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.

QbD Presentations on Parade: DynoChem's User Meeting

DynoChem has made available presentations from its user group this past May. Registration is required to access the content, but among the materials available are:

Roles of Mechanistic and Empirical Modeling/DOE in Achieving Quality by Design, by Paul Stonestreet of GSK

Practical Insight on New Model Development: Filtration and Centrifugation, by Rich Ballenger of Abbott

Process Modeling Based Approach Towards Quality by Design for an API Synthetic Step, by Shawn Brueggemeier, Emily Reiff, Olav Lyngberg, Lindsay Hobson, and Jose Tabora, BMS

Practical Aspects of Distillation Modeling in DynoChem, by Carolyn Cummings of Amgen

An Example from GSK's Design for Manufacture Initiative: Use of Dynochem in Conjunction with Lab and Pilot Scale Data to Advance Process Understanding, by Dharmesh Bhanushali of GSK

How Process Safety and Environmental Lab Can Guide Process Development, by Viviane Massonneau of Merck

Lean and Green: The Value of API Process Design, by David am Ende, Pfizer

--Paul Thomas

Progressive Collaborations: GSK Gets First Contributor to Patent Pool

Another exciting collaboration speeding development: Alnylam has become the first company to jump into the patent pool that GSK has established to aid development of drugs to confront tropical diseases. Alnylam will contribute some 1,500 current and pending patents, tripling the number that GSK has already contributed itself.

GSK CEO Andrew Witty: “The key objective of the pool is to make it easier for researchers across the world to access intellectual property that may be useful in the search for new medicines to treat neglected tropical diseases. The more companies, academic institutions and foundations that join the pool, the more effective it will be. Alnylam’s announcement today is therefore a welcome and significant step forward.”

--Paul Thomas