From the Editor: QbD and the People Space

In addition to the Design Space and the Control Space, should the “People Space” be added to the QbD lexicon?

By Agnes Shanley, Editor in Chief

The drug industry is busy following the example of Toyota in improving the efficiency of its manufacturing and development, and in embracing a vision of continuous improvement. As it moves forward with initiatives focused on ICH Q8-10, pharma is embracing Lean, Just in Time, OEE and other industrial engineering concepts with a vengeance. As this month’s cover story shows, more drug companies are also reducing the environmental impact of their processes and facilities.

But one area where performance may still fall short is in respecting the individual more — the patients who use its products, the physicians who prescribe them and the workers who make them. In addition to the Design Space and the Control Space, should the “People Space” be added to the QbD lexicon?

There are too many recent examples where the industry undervalued one, or all three, groups of people and wound up paying an extremely high price.
Admitting this fact is not about preaching or playing Monday morning quarterback, but about acknowledging significant loss — financial loss and lost prestige. Could some of it have been prevented?

April, for instance, brought cruel news of a 10% downsizing at one Big Pharma company, and cuts across the board in manufacturing and R&D. The goal: to reduce costs by $1.5 billion in two years.

The reason? Two drugs whose safety and efficacy did not measure up, but whose deficiencies were not clearly communicated to the physicians who would prescribe them and the patients who would use them. The truth did eventually come out.
Then there was that other pharma company with the outstanding continuous quality improvement program, which spent nearly $3 billion commercializing a drug with a very innovative delivery system that few patients or physicians seemed to want. On paper, it was a work of sheer genius, from the stabilization process used to allow the active ingredient to be manufactured to the device itself, which reflected the latest innovations in simulation and packaging design. Unfortunately, customers were looking for a smaller device and less complex dosing.

Where was QbD when this product idea was conceived? Couldn’t more customer focus groups have refined the delivery and dosing concepts?

But not only customers were neglected. The firm also transferred some of its skilled workers from a historically important site, in a major metropolitan area, to a somewhat isolated location with few employment opportunities, to make the new drug. Guess what happened when the drug’s manufacturing stopped.
Nobody’s perfect and every industry is entitled to its brilliant failures. But perhaps studying cases like these can help prevent more loss in the future.

One untold benefit of QbD would be in enabling drug companies to optimize staffing up front, to avoid the drastic number of job cuts that the industry has seen over the last few years. If a new drug’s concept is truly sound, if it is something that the customer needs and wants and physicians see the need for, then the number of people required to make it should become clear much earlier on.

Toyota was notorious for not laying people off. Granted, Japan, like the rest of the world, has since changed its tune about long-term job security. But, in the 1950s, when the company was forced to ask 2,000 people to resign, Toyota’s President Kiichiro Toyoda and his executive staff also stepped down. It was a powerful symbolic gesture.

Not that all CEOs should do the same, but lack of connection to workers and customers may be having an impact on some corporate Lean programs, inside and outside pharma. Insider critics have come up with new acronyms for Lean, ranging from the bitter “Layoff Every American Now” and “Lacking Any Management Ethics” to “Lean As Mistakenly Executed.” Can pharma, or any industry, afford more disconnects?

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