Danielle Rafferty
Director - Research Grants & Expanded Access Alkermes plc
Danielle Rafferty is deeply committed to expanding patient access to life-saving therapies through Early Access Programs (EAP). With experience supporting the development of innovative treatments in Oncology and Rare Diseases, Danielle understands the urgency and complexity involved when patients, families, and healthcare professionals seek access to investigational or pre-approval medicines.
Her work in EAP has involved navigating evolving global regulations, managing cross-functional coordination, and supporting access requests for assets in earlier phases of development. She brings a strong appreciation for the growing role of real-world data generation within Early Access frameworks and its impact on both regulatory strategy and patient outcomes. Beyond operational execution, Danielle is driven by a mission to improve equity of access, ensuring that patients around the world -regardless of geography – have timely pathways to critical therapies
Seminars
- Embedding post-trial access planning into clinical trial design to avoid last-minute ethical and operational dilemmas
- Evaluating when post-trial access, long-term extensions, or hybrid approaches make the most sense by disease, geography, and duration
- Anticipating regulatory constraints that may prevent post-trial access in certain countries and adjusting trial footprints accordingly
- Aligning clinical development, medical affairs, and access teams early to support continuity of care
