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I’m confident this change will happen. At the September 22, 2008, HSCI Stem Cell Summit, Rep. James Cooper (D-TN), in discussing what the results of the presidential election would mean to stem cell research, stated that his part of the country has an expression: “You dance with the one that brung ya.” Representative Cooper’s position was that if Senator McCain had been elected, even though he was on the record as supporting embryonic stem cell research, he would certainly not have lifted the ban, given the conservative members of the Republican Party he was courting with the nomination of Governor Palin for vice president. Given who “brung” President-elect Obama to the “dance,” I’m certain we will see change. I’m hoping for this change in the first 100 days.
(On December 12, 2008, Dr. William Lensch, an instructor at Harvard Medical School and affiliate faculty member at the Harvard Stem Cell Institute (and an Xconomist), will address these issues at the offices of Nixon Peabody in Boston, MA. If you are interested in attending, please contact Allison McClain at email@example.com.)
What other changes can we expect in the life sciences? For years, we have been talking about using the power of genetics or other biomarkers to direct individualized or personalized treatments. With the exception of a few successes in the treatment of cancer, progress has been slow. Now the hope is that legislation originally introduced by Senator Obama in 2007 to promote personalized medicine will change that. According to the Personalized Medicine Coalition, Mr. Obama’s legislation, “among other things, aims to improve the coordination of public and private efforts to facilitate the development of safer and more effective drugs, create a biobanking initiative, expand the genomics workforce, and improve the quality of clinical genetic testing.”
Recently, Rep. Patrick Kennedy (D-RI), in the Genomics and Personalized Medicine Act of 2008 (H.R.6498), added to the language of Mr. Obama’s 2007 legislation. The new language adds tax and test credits to encourage research and commercialization.
The Obama and Kennedy bills encourage government agencies, including the NIH, FDA, and CDC, to work together to establish a national biobank for use as a resource for researchers, and provide funding and training for diagnosis, treatment, and counseling of genetic diseases.
The Kennedy bill further provides incentives that would encourage the development of companion diagnostics by drug sponsors and by device companies, including, among other things, a tax credit for research expenses incurred in the development of a companion diagnostic test.
Given President-elect Obama’s support for personalized medicine, the recent passage of the Genetic Information Nondiscrimination Act (GINA) and the hope that tailored therapies will ultimately reduce healthcare costs, this “change” should be an easy one.
While the “change” necessary to encourage personalized medicine isn’t nearly as contentious as that for promoting stem cell research, the result will ideally be the same: moving federally funded scientific research from the laboratory to the clinic.
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 in the life sciences, including stem cells, RNAi and personalized medicine. The views expressed in this column represent only those of the author and not of Nixon Peabody or its clients.
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