Drug Development Simulation
The overall objective of the simulation is for participants to gain understanding of what is needed in the complex drug development process. More specifically:
- To understand the drug development process and the role of disciplines within the 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 development process.
- To learn to react on deviations and risks in the drug development environment.
The simulation starts with detailed pharmacological and chemical information on several preclinical candidates. The teams select one of these to start the development process. The simulation runs through the preclinical and clinical phases of development until dossier submission to the authorities.
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
- Explanation of the simulation
- Preparation in teams
- Target Product Profile
- Candidate Selection Meeting
- Introduction CMC and Drug Safety
- Preclinical Development Plans
- Market analysis
- First in Human (FIH) approval meeting
- FIH clinical data
- Introduction Clinical Development
- Preparation of clinical Phase IIA studies
- Marketing strategy
- Introduction Marketing
- Preparation of clinical Phase IIB and III
- Proof of Concept
- Full Development decision meeting
- Social event
Meeting the authorities
- Introduction Regulatory Affairs
- Evaluation of clinical Phase IIA data
- End of Phase II meeting
- Marketing report
- FDA advisory board
- Final evaluation
- Wrap up