In the pharmaceutical and biotechnology industry more small and even virtual companies are established thereby changing the traditional way of working in early drug development. In the last decade there evolved a trend to obtain Proof of Concept (PoC) as fast as possible directly in patients instead of healthy subjects or as part of an umbrella protocol in relative small cohorts directly after SAD and MAD parts in healthy volunteers.
Clinical pharmacology in patients differs fundamentally from healthy subjects. Healthy subjects can often be treated in cohorts between 8 and 12 subjects with mainly safety assessments (vital signs and ECG) and blood sampling. In early phase patient studies the cohorts will be small, i.e. 1 or 2 subjects and assessments will be extensive like for instance cognition or respiratory testing. Also the medical supervision is far more intensive than in healthy subjects, mostly 1 physician and 1 study nurse per patient visit. Also due to far more extensive in- and exclusion criteria in patient population, recruitment and screening will be more labor intensive in patient studies.
QPS Netherlands BV has been performing patient studies for more than 10 years, starting with 1 study every 2 years since 2006 increasing to 5 studies with approximately 60 patients in 2016/2017 in the area of Alzheimer’s disease and asthmatic patients.
In December 2016 first negotiations started between the Management Team of the CPU of QPS and the Medical Center Leeuwarden (MCL). MCL has the desire to establish a health campus at the premises of the MCL in order to attract businesses in the area of scientific and applied health and food companies for interaction and cross-fertilization with the area of expertise in health care of a large regional training hospital.
The Medical Center Leeuwarden or MCL (Dutch: Medisch Centrum Leeuwarden) is the hospital of the city of Leeuwarden (122,000 inhabitants compared to 200,000 in Groningen), and the largest non-university hospital in The Netherlands. It is one of the country’s major top-clinical centers, offering secondary and tertiary care. It has 647 beds, and offers all common specialties including pulmonology, cardiovascular surgery and neurosurgery. It is also a teaching hospital for numerous medical specialties, as well as nurses.
From 2017 onwards, discussion between QPS and medical staff and management of MCL resulted in the mutual agreement of the establishment of a dedicated clinical pharmacology patient unit on the premises of MCL in close vicinity of the policlinic stations of the medical specialists. Restructuring of the building is now finished and the new QPS clinic consists of adaptable function rooms and comfortable bedrooms for overnight stay in a design, which is warm and comfortable and especially designed for elderly patients. The first patient study will start on September 15, 2019.
Since 1995, QPS has provided discovery, preclinical, and clinical drug development services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email [email protected].