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 wasnt 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.
The study, subject of this months 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 Pfizers President of Operations Nat Ricciardi said in a keynote at ISPEs annual meeting inOrlando in November, the industry is moving toward a Golden Age of pharmaceutical manufacturing.
But its 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).
Wouldnt 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 dont 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 its possible to track each ones 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 its still the industrys stepchild and an extremely expensive one at that. Isnt it time to bring it, fully, into the light of day?
Its also time to learn more by imitating best practices from other industries such as electronics. As Pfizers Ricciardi urged at Novembers 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.
