FDA Attorney Edward Allera Quoted on Cell Therapy for Cardiac Disease

Edward John Allera, chairman of the Buchanan Ingersoll & Rooney's FDA/Biotechnology Section and a managing shareholder of the firm's Washington, D.C., office, was quoted in a June 1, 2009, article published by Nature Biotechnology. The article, titled "U.S. regulator wades into stem cell therapies for heart disease," discussed how the FDA's draft guidance on cell therapy for cardiac disease has been given a muted welcome by clinicians and industry. Since the April release of the guidelines, problems have been cropping up with existing bone marrow-derived cell therapies for heart disease in the clinic.

Allera weighed in on the issue saying, "My intuitive sense is that they'd had some issues [with companies doing cell therapy heart research ] already. Educated players understood this was coming."