Event

PSI Training Course: Pediatric Extrapolation

Dates: 
Session 1 - Monday 15th September 2025
Session 2 - Tuesday 16th September 2025
Session 3 - Wednesday 17th September 2025
Time: 13:00 - 16:00 GMT+1
Location: Online via Zoom

Who is this event intended for? 
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. 

What is the benefit of attending? 

  • Understand the pediatric drug development, pediatric regulation and related process.
  • Gain familiarity with the statistical methodologies, innovative designs and tools for extrapolation.
  • Gain familiarity with requirements and considerations in pediatric safety evaluation and assessment.

Overview

This is a short course where we will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective. In particular, the extrapolation concept will be presented through reviews and examples. We will list and give examples of the use of non-standard statistical methods that can and/or have been used in the pediatric development. These will include the use of adaptive designs, platform trials and Bayesian approaches. There will be opportunity to put these methods into practice during the practical session.

Day 1 (15th Sept, 13:00-16:00)

  1. Introduction - 30 min
    1. Overview of pediatric development
      1. Challenges and Need for pediatric research
      2. Key Regulations and process
      3. Pediatric plans across regions
    2. Overview of ways to overcome challenges to conducting pediatric research
  2. Types of Extrapolation: then vs now - 1.5 hours
    1. No extrapolation
    2. Partial extrapolation
    3. Full extrapolation
    4. Extrapolation as a continuum
  3. Recent Use of Pediatric Extrapolation - 20 min

Day 2 (16th Sept, 13:00-16:00)

  1. Statistical Approaches to overcome challenges in pediatric development - 3 hours
    1. Safety evaluations
    2. Efficacy evaluations
      1. Bayesian designs
      2. Adaptive designs
      3. Platform trials
      4. Single arm designs and the use of real world data (RWD)

Day 3 (17th Sept, 13:00-16:00)

  1. Workshop/Practical - 2.5 hours
  2. Summary


Required software: R (≥ 3.5.0) with pre-installed packages: ggplot2 and RBesT

 

Cost

Early Bird PSI Members: £320 +VAT
PSI Members: £360 +VAT

Early Bird Non-PSI Members: £430 +VAT
Non-PSI Members: £470 +VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.

Registration

To register for this event, please click here.

Speaker details


Speaker

Biography
JY Headshot
Jingjing Ye, BeiGene

  Dr. Jingjing Ye is a Fellow of American Statistical Association and is currently an executive director and global head of Data Science and Digital Innovations (DSDI), with Global Statistics and Data Sciences (GSDS) in BeiGene. She leads a global team with diverse background supporting business functions in R&D and outside R&D for their data, analytical and technology support. She has over 18 years’ experience in pharmaceutical industry and US FDA, with focus in cancer drug discovery and development. Her statistical and regulatory experience expands full spectrum on patients’ treatment journey from diagnosis, treatment, to living with the condition. Her main research interest is the innovative trial designs and analyses related to small populations, e.g., pediatric and rare diseases. She received her PhD degree in statistics from University of California, Davis and BS in applied mathematics from Peking University.
FS Headshot
Foteini Strimenopoulou, UCB

 

Foteini Strimenopoulou is a Statistical Methodology Fellow at UCB Pharma and a member of the UCB Statistical Innovation Group. Her work centers on developing and implementing advanced statistical methods to support both early and late-phase clinical trials. With a specialization in Bayesian statistics, she primarily focuses on designing trials for small populations, including pediatric patients and individuals with rare diseases. Foteini holds a PhD in Statistics from the University of Kent (UK) and a Bachelor’s degree in Statistics from the Athens University of Economics and Business.

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