Welcome to the course Clinical Development!

Welcome to Paul Janssen Futurelab Leiden!

Your course ‘Clinical Development Online’ starts next Monday, March 1nd. My name is Saco de Visser and I will be your teacher in this course. Once again, we have a nice small group of entrepreneurial professionals from industry, smaller biotech companies as well as academia participating in this edition of the course! I am looking forward to your contributions and interactions we will have during the upcoming weeks!

Just to be sure; in this online course, we will not address regulations such as Good Clinical Practice (GCP), nor will we cover how to write a full research protocol for a clinical trial. Instead, we will focus entirely on an approach called Question-Based Clinical Development (QBCD). QBCD can help you establish the most efficient route for developing your novel medical intervention such as medicinal products (or drugs), medical devices, and medical nutrition. Furthermore, QBCD supports a rational development of these novel medical interventions.

The QBCD approach is based on Real Option Theory, which is derived from finance options procedures. QBCD begins with the formulation of key scientific questions that must be answered during the development program. In addition, QBCD takes into account the costs associated with answering these key scientific questions (or efforts needed), the risk of failure, and the value of the research project. In the course, we will provide you with a robust tool that will help you identify the optimal order in which to address your key questions. You will be introduced to the QBCD approach in a step-by-step fashion through discrete weekly learning objectives.

Be advised to schedule at least 5 hours each week to do assignments (especially the 4 case studies in the last 2 weeks), study the course material and discuss topics with your classmates (meet them in your online classroom) and/or with me. This online course works via ‘the content-dripping principle’, meaning each week on Monday, a new weeks lesson will become available. Try to keep up to avoid having to catch up in the end!

During the course, it is possible to chat with me in a videocall. These calls are a nice way to ask questions and to meet each other. The first one is planned in the first week on March 3 at 20.00 (CET). All videocalls will happen in MS Teams. The first one can be found here. You can find the other videocalls in the course dashboard.

I hope you’ll find it a meaningful experience and look forward to reading your assignments and discussing the topics in the next weeks. Please feel free to contact me at anytime if you need me.

Enjoy!
Saco