Healthcare Intelligience 2020 Arjen Akkerman Q A Article Header v1r1

PRA Health Sciences’ Arjen Akkerman, Sr. Director of Chemistry Manufacturing Control (CMC) and Qualified Person, never intended to land in the clinical research industry. His plan was always to open his own retail pharmacy. Imagine his surprise when a practice interview turned into a lifelong career. After winning over the hiring managers at Pharma Bio Research, which would soon be acquired by PRA, Arjen embarked on an extraordinary opportunity—pioneering a GMP-compliant manufacturing facility.

Today, he continues to leverage his passion for pharmacy, can-do attitude, and desire to help patients to deliver groundbreaking solutions for sponsors. Below, he answers some of our burning questions.

What’s the biggest challenge our industry faces today?

Complexity. Not only from a trial design or regulatory perspective, but also in my work area in the formulation of the IMP itself. Manufacturing processes for formulations that can provide the correct pK result or AUC are becoming more and more complex.

Why did you become involved in clinical research?

My interest was sparked by the fact that, from a pharmaceutical point of view, we don’t have a lot of information about the molecule which we hope will end up as a marketed drug for a disease—one of the reasons we do clinical research. The fact that only a few of the molecules make it to the end shows how important our work is.

The fact that we're able to support manufacturing of the IP within PRA for early clinical phase while also conducting the clinical trial made me enthusiastic and provides me the satisfaction I like to get in my work. When sponsors confirm they are happy, coming to us again for the services we offer, it makes me proud.

In your experience, what has been the most important factor that has changed drug development?

Looking at this from a formulation perspective, the molecules have become more complex. We now have biological drugs—more disease targeted drugs for which the formulation cannot be administered as a simple tablet anymore.

What is the biggest misconception people have about clinical trials?

Many people believe that clinical trials are dangerous and risky to participate in because the drug and its effects are unknown.

What advice would you give to the next generation of researchers?

Always stay proactive using the tools (e.g. e-health, latest technics) in performing research.

How has clinical research affected your life personally?

Since starting to work in early clinical research, the interests I used to have changed. I am completely into manufacturing IMPs now, where before I was trained and interested in commercial drugs only.

If you had to describe yourself in three words, which would you choose?

Optimistic, specialist, and persistent.

If you think back, at what point could you have chosen a different career path and what would it have been?

At the university, I was trained as a pharmacist and my plan was to open my own retail pharmacy. To do so, I needed some work experience. When I started to look for this experience, I came in contact with PRA. Instead of opening my own retail pharmacy and working in pharmacotherapy, I was able to start a GMP-complaint manufacturing facility.

What’s a fun fact about your childhood?

I used to be a good swimmer in my childhood. I trained every day from six to seven am, Monday to Saturday.

If you were to write a self-help book, what would the topic be?

Success is the result of working hard and being creative, loyal, and persistent.

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