“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 …” Pharmaceutical Manufacturing’s newest contributing editor, Charles Dickens submitted that opener to me for the magazine’s 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’ famous opening line 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 the toughest economic and regulatory hurdles it’s ever encountered. 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. I think most would agree, that is indeed our best foot forward when it comes to managing through uncertainty to achieve and sustain better outcomes for patients and the industry alike.
I continue to see the industry’s technical community responding to these challenges in ways big and small. 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. Fortunately, many of those seeking solutions and those providing them will have a chance to put their heads together at INTERPHEX 2013, indeed fertile grounds for collaboration. I’ll be there too, seeking those telling stories of collaboration and success; and that, dear colleagues, is the tale I want to tell.
Steven E. Kuehn
Putman Media, Inc.