Pediatric Drug Development

We are a group of individuals from pharma, academia, and regulatory agency, within the Bayesian Scientific Working Group (BSWG), with special interest in pediatrics and therapeutic orphans.

Specific Objectives:

  1. To provide a venue for collaboration among professionals in pharma, academia and regulatory bodies and exchange learnings on challenges on pediatric drug development
  2. To explore statistical methodology that can be applicable in the design and analysis of clinical trials with particular interest in application to extrapolation and effective ways for communication of results.
  3. To illustrate based on existing successful development and provide advice on best practices that could be used by pharma and CRO statisticians in designing trials for pediatric therapeutics.
  4. To provide an environment for healthy debate among quantitative scientists and clinicians wholistic application of innovative design and challenges of clinical implementation.
  5. To disseminate information on research and best practices to broader scientific community as well as to engage in education efforts through conferences, workshops and seminars.
  6. Provide a repository information for statisticians in conduct of clinical trials for pediatrics.

      How to join the Scientific Workgroup:
       Please send email to Meg Gamalo ( or any of the members of the subteam.