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The Kansas City Star- Turning science into drugs a trial

The Kansas City Star- Turning science into drugs a trial



Bioscience “holds promise like no other area of human endeavor,” Kathleen Sebelius,

Health and Human Services secretary, told Tuesday’s town hall-style meeting on cancer  drug research at the Kauffman   Conference Center in Kansas City. 

Time and again, the scientists, doctors, drug makers and regulators who gathered Tuesday in Kansas City to talk about new cancer drugs spoke of the “valley of death.”

It’s the long-cursed chasm between jaw-dropping breakthroughs in basic science — often unearthed at universities — and the manufacture of drugs that can battle your tumor.

New drugs are being approved at about the same rate they were in 1950, a rate the assembled experts said belied advances in medical research.

Tuesday’s symposium was convened in response to large pharmaceutical companies moving away from start-to-finish drug development. Instead — and with unimpressive success — they have experimented with partnerships with academics and clinicians.

That shift has come as a way to make better use of basic science research carried out at universities and foundations, hoping to leverage the tens of billions of government dollars spent each year to support academic studies.

Bioscience “holds promise like no other area of human endeavor,” Kathleen Sebelius, Health and Human Services secretary, told Tuesday’s town hall-style meeting on cancer drug research at the Kauffman Conference Center in Kansas City.

Still, that promise must cross a treacherous terrain mined with befuddling science and seemingly booby-trapped with obstacles that make collaboration across organizations and disciplines exasperating.

Experts shared their frustrations over cutting deals on intellectual property rights, on splitting the cost of developing drugs, about the difficulty of testing two drugs for use together when their rights are owned by competitors, and regulations that seem to trail science.

They also talked about the conflicting metabolisms of a university campus and a corporate laboratory. They talked about the trouble with animal studies that can dash the hopes of otherwise exciting drugs when they show even slight safety risks.

And they noted how researchers headed down the same dead ends that stumped their competitors because companies kept results of failed studies private.

The results from breakthroughs, such as mapping the human genome 10 years ago, have yet to yield a wondrous generation of drug solutions.

Researchers, regulators and drug company officials said they have yet to perfect ways to collaborate efficiently.

So the University of Kansas Cancer Center, the Friends of Cancer Research, the Kansas Bioscience Authority and the Council for American Medical Innovation brought the leading lights from academia, industry and government to talk about solutions.

Much of the discussion centered on so-called personalized medicine — the recognition that genetic differences mean some people respond dramatically differently to different drugs or therapies. It is a seductive addition to medicine born from emerging genetic know-how.

Personalized medicine also poses a dilemma for making drugs. A pill that can be sold to millions to produce even marginal improvements in health can be tempting for a drug company and its shareholders. A capsule that can promise an outright cure — but to perhaps only thousands or just hundreds — might never be profitable.

“This is the big question of our era,” said Chris Austin, director of the National Institutes of Health Chemical Genomics Center. “How do we translate science into drugs.”

For now, not so well.

“That’s not a place we want to be,” said Vicki Seyfert-Margolis, a science adviser at the Food and Drug Administration.

The obstacles are not all legal and bureaucratic. She and FDA Commissioner Margaret Hamburg said the agency needed more money to improve what it called “regulatory science,” or increased sophistication in understanding the safety and efficacy of new kinds of drugs.

While genetics research was long hailed as the holy grail of medicine, mapping the human genome has revealed as many perplexing complexities as promising cures. A few years ago, scientists believed cancer broke down into 200 types. Now that number is believed to be more than 2,000.

On the one hand, that offers a chance to develop drugs that better target specific enzymes or proteins. At the same time, it is a call for thousands instead of hundreds of cures.

“How does it make economic sense to do that? We need,” said Roy Jensen of the KU Cancer Center, “to come up with new models.”