Biologicals Development Simulation

LEARNING OBJECTIVES

The overall objective of the simulation is for participants to gain understanding of what is needed in the development process of biologicals. More specifically:

  • To understand the biologicals discovery and development process and the role of disciplines within this process.
  • To experience the interfaces and interactions between the different disciplines.
  • To learn about results of actions and decisions to be taken at crucial points in the process.
  • To learn to react on deviations and risks in the biological discovery and development environment.

COURSE DESCRIPTION

In three days a biological drug candidate will be selected, a production process developed and a clinical trial program executed. In a multidisciplinary approach, an effective and safe novel biological will be developed for patients with an unmet medical need. The simulation starts at the stage of lead finding and ends with the presentation of Proof-of-Concept results to the managerial board.

ABOUT LBS-DRIVEN SIMULATIONS

A unique condensed method of training that allows participants to gain insight in the overall working process of their organization.

The participants operate in a team setting to make strategic choices, to make decisions and to improvize. They learn to speak the language of their colleagues and to respect other disciplines.


A Brief Tentative Schedule

Day 1

From lead to clinical candidate selection

MORNING

  • Explanation of the simulation
  • Preparation in teams
  • Proposal to management for lead finding, output, workflow

AFTERNOON

  • Start discovery experiments
  • Preparation Clinical Candidate meeting

EVENING

  • Clinical Candidate meeting
  • Evaluation

Day 2

Preclinical  development

MORNING

  • Introduction on CMC
  • Preparation milestone map for development

AFTERNOON

  • CMC, bioanalysis and safety studies
  • First in Human approval meeting
  • Introduction on clinical development

EVENING

  • Prepare clinical development plan
  • Evaluation
  • Social event

Day 3

Clinical  validation

MORNING

  • Clinical development
  • Long-term toxicology studies
  • CMC commercial process

AFTERNOON

  • Proof of Concept meeting
  • Final evaluation
  • Wrap up