By Agnes Shanley, Editor in Chief

Every month brings new books on the topics of Six Sigma, Lean, Lean Six Sigma, Toyota Production System and the like. Many of these books are very fine. Most wind up going off on various tangents. And, let’s face it, many of them are excruciatingly dull (although a few of them wound up being very helpful when the leg of an old sofa fell off recently and I needed to prop it up.)

One thing that many of these books have in common is that they are not written by anyone with C-level, or even upper management, experience, much less with that experience in the pharma industry. So they are written by and for members of the Lean Six Sigma club, a close relative to the Process Analytical Technologies (PAT) club and other special interest groups out there that have failed to get senior pharma management’s attention and commitment.

And lack of management support appears to be a very real problem in pharma Lean Six Sigma circles right now. At BIO 2010 in Chicago earlier this month, we heard one presentation—the only presentation of its type on the program, by the way—from a very smart, engaged and committed team of people from drug development and R&D, at a major pharma company.

Reading between the lines, though, I could see that they hadn’t gotten management to buy into most of the concepts they were advancing. The ideas of servant leadership, visiting the “gemba” and the inverted triangle, apparently, were brand new to executives at that company.

And even when teams at companies do get key aspects of Lean Six Sigma and Toyota “right,” as Wyeth Pearl River has, as Aventis and AstraZeneca did with jidoka (in the form of PAT), their reward often appears to be getting sold.

Instead of folding all the best practices into the corporate fabric, senior managers may allow these practices to be implemented, but in a very spotty way that, in the end, fails to yield lasting value. Then they can easily justify gutting an entire facility and eliminating jobs, in the name of increasing shareholder results.  How long can that type of improvement be sustained?

There is a very different sort of book out there now, a book that was written by a former pharma CEO, who is now consulting: John Avellanet. Entitled “Get to Market Now!” the book’s tagline is, “Turn FDA compliance into a competitive edge in the era of personalized medicine.”

The ROI of FDA Compliance, and Smart 21st Century Compliance

This message couldn’t come at a better time.  Today, many senior pharma executives still delegate compliance to a lower level, and take a rather regal approach to those who, in other industries, would be their primary customers, the consumers of their products and the drivers of continuous improvement. It’s feedback from these consumers, on a regular and systematic basis, that has allowed continuous improvement to take place in other industries.

An example that Gawayne Mahboubian-Jones, program manager, excellence in science and design with Philip Morris International, points to is statins. Patients complain of side effects in online forums, yet pharma management appears to say, “Well that’s the price you pay for lowering your cholesterol. Live with it.” He also addresses the tremendous variability in API loading within different medications (allowable to 5% in the UK, and 10% in the US). For more on this, stay tuned to an interview that will come out next week.

Maybe that type of approach was taken with the first automobiles . . . as in, “Sure the brake is hard to use, but this is a lot faster than your horse.” Could Toyota have become what it did if it didn’t pay attention, often, to the consumers of its products? It’s returning to this attention and consumer focus that appears to be allowing Toyota’s management team to dig out of its current $5-billion public opinion nightmare.

Ditching the Old “Command and Control” Mentality

The financial benefits of smart FDA compliance appear to be even farther from senior management’s radar screens. As Avellanet says, most are still playing a “wait and see” game. How many top pharma executives today truly grasp the importance of concepts such as Quality by Design, Process Analytical Technologies and the new process validation draft guidance? This book offers compelling reasons for this mindset to change, from someone who understands the senior management position.

As long as the industry fails to take a holistic, cross-functional view of regulatory compliance, risk management, and operational excellence, it will continue to see consent decrees, product recalls and tremendous waste. Given drugs coming off patent, and the impact of healthcare reform in the US and price controls in Europe, can this continue much longer?

Avellanet offers concrete examples and the book is engaging and very well written, and full of interesting allusions and anecdotes.

Most importantly, Avellanet offers very practical tips on how to implement some of the sweeping changes in mindset that smart drug development and manufacturing require, in bite-sized steps.

Each chapter ends with a practical a checklist for senior managers to run through with teams. And, these checklists are already available via the book’s website, even before you buy the book. John’s also allowed us to excerpt two key chapters, for our readers, on Quality by Design (QbD) and on Lean Quality Systems.

He has posted a table of contents and introductory chapter on the site as well.

Rather than summarize the contents, I urge you to check out the book’s website and excerpts we’ve posted. If you don’t choose to buy it for yourself (it’s not only for the C-level), or give it to your unit VP, or higher up, as an anonymous present, just print out the checklists and work with them. Interesting things may happen.

John talked about the book and some of the concepts behind it recently in this audio interview. Click play below to listen.

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