Universities should play bigger role in drug development

Top federal health officials were in KC for a conference to discuss an expanded role for academia

0 | Government, KU Medical Center

Former U.S. House Majority Leader Dick Gephardt, left, lead a panel discussion that included FDA Commissioner Dr. Margaret Hamburg, center, and NIH Director Dr. Francis Collins, right.

Former U.S. House Majority Leader Dick Gephardt, left, lead a panel discussion that included FDA Commissioner Dr. Margaret Hamburg, center, and NIH Director Dr. Francis Collins, right.

— The nation's top health officials were here today to talk about the need for new approaches to developing and approving cancer treatments and other drugs.

“The system is not really set up to support developmental therapeutics. We're asking the current system to do what it was never set up to do,” said Dr. Roy Jensen, director of the University of Kansas Cancer Center. “There's a fundamental disconnect in how things are set up.”

Jensen said the current, traditional model of drug development relies on major pharmaceutical companies selecting a “blockbuster” drug to bring to market after investing considerable time and money to get a treatment federally approved as safe and effective.

But he and others who spoke at the conference hosted by the Kauffman Foundation said it is time for universities and disease fighting philanthropies to play a more active role in drug development and in greater collaboration with the drug industry and federal regulators.

Targeted cures

Jensen said advances in gene and molecular sciences now make it possible for researchers to find treatments or cures tailored to relatively small groups of people with certain gene markers. Though potentially very effective, it currently is difficult to get those types of drugs approved, made and distributed because they generate little profit compared to products that can be prescribed and sold to millions of people.

But the cure for cancer most likely won't be a single “blockbuster” vaccine or treatment because there are so many types of cancer, Jensen said.

“There may be 2,000 kinds of cancer,” he said and it would be “extraordinarily difficult,” for drug companies to bring to market treatments that target as few as 5,000 patients.

Jensen predicted the current drug development model was “one of the things that's going to die,” as new treatments become possible. He said he believed universities and philanthropies could “help bridge” the move to a new funding model for drug development.

“The economic model for drug development that relies on the big pharma blockbuster drug is really dying,” Jensen said. “That model is rapidly disappearing and we need to figure out what will replace it.”

Top health officials

The “town hall meeting,” as some billed it, drew the nation's top health officials including U.S. Secretary of Health and Human Services Kathleen Sebelius, U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg and Dr. Francis Collins, director of the National Institutes of Health.

photo

KHI News Service

FDA Commissioner Dr. Margaret Hamburg

Former U.S. House Majority Leader Dick Gephardt, now chairman for the Council on American Medical Innovation, moderated one of the panel sessions.

Ellen Sigal, founder of the group Friends for Cancer Research, played a key role in organizing the gathering.

She said she started working on the conference about 18 months ago after talking with Jensen and learning about the drug developments underway at the KU Cancer Center, which has worked in collaboration with hospitals, the Kansas Bioscience Authority, the pharmaceutical industry and other organizations.

“We thought it important to bring the FDA, the NIH and the secretary (of HHS) here to see all the elements and expose the country to how it is all coming together here,” Sigal said. “We're all looking for a tangible model.”

She said the KU approach to drug development could be a model for the rest of the nation.

Kansas “gets it”

Tom Thornton, president of the Kansas Bioscience Authority, also said the state was well positioned to be a national leader in drug development.

“They're begging the question of what is the next innovation model,” he said of the conference speakers. “How do you turn (medical) innovation into entrepreneurship and also support commercialization? We have a model here in Kansas that effectively does what everyone is talking about. We have a credible, realistic shot to be a leader at a time when the industry is changing.”

Thornton said there is evolving in Kansas and Kansas City a “highly targeted approach” to drug development that relies on academic, industry and financial collaborations done in an “open and transparent manner,” that could become a national model.

Thornton said Kansas in the past five years had increased its percentage of NIH grants by 37 percent and also has the “highest concentration of clinical (drug) trials in the country.”

“This is a state that gets it,” he said.





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