A21. Medicine Access: Innovation in Action
Tracks
Reimbursement/Market Access
Tuesday, June 3, 2025 |
4:30 PM - 5:30 PM |
C2.2+C2.3 |
Chair & Speakers
Simone Leyden AM
Senior Director Global Public Affairs and Patient Advocacy
Telix Pharmaceuticals Limited
Medicine Access: Innovation in Action to Drive Patient Access
Abstract
As precision medicine and radiopharmaceuticals redefine how we diagnose and treat cancer, access frameworks must keep pace. In this case-based session, Simone Leyden (Telix Pharmaceuticals) and Kat Williams (regulatory and market access consultant) explore the real-world challenges and solutions involved in bringing novel radiopharmaceuticals to patients — from regulatory flexibility to innovative reimbursement models.
Drawing on global experience across regulatory submissions, early access schemes, companion diagnostics, and theranostic product launches, the session will highlight practical strategies that have enabled timely, sustainable access in oncology and rare diseases. Special attention will be given to emerging trends, such as alpha-emitter therapies, managed entry agreements, and global harmonization pressures in the post-COVID regulatory environment.
Designed for regulatory, access, policy, and industry professionals, this interactive session aims to equip attendees with actionable insights into navigating the next wave of access innovation — ensuring patients receive the right treatment at the right time, regardless of complexity.
Drawing on global experience across regulatory submissions, early access schemes, companion diagnostics, and theranostic product launches, the session will highlight practical strategies that have enabled timely, sustainable access in oncology and rare diseases. Special attention will be given to emerging trends, such as alpha-emitter therapies, managed entry agreements, and global harmonization pressures in the post-COVID regulatory environment.
Designed for regulatory, access, policy, and industry professionals, this interactive session aims to equip attendees with actionable insights into navigating the next wave of access innovation — ensuring patients receive the right treatment at the right time, regardless of complexity.
Biography
Ms Kathryn Williams
Chief Regulatory Officer
Neurizon Therapeutics
Medicine Access: Innovation in Action to Drive Patient Access
Abstract
As precision medicine and radiopharmaceuticals redefine how we diagnose and treat cancer, access frameworks must keep pace. In this case-based session, Simone Leyden (Telix Pharmaceuticals) and Kat Williams (regulatory and market access consultant) explore the real-world challenges and solutions involved in bringing novel radiopharmaceuticals to patients — from regulatory flexibility to innovative reimbursement models.
Drawing on global experience across regulatory submissions, early access schemes, companion diagnostics, and theranostic product launches, the session will highlight practical strategies that have enabled timely, sustainable access in oncology and rare diseases. Special attention will be given to emerging trends, such as alpha-emitter therapies, managed entry agreements, and global harmonization pressures in the post-COVID regulatory environment.
Designed for regulatory, access, policy, and industry professionals, this interactive session aims to equip attendees with actionable insights into navigating the next wave of access innovation — ensuring patients receive the right treatment at the right time, regardless of complexity.
Drawing on global experience across regulatory submissions, early access schemes, companion diagnostics, and theranostic product launches, the session will highlight practical strategies that have enabled timely, sustainable access in oncology and rare diseases. Special attention will be given to emerging trends, such as alpha-emitter therapies, managed entry agreements, and global harmonization pressures in the post-COVID regulatory environment.
Designed for regulatory, access, policy, and industry professionals, this interactive session aims to equip attendees with actionable insights into navigating the next wave of access innovation — ensuring patients receive the right treatment at the right time, regardless of complexity.
Biography
Kathryn Williams is an entrepreneurial regulatory affairs and health policy leader with over two decades of experience spanning the biopharmaceutical, medical device, and medtech sectors across Australia, the U.S., Europe, and Asia. She currently holds positions at Lucid Health Consulting, supporting biotech clients through critical regulatory junctures and market access strategies and Neurizon Therapeutics.
Driven by a strong belief that the process is the product, Kathryn is committed to embedding regulatory and access considerations from the earliest phases of development — ensuring therapies are not only scientifically rigorous, but also realistically approvable and accessible. Her work blends deep technical expertise with a fierce commitment to ethical patient engagement, especially in rare diseases where unmet needs are urgent and time is precious.
Before joining Neurizon, Kathryn served as Vice President of Regulatory Affairs and Quality at Clarity Pharmaceuticals, where she led the successful advancement of several radiopharmaceutical programs through global clinical development.
Kathryn holds postgraduate qualifications in health economics and market access, and is currently completing her Juris Doctor in law. She has been a long-time volunteer in the MND and MS communities and is a passionate advocate for equity in access to care, a theme that permeates both her professional and personal work.
Known for her clarity, pragmatism, and collaborative approach, Kathryn is frequently called upon to advise executive teams, boards, and investors on how to navigate uncertainty and unlock value in complex regulatory landscapes. Whether in the boardroom or on the ground with patient groups, her goal remains the same: to ensure the science serves the people it's meant to help.
Ms Kathryn Williams
Chief Regulatory Officer
Neurizon Therapeutics
A21. Medicine Access: Innovation in Action
Abstract
As precision medicine and radiopharmaceuticals redefine how we diagnose and treat cancer, access frameworks must keep pace. In this case-based session, Simone Leyden (Telix Pharmaceuticals) and Kat Williams (regulatory and market access consultant) explore the real-world challenges and solutions involved in bringing novel radiopharmaceuticals to patients — from regulatory flexibility to innovative reimbursement models.
Drawing on global experience across regulatory submissions, early access schemes, companion diagnostics, and theranostic product launches, the session will highlight practical strategies that have enabled timely, sustainable access in oncology and rare diseases. Special attention will be given to emerging trends, such as alpha-emitter therapies, managed entry agreements, and global harmonization pressures in the post-COVID regulatory environment.
Designed for regulatory, access, policy, and industry professionals, this interactive session aims to equip attendees with actionable insights into navigating the next wave of access innovation — ensuring patients receive the right treatment at the right time, regardless of complexity.
Drawing on global experience across regulatory submissions, early access schemes, companion diagnostics, and theranostic product launches, the session will highlight practical strategies that have enabled timely, sustainable access in oncology and rare diseases. Special attention will be given to emerging trends, such as alpha-emitter therapies, managed entry agreements, and global harmonization pressures in the post-COVID regulatory environment.
Designed for regulatory, access, policy, and industry professionals, this interactive session aims to equip attendees with actionable insights into navigating the next wave of access innovation — ensuring patients receive the right treatment at the right time, regardless of complexity.
Biography
