Pediatric Formulation Technologies and Considerations
Industry Roundtable Sponsored by Lonza
Date/Time: Monday, July 23, 2018 - 10:00 AM to 12:00 PM
This session encompasses academic, biopharma innovator and CDMO perspectives on pediatric formulation development. EMA and FDA legislation to increase the availability of medicines to pediatric populations have driven the demand for more effective formulation strategies. Multiparticulate formulation approaches have been increasingly used for oral pediatric applications due to their formulation and dosing flexibility. The choice of multiparticulate formulation strategy and approach can differ based on safety and efficacy considerations, target product profiles and commercial objectives.
- Introduction and overview of regulatory guidance.
- Formulation considerations and strategy for pediatrics.
- Pediatric drug product development, including formulation and device development, taste masking and assessment, and regulatory interactions.
- Technology considerations with solubility-enhanced API, taste-masking requirements, etc.
- Broader trends in patient-centricity and emerging technologies.
- Sven Stegemann, Professor for Patient-Centric Drug Development & Manufacturing, Graz University of Technology
- Karen Thompson, Senior Principal Scientist, Preclinical Development, Merck
- Skylar Wolfe, Manager, Clinical Supply External Manufacturing, BMS
- Matt Shaffer, Senior Research Engineer, Lonza Pharma & Biotech
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