Magazine Article | June 2, 2014

How Genzyme Got Its Manufacturing Mojo Back

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By Nick Taylor, Contributing Editor

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.

Looking back on that summer, Poole admits it was a very challenging time, with staff working night and day to resolve the issues and resume production at the facility. 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 pending drug marketing application. The warning 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 generated placed additional pressures on Poole and her team, but the biggest hit to morale came from elsewhere. A combination 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 supply shortage dragged on into 2010, tensions grew. “We could feel the frustration,” 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 company 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 manufacturing 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 dramatic and public decline became a major part of Poole’s job. In the short term, equipment needed upgrading, and quality systems required remediation, but Poole felt the plant’s people were central to achieving a sustained transformation. In the systems- 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 relation 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 owners 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 complex, the site continued to thrive. In retrospect, 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 surface the plant prospered, Poole thinks elements of the system were unprepared for the new level of complexity. Strengthening just a few parts can be counterproductive. “You can actually make the system more fragile,” says Poole.

Having arrived at the start of Allston Landing’s decline, Poole and her team began strengthening the system as a whole in a bid to not only fix the problems but also prevent them from ever happening again. To simplify the site from an operations standpoint, Genzyme began narrowing the focus of the plant exclusively to Cerezyme bulk drug substance production, moving the manufacturing of Fabrazyme and fill-finish and packaging operations to other parts of its industrial network (Myozyme had already exited the site).

Just as significantly, the Allston “People Plan” was created. Town hall meetings and luncheons were held to connect people, share stories, and rebuild morale, but Poole says programs to help staff with systems thinking, collaborative skills, emotional intelligence, and resilience were most impactful. “We wanted to ensure we had the talent and that the leadership and the workforce had the capabilities to adapt to all the changes,” says Poole.

Equipping Leaders To Rejuvenate A Demoralized Plant
At the core of the People Plan were two initiatives: a change-leadership-capacity building program and the Allston DNA Cafe. For the change-leadership project, Poole gathered 80 of the facility’s top leaders for a series of workshops. A practitioner of systems thinking was brought in to help the team see the plant for the complex ecosystem it was, not the series of simple linear cause-effect relationships their brains were wired to spot. This led to practical tasks like building feedback loops, which adapt an organization to change, and how to solve real-world problems using systems thinking.

The Allston DNA Cafe complemented these workshops. Poole again gathered the plant’s 80 leaders, but this time broke them up into groups of eight peers. Each group was coached by internal and external experts in action learning, the process of acquiring knowledge through actions and practice, as opposed to traditional instruction. The groups met once a month, with part of their time dedicated to building skills, such as how to ask a really good question. Each participant would also share real-life problems with the group and discuss potential solutions with their peers.

Poole is effusive about the initiative. “That program has been hugely successful. Testimonies from the individuals show this was impactful in their jobs and personal lives,” she says. Giving the leadership these new skills and renewed faith in their abilities helped them weather the setbacks that occur in any remediation effort. Having gathered the very personal metric of participant testimonies and seen the improvement at Allston Landing, Poole’s successor at the plant, Pat O’Sullivan, has continued running the change leadership program and smaller action-learning gatherings.

In her new role of senior vice president, biologics manufacturing at Genzyme, Poole is tasked with taking the lessons learned at Allston Landing and replicating them across the production network. The work has its origins in the early days of the Allston Landing crisis when Genzyme’s leadership decided to use the problems as the trigger for a companywide transformation. Other production plants throughout the industry face pressures similar to Allston Landing, whether it is the need to add more products or a combination of technological, social, and regulatory changes. Genzyme wants to prevent history from repeating.

As Poole sees it, increased complexity is inevitable. What matters is how a plant copes. “Companies that develop the ability to really understand and master this complexity, to be able to anticipate and adapt to all these forces of change, and reorganize themselves after a significant disruption will really have a huge competitive advantage,” she says. Tests of whether the lessons learned at Allston Landing have helped Genzyme master complexity await. If Allston Landing continues its revival, it may one day be presented with opportunities that could introduce further complexity. However, considering the journey the site has been on, it would be much better positioned to handle this complexity. Poole’s objective is to ensure the rest of the sites within the Genzyme biologics network benefit from the Allston experience.

The Metrics To Track To Foresee Decline
Genzyme’s plant in Belgium, which Poole led before moving back to the United States to manage the crisis, is at a stage of development comparable to Allston Landing in the early 2000s. The site has available capacity and infrastructure, but Genzyme is still determined to learn from its past experience in Allston. Poole says, “We’re having very thoughtful conversations about the Allston Landing experience and asking, ‘How do we know the Belgian site is capable enough to handle increased complexity before we introduce it?’”

If the process is handled well, Poole sees no reason the Belgian plant will suffer as a result of the increased complexity. The trick is to match the plant’s competence and capabilities to the new level of complexity. This means helping the leadership understand the new system and their teams’ roles within it, instead of just adding staff and equipment and expecting the rest of the site to carry on as before. “It’s when you add products and increase complexity without taking into consideration all parts of the system — including people and culture — that you fall into trouble,” says Poole.

We track a ton of things, but are they really the right metrics to measure organizational health?

Sandra Poole
Senior Vice President Biologics Operations at Genzyme

Throughout the expansion, the Belgian team will monitor the plant’s metrics and key performance indicators (KPIs), but the failure to predict the Allston Landing crisis has shown Genzyme one cannot rely on data alone. While Poole believes lessons learned at Allston Landing have left Genzyme better equipped to foresee and avert crises, she knows there are limitations to how well past experiences can help fix or prevent future problems. “Could I sit here today and reassure you that we would never have another setback or lose confidence in the future?” says Poole. “No one could honestly make such a claim about any plant. The task of today’s leadership is to complement technical leadership competence with the adaptive and systemic leadership capacity that is wellmatched to complexity.” For Genzyme, and all manufacturers, part of the challenge is to pick the right metrics. In hindsight, the factors tracked at Allston Landing before the crisis were clearly imperfect. Poole thinks there is still room for Genzyme and its peers to improve. “I’m not convinced that as an industry we have the right metrics. We track a ton of things, but are they really the right metrics to measure organizational health?” The question can only be answered by decades of accurate forecasts — or one very bad prediction.

At Allston Landing, a five-year period that is described by Poole as “truly the most challenging and painful in our company’s history” was neither predicted in advance nor evident in a review of metrics after the fact and was perhaps a perfect storm. “You can be sitting at the top feeling confident, but in fact you may not yet know that you are already sliding in terms of erosion in your capabilities. While nobody who worked there in the summer of 2009 will forget how quickly the situation can change, the plant is on a positive path forward and bears little resemblance to the site that faced such significant challenges five years ago. That’s the Allston story,” says Poole.

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