How can we keep healthcare affordable and accessible to all? How can we use science to benefit humans? Asking Ewoud-Jan van Hoogdalem a question often leads to even more questions like these. A self-described nerd, Ewoud has always been curious to learn why things are the way they are. This personality trait ultimately led him to his current role as PRA’s Vice President of Scientific Affairs – Clinical Pharmacology where he’s encouraged to ask the big questions. Today, Ewoud leads a skilled team of scientists who are constantly pushing the boundaries of drug development. Below, he answers some of our burning questions (and offers a few of his own).
What’s the biggest challenge we face today in our industry?
I believe the biggest challenge we face is the question: How do we keep healthcare affordable and accessible to all? Conceptually, there is no end to new science and new products, and no end to what patients may expect. To support affordability and access to new pharmacotherapy, we need innovation in clinical drug testing that reduces costs and timelines, and we need innovation in regulatory review and market access. I speculate that we will see a continuum from early clinical drug testing, via conditional early marketing approval, into routine drug use.
Why did you become involved in clinical research?
I had an early fascination with the interplay between inanimate (‘dead’) material like chemical substances and the human body. I believe the spark was the understanding that chemicals isolated from nature, like cardiac glycosides from Digitalis and alkaloids from mushrooms can have desired effects as well as deadly effects. How can we use that insight to benefit humans?
In your experience, what has been the most important factor that has changed drug development?
The agreement on the importance of scientific rigor. The insight that drug tests can be explorative or hypothesis confirming, and that the design of the test needs to support the objectives of the test in all aspects. When under pressure, this is where people may cave in and start cutting corners, ending up with a design that will generate only questions. We see this now in some COVID-19 drug studies where the pandemic rush is used as an excuse for sloppiness, and people sabotage their own study by poor design, whilst pointing out that “the virus is not waiting.”
What is the biggest misconception people have about clinical trials?
In my view, the biggest misconception about clinical trials is that they are to be done by yesterday’s design because it was approved by regulators. Clinical trials are to be tailored to what patients and the product need to meet each other in harmony, with the blessing of all stakeholders including regulators.
What advice would you give to the next generation of researchers?
Lead by science. Do the right thing with pride and be confident.
How has clinical research affected your life personally?
I take nothing for granted anymore; I am grateful for every day that I can contribute to things beyond myself.
If you had to describe yourself in three words, which would you choose?
Curious, obstinate, impatient.
If you think back, at what point could you have chosen a different career path and what would it have been?
That would have been at the end of secondary school when I had to take the fork in the road: hard science or softer science. With employability in mind, I went for the hard science, but ironically, my heart was with the softer science. In a parallel universe, there is a more interesting version of me doing archeology.
If you were to write a self-help book, what would the topic be?
“How to never give up, and to stop the people who want to stop you.”
Lenexa Kansas - Clinical Pharmacology Center
PRA Health Sciences offer a full-suite of global, clinical pharmacology services. Our Lenexa, Kansas, clinic is co-located with our bioanalytical…
Select Characteristics of Recreational Opioid Users Undergoing a Human Abuse Potential Study
Human abuse potential (HAP) studies are conducted to determine the potential abuse of a drug that has rewarding properties. Abuse potential refers to…
Pharmacokinetic Characteristics of Intranasal Administration of Oxycodone ARIR
Abuse of prescription opioids continues to be a serious public health concern, with as many as 12.5 million individuals aged 12 or older reporting…