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  4. Workshop: An introduction to probabilistic decisions support in drug development

Workshop: An introduction to probabilistic decisions support in drug development

Adequately framing probability concepts in drug development decision-making is key. This workshop provides theoretical insights on how Model-Informed Drug Development (MIDD) can be applied to facilitate probability-based decision-making in drug development.

Overview

This workshop introduces how MIDD can be used to support probabilistic decisions in drug development. Participants will explore a number of relevant concepts such as power, assurance, probability of pharmacological success (PoPS), probability of technical success (PTS), and probability of technical and regulatory success (PTRS). Important requirements for the basis of such probability predictions, including fit-for-purpose models and clinical trial simulations, are also highlighted. In addition to basic theory, the workshop includes relevant case-studies and practical recommendations on efficient communication of MIDD approaches.

Workshop goals

Provide a solid understanding of MIDD principles in probabilistic decision-making for drug development.

Workshop learning objectives

By the end of this workshop, participants will:

  • Apply MIDD approaches for probability-based decision-making in drug development.
  • Understand the difference between power and assurance in clinical study design.
  • Recognize key factors in characterizing variability and uncertainty in clinical trial simulations.
  • Realize communication challenges that exists in drug development teams, and how to overcome them.

Key topics covered

  • MIDD and the current state of affairs for pharmaceutical R&D
  • Target Product Profile
  • Definition of decision criteria & Go/No-go
  • Characterization and simulation of variability and uncertainty
  • Power vs. assurance in clinical trials
  • Probability of pharmacological and technical success
  • Clinical trial simulation

Target audience

This workshop is designed for scientists with a modeling and/or statistics background.

Workshop requirements

Knowledge of modeling and/or statistics, with a basic understanding of the overall drug development process. No special software installation is required.

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Pharmetheus AB
Kungsängstull 4 

753 19 Uppsala, Sweden

Visiting address: 

Dragarbrunnsgatan 77, 5th floor

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About Pharmetheus

Pharmetheus is a consultancy firm helping clients reduce uncertainty in technical and regulatory processes, increasing confidence in the development of new medicines that can improve patients’ lives.

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