Stem Cell Symposium Notes

On April 21, 2010 I attended UW-Madison’s Annual Wisconsin Stem Cell Symposium. Called, “The Road to Stem Cell Applications,” these observations have to do with some of the challenges discussed about the road ahead to further stem cell applications.

This meeting was held at the Bio Pharmaceutical Technology Center in Madison, WI.

Some participants expressed concern that the Food & Drug Administration has been too slow in adapting their standards and consultation to better accommodate the fast growing and robust stem cell research field. One speaker feared that too many FDA rules could possibly dampen the researcher’s inquisitive spirit. On a related issue, it was also noted that if standardization sets in too fast, certain otherwise significant secondary discoveries might not be pursued vigorously enough.

A new endpoint --- ending disease --- is the public’s goal for stem cell research. As one speaker said, “from being cool to the real thing.” The tension produced by the public’s desire to raise the bar for stem cell science from disease amelioration to ending diseases has become increasingly palatable. In spite of the delays owing to certain ethical and political policy constraints we have now arrived at the preclinical evaluation stage.

To date only one human embryonic stem cell therapy (Phase One) trial has been approved by the FDA. It is being conducted by the Geron biotech company located in Menlo, California. Geron funded UW’s Dr. Jamie Thomson’s human stem cell line discovery and later received a license from the Wisconsin Alumni Research Foundation to use Thomson’s stem cells.

Geron’s President and Chief Executive Officer, Dr. Thomas B. Okarma spoke at the Symposium and reviewed the history of Geron’s cell-based therapy project for patients with thoracic injuries. Their FDA application was over 22,000 pages and has already cost over forty million dollars. He emphasized how important it is for the greater stem cell community that his company get this trial done right the first time.

Several speakers suggested that continuous cooperation and dialogue among all stem cell stakeholders, including industry, academia and disease advocates, would be required to reduce existing tensions.

It was also noted that before embryonic stem cell therapies can move from the bench to the clinic, extensive education will be required to bring health professionals up to speed about this new and more complex cell-based therapy. The challenge facing scientist today is to move from individual patenting and marketing strategies to greater collaboration among all the disciplines involved. The investors, including taxpayers, are all demanding greater efficiency, effectiveness and accountability from the scientific community.