FIH Clinical Trial Planning for Radiopharmaceuticals: From IND to Patient Dosing

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.

Speakers

Jenny Keppler, MBA, Vice President, Translational Medicine, TD2 Oncology

Jenny Keppler brings over 25 years of leadership in radiopharmaceutical development, with deep expertise in radioligand therapy (RLT), translational research and regulatory strategy. She has played a pivotal role in advancing the field, including serving as Executive Director of the Institute for Clinical PET (now WMIS), where she was the industry lead in gaining FDA approval for FDG and negotiating cGMP standards.

Before joining TD2 Oncology, Ms. Keppler held senior executive roles, including COO at CTI Molecular Biomarker and ImaginAb, where she also served as acting VP of Clinical Development. Her career spans academic, CRO and biotech settings, with successful IND submissions across both small and large molecules, from preclinical through Phase II.

At TD2 Oncology, she leads translational and regulatory strategies for complex oncology programs, including radiopharmaceuticals and targeted therapies. She holds an MBA from USC, a BS in Marketing from the University of Phoenix, and an AS in Nuclear Medicine Technology. Ms. Keppler is a published expert in PET imaging and diagnostic radiopharmaceuticals.

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Theresa Bruce, President, Global Clinical Operations, TD2 Oncology

Theresa Bruce is a seasoned Clinical Operations Executive with over 30 years in clinical research, including more than two decades dedicated to oncology. She brings deep expertise in managing the strategic planning and execution of complex, global oncology trials, from first-in-human through late-phase development.

Theresa currently serves as President of Global Clinical Operations at TD2 Oncology, where she leads cross-functional teams and operational strategy for innovative cancer therapeutics, including radiopharmaceuticals. Her experience includes senior leadership roles on major RLT studies, including serving as Head of Europe and Australia for both the VISION trial (PSMA-617) and the Phase I ACTION study (68Ga-PSMA and 225Ac-PSMA). These roles placed her at the forefront of theranostic and alpha-emitting agent development.

She is widely respected for her ability to integrate global regulatory strategy, CRO/vendor oversight and cross-team collaboration to deliver high-quality clinical outcomes. Theresa’s leadership has advanced programs in solid tumors, hematologic malignancies and immuno-oncology, with a strong emphasis on trial innovation and operational excellence.

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