About us

Paul Janssen Futurelab Leiden is an international blended learning (online and on-campus) training program for entrepreneurial biomedical professionals.

Our view on continuous learning

To combine daily work and/or a busy family life with high quality education and training can be challenging. For workers in the field of the rapid evolving biomedical sciences this challenge is even greater. Paul Janssen Futurelab Leiden offers time and place independent distant learning as well as on-campus training using real-world teaching cases in an inspiring learning environment. This blend of online education and on-campus training is a perfect match for talented biomedical scientists who have the ambition to become the future generation Chief Scientific Officers.

Our partners

Futurelab is an initiative of the Leiden University Medical Center, founded thanks to a grant from ZonMw and Health Holland and in cooperation with the Center for Human Drug Research and Leiden University.

Our mission

To successfully treat complex diseases, we need detailed insight into both the cause and course of the disease. That’s why a multidisciplinary approach – from science to business – is essential when developing novel medical treatments. Unfortunately, however, few professionals possess the breadth and depth of skills needed in both biomedical science and entrepreneurship. At Paul Janssen Futurelab, we train ambitious biomedical researchers to become tomorrow’s leaders in the discovery and development of novel medical interventions. Our advanced online courses and on-campus training programs offer a new, integrative approach to learning. This learning-by-doing approach includes case studies based on real-world projects from both industry and academia. Our experts share inspiring stories about the development of new medicines, medical devices and medical nutritional products. At Paul Janssen Futurelab, the next generation of Chief Scientific Officers learn to develop innovative medical interventions more efficiently and more effectively for patients.

Our subjects

Unmet medical need

The generation for an idea for a novel medical intervention starts with identifying and understanding the unmet medical need of the patient.

Unmet medical need

Pathophysiology disease

Deep understanding of the biology of a disease is required to discover new targets for possible novel medical interventions.

Pathophysiology disease

Idea for novel intervention

A new idea for a novel medical intervention will benefit from discussion with peers and idea processing.

Idea for novel intervention

Scientific literature

Is my idea really novel or has it been tried already? Systematic reviews of the literature are required to focus R&D efforts.

Scientific literature

Commercial opportunities & Fair value/pricing

The development of a novel intervention requires an evaluation of the commercial opportunities and pricing should it be developed successfully.

Commercial opportunities & Fair value/pricing

Initial research funding

Starting the initial research for a novel medical intervention requires funding for the first pre-clinical experiments.

Initial research funding

Discovery phase

During this phase a novel product affecting the target is discovered that might lead to a new medical intervention.

Discovery phase

Project / business Plan

At this phase you need either a project plan to allocate a budget within your organisation, or you write a business plan to start a start-up.

Project / business Plan

Budget / VC-transaction (series-A)

Generating enough budget for the early development challenging. Depending on your position and future plans, there are various ways to go forward.

Budget / VC-transaction (series-A)

Start-up company

Being originally training as a scientist you will probably benefit from additional education & training in entrepreneurship.

Start-up company

Leadership & Entrepreneurship in R&D

Leading an R&D section at a biomedical company requires special skills that go beyond being an excellent scientist.

Leadership & Entrepreneurship in R&D

Pre-clinical research (initial)

The initial pre-clinical research phase will show whether your novel product is a promising candidate for the treatment of the studied disease.

Pre-clinical research (initial)

Production & quality Control (initial)

A small scale production of your product according to regulations is needed to allow pre-clinical and clinical research.

Production & quality Control (initial)

Pre-clinical research (cont’d)

In the ideal situation you will be able to demonstrate in pre-clinical disease models that your product is a valuable candidate for further clinical development.

Pre-clinical research (cont’d)

Budget / VC-transaction (series B)

Once you have reach this stage you will need an extensive budget that allow the clinical development of your product.

Budget / VC-transaction (series B)

Trial design, data-management & statistics

Before you start with the clinical development and the first clinical trials, you need to define the trial design, make sure the data management is set-up appropriately and the data are analysed thoroughly.

Trial design, data-management & statistics

Clinical development (First-in-Man)

The translation of pre-clinical research into medical research with human subjects is not a sinecure and requires in-depth preparation of a first-in-man trial.

Clinical development (First-in-Man)

Exit: IPO, merger, sale or liquidation (in case of start-up)

If you are running a start-up, you might reach an exit phase which may come as an IPO, merger, sale, or liquidation. All of these cases bring their own dynamics and challenges require specialised skills and expertise.

Exit: IPO, merger, sale or liquidation (in case of start-up)

Clinical development (cont’d)

Once your product passed the first-in-man study successfully, you will need to continue further development in clinical trials.

Clinical development (cont’d)

Safety / Vigilance

Registration, evaluation and reporting of adverse events will give you important information on the risk/benefit ratio of your product and is an important aspect in safe-guarding the well-being of trial subjects and patients in the pre and post-marketing phase.

Safety / Vigilance

Reimbursement

After getting the marketing authorisation for your product, a next crucial step is getting approval for the reimbursement of your product once it is prescribed for patients.

Reimbursement

Production & quality control (large scale)

Once you have reached this stage, you will need large upscaled production of your product for widespread use in the clinic.

Production & quality control (large scale)

Introduction in clinic / prescription

The use of your product in the clinic needs an introduction and sometimes training for medical doctors so that they are well informed about your product for the adequate treatment of the studied disease.

Introduction in clinic / prescription

Clinical development (post-market)

The development of your product is not finished once it is approved and used in the clinic. Further optimisation of your product may be warranted and a record-keeping of adverse events is important to detect rare adverse events that maybe related to your product.

Clinical development (post-market)