This workshop aims to introduce how Model Informed Drug Development (MIDD) principles can be applied to facilitate probability-based decision making in drug development. For example, “what this the probability that this drug candidate will meet the defined target product characteristics” or “what is the probability that a particular study design for asset X will be able to demonstrate superiority vs a comparator”.
Workshop learning objectives
By the end of the workshop, the participant will know how:
- How MIDD approaches can be applied to facilitate probability-based decision making in drug development
- The difference between power and assurance
- The importance of adequate characterization and simulation of variability and uncertainty
- Key factors to consider for clinical trial simulations
- The importance of accurate and effective communication of decision support
Workshop target audience
The target audience are scientists with a modelling and/or statistics background and a basic understanding of the overall drug development process.
This workshop aims to introduce how Model Informed Drug Development (MIDD) principles can be applied to facilitate probability-based decision making in drug development. The workshop will introduce a number of relevant concepts such as; power, assurance, probability of pharmacological success (PoPS), probability of technical success (PTS), probability of technical and regulatory success (PTRS) etc. Furthermore, the workshop will highlight important requirements for the basis of such probability predictions incl. fit-for-purpose models, clinical trial simulation methodology etc. In addition to basic theory with regards to these topics the workshop will include practical recommendations on application and efficient communication of MIDD approaches from tutors with extensive experience in this area.
Workshop logistic details
Workshop hours: Sunday 5th of November, 9am-5pm
Venue: Gaylord National Resort & Convention Center
The fee includes coffee breaks with snacks and a lunch.
The target audience are scientists with a modeling and/or statistics background and a basic understanding of the overall drug development process. The attendees are also expected to bring a laptop or tablet if they want to take active part in the hands-on exercise (no special software installation needed).
Non-members: 825 USD
ISoP members: 550 USD
Students: 275 USD