Multidisciplinary collaboration

Early clinical research and drug development require an integrated, multidisciplinary approach. Within the NKI Centre for Early Clinical Research, we therefore work closely with the departments of Radiology, Hospital Pharmacy, Nuclear Medicine, Pathology and the general clinical laboratories, among others. As a result, we have an infrastructure that enables intensive PK sampling, 24/7 medical coverage and inpatient and outpatient capability.

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Radiology

The radiology and nuclear medicine departments are very important in the discovery of new drugs. This is where PET and CT scans can be made to detect, diagnose and measure lesions. We can measure biomarkers and clinical or molecular endpoints through medical imaging. This allows us to determine how the drug distributes itself in the body and how effective the drug is.

The radiology team has extensive experience in performing biopsies on patients participating in early clinical trials. This allows a tumor biopsy to be taken before the start of treatment, during treatment and, if necessary, in the event of progressive disease.

Biopsies are used for various types of analyses and tests, for example, biomarker analyses, molecular tests, and response evaluation for diagnostics. This allows us to determine which patients respond well to treatment and monitor the safety of a new medicine.

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Nuclear medicine

The Department of Nuclear Medicine focuses on developing innovative methods to accurately measure treatment outcomes. This includes introducing novel tracers, labeling drugs, and evaluating biodistribution, theranostics, and dosimetry. A concrete example is the labelling of bispecific antibodies with zirconium to study the distribution of a drug in the body. Also, the tumor accumulation of drugs can be investigated at different dosages and dosage forms.

Within the NKI Centre for Early Clinical Research, we use nuclear medicine to identify the presence or absence of specific receptors or molecular changes. This allows treatments to be selected based on the molecular profile of the tumor, making it possible to apply personalized treatments.

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Pathology and General Clinical Laboratories

We develop new targeted treatments for patients with specific mutations, in close collaboration with the departments of pathology and molecular diagnostics. The pathology team examines tissue or samples obtained during surgery, biopsies, or punctures.

The biopsies are sent to specialized and trained pathologists to study characteristics of the tumor. We use various laboratory techniques, such as tissue staining, protein testing, DNA and RNA analysis, biomarker analyses, biobanking, molecular diagnostics (NGS, WGS), tumor sequencing, PK/PD sampling and research into circulating tumor DNA. In this way, we identify the characteristics of the tumor, such as shape, structure and genetic profile.

These analyses take place in both general clinical and specialized laboratories. In addition, we are equipped to routinely perform Whole Genome Sequencing, including comprehensive molecular reporting, which allows us to provide all our patients with a detailed understanding of their tumor.

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Hospital pharmacy

To make innovative therapies available to patients, we work with a specialized team of pharmacists who develop medicines and prepare them for clinical trials. They are certified for this by the Health Care Inspectorate and work closely with our Quality Assurance department, which ensures a reliable and fully standardized working method.

In our laboratory, we can also accurately determine the concentration of drugs in the blood, which allows us to assess exposure to the medication during studies.

In addition, our centre has its own pharmacy with GLP, GMP and GDP licences – a unique facility in Europe – which allows us to formulate and distribute medicines. This also allows us to perform pharmacological research such as mass balance studies, measurement of intracellular metabolites, pharmacokinetics and pharmacodynamic modelling.

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