Centre for Human Drug Research

Meet Wouter ten Voorde, Head of Business Development at CHDR Hi everyone! I’m Wouter, Head of Business Development at CHDR. My background is in Bio-Pharmaceutical Sciences, with a focus on business. After my studies, I completed a PhD in immuno-dermatology at CHDR, combining my interest in science with innovative imaging modalities and human challenge models.   I’ve now been working at CHDR for seven years, where I currently focus on finding interesting science that we can run in our clinical unit in Leiden. What initially attracted me to CHDR, and what still motivates me today, is the unique combination of scientific ambition and industry way of working. Ideas for improvement and innovation are genuinely taken seriously here, regardless of where they come from, while always keeping the company strategy and culture in mind.   The environment at CHDR is very collaborative, and there’s a shared drive to keep improving and challenging ourselves. That combination makes the work both dynamic and rewarding.

Advancing the use of OCV as a human immune challenge model Understanding how new therapies affect the mucosal immune system remains a challenge in early clinical development. In a newly published study, we characterised the immune response following oral cholera vaccination (OCV) in healthy volunteers and investigated how this response is affected by mycophenolate mofetil, a commonly used immunosuppressant. Beyond the study's primary findings, the work provides important groundwork for the use of OCV as a controlled challenge model in future clinical pharmacology studies. The data offer detailed insights into antibody responses, cytokine production and immune activation after mucosal vaccination. Read the publication here: https://lnkd.in/ep3QEpTa.

If your drug targets excitability, your biomarkers should too Last month, we highlighted how Transcranial Magnetic Stimulation (TMS) can be used to assess corticospinal excitability as a pharmacodynamic biomarker in early phase clinical research. But altered excitability is not limited to the cortex alone. At CHDR, we apply a range of validated excitability methods that allow us to study drug effects at three complementary levels, depending on the research question and mechanism of action: - Corticospinal excitability using TMS combined with EMG and EEG - Peripheral nerve excitability using nerve excitability threshold tracking (NETT) - Muscle excitability using muscle velocity recovery cycles (MVRC) These methods can be applied individually or in combination, providing detailed, mechanism‑driven insight into ion channel and receptor function, supporting proof of mechanism, target engagement and early proof of concept across a wide range of neurological and neuromuscular indications. Read the brochure below to explore how excitability methods can strengthen decision‑making early in development. #Neuroscience #Excitability #EarlyPhaseClinicalResearch #Biomarkers #DrugDevelopment

The route of administration matters more than you might expect for ketamine   In a recent publication, CHDR characterised the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of orally (PO) administered S-ketamine and compared it directly with intravenous (IV) administration in healthy participants.   Relative to IV administration, PO administration results in poor bioavailability of ketamine (9-12%), inverted pharmacologically active norketamine and hydroxynorketamine to ketamine metabolite-to-parent compound ratios (being higher for ketamine PO and lower for ketamine IV), and limited to complete absence of PD effects relative to IV administration. These findings should not only inform dose selection for future studies, but also support the interpretation of emerging safety and therapeutic outcomes with esketamine administered PO for the treatment of depression.   Read the article here: https://lnkd.in/exuAVYvf.   #ClinicalPharmacology #PKPD #DrugDevelopment

Meet Eric Houtman, IT Director at CHDR I’m Eric, IT Director at CHDR. With over 25 years in IT, and more than 20 of those in the CRO and clinical research space, I have spent my career building and optimising systems that support complex, high impact environments.   At CHDR, I am responsible for shaping and maintaining the IT landscape that enables our clinical research to run securely, efficiently, and compliantly. What I enjoy most is connecting technology with science, making sure our teams have the right tools and data to do their work at the highest level.   My journey here builds on previous roles in IT leadership, where I focused on digital transformation in regulated environments. That experience comes together at CHDR, where innovation and quality go hand in hand.   What makes CHDR special to me is the direct link between what we do and improving patients’ lives. Even though my work is behind the scenes, it contributes to something very tangible and meaningful.

Early phase clinical trials without biomarkers are a missed opportunity Phase I studies can deliver far more than safety, tolerability and PK data, if they are designed to answer the right scientific questions. In a recent white paper, our CEO Geert Jan Groeneveld explores how integrating translational biomarkers into early phase clinical trials can help determine whether a compound engages its target and produces meaningful biological effects, early enough to inform critical go/no‑go decisions. Rather than adding complexity or delaying timelines, this approach aims to make better use of early-phase studies by generating actionable insight early in development. Read the full white paper on our website: https://lnkd.in/eVyND2jh. #EarlyPhaseResearch #TranslationalScience #PKPD #Biomarkers #DrugDevelopment

In therapeutic development, several emerging trends are reshaping how early clinical research is approached In early‑phase research, there is a growing emphasis on generating data that does more than describe safety and tolerability. Increasingly, development decisions are informed by evidence of target engagement and pharmacological activity at an early stage. Several shifts stand out: - a stronger focus on mechanism‑based development - smaller, more informative early‑phase studies - greater translatability between preclinical rationale and early clinical data Rather than representing isolated innovations, these trends reflect a broader movement towards better‑informed decision‑making earlier in development. While approaches evolve, the underlying principle remains unchanged: early clinical research is most valuable when it is designed to answer clear scientific questions. #EarlyPhaseResearch #TranslationalScience #DrugDevelopment

MRI in patient studies through academic collaboration At CHDR, neuroimaging helps us understand what a drug actually does in the human body. In patient studies, MRI plays an important role in generating this insight.   Using advanced MRI techniques, we can non‑invasively assess how investigational compounds affect brain function, even in small patient populations. This provides sensitive, objective information early in development.   We do this in close academic collaboration with Leiden University Medical Center (LUMC), located just steps away from CHDR. By working with a dedicated 7‑tesla research MRI scanner that is fully embedded in our study designs, we ensure high‑quality data without impacting routine patient care.   Alongside MRI, CHDR applies a range of advanced imaging methods to support patient studies across different indications. Learn more about our imaging capabilities and academic collaborations here: https://lnkd.in/eN5kadbP.   #Imaging #MRI #PatientStudies #CNSresearch #AcademicCollaboration

Meet Geert Jan Groeneveld, CEO at CHDR Hi everyone! I’m Geert Jan, CEO of CHDR. I’m a neurologist and clinical pharmacologist and a professor of clinical pharmacology at Leiden University Medical Center. I did my residency at UMC Utrecht, where I also completed my PhD on finding new treatments for ALS. After a short but valuable period in clinical development at Genzyme, I realised I missed being close to research itself. That brought me to CHDR in 2009. I started as Research Director Neurology, later Neurology & Pain, while also continuing clinical work as a neurologist. Over the years, my role grew: from principal investigator and research director to board member as Chief Medical and Chief Scientific Officer, and since early 2024, CEO. What has always drawn me to CHDR is its unique position between academia and industry. We combine scientific curiosity with the ability to get things done. We design studies, measure drug effects in innovative ways, and help companies develop better medicines. CHDR has grown enormously over the past 17 years. My role has changed with it. As CEO, I want to help create the same inspiring environment that shaped me: a place where people can learn, grow, challenge themselves, and keep science at the heart of everything we do.

Why transparency in clinical data builds sponsor confidence   In early‑phase clinical studies, decisions and timely trial progression often depend on how quickly and clearly data move between teams. When study data are shared in a straightforward and consistent way, both the sponsor and the research site can assess progress and respond to developments without unnecessary delay.   At CHDR, we align on data format expectations and structure our data exchange so that sponsors have an accurate view of what is measured, when it is available and how it should be interpreted. This supports dose‑escalation decisions and helps keep study processes aligned.   Another aspect of transparency is the clarity of the underlying methods we use. All our methodological work is published in peer-reviewed scientific journals. Assessments such as NeuroCart® and PainCart® and our in-house developed immune challenges are described in detail, including their measurement properties and typical use cases. This provides context for the data generated during a study and helps sponsors understand the underlying framework.   For more detail on these methodologies, see the publications below: NeuroCart®: https://lnkd.in/eE8HMcT7 PainCart®: https://lnkd.in/e8QB-3_X KLH: https://lnkd.in/eDEDD22s