Drug Development Simulation – On-line

LEARNING OBJECTIVES

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.

COURSE DESCRIPTION

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.

Drug-Development-Simulation-th Download flyer

A Brief Tentative Schedule

Pre-Work

  • Access to the communication platform
  • Background on the Therapeutic Area
  • Explanation on the simulation

Block 1

Target Product Profile

  • Selection and deselection of clinical candidates
  • Target Product Profile
  • Introduction to Clinical Phase I

Block 2

(Pre-)clinical study planning

  • Toxicology and CMC
  • Clinical Development Plan
  • CMC Development Plan
  • Tox Development Plan

Block 3

Preclinical data

  • CMC activities GMP batch
  • FIH dose setting
  • Clinical Phase I protocol
  • Market analysis

Block 4

First in human (FIH) study

  • FIH board meeting
  • FIH clinical data
  • Marketing strategy
  • POC criteria

Block 5

Proof of Concept

  • Clinical Phase IIA/B protocol
  • Risk Management Plan
  • Proof of Concept meeting

Block 6

Regulatory affairs

  • End of Phase II meeting
  • Introduction Regulatory Affairs
  • Mechanism of Action

Block 7

  • Results pivotal trials
  • Marketing report
  • Environmental Risk Assessment

Block 8

Meet the FDA

  • FDA advisory board
  • Wrap up