Launching a first-in-human (FIH) clinical trial for a radiopharmaceutical therapy (RLT) presents a unique set of challenges that extend well beyond those of a traditional oncology program. From coordinating protocol requirements concerning isotope availability to site selection, including radiation compliance and detailed planning for isotope logistics, sponsors must navigate a complex operational landscape to bring their therapy into clinical use successfully.
In this webinar, the featured speakers will explore the critical operational steps required to move a radiopharmaceutical candidate from IND submission to first patient dosing. Drawing on decades of hands-on experience, this webinar will break down the essential infrastructure, partnerships and strategic planning elements required to ensure a smooth FIH launch.
Topics will include global regulatory considerations (FDA, EMA and beyond), best practices for site readiness and staff training and how to manage the logistics of radioligand supply chains. Attendees will also gain insights into how companion imaging, dosimetry planning and patient access strategies can be integrated early to streamline development and reduce risk.
Whether preparing for an initial IND submission or anticipating clinical startup, this session will offer practical guidance and real-world examples designed to help RLT developers avoid common pitfalls, accelerate timelines and build a strong foundation for success.
Register for this webinar to learn how to operationalize a successful FIH clinical trial for radiopharmaceutical therapies.
Attendees will gain insight into:
- How to design and execute a first-in-human trial for a radiopharmaceutical agent
- Regulatory considerations across the US, EU and other global regions
- Best practices for site readiness, radiation compliance and isotope logistics
- Operational strategies to accelerate timelines and reduce trial risk
Xtalks Pharmaville
Boston, MA, USA
