Paul Janssen Futurelab Leiden
Paul Janssen Futulab is an international training program providing blended learning (online and on-campus) to biomedical professionals with an entrepreneurial spirit. This training program is an initiative of the Leiden University Medical Center in collaboration with CHDR - our former CEO Adam Cohen is one of the founding fathers - and Leiden University.
The online course 'Clinical Development'
The development of new medical interventions (e.g., medicinal product, ATMP, vaccine, medical device) requires a lengthy and expensive research program. When drawing up the research program, it is important to carefully consider the scientific questions, the costs and the (financial) risks in advance. To approach these aspects in an integrated way and determine the most efficient R&D route, Paul Janssen Futurelab developed the Question-Based Clinical Development (QBCD) methodology with an associated software program, the Question Optimizing Calculator (QOC).
Real-world example in Nature Biotechnology
In the January issue of Nature Biotechnology we describe the QBCD approach in detail. The article can be read and downloaded via this link. In the article you will also find a real-world example where the QBCD methodology for the clinical development of an antibody in the pharmaceutical industry was applied. Based on this example you can try out the QBCD method with the free QOC tool. The QOC tool is available on the Paul Janssen Futurelab website and can be found on the tool page.
Interested in the QBCD method?
Translational and clinical researchers and regulators who want to dive deeper into the QBCD method can participate in the online course Clinical Development by Paul Janssen Futurelab. The online course will start on 4 May 2020, lasts 5 weeks and requires approximately 5 hours of study per week.
On the course page you will find more information on the online course. There you will also find a demo that gives you a good impression of the content and design of the course.