Overview: Clinical Pharmacology Considerations for Neonatal Studies

ABOUT THIS WEBINAR | In this webinar, FDA will discuss:

• An overview of the current status and the gaps related to the inclusion of neonates in drug development
• Clinical pharmacology considerations for planned studies in neonates
• General pharmacokinetic, pharmacodynamic, and pharmacogenomic considerations for clinical pharmacology studies in neonates
• Unique clinical and study design considerations for studying neonates
• Innovative approaches that can be incorporated into study design to address unique challenges in neonates

TOPICS COVERED

• Defining neonatal subpopulations that can be used for study design and study results reporting
• Clinical pharmacology and study design considerations for neonatal studies
• Innovative approaches to study design and analysis to address unique challenges in performing clinical trials in neonates

LEARNING OBJECTIVES

• Describe how neonatal subpopulations can be defined for the purposes of study design and reportin
• Discuss clinical pharmacology considerations for clinical studies in neonates for drug development
• Discuss innovative approaches that can be incorporated into study design to address unique challenges in conducting neonatal studies

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on submission of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations
• Researchers working on clinical pharmacology and clinical studies in the pediatric population including neonates
• Consultants focused on clinical pharmacology and clinical studies in the pediatric population including neonates
• Clinical research coordinators involved in studies conducted in the pediatric population including neonates
• Healthcare professionals specializing in pediatrics including neonates
• Foreign regulators

FDA SPEAKERS

• A Pediatric Research Imperative: Addressing Neonates in Drug Development: Dionna Green, Director, Office Pediatric Therapeutics (OPT) | Office of the Commissioner (OC) | FDA
• Clinical Considerations for Neonatal Drug Development: An Massaro, Supervisory Medical Officer, OPT | OC | FDA
• Clinical Pharmacology of Neonates and Considerations for Study Design: Elimika Pfuma Fletcher, Policy Lead and Senior Clinical Pharmacologist, Office of Clinical Pharmacology (OCP) | Office of Translational Sciences (OTS) | CDER | FDA