Off the shelf products are far different than patients getting treated with their own stem cells by their physician and yet the FDA wants to regulate our own cells as mass produced drugs. The costs associated with mass production are simply not feasible for doctors or even most commercial stem cell clinics and quite frankly such regulation is a result of politics and pressure from an industry that wants to protect certain interests. It's that simple.
Robert Perry
Sr. Director Manufacturing,
Operations & Supply
Athersys, Inc.
25 April 2014
http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/2014_AnnualMtgPresentations/SC5_R.Perry.pdf
Robert Perry
Sr. Director Manufacturing,
Operations & Supply
Athersys, Inc.
25 April 2014
http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/2014_AnnualMtgPresentations/SC5_R.Perry.pdf