Pediatric Center Of Excellence
Your trusted partner for customized, comprehensive pediatric product development consulting services
A Shared Vision
“New knowledge and new medicines can offer hope that children today will recover from illnesses and grow into healthy adults.” PhARMA Fact Sheet
- Medicines that work one way in adults may not work the same way in children.
- Children aren’t small adults and typically require unique dosage and formulation considerations.
- In the US, the Pediatric Research Equity Act (PREA) requires companies to assess safety and efficacy of new products in pediatric patients.
- The pediatric exclusivity provision of the BPCA (Best Pharmaceuticals for Children Act) allows companies to qualify for an additional six months of marketing exclusivity if they do the studies in children as requested by the FDA.
- The European Medicines Agency (EMA) mandated requirements and resulting incentives are similar but can result in different pediatric studies with respect to scope and timing.
- Not paying attention to pediatric (paediatric) regulations can negatively impact the progress of drug development programs for adult indications.
Services
NGT BioPharma Consultants’ Pediatric Center of Excellence was developed to provide global clients access to a wide range of cross-functional expertise and the opportunity to work with seasoned pharmaceutical experts who have successfully developed and brought multiple pediatric products to market. Our service offerings span all the essential, interdependent pediatric drug development functions, including but not limited to:
- Pediatric compound strategy (e.g., pediatric target product profile)
- Preclinical gap assessment (e.g., need for additional juvenile tox studies)
- Regulatory strategy, including Pediatric Study Plans (US) and Paediatric Investigational Plans (EU)
- CMC strategy (e.g., selection of age-appropriate dosage forms and formulation development; administration and dosing devices; taste masking and acceptability)
- Clinical strategy (e.g., indications, type and order of studies, defining age-groups)
- Clinical Pharmacology strategy (e.g., for dose selection, modeling and extrapolations)
- Business solutions (e.g., organizational design for pediatric programs, outsourcing strategies, partnering with global CROs and CDMOs)
Working with Big Pharma Globally
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Get in touch
For additional information pertaining to our Pediatric Drug Development Center of Excellence, please contact Daniel Schaufelberger or our CEO, Michael O’Brien via the contact information provided below.
