Pharmaceutical and biotechnology companies use contract research organizations (CROs), or contract labs, when they need to outsource a portion of their work. Contract labs offer a wide range of services within research and development. Some labs provide a single service, and others are more comprehensive in the scope of their work.
Aptuit Inc., an international contract research organization whose facilities span North America, Europe, India and Asia Pacific, is the latter type. The organization delivers client support from preclinical studies to commercial drug product launches, essentially creating an efficient path for drug development and clinical supply.
“We are contracted by clients to perform various drug development services,” says Paul Annable, senior project manager at Aptuit. “Within our specific site here in Kansas City, we support drug development from synthesis of the drug substance all the way to commercialization of the drug product.”
Clinical supplies support is the bulk of Aptuit’s business in Kansas City, where Annable is based. His team supports traditional molecular weight drug substances as well as large bio-molecular drug substances. The location also boasts a complete concert of drug product packaging capabilities.
“Our clients—ranging from virtual groups with a single molecule or idea all the way to large pharma—are a diversified group from around the world with one common goal: to improve the health of the patients they serve,” Annable says.
The Kansas City operational location is a large site that covers well into the thousands of square feet. “The project management group tends to work in a more virtual environment, guiding projects across multiple Aptuit sites with clients from around the world,” Annable says.
The site includes about 150 lab personnel involved with supporting drug substance synthesis, clinical trial materials supply, and clinical and commercial packaging. Within the project management group, which Annable is a part of, Aptuit engages more than 100 individuals in the United States and Europe.
“Individual site groups range from three to fifteen project managers, depending on the services supported by each site specifically,” Annable explains.
The expertise of the employees covers a vast range. Within the organization there are analytical chemists, organic chemists, physical chemists, pharmacologists, formulators, packaging experts, clinical trial managers and various diversified business support personnel.
Annable himself is an analytical chemist whose background is in research and development (R&D). He has been in the field for nearly twenty-five years, for half of which he has managed Aptuit’s spectroscopy laboratory in Kansas City. Five years ago, Annable moved into project management. His team currently supports about 30 clients.
“As spectroscopists, we support material characterization—reference standards, drug substance and identification of unknown entities presented in various sample matrices,” he explains. “Techniques typically employed range from FTIR, ICP, MS and NMR to chromatography’s ionic, normal and reverse phases.”
Analytical samples originate from multiple sources, including formulation and synthesis development projects, clinical stability, and problem solving situations. Sample counts are dictated by the flow and maturity of the projects they support.
Maintenance, inventory and hiring
Annable’s team utilizes myriad analytical instruments. Some of the techniques that get the most use include nuclear magnetic resonance spectroscopy (NMR); mass spectrometry (MS), including both liquid chromatography and gas chromatography; Fourier transform infrared spectroscopy (FTIR); thin-layer chromatography (TLC); ion chromatography; atomic absorption spectroscopy (AA); inductively coupled plasma emission spectroscopy (ICP); and many other techniques employing large bio-molecular testing instruments. In order to maintain these heavily used instruments and the rest of the equipment, Aptuit relies on highly trained individuals specifically hired for the task.
These individuals, who are also responsible for maintaining the site, are versed in the requirements of documentation in accordance with the industry, Annable explains. “Any changes or improvements in these areas are monitored through a quality assurance change control system.” When it comes to taking inventory, however, everyone in the group lends a hand, while making sure that all industry standards are met.
“Within our industry, an accurate, compliant accountability of all analytical samples is a regulated requirement,” Annable says. “We follow best practices in documenting the movement of samples through our laboratories and sample management office. Associates are dedicated to the single task of ensuring accurate and compliant sample tracking during the drug development process.” The facility’s smooth operation is partially owed to the careful selection of qualified staff.
“As you can imagine, within the framework described, challenges just from a scientific perspective require a talented and reactive team of specialists,” Annable says.
Any department seeking technical associates looks for suitable personnel who are not only well versed in their fields but also possess the skill set needed for that division. Once a person is chosen to work with the team, human resources oversees the rest of the hiring process.
But as with most labs, it’s not always easy at Aptuit. Not only is the road to drug development a nonlinear process, but accuracy, compliancy and timing are all absolutes that constantly affect the work.
“Challenges present themselves daily [and] require team effort to ensure that the goals of our clients and our industry are continually met and delivered,” Annable says. “Leading these teams and communicating with our clients is a very dynamic process. Our challenges come from all directions, such as creating the best tablet formulation that will provide the desired dissolution profile or offering packaging solutions for a multicountry clinical trial.”
How do Annable and his team meet these challenges?
With client involvement, Annable allows the project team to use its creativity to come up with unique solutions to major snags. Listening to the solutions and ideas of his staff, he says, is the best form of leadership. This type of management, in addition to the type of work that Aptuit conducts, provides Annable with the needed energy and enthusiasm to get through the daily hurdles.
“The most exciting aspect of our work is the support we provide as a drug product moves through the developmental pipeline. As we are all personally touched by medical issues, being part of the myriad drug products and their indications makes our job that much more pleasing and rewarding,” Annable says.
“From oncology to neurological indications, we have and are working on all medical fronts and are fortunate to work with our clients and their brilliant ideas, pushing for solutions to improve the health of patients around the globe.” Another factor that lends to the success of Annable’s management, and Aptuit as an organization, is the utilization of one of the most, if not the most, important skills in the business.
“Communication is the key to success in our industry,” Annable says. “You must communicate with both internal and external clients to ensure that everyone is aware of their project deliverables. Finally, your clients are keener than you are when it comes to their drug and where their project must be at the end of the day.”
And at the end of it all, a little bit of levity doesn’t hurt either, he adds.
Day to day
As project manager, Annable starts his day very early. With clients and colleagues scattered throughout the world, he has to work with the schedules of many.
“Time zones dictate when I can communicate with my team,” he says. “The management of projects of varied maturity in the drug development process requires consummate levels of direct involvement depending on the activities in which we are currently engaged.”
He spends many days in team and client meetings to discuss the status of the various projects, anticipated issues and potential solutions. Additionally, because timing is such a major component of his team’s daily activities, he ensures that everyone adheres to the initially drawnup schedule.
“Imagine a clinical study with a very specific patient enrollment process. Our clinical trial materials must be delivered to the clinic as promised in an accurate and compliant state to ensure that the first patient dosing is delivered as required,” he explains.
“Think of it in your personal health life: we must deliver as you would expect to be treated for your health concern. That fact is not debatable.”
And it is that fact, that promise to the patient he hasn’t met, and the promise to his clients and his team, that makes Annable look forward to starting each day. “Communication and delivery to promise are my daily goals,” he says. “I lead by example and expect the same from my talented team. The success of my clients goes right back to the fact we are doing something good for someone who is ill.”