Healthcare Intelligience Subject Matter Experts Arjen Akkerman Editorial Article v1r1

Many things have changed in the more than 17 years since Arjen Akkerman, Sr. Director of Chemistry Manufacturing Control (CMC) and Qualified Person, joined PRA Health Sciences. But throughout it all, one thing remained constant—Arjen’s unique determination to say yes.

Arjen never imagined he’d be working for a global company with more than 17,000 employees, let alone running one of the first Good Manufacturing Practices (GMP) facilities in the industry. He applied for a role at Pharma Bio Research (now PRA) during his final year of university as a way to practice his interviewing skills. To his surprise, that first interview would soon lead to a lifelong career—one he happily said yes to.

“When I started at Pharma Bio Research, there were only 500 employees. When we were acquired by PRA, we became 6,000. Today, we’re near 18,000,” Arjen shares. “We’ve become a leading global contract research organization (CRO). I think PRA is proactive in development. We always try to stay in front of what is possible in clinical research. We’re not following the industry—we’re taking the industry with us.”

A trained pharmacist, Arjen attended university with the goal of opening his own retail pharmacy. Although he only had some light background knowledge of GMP when he first joined PRA, one of the first questions his manager asked him was, “Can you support us with setting up a GMP-compliant facility?”

His answer, of course, was yes.

At the time, GMP manufacturing was still a relatively uncharted area within the clinical development industry. When Arjen joined PRA, the pharmacy area was just a few rooms—a dispensing area, a storage area, and an office. Arjen was one of two pharmacists. Today, that same department has grown immensely, thanks in large part to Arjen’s leadership and willingness to adapt to new, innovative processes.

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“I had left university the year before we built our first GMP manufacturing facility in 2004. When we started, I had no experience,” he says. “But the thing was, no one had any experience. It was a new revelation. We were all just trying to find a way to be compliant with the new regulations. However, once we completed our facility, we quickly noticed that sponsors and the pharmaceutical industry as a whole were interested in leveraging this new GMP facility.”

As the facility and team grew, Arjen took on a more client-facing role, helping sponsors develop a plan for their clinical trials early in the development process. The team discovered that by offering onsite manufacturing services, they could save sponsors time and money while also starting clinical trials earlier.

“We became a differentiator for selling studies,” explains Arjen. “Our business model and fast study startup timelines became attractive for the sponsor because they didn’t have to follow the traditional route of manufacturing and stability programs, which can take months. We do short-term stability in weeks and days—sometimes even hours.”

Arjen doesn’t just say yes to faster timelines. He happily takes on almost any challenge that comes PRA’s way. “From a formulation and manufacturing perspective, we almost never say no to a compound,” he says.

From manufacturing drug substances on the shelf into oral tablets and intravenous solutions to tablet pressing and familiarizing himself with 3D printing, Arjen is ready to discuss all possibilities with sponsors—even things that aren’t typical CRO tasks. He’s intent on taking on new, high-tech strategies and techniques that he believes will become normal practices in the future.

Fortunately, both PRA and the sponsors Arjen works with are both on board. “We’ve always said okay, we can do this—but we need to have extra equipment in place to support it,” Arjen says. “I think both PRA and the client have always been happy to provide whatever we needed to support projects from a manufacturing perspective. They both make sure we get the necessary tools to do it the right way.”

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Arjen’s curiosity and desire to explore new processes permeates throughout his personal life as well. As a child, he had a pet parakeet that would eat from his hand and sit on his shoulder. Realizing how smart that small bird was, Arjen knew that one day, he wanted to start an aviary. Flash forward several years and he’s now an avid bird breeder. After purchasing an old farm that he, his wife, and two daughters restored to live in, Arjen turned part of the property into an aviary.

“I have tropical birds from Africa—a continent I have visited many times—as well as from Australia and around the world,” he shares. “When you select a male and a female bird, the idea is that you can create a certain feather color when you breed the two. But each bird has properties that make them unique. The behavior of a bird depends on the duration of light they receive daily and relative humidity. It also depends on the composition of the nutrition the bird needs during different periods, such as the molting and breeding periods. Most of the time, while it sounds scientific, I’ve found it’s not that simple.”

It’s not unlike the work he does at PRA, where challenges arise regularly and the success of a formulation can be dependent on environmental circumstances.

“When you’re manufacturing batches and you’re responsible for making certain the patient gets 100% of the dose that’s supposed to be provided, challenges always come up,” Arjen says. “There are times we work until midnight trying to figure something out that must be ready by seven the next morning. To prevent this from occurring, we always do what we call a technical run—a mock run—to test everything, so there aren’t surprises during the actual clinical batch. Because lots of challenges occur during our mock runs, you become creative in your ways of thinking. I try to approach everything with a creative tone and trust that by talking things through, we’ll resolve the issue at hand.”

It’s that mentality that enables Arjen and his team to continue to say yes to sponsors’ unique needs—and leads to the development of life-changing medicines that can help real patients around the world.

“It’s always easier to say no,” Arjen says. “If you say no when someone asks you to do something hard, you won’t have the burden and challenges related to it. But if you choose to say yes, I think your success will be greater. In the end, that will help you and your organization.”

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