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Session 2: Clinical Development for Rare Diseases
Session Chair(s)
Shaghig Palanjian, MBA
Vice President, Global Head, R&D QA and Compliance
Shire, United States
Scott Schliebner, MPH
Senior Vice President, Clinical Development Services
TFS Health Science, United States
This session will focus on emerging issues related to the clinical development of new therapies for rare disease populations
Speaker(s)
Rare Disease Protocol Development
David Whiteman, MD
Takeda Pharmaceutical Company Limited, United States
VP Researhc & Development
Leveraging Informatics to Accelerate Rare Disease Clinical Development
Scott Schliebner, MPH
TFS Health Science, United States
Senior Vice President, Clinical Development Services
Clinical Logistics for Rare Disease Trials
Larry Blankstein, PhD
Synlogic, United States
Head of Clinical Operations
Overview of FDA Draft Guidance for Industry: Rare Diseases - Common Issues in Drug Development
Jonathan C. Goldsmith, MD, FACP
FDA, United States
Associate Director for Rare Diseases, Office of New Drugs, CDER
Panel Discussion
Jonathan C. Goldsmith, MD, FACP
FDA, United States
Associate Director for Rare Diseases, Office of New Drugs, CDER
David Whiteman, MD
Takeda Pharmaceutical Company Limited, United States
VP Researhc & Development
Scott Schliebner, MPH
TFS Health Science, United States
Senior Vice President, Clinical Development Services
Larry Blankstein, PhD
Synlogic, United States
Head of Clinical Operations
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