Thursday, March 8, 2012

Investment Potential for Human Embryonic Stem Cell Research Looks Dim

Questionable Investment Potential for Human Embryonic Stem Cell Program_StemCONN 2011

In 2005 without going to a public referendum Connecticut’s General Assembly and Governor passed into law an Act authorizing state funding of human embryonic stem research. The Act mandated that $100 Million dollars of public funds be used to support this research over a 10 year period. This research endeavor was initiated as an economic development plan for the state of Connecticut.

Is Connecticut’s plan working? Will hESC research generate economic development by attracting sufficient investor-based business to Connecticut?

The answer does not look promising.

“Investors are fearful to invest due to the unlimited risks. Investors want to make sure that they will be reimbursed”, said one panelist at the “Stem Cells for Profit” StemConn 2011 event last Tuesday in Farmington.

As of today, there is still no embryonic stem cell therapy to market.

Thee human clinical trials using hESC, however, have been approved by the FDA for phase 1 Safety trials in other states. But many scientists shared grave concerns about this at StemCell 2011. Since hESC technologies still holds serious risks and dangers for human subjects, investors justifiably worry that a bad trial outcome could devastate the industry.

One positive factor for investment is that FDA regulations do not appear to be a deterrent. In fact, one panelist commented that the “FDA relies on the scientific community to craft regulations”.

Instead, the immediate and critical problem for investors seems to point to the technical limitations of hESC research.

The lack of understanding of the complex molecular and cellular processes in both the undifferentiated and differentiated forms of the stem cell is a major shortcoming in getting a hESC therapy into market. Each embryonic stem cell line behaves differently, mandating each to be characterized. Not only does this compound the scientific and technical hurdles, but also, the cost to do business.

Dr. Kevin Eggan, a researcher from Harvard gave ample evidence of the enormous work it takes to tackle such technical problems during his presentation at StemConn 2011. Eggan’s research compared a number of different human embryonic stem cells to induced pluripotent stem cell (iPS) which took four years to complete, working full time.

The technical shortcomings related to basic embryonic stem cell biology constrain the likelihood of hESC therapies to make it to market. Until these scientific hurdles are overcome, robust investment potentials will most likely be lacking.

“Where is the money going to come from” to move science to a point where it will attract investment for economic development? Currently, the vast majority of funding which supports hESC comes from federal funding. “In 2009 Obama provided $143 million dollars to 330 hESC research projects”, said a panelist on “Current Status of Litigation Related to Federal Funding of hESC Research” at StemConn 2011.

With the fact that the federal government now funds hESC research, the $100 million dollar question remains for Connecticut: Will additional state funding toward hESC research provide competitive advantage to the state?

Connecticut should balance their decision to allocate future state-funding to hESC with caution and careful planning.

B. McClain
March 2011

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