This website covers knowledge management, personal effectiveness, theory of constraints, amongst other topics. Opinions expressed here are strictly those of the owner, Jack Vinson, and those of the commenters.

Pharmaceutical Technology IT special issue

Pharmaceutical Technology magazine published an IT supplement in their November edition.  It contains three articles that point to changes in the pharmaceutical information technology world - a world that is already changing fairly fast.  The links below are pdf's.

Challenging "The Process is the Product:" Clarifying the Role of Information Technology in Biopharmaceutical Process Development by Arthur R. Mlodozeniec, PhD

Most small molecule pharmaceutical compounds are defined by their chemical structure, and there are well-established methods for testing whether compounds from different manufacturing processes are the same.  But because biologicals are so complex in both their structure and their activity in the body, many biological pharmaceutical compounds are defined both by their chemical structure and how they are handled from beginning to end.  The author suggests that the reason for this is the lack of established, trustworthy testing and control technologies for biological processes.  He argues that with recent developments in sensing technology and quality control methodology, biologicals should be controllable to a point where manufacturers only need to prove that their end result meets the standard, rather than proving their entire process is exactly the same.

Integrated Information Management Approach to Drug Substance and Drug Product Scale-Up by Joseph Prang

Why is there a hard limit of 55 degrees in that processing step?  Why are there three filtration stages instead of two?  What range of compaction pressures were tested in coming up with the currently-used value in making those pills?  What is the difference between your Mentor and Evanston manufacturing facilities.  These questions are a small sampling of the things regulators and reviewers need to know regarding pharmaceutical manufacturing.  These questions are typically answered by digging through reams of documentation, manufacturing records and notebooks - documentation that spans years of development work and hundreds of individuals.  The goal is to understand the context in which decisions were made.  This article suggests an extension of the life cycle concept that the pharmaceutical (and other) industry applies to nearly everything.  In an integrated information environment, decisions should be traceable from their inception through testing and into final manufacturing settings.  Ideally, this will lead to more robust process development and safer drugs.

Why Search Matters: Information Retrieval in the Pharmaceutical Industry by Eric June

Here is a simple reason why information retrieval is important, "if an organization is unable to quickly retrieve relevant data, business crises may ensue."  The author focuses on the vast quantities of unstructured (not in a database, the written word information - frequently 80% or more of the information required to run a business.  The bulk of the article focuses on the capabilities of information retrieval (IR) technologies and how they are helpful in the context of the pharmaceutical industry.   The author highlights the problem of IT vendors delivering IR tools that only explore information stores created by the larger system from the vendor.  This is unacceptable because it ends up creating different silos of information and silos of accessibility, based on the capabilities of each vendors' IR capabilities.  Instead, vendors should provide open connections to their information stores, and companies can then choose the IR tool that look across all information within the company.

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