In the EU, Funding for Those Who Strive to Eliminate Bottlenecks

The Innovative Medicines Initiative, a project started jointly by the EC and EFPIA, has announced another round of funding for projects that aim to speed drug development, including those that solve data management dilemmas. Click here for more.

A-Mab Case Study: Read It and Weep?

Now that the A-Mab Case Study has hit the streets (click here), the next question is just how much of an impact it will have upon the arc of QbD. If you're fairly new to Quality by Design and how it might be implemented at your facility or company (whether you're in biologics manufacturing or not), A-Mab will: a) give you loads of exciting concepts and data to ponder, hopefully opening doors to innovative QbD work; or b) intimidate the heck out of you and cause you to break down in tears.

A-Mab is 278 pages of intense concepts, data, and charts related to how QbD can be applied throughout the development of a typical biologics molecule. Where do you start? Where do you find what is truly relevant for your operations and applications?

I posed these questions, separately, to two people who were integral in shepherding the A-Mab project through--Sam Venugopal of PRTM Management Consultants, and John Berridge, a consultant and project manager for ISPE's PQLI initiative. (Click on their names to read summaries of our talks.) Both men admit that manufacturers will have to work hard to digest the document and assess how it applies to them. But both also see the document for what it is--a milestone for Quality by Design and unlike anything else that's been done previously.

Workshops focused on A-Mab will be held throughout 2010 by ISPE and CASSS.

GSK's Peterson Has Just What Your Design Space Needs

In case you missed it, we recently posted an article on multivariate predictive distribution by GlaxoSmithKline's John Peterson, director of the research statistics unit in the company's drug development sciences department. (The article will also appear in the Nov/Dec issue of Pharmaceutical Manufacturing magazine.) When we first approached Peterson--a highly accomplished statistician, among other things--about writing an article, it was with an eye towards explaining Quality by Design and the concept of a design space from a statistical viewpoint, but for readers who are non-statisticians. Peterson willingly assented and, if you read the article, I hope you agree that he has not only done as planned, but has also put forth some pretty heady concepts that statisticians involved in drug industry Quality by Design projects will benefit from tremendously.

The article seeks to encourage us to, as he says, "understand randomness and think stochastically." It's a testament to the power of statistics to help manufacturers understand and control their processes, in the name of making drug development smarter.

Great appreciation to Dr. Peterson for sharing his vision for us. I hope that you get as much from the article as I, a non-statistician, have, and we'd love to hear your comments.

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.

Looking Ahead to IFPAC

As PAT and QbD have taken hold, IFPAC (the International Forum for Process Analytical Technology) has become an increasingly relevant, and well attended, trade show, and has become increasingly dominated by pharma-focused content. 2010's show begins January 31 in Baltimore, and the agenda is now available online.

The Henry Ford of Drug Development? Have We Heard This One Before?

Quote of the day: "This device is to drug discovery what the assembly line was to the automobile or the silicon chip to information technology." I'm sure this device to inject proteins into cells to accelerate drug development is useful, but could this McMaster U. researcher be prone to just a bit of exaggeration?

Merck's Clark: Merger with S-P Will Increase Not Just Size But Innovation

Upon completion of Merck's merger with Schering-Plough, CEO Richard Clark shares thoughts on "Merging into the Fast Lane of Drug Development" in today's Huffington Post.