When starting a business, an up-front investment is necessary to hire the talented personnel, acquire the appropriate equipment and instrumentation, and secure the space required to operate the new business successfully. Typically those initial activities require an investment of time and money prior to securing the work that will fund those resources, but new business owners likely have anticipated, and are prepared to accept, that initial risk or the business never would have been started. Once the business is operating successfully, however, the decision to continue expanding in anticipation of work, or expand only in response to increased workflow, becomes more difficult.
Both approaches have tangible risks. When a company chooses to expand proactively, it assumes the financial burden of the growth prior to the increase in revenue associated with the new projects. While that risk may worry the board of directors at many corporations, expanding reactively places clients’ projects and timelines at risk. Therefore, when planning a sustainable strategy for growth, the management team at any company should consider the value of the company’s reputation and weigh the short- and longterm opportunities and financial risks for the company.
At MicroConstants, we have earned a reputation in the industry for providing high-quality contract research services to our clients. Since the majority of our new business comes from referrals, that reputation has been fundamental to our growth and sustainability as a company throughout the last decade and is not something we are willing to put at risk. So to maintain our reputation, we have chosen the proactive approach to growth and generally hire individuals, acquire instrumentation, and secure space in anticipation of increased workflow rather than wait until after the work arrives. There is some risk to our approach; however, we believe there is a greater risk in being underprepared and potentially disappointing a client.
Our clients expect us to provide advice and guidance based on our scientific expertise; therefore, it is important that we hire experienced scientists to develop our analytical methods and oversee our departments. These individuals make up the backbone of our teams and add value to every clients’ projects. Filling these positions with the best candidates often requires a significant amount of time and effort since these scientists are in high demand. With that in mind, our proactive approach allows us to take the time required to find those exceptional individuals. The alternative approach—waiting to fill key positions out of necessity or in response to a flood of new work—can lead to hiring individuals that may not be experienced or skilled enough to handle the position. These individuals will often not last long in their positions, and high turnover causes lack of continuity in the group. In the end, this approach is a disservice to clients, increases pressure to fill the position as quickly as possible, and results in a revolving door in the department, causing unwanted stress in the company.
Our management team is also proactive in the way it purchases our analytical tools. When it comes to purchasing equipment and instrumentation, one of our objectives is to anticipate our clients’ needs (often before they have) and add value to their projects by already being positioned to meet those needs. This way, when we are tasked with some of the toughest analytical challenges, we have the instrumentation in place and the highlyskilled individuals integrated into our team to quickly solve those analytical challenges that our clients and other CROs may be unable to overcome. Our method development team has been instrumental in helping us achieve this objective by evaluating new technologies (equipment, instrumentation, software packages, etc.) and making recommendations to the management team. Through their efforts, and with the support and vision of our management team, we have acquired and implemented many new technologies that have helped us maintain our competitive edge.
In 2008, our method development team recommended the purchase of a Spark Holland Symbiosis online SPE system, to be coupled with one of our tandem quadrupole mass spectrometers. The team felt several ongoing projects would significantly benefit from this type of system if one was available to them. It turns out they were correct. Within two years, we had acquired, installed, and qualified three Spark Holland systems, all coupled with Waters Quattro micro tandem quadrupole mass spectrometers. These systems have allowed us to analyze extremely unstable compounds in biological fluids by performing the extractions without external manipulation and with minimal sample handling. Since installation, we have been asked to work with several unstable compounds that would have been virtually impossible analytically without these tools being available to our method development team. With the online SPE already in place, we developed novel methods for these unstable compounds much more quickly and secured several new clients and entire clinical programs. The systems also provide automation for some of the less challenging compounds we are asked to analyze, which reduces the effort required by our scientists in the lab and shortens our timelines for our clients.
Another significant investment in instrumentation that enabled us to improve the quality of our services came from our DMPK group recommending the purchase of a Q-Tof mass spectrometer to expand our drug metabolism services. We carefully evaluated the cost of the system while also considering the new service offerings and potential value it would allow us to provide to our clients and their projects. Although it was not a decision we made lightly, we did purchase a Waters Q-Tof Premier in 2009. The system was initially purchased primarily to perform metabolite profiling studies, but it also wound up providing an unexpected solution to a completely different problem. A client sponsored a large analytical study in which 11 different compounds were evaluated for binding to a specific protein. Rather than separately develop the analytical method for each compound on a tandem quadrupole mass spectrometer, all 11 methods were developed simultaneously on the Q-Tof with sufficient sensitivity and outstanding linearity. The selectivity of accurate mass detection and the consistency of the ultra performance liquid chromatograph to which the Q-Tof was coupled, permitted the use of a generic method for all compounds without separate infusion and tuning of each compound. Additionally, all 11 analytes were included in each calibration standard, so one set of injections provided 11 calibration curves. The time savings allowed the project to be performed within budget and on schedule. This purchase has allowed us to successfully grow our DMPK department and provide higher-quality services for our clients’ drug metabolism studies.
In addition to purchasing new technologies, laboratory management must also decide when to upgrade existing instrumentation or purchase the latest models. To stay on the cutting edge and develop the best possible methods, analytical labs really cannot afford not to upgrade their systems and instrumentation. Therefore, our management team has been extremely proactive in the acquisition of the latest instrument models to meet future demands for increased sensitivity and capacity. One of our more recent acquisitions was the Waters Xevo TQ-S tandem quadrupole mass spectrometer coupled with the Acquity UPLC system. The speed, sensitivity, and accuracy of the new LC/MS/MS system have allowed us to quantify compounds at lower concentrations than previously possible and shorten our method development timelines. Since the installation, we have also been able to increase our overall throughput and capacity, thus improving the quality of our services for all our existing and future clients. A few months after we purchased the new system, a client requested a method with a lower limit of quantitation (LLOQ) of 0.25 pg/mL for one of their compounds in human plasma to support an upcoming clinical trial. With this instrument already in place, we were prepared to confidently move forward with this new project. Had our management team waited to reactively purchase the Xevo TQ-S, there would not have been enough time from the inquiry to the start of the study to acquire, install, and qualify the new system and develop and validate the method to the requested LLOQ.
At MicroConstants, we have chosen to proactively hire individuals with the scientific expertise our clients have come to expect from us and acquire the latest instrumentation needed to solve the toughest analytical challenges. This expansion approach has contributed to our positive reputation and enabled us to provide the highest-quality contract research services to our clients. For these reasons, we will continue to expand proactively in an effort to reduce risk for our clients, maintain our reputation, and reach our long-term goals.