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The lists of the top pharma/biotech stories for 2009 that I have been seeing online focus mostly on the rise of biosimilars, the spate of mergers and the plurality of Hatch-Waxman litigations that have grabbed the headlines almost daily, along with the policies of the new PTO Director and attacks on gene- and business-method patenting.

Let’s not forget one major policy shift that President Obama initiated early in the year that may do more for the health of our citizens than the gut-shot health care reform bill stumbling toward further compromise. On March 9, 2009, President Obama signed Executive Order 13505 that lifted a more than eight-year ban on Federal Funding for research on embryonic stem cells.

Prior to the order, U.S. researchers could conduct research on ESCs with private funds, but this research had to be strictly segregated from any resources made available by the feds. In other words, an instrument bought with private funds could not be set on a lab bench built with federal funds. This problem is not entirely remedied by the Executive Order since Congress continues to attach an amendment to general funding bills that prohibits the use of federal funds to destroy or harm human embryos. In other words, researchers can now use ESCs, but they can’t make them from scientific scratch.

Still, this is an important step forward to enhance the ability of U.S. researchers to contribute and complete in this new and increasingly promising area. In August, the NIH issued guidelines which it will use in deciding if grant applications for stem cell research are fundable, and in approving ESC lines not previously approved for use in research. The stem cells must have been derived from embryos in excess of clinical need for in vitro fertilization, they must be voluntarily donated by the “parents,” and not bought or sold. Also, the human embryos cannot be the result of cloning experiments. See,

In early December, NIH approved, inter alia, the use of 11 cells produced at Harvard using private funding. This is significant, since there are an estimated 700 ESC lines in the worldwide research community, and research on most of them may well be fundable now. Reports of phase I/II clinical trials using ESCs to treat a wide range of mostly hopeless conditions are frequent already. A very recent news story reported that a Scottish researcher plans to use ESCs in an attempt to treat stroke victims. Let’s hope that executive order 13505 and the NIH regulations open the floodgates for both new business opportunities and, more importantly, new hope for the new year.


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