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INSIGHTS JUNE 2014 54 LIFESCIENCELEADER.COM PHARMA MANUFACTURING HOW GENZYME GOT ITS MANUFACTURING MOJO BACK By N. Taylor In the summer of 2009, Sandra Poole, newly appointed head of Genzyme's Allston Landing biologics plant, and the site's leadership team were confronting arguably the toughest job in biotech at the time. Days before her arrival, Genzyme shut down the site after discovering a viral contaminant. There would be no settling-in period. The entire company and thousands of patients were relying on this team to fix the problem. N I C K T A Y L O R Contributing Editor How Genzyme Got Its Manufacturing Mojo Back ooking back on that summer, Poole admits it was a very chal- lenging time, with staff work- ing night and day to resolve the issues and resume production at the facil- ity. The sixth and final bioreactor came back online around 2:30 a.m. one August morning, but the saga was just beginning. Earlier that year, Genzyme had received a warning letter from the FDA following inspections of the Allston Landing plant. The FDA also indicated that additional information was needed regarding a pend- ing drug marketing application. The warn- ing letter was followed a year later with the FDA's announcement that it would seek an enforcement action, which resulted in a consent decree and a $175 million fine. Activist shareholder Carl Icahn got his people on Genzyme's board, and in 2011, Sanofi bought the company. The events and the headlines they gen- erated placed additional pressures on Poole and her team, but the biggest hit to morale came from elsewhere. A combi- nation of low inventories of Fabrazyme and Cerezyme, the facility shutdown, and reduced output during remediation meant Genzyme was unable to meet demand for the products. Patients were initially understanding, Poole says, but as the sup- ply shortage dragged on into 2010, ten- sions grew. "We could feel the frustra- tion," recalls Poole. This was the low point. "The worst thing was the feeling of having failed. We tried our hardest, but yet ... ." By the time the staff reached this low point, they had fallen a long way. Allston Landing was the foundation on which the Genzyme success story was built, and staff was proud of its role in turning the com- pany from an upstart biotech into a major force in the biopharma industry. In 2008, the future looked bright. Having added a third product and expanded a manufac- turing suite, the metrics showed the plant was in good health. Everything suggested its second 15 years would be as successful as its first, but the forecast was wrong. WHY GOOD PRODUCTION PLANTS GO BAD Rebuilding confidence after such a dra- matic and public decline became a major part of Poole's job. In the short term, equip- ment needed upgrading, and quality sys- tems required remediation, but Poole felt the plant's people were central to achiev- ing a sustained transformation. In the sys- tems-thinking model followed by Poole, a plant's people and culture sit at the center of an interconnected ecosystem. Each part of the system must function well in rela- tion to the others for the plant to succeed. The problem? When you are in the middle of the system, it is really hard to see and keep track of the interactions. Poole thinks this limitation played a role in the problems faced at the Allston Landing site. As the plant grew and added new product lines, the system became more complex. Many facilities go through this process, with the early years of rising confidence and capabilities giving the own- ers sufficient faith in the plant to increase volumes or change the product mix. Yet if the staff, processes, and equipment are not individually and collectively prepared to deal with the increased complexity this brings — and attuned to signs it is causing problems — the situation can unravel. This is the Allston Landing story, Poole says. The plant was built to produce Cerezyme, and output tripled in the first few years. Fabrazyme was then added, and, while the system became more com- plex, the site continued to thrive. In ret- rospect, the addition of Myozyme in 2004 and subsequent need to expand output above anticipated levels may have been the tipping point, though. While on the sur- face the plant prospered, Poole thinks ele- ments of the system were unprepared for the new level of complexity. Strengthening L 0 6 1 4 _ P h a r m a _ M a n u f a c t u r i n g _ G e n z y m e . i n d d 1 0614_Pharma_Manufacturing_Genzyme.indd 1 5 / 2 1 / 2 0 1 4 1 1 : 5 6 : 0 3 A M 5/21/2014 11:56:03 AM