Angi Robinson has been designing and conducting specialty studies, including pediatric and rare disease studies (including CGT) for more than 25 years. She has provided strategy, oversight, and full management support for rare disease studies at Premier Research for over 20 years, including global programs in ultra-rare indications.
Ms. Robinson has a thorough understanding of drug development with extensive supervisory experience and management in conducting registrational-enabling clinical trials for orphan drugs. Ms. Robinson’s experience encompasses complex study designs such as PK/PD and adaptive design, and she has worked with products granted expedited designations by the agencies like FDA Fast Track, Breakthrough Therapy, RMAT and PRIME designations — including advanced medicines. Specifically in orphan drugs, Ms. Robinson has supported 12 products resulting in FDA and EMA approval.