By Agnes Shanley
The last gasp of winter, 2011, brought with it record snowfalls and tragic natural disasters, as well as some quiet and unheralded news that, some observers believe, may signal new competitive pressures in store for the drug industry.
Two Asian electronics manufacturers, South Korea’s Samsung and Japan’s Fujifilm, have entered the global biopharmaceuticals business. Fuji acquired two Merck contract manufacturing subsidiaries, Diosynth in the U.S. and MSD Bio in the U.K., while Samsung will be partnering with Quintiles on biosimilars development.
Were these simply two zany moves that don’t really fit into the companies’ business plans and will be regretted? Probably not. Fuji had systematically laid the groundwork for this a while ago, when it established a pharma holding company with partners.
Key target areas include a business where big name brand and generics companies aren’t performing all that well: cancer drugs (now in extremely short supply here in the U.S).
The whole idea of companies from an industry with a manufacturing focus, and a nine-sigma-plus manufacturing environment, moving into pharma, especially biopharma, is interesting. Electronics companies have been using the techniques that define QbD for quite some time. What in-house analytical knowhow might these companies have, which might be applied to pharma processes? Will they throw the traditional pharma view of the pharma value chain and technology transfer on its head and leave big pharma struggling to catch up?
But that brings us to the same question that you, and FDA and other regulatory agencies, have been asking for a decade or more: How soon can more traditional established drug manufacturers, including generics companies, change their approach to development and manufacturing?
To play devil’s advocate for a moment, I ask: Are the newer concepts of process analytical technologies (PAT), Quality by Design (QbD) or process validation helping or hindering this change? After all, other industries, including electronics, never found it necessary to create whole new acronyms for these approaches, which grew organically out of the way they evolved and what they were already doing.
But highly regulated pharma is different, you say?
Has the industry been on a yellow brick road of sorts, like the travelers in the Wizard of Oz or the thirty birds in the Sufi poem, who set off on an impossible quest, only to find that they already had exactly what they needed?
In today’s competitive environment, does pharma have time for quests of any kind?
Despite all the clarity and science behind the new process validation guidance, many people still grumble about it, and how expensive it will be. You support PAT and QbD, yet these terms still elicit polite mumblings about quality imperatives and motherhood and apple pie, but relatively little interest, and action, in the mainstream.
Change advocates and critics could argue that pharma doesn’t yet have what it needs, to develop and make products as safely and efficiently as possible. They could point to the waste all around them—-high cycle times, inventory turns, exorbitant development costs and timelines, recalls, consent decrees and hundred-million-dollar-scale fines for quality and compliance failures.
They could point to the waste, and incessant recreating of the wheel at FDA, which continues to be a target for political conservatives and liberals alike. Only weeks after conservatives wrote an editorial calling for the destruction and creation of a whole new FDA, and demanded a rehashing of the Agency’s heparin response, we heard liberal counterparts and even President Obama calling for essentially the same thing.
All of this despite the positive change programs that had already been started—-Critical Path, the Transparency Initiative (now short of its leader), the ambitious IT development projects (FDA’s IT director recently defected to industry) and 21st Century cGMPs. Will anyone actually see all these programs through, or will they just remain evidence of good intentions, abandoned?
If industry may not have all the knowledge it needs to make quantum leaps in efficiency and quality, it has already had the means to acquire that knowledge. And it is not only to be found in the writings of Deming, Juran, and the industry’s own thought leaders, but in the good old cGMP’s, written decades ago.
So much of what has been argued for—more intelligent sampling and an end to the “three batches” mindset, quality systems, process control, and even QbD—is already in the cGMP’s. Add to that the power of materials science and chemical engineering, and pharma already has everything it ever needed to advance.
So, at times, one wonders, why was it necessary to develop the three-letter acronyms that pharma wrestles with today? Using the old thesis, antithesis, synthesis pattern, will pharma come up with a new vision incorporating the brilliant acronyms of the past decade, and reinvent GMP’s in a way that will enhance buyin? After all, as Emil Ciurczak has often said, it’s not GMP’s themselves but their interpretation by fallible humans that has been at fault.
President Obama has just asked U.S. government agencies to re-evaluate regulations . Could this have some impact on FDA guidances?
Could cGMP’s, written before the first moon launch, be re-evaluated, and the essence of PAT, QbD, Quality Systems and process validation guidances incorporated into them so that they blend into one organic whole, rather than so many disjointed pieces? If not, which directives and guidances should FDA abandon? What will be the impact on industry?
As the old classics remind us, the journey is at least as important as reaching the goal. But time is of the essence.
Competitive pressure may be about to intensify. We’re already seeing the impact of the “patent cliff.” Are we now about to see the long-anticipated entry of nimble manufacturers with expertise in other industries—-electronics, food processing, chemicals, automotive?
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