Ali Afnan: Pharma Faces a New Year: Will it Mirror, or Break Away From, the Past?

Effective change must improve business performance, and not just a process.

By Ali Afnan, PhD, Principal, StepChange Pharma, Inc.

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As this year comes to an end, it’s a good idea to take stock of the past year and look at where the pharmaceutical industry may be heading. Will the future mirror the past?

Layoffs have eased, but appear to be continuing, on a smaller scale. Will the situation change in the coming months, as more major drug brands lose patent exclusivity?

Are we reaching a point where taking a product to the OTC market becomes a strategic way to reduce income loss?.

What can we expect next year? 

Recently, I’ve had many opportunities to talk with pharmaceutical professionals across many functions. Almost all say they are still struggling with the process analytical technology (PAT) and 2011 process validation guidances. Both documents facilitate scientific, but relevant, implementation, but neither is prescriptive in specifying “how” to plan and execute relevant actions.

Ironically, industry seems to be reacting the same way to ICH Q8, even though the text and Q&A are, effectively, very prescriptive. In many cases, industry implementation has become a process of copying past implementation practices, or worse still, hypothetical examples, without deviating.

Consequently, most people I’ve met seem to be burdened with how to define the design space, rather than a much more important question: what are the best practices for manufacturing and the business?

The ultimate need will always be the business need, and how to implement effective change that improves business performance, and not just a process.

People ask whether QbD and PAT will become mandatory. If this were to happen it would not happen within the next few years, simply because it takes so long to implement such changes in regulations.

However, the process validation guidance is a different case. According to the Code of Federal Regulations (CFR), process outputs must be validated. But guidances don’t stipulate how to demonstrate that a process is valid, so manufacturers can choose methods and guidances that are equal, or better than, FDA’s current thinking, as articulated in its guidance documents.

Should QbD be mandatory? I believe it always has been and will continue to be so. Regulators don’t require it, but market conditions will. If done right, QbD will assure “survival,” in Darwin’s terms: Survival of the fittest. 

Up until now in its history the industry has been profitable even when not "fit," primarily because the consumer is powerless to act unilaterally. Still, there is ample evidence that not all firms survive market forces.

Our industry tends to follow rather than to lead or innovate. Consequently, examples hinder and stifle innovation. What Q8 did not offer in prescriptive language is now being published as "working models" and "examples." Are examples needed by the sector, and is our industry only blessed with a small group of "wise scientists" who can lead the rest?

I believe it most important that innovation and innovative practices address business needs. Every other industry has demonstrated the principles enunciated in the PAT guidance as necessary for successful manufacturing.

Juran and Deming amongst other gurus of quality have shown that Quality by Design, when implemented correctly, is not only necessary but vital to improving, flourishing and growing. If pharma were to implement PAT and QbD purposefully and with a vision of improving performance, then other issues, such as drug shortages, would soon become a thing of the past.

President Obama’s recent order regarding drug shortages should have referred to a previous order (OMB A-119) issued in 1998 by president Clinton. This order supported the use of consensus industry standards.

Such standards have vital to improving performance improvements in all other industries. The root cause of the shortages is processes whose output is not assured, or confirmed to not being able to make quality product. Faster review of NDA's, ANDA's and supplements (PAS) will not change the philosophy and practices of the industry. 

Here are the changes I would hope to see take place next year:

(1) FDA needs to revamp changes to 314.70. This work was started and progress was good, but the work was suddenly stalled and no explanation was given to the public. It can be restarted easily and quickly, picking up from where it was stopped.

(2) Industry needs to look within its own operations to determine its needs, instead of focusing on published examples defining its needs or operations.

After all, who could know an industry’s needs better than the manufacturers that comprise it?

Wishing you a successful new year.
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