Leigh-Ann Durant
Head, North America Medical Governance Merck
Leigh-Ann Durant is Head of North America Medical Governance at EMD Serono, with more than two decades of experience across the biopharmaceutical industry. Her expertise spans global medical governance, pharmaceutical regulation and compliance, drug development, commercialization, product launches and lifecycle management. Previously Head Lawyer for US R&D and Associate General Counsel at EMD Serono, Leigh-Ann provided legal and strategic support across research, clinical development and Medical Affairs, giving her a multidisciplinary perspective on navigating complex regulatory and operational environments while bringing therapies to patients.
Seminars
- Examining how Expanded Access is evolving from a reactive access mechanism to a strategic function embedded within launch planning, post-trial access and evidence generation
- Assessing the growing impact of post-trial access, global pricing pressures and reimbursement considerations on program design
- Understanding how geopolitical, regulatory and market dynamics are influencing access strategies across different regions
- Identifying the biggest opportunities, risks and priorities shaping Expanded Access over the next 12-24 months
- Assessing inherited access programs against internal standards without interrupting treatment
- Prioritising remediation activities while maintaining non-negotiable patient continuity
- Aligning governance, documentation, and vendors under a new operating model
- Managing internal risk and accountability during program integration