Bioanalysis at Quotient Sciences - Q&A with Stuart McDougall
As the Head of Bioanalytical Services, Stu leads a diverse team of highly educated bioanalytical chemists who are able to develop, validate and use very specific and sensitive mass spectrometry-based assays for drugs, metabolites and biomarkers in a wide variety of biological matrices. Measuring drug exposure in biological systems is fundamental to drug development, in terms of both Pharmacokinetics (PK) and Pharmacodynamics (PD), to better understand ADME (Absorption, Distribution, Metabolism and Excretion), toxicity and efficacy.
Tell me a bit about yourself…
I have been at the Alnwick site for over 33 years and just like our bioanalytical department, my career has evolved over those years. I first started in life sciences as a metabolism scientist in DMPK, and now lead a team of talented bioanalytical chemists as department head. Over the years I have worked for some of the world’s largest organizations (pharma and CROs) and contributed to hundreds of drug development programs. Because of my experience, I am currently a member of the European Bioanalysis Forum (EBF) and in this capacity; I work with representatives from member companies to recommend best practices, comment on regulatory issues and organize scientific meetings to share the latest developments. I am also a member of the American Association of Pharmaceutical Science (AAPS) where I have been fortunate to present on bioanalysis in both Europe and USA
Can you tell me more about your team?
In 2016, the Arcinova bioanalysis department was a small group of scientists, but because of these talented individuals and our customer focus, we paved the way for significant investment in both equipment and people – growing the team to where it is today. My team are brilliant. They are a hardworking group of highly trained and dedicated individuals who work very well together and ultimately get the job done. Their dedication to project delivery throughout the course of the last five years has not gone unnoticed and they are greatly appreciated. We could not have got to where we are today without them.
While working at the Alnwick site, can you describe the changes within your department?
Innovation is the primary driver in pharmaceutical drug development. As more potent and effective medicines are discovered, the demand for more sophisticated, selective and sensitive methods for their measurement in biological systems are needed. Over the years that I have worked in the pharmaceutical industry, we have moved away from UV-based assays capable of measuring µg/mL levels of drugs, to assays that are now capable of accurately measuring sub-ng/mL levels by MS, which is almost a million fold increase in sensitivity! We are able to utilize this increase in sensitivity to our advantage, measuring the fate of a drug to much lower concentrations, thus enabling us to measure the fate in the body over a longer elimination phase. Additionally, we can also develop analytical methods using much smaller blood volumes, allowing us to support the 3R’s initiative (Replace, Reduce, Refine), which ethically reduces the number of animals used in drug development, contributing to humane animal research.
What do you think sets you apart from all the other bioanalytical laboratories across the globe?
We provide quality data on time. It is a simple philosophy. We analyze countless numbers of samples for both preclinical and clinical trials, we have built and validated over 400 assays and we leverage innovative technology for LC-MS. We also specialize in a range of other bioanalytical techniques and have become recognized as specialists in areas such as ICP-MS with a very large number of ICP-MS instruments, and are probably the largest GLP/GCP elemental bioanalytical lab in Europe. We have also developed extensive experience in protein and polypeptide analysis by LC-MS. Specifically, we developed and validated LC-MS assays for insulin, as well as, the commercial insulin analogues used for treating Type I diabetes. These assays are very selective and able to measure extremely low levels of insulin drugs and their active metabolites in plasma. .
Our team has over 25 years’ experience working on elemental assays, in both pharmacokinetic endpoints (elements in drugs), and pharmacodynamics biomarkers, monitoring changes in element levels in disease states and after treatment. Our dedicated method development team have accumulated over 100 years of combined experience covering small chemical drugs, polypeptides, proteins, biomarkers and elements. As such, they are very capable of solving the most complex analytical challenges. In addition, our Study Directors and Quality Control teams are very experienced in steering projects and delivering quality data that complies with regulatory guidelines.
Our offering is extensive and covers all areas of bioanalysis. We can support drug development from early preclinical up to late stage Phase III trials, for both small and large molecules by mass spectrometry in biological fluids and tissues. Our experience enables us to guide our clients to the best outcome for the project, with the quality, care and on-time delivery.
What is Quotient’s USP?
We pride ourselves on being highly responsive and we have a client centric approach, which means Method Development lead times are typically 4-6 weeks against an industry standard of 12 weeks, or more. Ultimately, if clients choose us as their bioanalytical partner, we can rapidly accelerate their drug development timeline. With years of experience both as ‘drug developers’ and as ‘service providers’, we have a unique insight into providing our clients with the best possible solutions to their complex drug development problems.
For more information about our bioanalytical services click here: https://www.quotientsciences.com/bioanalysis/