FDA and other agencies," said Antonio Wolff, M.D., associate
professor of oncology at the Sidney Kimmel Comprehensive Cancer
Center at Johns Hopkins. Wolff attended the conference in
2004.

"In addition, the opportunity to present my proposal to a
large group provided me with instant peer review and valuable
critique of my plans and ideas," Wolff said. "In my specific
case, it helped me and my colleagues fine-tune a large project
prior to its submission to the National Cancer Institute."

Duke oncologist Kimberly Blackwell, M.D., who participated
in previous workshops, said this specific type of training in
drug development is essentially unavailable in cancer
research.

"Bringing together these groups of people for collaboration
makes this workshop an incredibly productive environment for
cancer researchers," said Blackwell, assistant professor of
medicine-oncology at the Duke Comprehensive Cancer Center. "The
tools and insight I've gained have helped me to navigate the
confusing pathway of drug development, and this has proved
invaluable as I work to develop new therapeutics for my
patients."

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