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
Speaker Interview
Would you be able to share a few sentences about why your session is so important for today’s EAP landscape, as well as what you will be discussing?
The session on “Designing Post-Trial Access Strategies Before the First Patient Enrolls” will focus on proactive and customized planning of individual post-trial access programs. The goal is to leave attendees understanding the options they can bring back to their organization and how and when to lead these strategic conversations.
How has Expanded Access changed in the last 12–18 months - and what’s driving that shift?
The need for post-trial access continues to drive a large portion of company’s expanded access requests. Difficult reimbursement negotiations driven by tightening budgets and an unstable global economy has increased the demand and duration of programs.
What are the biggest challenges being faced by expanded access teams today?
Sustainability. It is becoming increasingly difficult to design multiple programs that center patients needs while balancing available resources.
What’s something the industry isn’t talking about enough?
Balancing the increasing demands from patients and patient advocacy groups to open programs earlier and earlier and the default nature of organizations to try to de-risk programs as much as possible.
What will your session cover and what will it help teams overcome?
My session aims to help attendees think strategically about their company’s post-trial access needs and hopefully avoid some pitfalls from prior experiences.
What are you most looking forward to at the summit?
Connecting with colleagues. These sessions are always a wonderful opportunity to learn from the best in the business and bring back learnings and best practices to implement into ongoing programs.
Danielle Rafferty
Director - Research Grants & Expanded Access Alkermes plc
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