Angi Robinson | Sr Vice President, Specialty Areas
Premier Research
Angi Robinson has been designing and conducting specialty studies, including pediatric and rare disease studies, for more than 24 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 nine products resulting in FDA and EMA approval.
Ms. Robinson earned a bachelor’s degree in cell and molecular biology from Tulane University in New Orleans, LA.
Appearances:
Day 2 - World Orphan Drug Congress USA 2026 @ 12:00
Continuity by Design: A Site‑ and Patient‑Centric Approach to Trial Consolidation
In rare disease development, evolving development plans can leave sponsors managing multiple active trials with overlapping sites, investigators, and fragmented governance. In this case study, Mirum describes how it consolidated four ongoing studies across two indications into a single, unified trial. Developed in close collaboration with regulators, the approach was grounded in maintaining continuity of care through a site- and patient-centric model, while enabling a more streamlined and adaptable development pathway.
The discussion will highlight the governance and operational principles that supported consolidation—improving oversight and reporting efficiency—while delivering measurable resource and budget benefits and preserving access to treatment for patients, up until commercial launch.
Key takeaways
-Decision criteria and sequencing for consolidating active trials into a single-study approach
-Governance practices that simplify oversight and improve execution
-How protocol design can reduce friction for sites and strengthen patient centricity
-Operational lessons learned and practical considerations for teams navigating trial consolidation
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