Emil Ciurczak continues his reporting from IFPAC in Baltimore:

There were many sessions today, but the one that captivated me and held me in my seat was on imaging. The session, organized by Carl Anderson (Duquesne University) and Steve Hammond (Pfizer), consisted of nine disparate talks tied together by the theme of imaging. Some of the highlights:

Raman spectroscopy, particularly hand-held Raman, is gaining favor as a pharmaceutical QC tool, given its convenience, speed and accuracy.  A number of presentations at USP’s annual science meeting in Toronto discussed how hand-held Raman is being successfully used as part of pharmaceutical anticounterfeiting toolkits.

But Raman still lacks some of the ease of method transfer, calibration and validation found with other analytical techniques.

An fyi: Steve Simske of Hewlett-Packard offers a nice, unbiased (though HP-oriented) perspective on current anticounterfeiting measures from his Security Printing and Imaging blog. Definitely worth a view. Today he reminds us of the potential benefits of using stable isotopes as a way of authenticating processes by which APIs and drugs are made.

It's a topic we've covered quite a bit, with some help from John Jasper of Molecular Isotope Technologies, who's worked with FDA, J&J and others to advance the technology:

J&J Looks at Stable Isotopes for Process Analysis

Isotope Analysis Expands Its Forensic Niche

Stable Isotopes Find a New Role in PAT

--PWT

One session on Wednesday morning addressed the use of molecular modeling in drug development. Ian Wilson, Portfolio and Strategy Manager, GE Healthcare discussed the development of PET clinical biomarkers. He mentioned the need to collaborate early, and the fact that academic partners can be great partners.  One important question to ask, he notes, is whether or not you need preclinical capabilities.

He then went on to  discuss GE Global’s clinical imaging network, an expertise hub for image acquisition and analysis designed to help speed drug development.  Merck, University of Manchester’s Wolfson Molecular Imaging Center and University of Texas MD Anderson’s Cancer Center are all actively involved in imaging research. (For some clinical case studies, click here).

Anderson and GE are developing the center with the goal of being able to take compound development, perform pathology, tissue and biomarker analysis, so that sites can be identified that have high or low levels of expression of a given target that is linked to progression of specific cancer…

Also important were: Imaging platform development, operational rigor, and manufacturing platforms such as PET and SPECT.

A major dilemma for industry right now is lack of resources, Wilson said.  Companies are focusing so heavily on drug development that many ask, should these efforts be diluted by dedicating resources to imaging?

AMS