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May 2005 Drug Development |
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Drug development:
Not just a matter of speedBy Mark Sunderland
The author is President, Biomedical Industry Group, Ottawa (
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) and columnist for DPN.
We are all exposed to media announcements when a new drug is discovered, and the news is especially exciting when the new drug has the promise of soothing our own particular aches and pains. And then we wait. And we wait because the process that follows the promise is probably the most arduous in medical science.
Most people know there is a methodical and rigorous testing period that leads to the launch of a new pharmaceutical, but few people know about the depth and the complexity of the process ñ not to mention the cost and the tortuous route of taking a new drug from inception to a neatly packaged pharmaceutical product ñ and all in a manner that is safe and commercially viable.
In the case of pharmaceutical drugs, there is on the one hand an urgency to get to market both for humanitarian and commercial reasons ñ and on the other hand there is the rigorous analytical process of verification and validation, and in a period that averages 10 years and costs on average US$800M, the efficacy and long range impacts have to be completely understood.
At the heart of drug development is an analytical process that is highly specialized and absolutely vital to new drug development. Addressing this fact is Ottawa-based Ionalytics Corp. (ionalytics.com).
 Ionalytics is an analytical instrument company that has commercialized a technology to assist and accelerate the pharmaceutical analytical process. In drug development the analytical process is all about separation and the ability to separate out the things that are not wanted from the things that are. Ionalytics proprietary technology is central to the system that enables a rapid and accurate separation process to be accomplished, consequently bringing a whole new dimension to the science of separation.
In pharmaceutical research, the term ìMethods Developmentî defines the process for determining how much of a sample drug or its components are present in a particular patient or animal sample. The developed method may vary from one test to another but the separation techniques of liquid chromatography and mass spectrometry are commonly used. These two complimentary technologies separate compounds based on two very different characteristics. However not all samples can be fully characterized using these two separation technologies.
Ionalytics has commercialized a new tool for separation based on a technology called FAIMS (High-Field Asymmetric Waveform Ion Mobility Spectrometry). FAIMS separates compounds based on changes in ion behavior in the presence of high electric fields. This separation technique exploits a very different characteristic of a compound and is complimentary to the other commonly used separation techniques.
 When FAIMS is used in combination with these techniques, more information about the potential drug is obtained. One major pharmaceutical company has stated that FAIMS can simplify roughly 2/3 of the analytical methods challenges that they face on a daily basis.
At the end of the day, FAIMS is a tool that allows pharmaceutical researchers to solve methods development problems faster. When sample testing time decreases, sample throughput increases, which means it takes less time and less money to get a drug to market. Consequently, Ionalytics has user customers at many of the major pharmaceutical manufacturers, including Merck and GlaxoSmithKline.
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