Are You Innovating and Imaginating All By Yourself?

One of the many people I spoke with this past week at the AAPS show in Los Angeles was Ted Grasela, CEO of Cognigen Corp., which advises manufacturers on model-based drug development. Grasela delivered a presentation on the importance of modeling and simulation to development, and on strategies that pharmacometricians and statistical experts can use to influence drug development in a positive way. It's time for modeling and simulation to take its rightful and significant place in drug development decisionmaking, Grasela said.

Most importantly, statistical modeling can be a kind of glue that binds the entire drug development process and the people involved. “People are innovating and imaginating all over the place," Grasela says, "but often these islands of innovation that never get linked with one another.”

Here's my full writeup of Grasela's presentation. I stopped by the Cognigen booth afterwards for a chat with Grasela and Cognigen colleagues, and came to appreciate their ideas of bringing more science to the development process. Here's the Cognigen home page for those interested.

Should We Call It an ELNLIMS?

We won't call it the holy grail, but the announcement by Thermo Scientific and Symyx regarding the release of an integrated LIMS/ELN product is a significant step towards a fully integrated, electronic laboratory. Researchers should have more power and functionality at their fingertips, with fewer obstacles towards accessing and sharing data. That spells more efficient development efforts.

In a press release last spring announcing the Thermo-Symyx partnership, Symyx president Trevor Heritage boasted that lab professionals will have the “ability to record and execute experimental protocols, capture results, access and analyze data, build reports and collaborate with colleagues seamlessly."

Given that it's now just six months since the partnership was announced, clearly there will be bugs to be worked out of the new offering, but that's to be expected.

Another intriguing question: What do we call something that combines a three-letter and four-letter acronym? ILMS (Integrated Lab Management System)? I'll have a chance to speak with representatives of both

What's on Your QbD Calendar?

Some great events taking shape this fall for Quality by Design, in case you hadn't heard:

Practical Solutions to PAT and QbD Workshop, Oct. 20-21, London

Process Chemmistry in the Pharma Industry (with Special Emphasis on Continuous Manufacturing), Nov. 2-4, Durham, N.C.--James Evans of the Novartis-MIT Center has put together a great panel on continuous mfg.

AIChE QbD Topical Conference, Nov. 8-13, Nashville, TN--the QbD thread runs throughout the event.

Eastern Analytical Symposium, Nov. 16-19, Somerset, NJ

AAPS and ISPE meetings in early November (both in Southern California) will also have plenty of QbD on tap.

--Paul Thomas