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Speakers

Christian K Schneider

M.D., Chief Medical Officer, Strategic Product Development Consulting, Biopharma Excellence at Cencora PharmaLex

Erika Wissinger

Ph.D., Senior Director, Market Access and Healthcare Consulting, Cencora

Dennis Earle

Senior Director, Development Consulting & Scientific Affairs at Cencora PharmaLex

Dr. Brad Carlin

Senior Advisor, Data Science and Statistics, for Cencora PharmaLex

On-Demand Roundtable Webinar

Exploring the principles integral to rare disease drug development

Gain insights into the rare disease drug development lifecycle and strategies to improve outcomes at each stage of the journey.

On-Demand 1 hour Your Desk!

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.

Key learning objectives:

  • The importance of early health authority interaction and leveraging expedited pathways
  • Developing natural disease history and disease registries
  • Adopting optimized study design methodologies such as the use of Bayesian statistical approaches
  • Exploring product classes for rare disease innovationç
  • Understanding how to navigate the HTA, pricing and payor pathways.
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