From the Editor: Into the Light

Drug manufacturing can only advance if drugmakers, regulators, academics and vendors join forces to mine and interpret new data.

By Agnes Shanley, Editor in Chief

In October, to relatively little fanfare, the results of a long and challenging study of drug manufacturing were released. The inaugural Pharmaceutical Industry Benchmarking study conducted by Jeffrey Macher of Georgetown University (Washington, D.C.) and Jackson Nickerson of Washington University (St. Louis, Mo.) grew out of research that the two did on semiconductor manufacturing, while they were both graduate students in California. We had expected the results to come out much sooner (the previous phase of research, studying FDA inspections, came out last year), but it wasn’t easy to collect all that data or establish the rapport and trust required from pharma companies and FDA.

What received the most play in the press when the study came out — the statement that the drug industry wastes over $50 billion per year on manufacturing — grew out of initial interviews with a cross-section of 50 top executives from the manufacturing, regulatory and vendor communities. And, Nickerson and Macher say, that number is quite conservative.

Cover: November/December 2006 Pharmaceutical ManufacturingThe study, subject of this month’s cover story (see "Analyze This"), suggests that increasing manufacturing complexity has a negative impact on drug yields and cycle times. But it also shows what is possible when IT is harnessed effectively, and when employees on the front line are empowered to make day-to-day decisions.

As the industry moves to personalized medicine and combination drug devices, the need for better management of drug manufacturing operations is urgent. As Professor Macher notes, some AIDS medications today already require 100 to 150 manufacturing steps, moving closer to the 400+ required in semiconductor manufacturing.

A great deal of ingenuity will be needed to address these challenges. As Pfizer’s President of Operations Nat Ricciardi said in a keynote at ISPE’s annual meeting inOrlando in November, the industry is moving toward a Golden Age of pharmaceutical manufacturing.

But it’s not there yet. The data in the Macher/Nickerson study beg to be analyzed to determine causes and effects. Such analysis would help individual manufacturers and the industry destroy remaining roadblocks to manufacturing efficiency.

Nickerson and Macher are planning to analyze the data as they can. But other academic institutions are also examining drug manufacturing — Purdue via NIPTE, CAMP and CPPR, MIT and Rutgers, to name a few — and industry groups should care about this information (PhRMA first among them).

Wouldn’t it make sense for some consortium such as PhRMA to advance this study by funding its next phase, and expanding it to involve other academic groups? Doing so would serve the industry and the public at large.

But, at this point, anyone with the required sitzfleisch, whose eyes don’t glaze over when faced with hundreds of pages of statistical data, can draw some conclusions from the data in the report (if you haven't seen the report, click here to access it). No doubt many of you already are. Individual companies are numbered, so it’s possible to track each one’s performance in different areas and note trends. Perhaps it could be chipped away at, slowly, by teams, as a part-time project? (“Not another one,” you say.)

Although drug manufacturing may be moving toward a Golden Age, this study suggests that it’s still the industry’s stepchild — and an extremely expensive one at that. Isn’t it time to bring it, fully, into the light of day?

It’s also time to learn more by imitating best practices from other industries such as electronics. As Pfizer’s Ricciardi urged at November’s meeting: SWIPE, or steal with integrity and pride from everywhere. We promise to provide you with more benchmarking examples from different industries and companies around the world. We have launched a joint survey with APQC on product development as well as a pharma offshoot of its “Innovation Index” study. Both will focus on pharmaceutical manufacturing, but those who take part will receive benchmark reports from APQC comparing their practices against the rest of pharma, and all of manufacturing. Results will also be summarized and published in our magazine. For more information, visit www.apqc.org/pharma-inn.

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