Time Warp: Pharma Needs to Get Past the "Desired State" and Mantras of Yesterday

This week I did some time traveling and was transported back to 2003, during a presentation given at the Bioprocess International conference in Raleigh.

It was a fiine presentation by a well-known professor at MIT. There was just one problem. It’s the identical presentation that we’ve seen again and again for the past six years.

Is it a timeless classic? Yes.

Is the industry in crisis? Yes. But, at this point, it needs another set of mantras and images. It also needs data on trends and practical, inspiring examples.

Not just a set up of here’s the desired state, and empty statements about PAT and OpEx getting us there. It made me wonder what work MIT is doing to survey the industry today, and why it doesn't share some of that information, like George Washington/Georgetown did and as the University of St. Gallen does. Real stories and data are needed.

This is not to criticize the professor but a continued overuse of images and thoughts that are already quite long in the tooth. The industry does not need yet another send up of the classic WSJ article, or Dr. McClellan’s potato chips and soap flakes quote.

And while we’re at it, let’s retire that tired old Six Sigma pyramid that sneaks into so many presentations . . . and take it down, once and for all.

As well as the dull and colorless phrase, "The Desired State." Please.

These are all relics of earlier days when FDA’s PAT Team was out there stumping for smart manufacturing, and FDA was studying manufacturing and critical path issues to better understand them.

By all accounts, FDA is still studying these problems, and it looks like it will be studying them in greater depth and with more resources, but the world has changed dramatically since then.

Perhaps it’s time to get past the mantras and icons of yesterday and develop more inspiring ones for tomorrow.

--AMS