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BIME-G4408

Initiation in translational medecine and clinical biology

academic year
2025-2026
2026-2027

Course teacher(s)

Mariana IGOILLO ESTEVE (Coordinator), Hilde STEVENS, Maria Montserrat Soriano Gabarro and Marie TRE-HARDY

ECTS credits

5

Language(s) of instruction

english

Course content

Initiation in translational Medicine

Basics of Preclinical Research​​ – Titulaires: Mariana Igoillo-Esteve - Hilde Stevens - Joëlle Nortier

  • Translational medicine, core principles​​
  • Drug development – Setting the scene: Overview of drug development cycle, drug discovery, preclinical toxicology​​
  • Experimental design and data analysis for in vitro research and animal experimentation ​​
  • Good research practice​​
  • Intellectual property (IP) and IP strategies: European Patent Convention, Biotechnology Directive 98/44/EC​

Basics of Clinical Research – Titulaire: Montse Soriano Gabarró

  • Definitions & terminology, drivers and actors in Clinical Research. The importance of clinical trials​
  • Distinction between epidemiological, interventional and observational clinical studies. The characteristics of each​
  • The different phases of clinical trials (Phase I, II, IIIa/IIIb, IV). Their objectives, advantages, limitations and challenges ​
  • Key concepts for an appropriate clinical protocol design ​
  • Good clinical practice (GCP)​
  • The ethical environment. Informed consent, declaration of Helsinki. The role of ethical review. Examples on where ethical ambiguities and debates still exists.​


Clinical Biology- Titulaire Marie Tré-Hardy

Introduction to a Clinical Biology Laboratory

  • Workflow of a Clinical Laboratory: From Pre-Analytical to Analytical  Phases
  • Analytical Techniques / Quantification Methods
  • Quality assurance in the laboratory :
    • Some notions of biostatistics: the different variables and their measurement (pre-analytic variation, analytical and biological variation)
    • Quality control: Definition, quality assurance, material and control, quality control goal, method performance, QC graphic representation, Westgard rules, ISP control

Immunoassay techniques

  • Introduction :
    • Definitions : Immunoassay, Antigens, Haptens, Antibodies, Monoclonal Antibodies, Polyclonal antibodies, Antigen/Antibody interaction
  • Immunoassays :
    • Agglutination, Precipitation (nephelometry, turbidimetry) and immunoassay with marker
    • Isotopic and non-isotopic methods
    • Immunoassays with marker: Competition method (Definition, Schemes, Pros & Cons)
    •  Immunoassays with marker: Immunometric method (Definition, Schemes, Pros & Cons)
  •  Mandatory conditions for an immunoassay
    • Antibodies used in immunoassays (characteristics of a polyclonal serum, antibodies’ production, etc.
    •  Radioactive marking
    •  Enzymatic markers
    • Luminescent markers

Case studies in Clinical Biology and translational medicine- Titulaires: Mariana Igoillo-Esteve, Marie Trè-Hardy

  • Examples of translational research and clinical biology in diverse pathologies

Objectives (and/or specific learning outcomes)

For the Basics of Preclinical Research submodule, at the end of the course the student should:

  • Understand the challenges of the (evolving) drug development cycle, in particular the pre-clinical challenges
  • Outline the evolution from chemistry-based to target-based drug discovery
  • Understand target identification and validation
  • Recognise drug screening and design
  • Understand the basis of a rational experimental design and data analysis

For the Basics of Clinical Research sub-module, at the end of the course the student should:

  • Understand the primary objectives of clinical trials and be able to illustrate the different motivations for conducting clinical research with relevant examples.
  • Differentiate between the various phases of clinical research (Phases I, II, IIIa/IIIb, and IV), and critically evaluate the objectives, advantages, limitations, and challenges associated with each phase.
  • Identify and explain the key components of a clinical trial protocol, including the scientific and methodological rationale underlying their inclusion.
  • Understand the range of clinical trial designs used to evaluate efficacy, effectiveness, and disease impact, and be able to justify the selection of an appropriate study design for specific research questions, disease contexts, and target populations. Additionally, recognize common factors contributing to the failure of clinical trials.
  • Demonstrate a thorough understanding of the ethical framework governing clinical research, including the historical development of informed consent and Good Clinical Practice (GCP), the role of the International Council for Harmonisation (ICH) guidelines and the Declaration of Helsinki, the function of ethics committees, and ongoing ethical challenges and debates.
  • Discuss the role of regulatory authorities and public health agencies in clinical research, and explain how interactions with these bodies can influence clinical trial design, conduct, and interpretation, while demonstrating familiarity with key regulatory requirements and guidance documents.

Teaching methods and learning activities

This Teaching Unit involves lectures, interactive seminars, inverted classes and group works

Course notes

  • Université virtuelle

Contribution to the teaching profile

The courses in translational medicine will enable the students to:

  • develop further their critical thinking 
  • discover the different disciplines involved in the complex process of translating advances from preclinical research into new therapeutic or diagnostic approaches
  • understand how patient-centred strategies can contribute to the development of therapeutic approaches custom-tailored to the patient needs
  • appreciate the importance of Clinical Biology in Diagnostic, disease and treatment monitoring 
  • provide the knowledge to understand the evolution of medical practice and innovative processes in the healthcare sector, and to seize the new professional opportunities associated with it

The courses in clinical biology will enable the students to:

  • Understand the main types of immunoassays and be able to identify and explain the various techniques used to measure targeted molecules in human therapeutics.
  • Develop a critical mindset regarding the advantages and limitations of these techniques, whether used in routine practice or research.

Other information

Contacts

mariana.igoillo.esteve@ulb.be
montse.soriano.gabarro@ulb.be
Hilde.stevens@ulb.be
Marie.Tre-Hardy@ulb.be
joelle.nortier@ulb.be

Campus

Erasme, Plaine

Evaluation

Method(s) of evaluation

  • written examination
  • Oral examination

written examination

  • Open question with short answer
  • Closed question with multiple choices (MCQ)

Oral examination

  • Open question with long development

There is no negative marking for incorrect answers in the multiple-choice questions (MCQs)

Mark calculation method (including weighting of intermediary marks)

The course is divided into two Learning Activities (LAs): Introduction to Translational Medicine and Clinical Biology. Students must take a separate examination for each of these two learning activities.

Each examination is graded out of 20 points. The final grade for the course unit corresponds to the average of the grades obtained in the two learning activities. However, to successfully complete the course unit, students must obtain a minimum grade of 10/20 in each learning activity.

If a student fails one of the learning activities, even when the average grade across both activities is equal to or greater than 10/20, the student will be required to retake only the examination corresponding to the failed learning activity. The grade obtained for the successfully completed learning activity will be carried forward to the second examination session.

In such cases, no final grade will be awarded for the examination session. Instead, the student will receive the notation NDP (Note de présence).

Language(s) of evaluation

  • english
  • french

Programmes