As Maryland’s bioscience industry focuses more on running clinical trials for drug developers, there’s a growing demand for the highly-trained workers needed.
Montgomery College answered that call this summer, with a course that focused on clinical trial project management and was offered to anyone with a bachelor’s degree. Eighteen people graduated from the course Saturday, including one who was immediately snapped up by Amarex Clinical Research, a Germantown contract research organization.
“There’s a huge need for this type of training,” said Mukesh Kumar, senior director of regulatory affairs and quality assurance for Amarex. “There’s no training program anywhere on the local East Coast.”
In fact, Amarex developed the course for the college, following a discussion last year on the bioscience industry’s needs. The 80-employee company also provided representatives to teach classes at the 13-week course, which took place Saturdays.
“This is a growing field,” Kumar said. “Most of Big Pharma locations are in other places, but now you have a lot of small companies graduating to clinical trials. Maryland traditionally didn’t perform a lot of clinical trials, but we’re doing more now.”
He said Amarex is interviewing several of the graduates and plans to hire one or two more.
Maryland’s bioscience industry comprises more than 500 companies, with as many as 100 performing contract work for other companies, said Judith Britz, executive director of the Maryland Biotechnology Center in Baltimore. All told, Maryland’s bioscience industry employs more than 33,000 people, she said.
“This is a skill set that’s really critical to every organization, not just contract research organizations, especially if you have a regulated product,” Britz said. “There has to be an understanding within every company of the fundamental principles of clinical trial execution and of the requirements for the [U.S. Food and Drug Administration].”
She emphasized that although many young bioscience companies would benefit from having their own workers with some trial skills, contract research organizations continue to be an important part of the industry. These organizations allow smaller biotechs to outsource clinical trial work when the smaller company lacks the resources to perform the trial in-house.
“We’re in the DNA Alley and the knowledge economy area,” said Sanjay Rai, vice president and provost at Montgomery College. “We have to find a way of commercializing that knowledge.”
He reiterated the oft-repeated observation that Maryland is near the top in research dollars but near the bottom when it comes to commercializing that research. Rai said finding ways of creating workers to boost commercialization efforts is a key step.
The college also offers a chief science officer program to train scientists in business operation skills. Rai said that program’s success led the college to start the clinical trial project management course.
“There’s no programs like these anywhere, especially at the community college level,” Rai said.
He said if Maryland can build its clinical trial work force, it might be able to retain more companies and attract those looking for such workers.
The college will offer the clinical trial project management course again in November, when it will accept 25 students, Rai said.
Britz said the training works well with the work at University of Maryland’s Center for Excellence in Regulatory Science and Innovation. The center is a collaborative initiative between the university’s College Park and Baltimore campuses that focuses on the science of developing tools, standards and approaches to asses the safety, efficacy, quality and performance of FDA-regulated products in an effort to help modernize and improve the ways drugs and medical devices are reviewed and evaluated, according to university information.
Montgomery County is focusing on the people directly involved in monitoring trials, while the center is looking at the regulatory science and statistical data, Britz said.
“The industry is enhanced by offering these courses,” she said.