Initiation in translational medecine and clinical biology

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: To be defined
• 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

• 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

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:

• Develop a basic appreciation of the main motivations for conducting clinical trials, and be able to provide examples of each
• Understand the distinctions between and characteristics of different phases of clinical research (Phase I, II, IIIa/IIIb, IV), and the inherent advantages, limitations, and challenges of each
• Be able to articulate the major elements of a clinical trial protocol, and the underlying rationale for inclusion of each
• Appreciate and understand the different clinical trial designs to assess efficacy/effectiveness/impact on diseases, and be able to defend the choice of study design for specific research questions, diseases and populations. Describe some of the common failings of unsuccessful clinical trials.
• Comprehend the ethical environment around clinical trial conduct, including the historical evolution of current informed consent and GCP, how ICH and Declarations of Helsinki fit in, the role of ethical review, and where ethical ambiguities and debates still exist.
• Be able to discuss when and how interactions with regulatory authorities and other public health agencies can shape clinical trial design, and key relevant regulatory guidance

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

Course notes

• Université virtuelle

Contacts

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

Campus

Erasme, Plaine

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

Language(s) of evaluation

• english
• french