CRO internship: not getting coffee, but real contributions to science

Update Anne & Carlijn

In this blog, we’ll give an update on how it’s been so far for Anne and Carlijn to work on real projects that could have a real impact on the organization and even on drug development.

Anne Miggelenbrink is a Medical Biology student at Radboud University.

Carlijn Hut is a Biomedical Sciences student at the University of Groningen.

Integrate imaging into Phase 1 studies, Anne’s approach

To answer this question, one paragraph is way too short. So, we’ve written a whole blog on an unconventional method, not yet widely used in CNS drug development. Anne explains, “First I did market research, what methods in CNS drug development are used in Phase 1 to evaluate Blood Brain Barrier crossing? Knowing the current status, I could compare this to imaging and TRACER’s methods and see the potential benefits imaging could bring to drug development programs (but also some hurdles). Furthermore, I found out there are CNS-related tracers on the market, some already commercially available and others that can be used in a clinical research setting. I’ve added them to a list, complete with indications, that drug developers now get access to. They only have to download it to learn their options.”
Read the blog:
CNS drug development

So, what did I learn from this?

Anne, “I did a literature review and found out there are more than 150 tracers available for CNS and what stage they’re in – some still in preclinical or clinical testing, but others already commercially available. I also learned about the many applications for research, among others, patient stratification, response monitoring, and the methods and possibilities of direct labelling and using separate imaging biomarkers. Furthermore, I’ve learned about the timelines, costs, activities, and infrastructure needed to initiate and conduct these kinds of studies.

Mapping the clinical study process: Carlijn’s insights

Before clinical research can be conducted, many different steps and activities need to take place, involving numerous people. This happens both internally, between different divisions of the company, and externally, with various stakeholders. Of course, there is the sponsor, but also ethical committees that need to approve the study, clinical sites where the study takes place, and the external monitor, who ensures everything follows the plan and guidelines. Carlijn, “I did a stakeholder analysis and conducted interviews with everyone involved in the process. In just a few months, I gained a clear understanding of the full process needed to actually test a new drug in patients.”

(Steps and methods Carlijn uses to understand current processes and gain insight into opportunities for optimization.)

So, what did I learn from this?

Carlijn, “A major thing I learned is that having a small organization is a big advantage. It offers flexibility and speed, allowing for faster and more flexible study initiation and conduct. People working closely together with short communication lines simply get things done quicker.” This is great for clients of TRACER, but there’s a bigger learning here. Carlijn, “What I can advise any business, no matter what size, is to periodically evaluate all processes and find out what can be improved. As you can see in my case, it can even be done by an intern. Or, maybe better, it can be done better by an intern. In the beginning, I did not know much about clinical research, which made me ask the ‘dumb’ questions, inspiring others to take a different approach.”

Visiting the GMP facility

Anne and Carlijn visited one of our CMC/GMP manufacturing sites, where they had a tour of the various labs. Carlijn, “It was really interesting to be able to take a look around. It is very impressive to see how many measures have to be taken to work in such a lab. You think about it beforehand, but once you walk around, it is even more impressive seeing what can be done and that, ultimately, labeling for the patients’ doses is done right there. It then becomes really clear that in a clinical trial, many parties have to work together to get results.”

What’s next?

The internships are not over yet, even though from the amount of work done, you might expect that. What awaits you in the coming months?

Coming up: visualization of the standardized process

Carlijn, “Over the next few months, all the interviews are going to be processed, eventually resulting in a visualization of the standardized process. Furthermore, if there is still time, I will do a PESTEL analysis to see if this process is future-proof. it will also be interesting for me to see how my suggestions will lead to an improved process in practice.

Coming up: single and multi-site studies

Anne, “The question above was only my first research question. I’ll continue by investigating differences between single-site and multi-centre studies, examining their timelines, costs and value proposition. So, in a next blog I will keep you posted on those results.”