Biological Development Simulation
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 in the area of oncology. The simulation starts at the stage of target identification and ends with the presentation of clinical Phase I/II results to the managerial board.
Learning objectives
The overall objective of the simulation is for participants to gain understanding of what is needed in the development process of biologicals in the oncology indication. 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.
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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 target identification to clinical candidate selection
MORNING
- Explanation of the simulation
- Preparation in teams
- Proposal to management for target validation, output, workflow and preliminary oncology indication
AFTERNOON
- Selection of appropriate platform
- Target validation 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
- Introduction on clinical development
- Prepare clinical protocol
EVENING
- Internal clinical acceptance meeting
- Evaluation
- Social event
Day 3
Clinical trials
MORNING
- Pre-IND meeting
- Clinical development
- CMC commercial process
AFTERNOON
- End-of Phase II meeting
- Wrap up