Module

Clinical Development

The Clinical Development program at Paul Janssen Futurelab Leiden provides “learning-by-doing” training to ambitious postgraduate biomedical researchers who wish to further their career and increase their knowledge on the development of novel medical interventions. The program focuses on several important aspects associated with the development medicinal products, medical devices, and medical nutrition products. The Clinical Development program consists of three sequential courses:

Clinical Development Online

In this five-week online Futurelab course, you are introduced to the question-based method of clinical development. This approach, which is based on the so-called Real Options Theory, facilitates the rational and efficient design of a pathway for developing novel medical interventions. Although this approach is used only rarely in the biomedical sector, it is used commonly in many other industries. During this course, you will learn how to apply this approach using the Futurelab tool. You will also learn to formulate key questions to be answered during the development process and to estimate both the associated costs and the likelihood of answering these key questions. It is important to note that each course must be completed before the next course can be taken. Moreover, although course participants are expected to pursue all three courses in the program, it is possible to take this online course as a stand-alone (i.e., terminal) course.

A multifaceted online course

In this online course, a variety of exercises will help you master the Futurelab tool and use question-based development to approach real-world scenarios based on real-world case studies. In addition, the online course uses a wide variety of teaching methods, including animations, tutorials, scientific articles, interviews with industry experts and authorities, Futurelab talks, self-assessment tools, quizzes, assignments, online discussions with fellow course participants, and feedback from Futurelab experts.

Online, for your convenience

Each week of the course starts by watching an episode of the Futurelab series QUESTIONS!, in which physician-researcher Claire, who recently obtained her Ph.D., starts in her new job at a biotech company. Being responsible for the development of a novel compound, Claire quickly discovers the advantages of using the question-based approach compared to the more commonly used Net Present Value (NPV) method.

Study time

You will be expected to spend approximately 5 hours per week for five consecutive weeks.

Learning outcomes

  1. Upon completing this course, you will be able to design the optimal path for developing a novel medical intervention. Specifically, you will be able to:
    recognize the disadvantages of using the NPV method and the advantages of using the question-based approach;
  2. identify the most important questions that will need to be answered during the development process;
  3. identify the uncertainties associated with answering these questions; and
  4. identify the costs associated with the development process and estimate the potential revenues that may arise following successful development.

Requirements

  • A master’s degree in any subject related to biomedical science
  • Several years of relevant working experience

Included in this course

5-week Online course
Online exam

We offer a 25% discount to non-profit organizations. Select your option and select your start date:

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Program information

Online course starts23 Oct 2017

Online exam07 Dec 2017

On-campus start dateJune 2018

Course length5 week

Course practice5 hours a week

Program information

Online course starts15 Jan 2018

Online exam05 Mar 2018

On-campus start dateJune 2018

Course length5 week

Course practice5 hours a week

Your teacher

Saco de Visser

Head of Education and Clinical Pharmacologist

Clinical Development contributors

Clinical Development Online

Paul Stoffels

Chief scientific officer
Johnson & Johnson

Clinical Development Online

Tom Huizinga

Head of the Department of Rheumatology
Leiden University Medical Centre

Clinical Development Online

Marcel Kenter

Director
Paul Janssen Futurelab Leiden

Clinical Development Online

Koen Andries

VP Scientific Fellow Infectious Diseases Discovery
Janssen Pharmaceutica NV

Clinical Development Online

Andreas Wallnöfer

General Partner
BioMed Partners Venture Capital (former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche Ltd.)

Clinical Development Online

Justin Hay

Pharmacokinetics Assessor
Medicines and Healthcare products Regulatory Agency

Clinical Development Online

André Elferink

Clinical epidemiologist
Dutch Medicines Evaluation Board

Clinical Development Online

Rob Zuiker

Senior Clinical Scientist
CHDR

Clinical Development Online

Barbara J. van Zwieten-Boot

Vice Chair
Medicines Evaluation Board, The Netherlands

Clinical Development Online

Hans-Georg Eichler

Senior Medical Officer
European Medicines Agency

Clinical Development Online

Robert Klautz

Thoracic Surgeon
Leiden University Medical Centre

Clinical Development Online

Matthijs Moerland

Research Director Translational Biomarkers
CHDR

Clinical Development Online

Joris Rotmans, MD, PhD

internist-nephrologist
LUMC

Clinical Development Online

Janneke Meulenberg

CEO
Arthrogen

Clinical Development Online

Inge de Lepeleire

Director Translational Pharmacology
MSD Europe

Clinical Development Online

Koos Burggraaf

Research Director CVS & Metabolism
CHDR

Clinical Development Online

Johan Garssen

Director Immunology Platform
Danone/Nutricia Research

Clinical Development Online

Ingrid de Visser

Senior Clinical Scientist
CHDR

Clinical Development Online

Rick Kuntz

Senior Vice President and Chief Scientific, Clinical and Regulatory Officer
Medtronic

Clinical Development Online

Geert Jan Groeneveld

Research Director CNS
CHDR

Clinical Development Online

Oliver Bisazza

Director Regulatory Policy
Medtronic

Clinical Development Online

Saco de Visser

Head of Education and Clinical Pharmacologist
Paul Janssen Futurelab Leiden

Clinical Development Online

Adam Cohen

CEO and clinical pharmacologist
Centre for Human Drug Research

Clinical Development Online

Richard Shull

Head of Deal Structuring and Trading Fundamentals
Shell

Clinical Development Online

Pierre Peeters

Former site head early stage development
Organon

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