Research & Development

Level 1 -

Preclinical development of antibodies: Toxicology, pharmacology, and proof of concept

Presentation

Why participate?

Present methodological, technological, and regulatory considerations specific to antibodies during the preclinical development phase.

Training Context:

Preclinical studies aim to demonstrate proof of concept, evaluate product toxicity, and define the first dose to be administered to humans. This phase is critical to the success of the product in clinical development. The use of animals and the importance of these studies for patient safety have led to the implementation of a strict regulatory framework.

Learning objectives

  • Understand the key stages of the preclinical phase: compound toxicity assessment, animal species selection, and execution of in vitro and in vivo regulatory toxicology studies.
  • Master the specificities related to monoclonal antibodies: regulatory aspects, PK/PD characteristics, and toxicity.
  • Grasp the concept of preclinical proof of concept: demonstrate the potential efficacy of antibodies before clinical trials.
  • Understand the importance of the First-In-Human (FIH) dose: determine a safe and appropriate dose for clinical studies.

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

R&D professionals, project managers, business developers, engineers, clinicians.

Prerequisites

Solid knowledge in biotechnology and/or therapeutic antibodies, or completion of the “Fundamentals of therapeutic antibodies” training.

Duration

1 day, 7 hours

Price

750 € HT (Public)
600 € HT (Membre)
300 € HT (Académique)

Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.

Trainers

Catalogue de formations-MabDesign-2023.pdf (15)

Jean-paul

BRIFFAUX

Expert Consultant en Toxicologie
Jacques goutalier.pdf

Jacques

GOUTALIER

Expert Consultant indépendant

Rating

Participant satisfaction rate :

4/5
(average over 80 people).

Return rate of satisfaction questionnaires :

100%

The benefits of our courses

  • Personalized support
  • Skills assessment
  • Certificate of completion
  • Training quality evaluation
  • Accessible to people with disabilities (please contact us)

How to access and deadlines

Registering online or by e-mail is a pre-registration. We will process your request within one week:

  • Contact by e-mail or telephone
  • Sending of administrative and educational documents: training agreement, training programme and positioning questionnaire.

Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.

When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.

For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr