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Christian K SchneiderM.D., Chief Medical Officer, Strategic Product Development Consulting, Biopharma Excellence at Cencora PharmaLex |
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Erika WissingerPh.D., Senior Director, Market Access and Healthcare Consulting, Cencora |
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Dennis EarleSenior Director, Development Consulting & Scientific Affairs at Cencora PharmaLex |
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Dr. Brad CarlinSenior Advisor, Data Science and Statistics, for Cencora PharmaLex |
Navigating a path to clinical, regulatory, and commercial success with rare diseases requires a deep knowledge of the disorder, the development space, both regulatory and market access considerations, as well as commercialization management. Given the complex and rapidly evolving nature of rare disease R&D, adopting a holistic approach to both study design and regulatory interpretation, while building a rapport with the health authorities is crucial. The roundtable event will explore challenges and considerations from a study design, regulatory, reimbursement and commercialization perspective.