Angi Robinson has been conducting specialty studies (including pediatric and rare disease studies) for more than 20 years. She has provided oversight and full management support for rare disease studies at Premier Research for over 16 years, including global programs in ultra-rare indications.
Ms. Robinson has supported FDA Pre-IND meetings, IND submissions, and NDA project directorship. At Premier Research, Ms. Robinson was involved with the launch of the first Best Pharmaceuticals for Children Act – Coordinating Center, collaborating with leadership staff at NICHD in this capacity. Ms. Robinson’s experience includes multiple study designs including PK/PD, and adaptive design and she has worked with products granted expedited designations by the agencies including FDA fast track, Breakthrough therapy, and PRIME designations — including advanced medicines. Specifically, in orphan drugs, Ms. Robinson has supported six orphan drug products resulting in FDA and EMA approval including two enzyme replacement therapies approved in 2015.
Ms. Robinson earned a bachelor’s degree in cell and molecular biology from Tulane University in New Orleans, LA.
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