• WisBusiness

Thursday, December 1, 2011

Geron’s move highlights hurdles to bringing stem cell therapies to market

By Tom Still
The decision by a California company to halt its study of a stem cell-based treatment for spinal cord injuries is less about whether such therapies will work than the monumental regulatory and financial hurdles that stand in the way.

In a move with implications for Wisconsin researchers and companies working with embryonic stem cells, Geron Corp. announced in November it will stop spending $25 million a year to bring a stem cell treatment to market.

The reasons are clear: It would have taken up to 10 years to develop a treatment that meets with U.S. Food and Drug Administration approval, so Geron’s executives decided to put their money behind other experimental products that could get to market faster.

Geron executives and researchers outside the company remain confident in the science behind the spinal cord treatment, which has worked in laboratory animals, but the long and arduous pathway to win FDA approval appeared to be too much to overcome.

The Menlo Park, Calif., company had long been viewed as the leader in stem cell therapies, thanks to patents on technology used to grow, manipulate and inject embryonic stem cells into the human body. Stem cells are cells capable of morphing into any one of more than 220 human cell types. Many of the patents licensed to Geron were the result of work performed at the UW-Madison, where researcher James Thomson and his team first isolated embryonic stem cells in 1998.

Is Geron’s decision a setback to the U.S. stem cell research industry? Not necessarily so, because most research is still funded through academic channels. Also, Geron was focused on a specific therapy – mending damaged spinal cords – while companies elsewhere are developing other uses for stem cells.

Cellular Dynamics International, a Madison company founded by Thomson and others, is a ready example. Thomson has long insisted that stem cell “cures” or treatments were years in the future, given the revolutionary nature of what is still a very young field of science. His company has focused instead on using stem cells for disease modeling, testing new drugs, diagnostics and other research applications.

“For us, it validates the basic business plan: Steer clear of therapeutics for the foreseeable future,” said Dr. Tim Kamp, director of the stem cell medical program at the UW-Madison and a co-founder of CDI.

Business plans for any U.S. company involved in seeking biotechnology cures, treatments or diagnostics must include seeking necessary approvals from the FDA, which regulates development of drugs, medical devices, biologics, vaccines and more. Increasingly, however, the bioscience industry has complained about the FDA’s regulatory pace. For example, the president of the national Biotechnology Industry Organization, former member of Congress Jim Greenwood, called on federal lawmakers to “build a 21st century FDA” or risk losing U.S. competitiveness in the life sciences.

“The Geron experience underscores how broken the FDA process has become in this country,” said Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation. WARF is the private, non-profit group that handles UW-Madison patents and licenses them to potential users.

Others say the FDA is simply being cautious in the wake of some high-profile drug failures and because its regulators, like others in the field, are new to stem cell research. Still, skeptics say the system has become so cumbersome that innovation is being stifled.

“Geron spent about $45 million to prepare its IND (Investigational New Drug application) alone. There aren’t many companies that can afford to do that,” Gulbrandsen said.

For many years, the biggest threat to stem cell research came from opponents who questioned the ethics of how the cells themselves were derived. Today, it appears, an emerging challenge may be the possibility that researchers and investors frustrated by paperwork and costs go outside the United States to develop stem cell therapies that should be kept home.

-- Still is president of the Wisconsin Technology Council. He is the former associate editor of the Wisconsin State Journal in Madison.


Comments: 9

At December 1, 2011 at 7:11 AM, Blogger G & Co. Holding Firm said...

Advanced Cell Technology is currently in FDA approved human clinical trials utilizing stem cells to treat and possibly cure Age Macular Degeneration ( AMD ) and Stargardt's Macular Degeneration ( SMD ). They will soon start clinical trials in Europe as well.

At December 1, 2011 at 10:20 AM, Blogger dante said...

Gern was set up to fail...think about what success means to the medical industry....a dry up in revenues..

Stem cell promise for multiple sclerosis

Biplab Das

New research has found a way to replenish the fatty layer or myelin sheath around nerve cells1 — a finding that could yield a cure for neurodegenerative diseases such as multiple sclerosis.

Researchers have now understood how the right mix of biological growth factors coaxes human embryonic stem cells (ESCs) to form oligodendrocytes, a type of nerve cells that form the myelin sheath.


At December 1, 2011 at 4:46 PM, Blogger dante said...

Tuesday, November 29th, my paralyzed son Roman Reed and I attended the farewell party of the Geron stem cell research department.

Roman squeezed his wheelchair in beside Chief Scientist Jane Lebkowski, Joe Gold, sixteen years at Geron, and Kate Spink, who had organized the world's first human trials with embryonic stem cells.

It was a roomful of giants: 66 of the world's best stem cell research scientists and technicians. They had succeeded in the initial stage of the world's first human embryonic stem cell trials. These were safety trials for GRNOPC1, a stem cell product which might ease previously-incurable spinal cord injury paralysis -- they should have been lauded as heroes -- instead they were losing their jobs.

It would be different if their experiment had failed. But they had done everything right, played by the rules all the way: and in so far as they had been allowed to go, they had triumphed.

By FDA requirements, the first trial for any new drug or therapy must be safety. Could the cells be injected into a newly-paralyzed person without doing them harm? Opponents of the research had always maintained that the stem cells would cause cancer.

Didn't happen. There was no harm done to any of the patients.


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