Navigating the Twists and Turns of the Discovery Drug Development Process

At KCAS, our Discovery group performs bioanalytical / biomarker method development that can include any of the various components required for a validated method under the GLP guidelines.  So why is Discovery group needed?  The beginning stage of drug development is a stage of trial and error.  It is generally accepted that for every pharmaceutical drug molecule that makes it to the market, approximately 10,000 or more compounds will need to be tested.  From the time that a lead compound is discovered, it could take approximately 12 years before it reaches the market.  Researchers have to answer questions such as effective dose, therapeutic threshold, lethal dose, pharmacokinetics and pharmacodynamics properties.  Keeping this in mind, it is crucial these questions are answered quickly and reliably before the researchers can determine the fate of a given lead compound.  Here at KCAS, we utilize state of the art instrumentation, highly trained personnel, and effective collaboration with sponsors, to produce quality and defendable data while meeting or exceeding timelines.

KCAS is equipped with top of the line LC-MS/MS instrumentation for trace level quantitation.   These well designed, robust instruments cut down on the method development times and allow the highest sensitivity, widest quantitation range, even for challenging atypical compounds.  All of the mass spectrometers are Sciex triple quadrupoles or Qtraps.  These platforms allow for a wide range of solutions to common instrumentation problems, and offer the best sensitivity of all the LC-MS/MS platforms currently available on the market.  When our team is tasked with developing a method/assay for an atypical compound or class of compounds, one that perhaps doesn’t ionize readily, the 6500 LC-MS/MS platform is the best tool for success.  It allows us to reach maximum sensitivity for the lowest limit of quantitation, and obtain a suitable separation with proper selectively by coupling to an UPLC front end.

Staying current with the latest technology in LC-MS/MS instrumentation is essential in helping answer researchers’ questions.  Another significant component of problem solving is the people involved.  For this reason, KCAS is staffed appropriately with highly trained personnel, allowing us to have a competitive edge over other CROs.   Our laboratory staff possesses expertise in instrumentation, setup, preventative maintenance, upkeep, and troubleshooting.  In addition, we have a robust training program that includes continuous learning and cross training.  Our dedicated instrument operators, along with service contracts, are able to maintain the instruments’ peak readiness, therefore, minimizing instrument downtime and meeting timelines.

The Discovery team routinely produces quality data, meeting rapid turnaround times, with a cost structure that brings value to our sponsors.  The analysis uses an acceptance criterion selected by and suitable for our sponsors experimental design.  We can mimic regulated (GLP) validation process by performing tests such as benchtop stability, freeze/thaw, matrix effect, etc.  We are also flexible in what goes into the battery of tests we can perform.  We help our sponsors design the experiments they need while reducing /eliminating experiments that are non-value added.

Our team will tackle any analysis or molecule you can imagine from small drug like molecules to atypical molecules.  We take the time to research and develop methods that may not be available at any other laboratories.  We have been highly successful working with exotic matrices, metabolome analysis in whole blood, free and total drug measurements by rapid equilibrium dialysis, peptides, mix mode macromolecules, and free fatty acids.   Although we can perform the standard bioanalytical GLP-like testing to meet your basic needs, we also offer much more.  If researchers have something in mind, the discovery team is ready and willing to make it happen.

The area of drug development and research consists of many twists and turns.  Researchers start a project and have an idea what the results should resemble, however, as scientists we all know that sometimes data can be confusing and not turn out exactly as you had imagined.  Furthermore, often times our clients are not analytical chemists.  With regular communication, our clients stay in the know about what is happening with their project.  If we discover an issue that cannot be solved in a timely manner, we communicate that directly.  Then with our expert advice and guidance, we offer multiple paths forward in order to meet client timelines or data expectations.   We are here as an extension of your lab to offer our knowledge and expertise.

Drug development can be a long grueling process, but the Discovery team at KCAS is here to work side by side with your team and ease the process.  We have the latest equipment, with the expertise to handle any molecule or testing you need to meet your research goals. As a solution based company, we are ready to focus our expertise on your problems to move your molecules though the drug discovery pipeline. In the world of drug development, collaboration between a discovery team and the client is the key to transferring a drug like molecule from one of 10,000, to a marketed pharmaceutical that will improve health worldwide.

If you have any questions about this or any other services from KCAS, we invite you to reach out using the form below!