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Traditional one-size-fits-all treatments must be tailored to the individual because people don’t react exactly alike.”
—Elias A. Zerhouni, M.D, Former Director, National Institutes of Health1
People are not all the same, and as the amount of detailed molecular information on what makes each person unique increases, we are better able to tailor therapeutic approaches to an individual’s own biology. Personalized medicine is finally becoming a reality.
For drug companies, personalized medicine often takes the form of pharmacogenomics, where drug development teams try to correlate drug response and/or adverse effects with specific genomic biomarkers such as genotype or gene expression profile. Though we’re still in the early stages of personalized medicine, these efforts are already producing results—as of August, 2015, the FDA listed 137 approved drugs that include pharmacogenomic information in their labeling, some with multiple biomarkers.2
To take advantage of this rapidly growing field, some pharma companies have built in-house teams to conduct pharmacogenomics studies. However, many choose to turn to CROs for their pharmacogenomics expertise. QPS is a leading global CRO that has recently started expanding their pharmacogenomics offerings to help drug companies deliver on the promise of this potentially powerful approach.
Who is QPS?
In 1995, Benjamin Chien, PhD., founded QPS—then called Quest Pharmaceutical Services—with the goal of providing high-quality bioanalytical LC-MS/MS contract services. Under his leadership, the single site company grew through expansion and acquisition to become a leading global CRO with eight sites on three different continents. Now, over twenty years later, QPS offers a range of services covering all stages of drug discovery and development, with specific offerings in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Development, and Clinical Development. Their mission—to accelerate the development of medicines worldwide by enabling cost effective breakthroughs in pharmaceutical innovation.
To achieve this mission, QPS strategically incorporates the latest technologies that can give their customers better data faster. The addition of a Translational Development service that offers pharmacogenomics studies in a CLIA-compliant lab is just the latest example of how QPS delivers cutting-edge approaches to its clients.
No such thing as a typical day in QPS’s pharmacogenomics lab
Pharmacogenomics (PGx) is defined as: The study of variations of DNA and RNA characteristics as related to drug response.
Pharmacogenetics (PGt) is a subset of pharmacogenomics (PGx) and is defined as: The study of variations in DNA sequence as related to drug response.”
—Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories 3
While the FDA defines pharmacogenomics as the study of DNA and RNA characteristics as related to drug response, for the QPS pharmacogenomics (or PGx) lab, this translates primarily into genotyping, qPCR, and gene expression studies. Drug companies use this data in many different ways, including developing and validating biomarkers; guiding decisions about patient stratification, dosage, and treatment; and evaluating toxicity and PK properties.
With such a variety of applications, it’s no surprise that every day is different for the QPS PGx lab. One day may start with set up of a genotyping assay and end by completing regulatory paperwork, while the next might have two qPCR assays and a report for the client . Additional diversity stems from the customized nature of the assays performed by the PGx lab—nothing is off-the-shelf and each assay is specific for each client’s study. However, one thing that is shared by almost all the PGx studies is the high level of automation in each assay.
Automation to ensure quality
It’s a given that just about every scientist will say they want to generate high-quality data, but it’s the steps that are taken to ensure quality that really matter. For the PGx lab, one of the biggest worries is contamination—when performing PCR on human DNA, contamination from the scientist performing the assay can be a serious issue. To keep operator contamination to a minimum, the PGx lab automates as many steps as possible.
“The assays are very sensitive to contamination, and that’s one of the risks we offset by using an automated liquid handler. We’re one of the most automated labs at QPS,” says Ming Lai Cheng, a Senior Research Associate who heads the PGx lab.
With automation also comes more consistent liquid handling, a must for the PGx lab since the majority of their studies are quantitative. With the exception of genotyping, which is typically an is-it-there-or-not question, the pharmacokinetic, dose-response, bioavailability, and other similar studies performed by the PGx lab rely on either comparison to a standard curve or absolute measurement of the sample. Variations and inconsistencies in liquid handling would throw these measurements off, negatively impacting data quality.
Because generating high-quality data is so important to Ming and her team, they need to be sure that they can rely on their liquid handlers—that when they pipette 9 µl it is really 9 µl (+/- 10%). One way they maintain confidence in their robots is by bringing in Artel’s Liquid Handling Service for volume verification. An Artel scientist visits the PGx lab periodically and uses the same methods performed by Ming’s team to verify that the liquid handlers are meeting manufacturer’s specifications.
In addition to providing peace-of-mind about performance, Artel’s volume verification also helps the PGx lab meet stringent CLIA requirements for their liquid handlers’ performance qualifications (PQs). Remaining CLIA-compliant enables the PGx team to support not only pre-clinical studies but also individually-reported patient samples for clinical development.
It’s not just personalized medicine
Personalized medicine is a hugely popular topic that receives a great deal of press, but pharmacogenomics studies are critical for so much more. While pharmacogenomics data helps drug companies better target their compounds to the appropriate patient, FDA submission of this data is voluntary when the compound is the traditional small molecule. That all changes with newer therapeutic approaches, such as nucleic acid-based drugs like the antisense RNA drug Mipomersen, or gene therapy approaches that rely on nucleic acid-based delivery. For these situations, pharmacogenomics information is critical to understanding the mechanism of action and safety, and therefore typically required by the FDA. Ming’s team at QPS already handles studies like these, and expects to see more as interest in developing these newer approaches continues to increase.
A passion for their work
With so much going on and clients that demand fast turn-around times, working in the PGx lab may sound tough. But Ming and her team are passionate about their work—“The quality is very high because everyone cares about what they do,” says Ming. Whether working on personalized medicine projects, or helping drug companies push new therapeutic modalities forward, the PGx team at QPS remains committed to generating the highest quality data for their clients.
- The Promise of Pesonalized Medicine. NIH Medline Plus. Winter 2007. 2(1): 2-3. http://www.nlm.nih.gov/medlineplus/magazine/issues/winter07/articles/winter07pg2-3.html. Accessed 8/5/2015.
- Table of Pharmacogenomic Biomarkers in Drug Labeling. FDA website. http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm. Last updated 5/20/2015. Accessed 8/5/2015.
- Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. FDA website. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073162.pdf. April 2008. Accessed 8/5/2015
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