Developing ‘revolutionary’ drugs — This company has spent a billion dollars over 25 years and has come up empty. What now?

The headline on the cover of the San Francisco Business Times told it all.

“Running on Empty: What do you do when 25 years and a billion dollars have not produced an approved drug?”

It was a clear illustration of the enormously expensive task and challenges involved in developing cutting-edge therapies — an illustration that applies as well to the $12 billion California stem cell and gene therapy program. It too has yet to finance an approved stem cell or gene therapy treatment during its 18 years of work and the expenditure of $3.5 billion from California taxpayers.

“By some estimates, only one in 10 drugs that make it into clinical trials survives the financial, clinical and regulatory gauntlet to come out the other side with an approved drug, a process that typically takes a decade or more,” [said reporter Ron Leuty].

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Hope, however, does not burn eternal. At some point, the three companies and [The California Institute for Regenerative Medicine, or] CIRM are going to need more cash. In the case of CIRM, it will need to appeal to voters to save its program. The question is whether the voters will buy the deal.

This is an excerpt. Read the full article here