Here’s to the Next 10 and 50 to Follow

A happy 10th anniversary to both the FDA’s Pharmaceutical GMPs for the 21st Century as well as Pharmaceutical Manufacturing magazine

By Steven E. Kuehn, Editor in Chief

“It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity…”

Contributing editor Charles Dickens submitted that opening line to me for the April cover story, describing the state of the industry 10 years after the FDA introduced Pharmaceutical GMPs for the 21st Century – A Risk-Based Approach. OK, with the exception of the part about the 10th anniversary of the FDA’s sweeping policy mandate, that last sentence was factually incorrect.

But what is true, is that over the past 10 years, the pharmaceutical industry has changed dramatically and is at a point where the next 10 years are likely to set the tone and direction for the 50 following it. Actually, Pharmaceutical Manufacturing’s April cover story on the state of the industry by contributor Angelo DePalma posits: “GMPs for the 21st Century has profoundly influenced how drug companies manage risk, particularly but not exclusively with regard to manufacturing. The risk-based approach becomes particularly challenging given the backdrop of merger and acquisition activity and a heavier reliance on outsourcing for manufacturing and R&D. For manufacturing, this means negotiating the moving targets of productivity and supply chain demands.”

And like Dickens’ unforgettable opening sentence in Tale of Two Cities, the industry is at once experiencing the best of times with fast-paced advancements and dramatic impacts on global disease, particularly in the biopharmaceutical space; and the worst of times, with Big Pharma restructuring HARD and facing some of the toughest economic and regulatory hurdles it’s ever encountered. Financial powerhouse KPMG recently surveyed executives from 107 pharmaceutical and life sciences sector companies with revenues of more than $100 million; the majority (45%) earning more than $10 billion. According to KPMG’s “2012 Industry Outlook Survey,” despite the growing concerns over regulation, the study’s respondents predict modest growth fueled by three top initiatives: 1) “Navigating significant changes in the regulatory environment,” 2) Significant investment in organic growth,” and 3) “Significant improvement of operation processes and related technology.” Those surveyed also were asked what might constrain planned growth. Sixty percent identified “Regulatory and legislative pressures,” as their biggest barrier to growth. What are among their greatest regulatory concerns? Pharma executives first cited government pricing and reporting, then taxes followed by price controls; but next in the top four was “Good manufacturing/clinical practices.”

To my mind, never have the risks, or the potential of reward been in such sharp contrast. Pharma’s near future is dependent on getting GMP right — and in the process (pun sort of intended) driving manufacturing, process and data management efficiencies in, while driving cost and complexity out.

Regardless of what side of the aisle one’s on, the collaboration between those with the capital and a vision and those with vision-answering technologies and services (in pursuit of said capital) have never played a more critical role in delivering the industry’s tremendous promise or sustaining its long-term health. 

The current era in pharmaceutical manufacturing started by the FDA’s policy also launched this publication, a fact that we are quietly celebrating with this issue. Launched as “The Drug Industry’s Voice for Manufacturing and Operational Excellence,” Pharmaceutical Manufacturing remains focused on delivering articles and multimedia content to help the industry manufacturing more efficiently, decrease the time it takes to get products to market while improving quality and minimizing risk. We’ve become a trusted source and we have you, dear readers, to thank, as well as our many editorial contributors, staff, advertisers and our publisher, Putman Media. We’ve been here for the past 10 and we’ll be here for the next 10. As far as the 50 after that? Well, if I’m still breathing by then I’m willing to bet I’ll be thanking the pharmaceutical industry for getting me there.

Published in the April 2013 issue of Pharmaceutical Manufacturing magazine

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