Genzyme maintains focus on remediation

Just sticking to the program is keeping Genzyme on track in remediation efforts at its Boston-area plant, currently operating under consent decree with the FDA. The company noted last week that supplies of Gaucher disease treatment Cerezyme have stabilized and the treatment has been removed from the FDA list of drugs in short supply.

Tracking the progress of the plant rehab, it's difficult to imagine that the company is in the midst of a protracted, high-visibility buyout attempt by Sanofi-Aventis. Spokesperson Erin Emlock cites the leadership changes over the past year--the hiring of Ron Branning as president for manufacturing and corporate ops and Scott Canute as senior VP for product quality, as well as the appointment of manufacturing-savvy Dennis Fenton to the board--among key factors keeping the remediation on target.

In addition, she credits consultancy Quantic for ongoing oversight in the work to improve quality and compliance at the Allston Landing facility. The recent transfer of some fill/finish operations to other locations will be followed by more such transfers for other treatments, planned for the first half of this year. The transfers, she says via email, represent another step toward freeing the facility to focus solely on production of Cerezyme and Fabrazyme.

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.