Vice President, Strategy and Government Affairs Catalent, Inc. Somerset, New Jersey
Pharmaceutical products are made for patients, but traditional drug development is largely driven by API pharmaceutics, cost and timelines. It overlooks the patients needs and gaps in existing lines of care, which results in a lack of patient compliance. Plus, it can add time and cost if reformulation is required during late phases.
The OptiDose™ Design Solution is a comprehensive early dose form assessment and a strategic development assessment tool to help drive the dose design decision process. It combines pharmaceutics, dose form design and patient characteristics to provide a clear, optimized roadmap to help drug develops achieve their desired drug development endpoints. This design driven approach combines a scientific data-driven tool with Catalent’s comprehensive assessment and development expertise to craft the ideal dose form to optimize your molecule’s potential to create better treatments and launch successful patient-focused products to market faster.
This session will provide an overview of the Catalent’s OptiDose Design process and insights into key patient considerations that impact dose form selection and solutions to improve product success.
OptiDose design methodology and key product, patient factors
Regulatory and Patient Advocacy perspective on role of patient in development process
Overview of challenging patient populations and considerations during dose design with Specific solutions to address patient needs and challenges