Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation

Affiliations

• ¹ Translational Medicine, Translational Informatics, Sanofi, Bridgewater, New Jersey, USA.
• ² Clinical Development, Metabolic Disease Department, AstraZeneca, Gaithersburg, Maryland, USA.
• ³ Global Health Policy, Regulatory Affairs, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
• ⁴ Quantitative Clinical Pharmacology, Early Clinical Development, Innovative Medicines and Early Development Biotech Unit, AstraZeneca, Cambridge, UK.
• ⁵ GRAPSQA/Global Medicines Development, Astra Zeneca, Paris, France.
• ⁶ Translational Med & Clinical Pharmacology, Boehringer-Ingelheim Pharma, Ridgefield, Connecticut, USA.
• ⁷ Clinical Pharmacology and Exploratory Department, Astellas Pharma, Northbrook, Illinois, USA.
• ⁸ Translational Medicine, Novartis Institutes for BioMedical Research, East Hanover, New Jersey, USA.
• ⁹ Clinical Pharmacology, Pfizer, Groton, Connecticut, USA.
• ¹⁰ Translational Medicine, Pharmacokinetics, Dynamics and Metabolism, M&S, Sanofi, Frankfurt, Germany.
• ¹¹ Global Clinical Development, Bayer HealthCare, Basel, Switzerland.