Sara Radenovic
Director, Managed Access Programs Bristol Myers Squibb
Sara is Director of Managed Access Programs at Bristol Myers Squibb, where she leads initiatives enabling patients to access innovative therapies outside of clinical trials. She began her career in clinical development at an academic CRO and spent two years at a biotech in Berlin before joining GSK in 2018 as a Global Clinical Development Manager overseeing late-phase trials.A pharmacist by training, Sara earned her doctorate at the Charité University Hospital in Berlin and previously worked in academia before moving into industry. Outside of work, she volunteers with the Healthcare Businesswomen?s Association (HBA) as President for Education and Events for the Northern European region.
Seminars
- Comparing the pros and cons of fully in-house, fully outsourced, and hybrid approaches to program management
- Leveraging vendor expertise for complex countries or niche therapies while maintaining control over core markets
- Learning from real-world case studies on outsourcing, internalizing, and transitioning programs smoothly
- Comparing how FDA, EMA, and national health authorities interpret the use of RWD in expanded and post-trial access programs
- Examining differing company approaches, from limiting programs to treatment-only access to actively incorporating structured evidence generation
- Exploring real-world examples of where regulators accepted or rejected RWD submissions in filings and approvals
- Defining the boundaries of ethical and compliant RWD collection when patient care is the primary purpose