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Optimizing Orphan Drug Development and Using Appropriate Methodology: Key Tips for Success
Session Chair(s)
Gopalan Narayanan, MD, FFPM, FRCP
Vice President, Disruptive Biologics
Voisin Consulting Life Sciences, United Kingdom
Key Tips for Orphan Product Development
Learning Objective : Describe how to plan the clinical development of orphan products including program risk assessment and possible solutions for gaps; Plan an efficient global regulatory strategy; Use optimum methodology for gathering evidence.
Speaker(s)
Developing Products for Orphan Diseases: Perspectives of an Ex-Regulator
Gopalan Narayanan, MD, FFPM, FRCP
Voisin Consulting Life Sciences, United Kingdom
Vice President, Disruptive Biologics
Key Tips for Orphan Product Development
David G Shoemaker, PhD
Rho, Inc., United States
Senior Vice President, R&D
Management of Rare Diseases: Orphan Drug Discovery Combining Evidence-Based Medicine and Genetic Information
Manish Khatri
Novartis, Switzerland
Director, Scientific Lead - data42, Global Drug Development
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