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ORISE Fellowship Opportunity at the FDA: Analysis of Negative Pediatric Trials

From: Mulugeta, Yeruk <Yeruk.Mulugeta>
Date: Mon, 31 Aug 2020 19:21:14 +0000

The Division of Pediatric and Maternal Health at the FDA in collaboration w=
ith the Division of Psychiatry is seeking a fellow who is interested in wor=
king on a regulatory science project.

Up to 42% of recently completed pediatric trials have failed to establish e=
ither safety or efficacy, with the majority failing to establish efficacy, =
leading to an inability to label the product for use in children. The proje=
ct is a retrospective review and analysis of patient level data (adult and =
pediatric) from new drug applications (NDAs) to explore trial design elemen=
ts or conduct that may contribute to the negative findings and provide a fr=
amework for optimizing trial design for future pediatric drug development.

Under the guidance of mentors with clinical, regulatory and statistical exp=
ertise, the participant will gain knowledge in trial design considerations =
that can impact response in drug development. In addition, the participant=
 will learn about methodological features of studies, data curation and dat=
abase building, data analysis, dissemination of results (presentations, pub=
lications), etc.

Opportunities are available for current students in a Ph.D. or other profes=
sional doctorate program and graduates with a doctoral degree in statistics=
, pharmacometrics, etc.

Interested applicants should apply directly using the link below:

Lily Mulugeta, PharmD

Associate Director, Policy and Research
Division of Pediatric and Maternal Health
Office of New Drugs, CDER, FDA

Received on Mon Aug 31 2020 - 15:21:14 EDT

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