Time for a reset?
Still, uncertainty remains. Mayleben, Aastrom Biosciences's CEO, says FDA's regulatory culture in the stem cell area needs
to evolve toward the kind of culture it exhibits in oncology, which involves a more enlightened risk/benefit assessment with
respect to unique, emerging products. But it may be the public at large that pushes these therapies forward, by whipping up
demand for access. "Everyone knows someone that has a condition that might link up to these kinds of technologies down the
road," says Geetter. "It doesn't matter whether you are a Republican or Democrat. There are some interesting, although quiet
institutional supporters of hESC research that cross political lines."
Everyone knows someone that has a condition that might link up to these kinds of technologies down the road.
These supporters—which include thousands of patients—should speak out now. When they do, pharmaceutical companies will be
compelled to listen. The promise of cell-based therapies, while there have been setbacks, hasn't been broken; it may just
need more funding and a little risk-taking to gain the traction it will need in the commercial world. Using new scientific
procedures and different cell types, stem cell companies have largely moved past the political and ethical debates that ignored
the vaulting promise of science. To keep pace with the changing contours of disease, politicians and their constituents should,
Ben Comer is Pharmaceutical Executive's senior editor. He can be reached at firstname.lastname@example.org