Clinical Development
Clinical development is a crucial part of R&D projects for new products. Learn the basics of clinical development and valuation calculations using teaching cases based of real-world R&D projects.
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Clinical Development Online
standalone or part of the blended course package
Want to have a look at the way we teach online?
Learn how to use the QBCD approach to formulate key questions when developing a new medical intervention
Learn how to deal optimally with development risks and costs
Learn how to work with the QBCD software program
Discuss online with peers and receive feedback from your course instructor
Clinical Development On-campus
prerequisite: online course
Everything from
Online +
Experience the challenge of decision making on R&D projects
Learn from the successes and failures of real-world R&D projects
Learn from your group members in small, interdisciplinary working groups
Hear about first-hand experiences from industry experts
Learn more below or sign-up for this course directly
One module, different options
The best way to experience our modules is to follow the blended route. The online course acts as a prerquisite for the on-campus part.
This module scores 82%
Scholarship
Scholarships are available for our courses. Read more about current scholarships and how to apply.
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The mix worked well
I was impressed with the versatility of the learning environment. The mix of texts, PDFs, videos, questions and assignments worked wonderfully well!
Erik van Beers, Skyline DX, Clinical Development Online graduate
Nicely set up
I think this course is very nicely set up, with a mix of videos, explanations, examples and self-assessments.
Nicoline Treijtel, Astellas, Clinical Development Online graduate
Out of my comfort zone
“I loved the ‘corporate finance’ bit, really out of my comfort zone, but it did give me so much more insight into the financial considerations in clinical development”
Meta Roestenberg, Leiden University Medical Center, Clinical Development Online graduate
Excellent learning opportunities
The cases were excellent and the manner in which they were presented provided excellent learning opportunities.
Vickas Patel, GlaxoSmithKline, Clinical Development Online graduate
We understand if you want to have a look at this course. Login or create an account to access a free demo of the online course.
A confirmation email will be sent to new registrations. After completion, you're able to acces the online demo.
This online course can be taken as a stand-alone course or as part of the blended learning-by-doing course Clinical Development, giving you the freedom to learn online in a time and place independent fashion from anywhere where you have internet access. At the end of the online course you will take a short online exam; participants who pass the exam will receive a certificate of completion and are eligible for the on-campus course held in the beautiful Castle Oud Poelgeest near Leiden in the Netherlands.
What makes this course special?
This online course is the first part of our blended course that also includes an on-campus course. In the online course, you will be introduced to Question-Based Clinical Development (QBCD), an innovative approach to designing a rational and efficient pathway for developing new medical interventions. The QBCD concept is derived from Real Options Theory, which is commonly used by the oil industry to deal with the high levels of uncertainty and large investments that are also common to clinical development. Adapted to the biomedical industry, QBCD offers significant advantages compared to the commonly used net present value (NPV) and risk-adjusted project value calculations. Specifically, the goal of QBCD is to optimize project value by identifying and addressing critical questions early, thereby streamlining the development of new medical interventions.
What will you learn?
In this 5-week course, you will learn the basic principles of QBCD and how to apply this approach to teaching cases based on real-world R&D projects. Using these principles and clear examples, you will learn to identify the key questions that must be answered when developing new medical interventions such as medicinal products, vaccines,
4 things you will take away from this course
During this course, you will:
- Learn how to use the QBCD approach to formulate key questions when developing a new medical intervention;
- Learn how to deal optimally with development risks and costs;
- Learn how to work with the QBCD software program; and
- Engage in online discussions with your peers and receive feedback from your course instructor.
Article in Nature Biotechnology
We recently published the QBCD approach in the prestigious journal Nature Biotechnology; you can download the article (if you experience problems downloading the file, please contact us).
I know enough, let's
Clinical Development contributors
On-campus
Nacer Lounis
Senior Principal Scientist
Janssen Pharmaceutica
On-campus
Tine de Marez
Senior Director, Compound Development Team Leader TB
Johnson & Johnson
On-campus
Erik Niks
Neurologist - Pediatric neurologist
Leiden University Medical Center
On-campus
Piet Hinoul
Chief Medical Officer
Virtual Incision
On-campus
Ad Sitsen
Owner
ClinPharMed Consultancy for Drug Development
Paul Stoffels
CEO
Galapagos
On-campus
Marcel Kenter
Director
Paul Janssen Futurelab Leiden
On-campus
Koen Andries
VP Scientific Fellow Infectious Diseases Discovery
Janssen Pharmaceutica NV
On-campus
Andreas Wallnöfer
General Partner
BioMed Partners Venture Capital (former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd.)
On-campus
André Elferink
Clinical epidemiologist
Dutch Medicines Evaluation Board
Hans-Georg Eichler
Senior Medical Officer
European Medicines Agency
Inge de Lepeleire
Director Translational Pharmacology
MSD Europe
Johan Garssen
Director Immunology Platform
Danone/Nutricia Research
Rick Kuntz
Former Senior Vice President and Chief Scientific, Clinical and Regulatory Officer
Medtronic
Oliver Bisazza
Former Director Regulatory Policy
Medtronic
Saco de Visser
Teacher and Clinical Pharmacologist
Paul Janssen Futurelab Leiden
Richard Shull
Head of Deal Structuring and Trading Fundamentals
Shell
Pierre Peeters
Early Clinical Development Expert
Curare Consulting