To Bridge the PAT Divide, Stop Preaching to the Choir

Advocates need to communicate the benefits of PAT more forcefully to senior management.

By Agnes Shanley, Editor-in-Chief
ashanley@putman.net

With all the good news about PAT — new technologies being commercialized, adopters disclosing more information — it’s easy to forget that most pharmaceutical companies are not on board. Some will never be.

Even though the instrumentation and mathematical underpinnings for PAT have been around for decades, for many people working in quality assurance or manufacturing, PAT might as well be science fiction. I realized this point clearly a few months ago at a GMP event. I’d assumed that PAT and risk-based manufacturing were at the top of everyone’s priority list, but when I asked the audience, a representative cross section of quality and manufacturing professionals, whether any of them were working with PAT, or expected to be, only one hand (a vendor’s) went up.

Nobody wants to criticize PAT, which would be like criticizing science itself. But, within the industry, there’s still a great divide separating companies that see PAT’s value from those that don’t. Even within individual companies, this divide separates PAT’s engineering and technical experts from everyone else.

A PAT clique, led by engineers and senior manufacturing executives at forward-looking companies, thought leaders from academia and research institutes, vendors and FDA, is improving communication and sharing knowledge. They meet at Arden House, IFPAC, ISPE and even PhRMA meetings.

Smart innovators — such as chronometer inventor John Harrison, above — have always gone “straight to the top” to get their message across.

Having this avant garde is necessary, of course, but, unless this clique can take its message more forcefully to senior executives, bean counters and to more small- and mid-sized companies, PAT risks becoming either the province of an elite, or just another great idea that never gained full acceptance.

For, despite its long-term benefits, PAT’s implementation costs can be daunting — $300,000 will pay for a basic program. Many companies are reluctant to make any kind of commitment unless they can see a clear impact on the bottom line. One technical expert at a small drug manufacturer told me that he has been trying, unsuccessfully so far, to convince senior management to invest in PAT for five years.

And even at larger companies with official PAT programs, the going isn’t always smooth. One person heading up a prominent global manufacturer’s North American PAT effort told me a story of postponements and budget problems. After postponing efforts, money that had been allocated on the corporate level failed to materialize and costs shifted to individual plant budgets. As a result, the project has progressed in fits and starts over the past few years and is only now coming into its own.

And this person works for a company that endorses PAT and is considered a leader in PAT implementation. One can only imagine how difficult it must be to convince decision-makers within companies that don’t have official PAT programs.

Perhaps time will change this picture. After all, at this point, the industry doesn’t have the expertise with analytics that chemicals, polymers and telecom do, says Dan Klevisha, vice president of Bruker Optics, Inc.

But how much time does the industry really have? Pharmaceutical companies within the PAT elite have already begun sharing more information with the industry. Perhaps they could intensify these efforts. FDA might also help by moving beyond the confines of the “PAT clique,” which can, at times, appear somewhat self-congratulatory, and reaching out to top executives.

Surely, it’s not FDA’s responsibility to get CEOs to accept PAT, but the PAT team might take its technical message and translate it into dollars-and-cents for more CEOs, CFOs, COOs and CIOs, and others who control corporate budgets.

Smart innovators have always gone “straight to the top” to get their message across. Consider John Harrison, who invented the first chronometer in the 18th century — a device that allowed navigators to find their longitudinal coordinates to prevent ships from being lost at sea. Prevailing wisdom was that his invention was merely a device and not a breakthrough. Harrison took his invention directly to shipbuilders, ship owners, and even King George, to get funding and acceptance, and ultimately prevailed.

Gaining the attention of top executives and financial types will be particularly critical this year. And more information should be shared with companies of all sizes and types. After all, at this point, PAT is like a chemical reaction with high activation energy, says Nancy Mathis, head of Mathis Instruments. “All the reactants are present," she notes, "but until the first several companies start using PAT and sharing the documented evidence of ROI, the yield will be low.”

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