The Obama Presidency: Some Needed Changes Likely Coming in the Life Sciences

For months and months, we heard the mantra of “Obama: the change we need; change we can believe in.” The election is finally over. The people have spoken. Now that Senator Barack Obama is president-elect, it is my hope that certain “changes” supported by the president-elect will help jump-start two areas of focus in the Boston life sciences community: embryonic stem cell research and “personalized medicine.”

Since 1996, a law has banned federal spending on research that harms human embryos. In August 2001, President George W. Bush issued an executive order that loosed this restriction slightly by allowing federal funding for embryonic stem cell research that used one of the few then-existing stem cell lines. Now, seven years later, President-elect Obama is reviewing President Bush’s order and may reverse or amend the decision made in 2001. Expectations are high for a change. In a 2007 news release supporting legislation to loosen restrictions on stem cell research, Mr. Obama said:

I am frustrated … that we are preventing the advancement of important science that could potentially impact millions of suffering Americans … My hope, and the hope of so many in this country, is to provide our researchers with the means to explore the uses of embryonic stem cells so that we can begin to turn the tide on the devastating diseases affecting our nation and our world.

Some have asked why, given the advances in stem cell research with the federal prohibitions in place, particularly the dramatic results seen in the last few years with making stem cell-like cells from skin cells (also known as reprogrammed or induced pluripointent stem cells (iPS)), any change is needed. But there are a number of reasons why removing limitations on embryonic stem cell research is “change we need.”

Research in reprogrammed cells, while dramatic, is still in its infancy. In fact, the first reprogrammed cells were reported just a few short years ago. As a result, many issues need to be worked out. iPS cells are currently produced, at least in part, through the introduction of genes associated with cancer, using a virus that could lead to cancer-causing mutations. Needless to say, more research is needed before this methodology reaches the clinic.

Another important issue is the equivalence of iPS and other types of stem cells. Are the cells the same? Do certain types of stem cells have properties that might provide clinical advantages? Some scientists believe that iPS cells will never be suitable for cell therapy. Time and research will tell. Relaxing the ban would allow scientists in the field to use equipment and facilities funded with federal research dollars, potentially accelerating research while, at the same time, reducing research costs.

Relaxing the ban could provide another important dividend. For ethical and political reasons, many pharmaceutical and biotechnology companies have stayed away from stem cell research. It is hoped that federal support of stem cell research will encourage commercial investment, resulting in what we all hope for: clinical treatments.

Will the Obama administration change the federal position on embryonic stem cell research?

Author: David Resnick

David Resnick is a partner and the co-team leader of the Biotechnology/Chemistry team at Nixon Peabody. David assists clients in obtaining and defending intellectual property protection for cutting edge technologies in the life sciences, including stem cells, regenerative medicine and RNAi. David has developed a particular focus on the areas on pharmacogenomics, proteomics, and disease biomarkers and their application in the evolving field of personalized medicine. David also assists clients by evaluating their intellectual property portfolios, as well as the intellectual property held by competitors or potential acquisitions or partners. In connection with these activities, he has been involved with strategic patent prosecution, due diligence and freedom-to-operate analyses. David’s clients include many Boston area universities, research hospitals, and life science startups, as well as large pharmaceutical companies.