Global Concerns Discussed at BIO

While it may seem that pharmaceutical manufacturers are bitter enemies on the competitive battleground, it turns out that most of them have the same problems and concerns and are willing to help one another if possible. This was the message from the BIO conference session, “Management of Global, Diversified Manufacturing Organizations.”

By Bill Swichtenberg, Senior Editor

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While it may seem that pharmaceutical manufacturers are bitter enemies on the competitive battleground, it turns out that most of them have the same problems and concerns and are willing to help one another if possible. This was the message from the BIO conference session, “Management of Global, Diversified Manufacturing Organizations.” Each speaker took one global manufacturing topic and expanded on his or her company’s relevant experiences.

Moderator Blair Okita of Genzyme touched on the importance of the tech transfer process. He sees it as made up of the “4 Ps” (process, people, plan, plant) – a transfer that involves formal agreements, quality agreements and philosophy. According to Okita, the key to the process is people. There must be a transparent technology shift, despite language and cultural differences. “There is no such thing as a stupid question” when dealing with the transfer process, he said.

Lonza’s Stefan Borgas talked about building new plants and understanding the problems associated with hiring talented employees from different cultures. With Lonza in the process of building five new plants around the world, Borgas joked, “We have turned into a construction company more than anything else.”

Lonza is building two new plants in Singapore and will have to hire an estimated 650 biotech professionals. In developing new plants, it is critical to attract, develop and retain good employees, said Borgas. In Singapore, the hiring is based on a five-year plan. Lonza started with key hires who have since been training at company sites in the U.S. and Western Europe. The company hopes to have almost 200 people trained by year’s end and an entire workforce in place before the plants even open.

Borgas said that in the current environment, “Buying talent (by pillaging other manufacturers) has been easier than building from within.” He is optimistic that this will change in the near future. He also stated that there has been an overemphasis on academics compared to the need for a vocationally trained, skilled manufacturing workforce.

Genentech’s Pat Yang said he believes that the footprint of future bio plants will shrink. Genentech is already taking a “2x in 5” approach, meaning that the company aims to double its titer size every five years to save space. He also stressed that a balance is needed between innovation and efficiency, as sometimes these concepts directly compete with one another.

Mike Kamarck of Wyeth Biotech said he also sees a change of philosophy regarding plants. “Biology is now trumping stainless steel,” he said. Switching from a single site to multiple sites and retaining efficiency requires harmonization, according to Kamarck. Wyeth has spent $3.5 billion on network infrastructure to enhance its efforts.

Andy Skibo of Amgen spoke about risk mitigation. There is risk in all parts of the company, he said, adding that in manufacturing, risk assessment is vital in evaluating inventory, external capacity and internal capacity. Each of these processes must be explored on a risk vs. cost basis, although quantifying these risks is difficult, Skibo admitted. He said the focus for a successful program has to be on “prevention, not reaction.”

Remo Colarusso from Johnson & Johnson spoke on when and what global systems and tools can be used company-wide. When deciding to implement a system across the entire global network, he said, the factors that J&J considers include: money/ROI; compliance issues; and cultural (e.g., process measurements). Colarusso said J&J has developed a process they call “CompStat” that is a balanced scorecard of business metrics. “We want all plants to measure things in certain ways,” he noted. “Without this, we can’t compare across our own facilities.”

In the question and answer session, the manufacturers stressed collaboration. The companies regularly talk to one another about capacity to meet each of their needs. “Idle capacity is no good for anyone,” said Yang. “Trying to plan capacity is an almost impossible task.”

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