Curious about the woman who's charged with cleanup at Genzyme? Skip on over to the Boston Globe, where Sandra E. Poole gets the profile treatment. Poole, who took over in July as Genzyme's senior vice president and site leader at the embattled Allston Landing facility, is pushing hard to get the plant--and Genzyme's reputation--back on line.
Genzyme has been under FDA fire for manufacturing deficiencies since February. Then, in June the Allston Landing facility was contaminated by a virus, forcing a temporary shutdown so the plant could be sterilized. That shutdown, coupled with wider-than-expected contamination of Genzyme's key drug, has weighed heavily on the company ever since. Patients, too, have suffered from drug shortages.
Now, however, the plant is up to full production for the first time since June. European regulators have made an inspection visit. Next comes the all-important FDA site inspection. It's not yet scheduled, and the agency won't say when it might be. But Poole says she's ready, not only for the Allston Landing inspection, but to oversee other Genzyme manufacturing operations. "Do I feel like I'm under a magnifying glass?'' she told the Globe. "I suppose. This is a vital effort for Genzyme. This is really being billed as a global program. We're developing a remediation program that we'll use at all our biologics plants.''
- read the Globe story