Getting Ahead of the Expanding Landscape: Radiopharmaceutical Dosimetry
Sponsored by: Medpace
Date: 8 July
Days to go: 26
Time: 2PM London/3PM CET
The demands for radiopharmaceutical dosimetry are growing rapidly. This need impacts design of clinical trials for a wide variety of oncologic diseases (e.g. neuroendocrine tumors (NETs), prostate cancer, lung, breast, and GI cancer) and is changing the way theragnostic trials are being conducted and designed. Biotech companies and nuclear medicine departments are focusing on dosimetric approaches that enhance therapeutic benefits to patients while adhering to regulatory authority requirements. Well informed dosimetry input is essential for achieving success in radiopharmaceutical therapy clinical trials.
In this webinar, Medpace experts explore the medical, operational, imaging, and regulatory considerations for radiopharmaceutical dosimetry. With a focus on solid tumors, we discuss the current landscape and how this may alter your approach to dosimetry and your overall program. We explore the challenges of conducting dosimetry in all phases of trials, offering insights into trial start-up, dosimetry conduct, collection, and implementation to seamlessly execute radiopharmaceutical therapy studies as part of your overall clinical development plan.
Join experts from Medpace’s radiation oncology and radiation imaging teams as they explore:
• Medical Considerations: Current dosimetry requirements in radiopharmaceutical programs; how this impacts your clinical development plans and overall strategy
• Imaging Advancements: The new and exciting aspect of dosimetry in oncology imaging for a variety of indications, with a deeper dive into solid tumors
Jess Guarnaschelli, MD,
Medical Director, Hematology & Oncology
Dr. Jess Guarnaschelli is board-certified by the American Board of Radiology in Radiation Oncology, Radiation Biology and Radiation Physics. She brings more than a decade of experience in clinical research, academia, and clinical radiation oncology practice. Dr. Guarnaschelli is well-versed in clinical trials having worked with many radioisotopes, radiopharmaceuticals, and drug indications. Dr. Guarnaschelli has extensive involvement in clinical trials of solid tumor indications including but not limited to breast, head and neck, gynecologic, lung, and brain malignancies.
Alexia Daoust, PhD,
Imaging Project Manager
Dr. Alexia Daoust has a PhD in molecular biology in the field of imaging. She completed five years of post-doctoral training at the National Institute of Health, National Institute of Neurological Disorders and Stroke in Washington, DC. She has worked in imaging contrast agent development for both nuclear medicine and MRI, including preclinical and clinical research. During her tenure at Medpace, Dr Daoust has managed Phase I-III trials in oncology, with an emphasis in radiopharmaceutical trials including quantitative SPECT and PET as well as radiation dosimetry. This diverse experience gives her a unique perspective on the imaging aspects in the clinical development of diagnostic and therapeutic radiopharmaceuticals.
Michael Payne-McGlen, BSc,
Michael Payne-McGlen is an Imaging Technologist with over 5 years of experience in Nuclear Medicine Imaging with expertise in Imaging for Radiopharmaceutical Development. He is an IPEM Accredited Registered Clinical Technologist and has a BS in Theoretical Physics, GDip in Nuclear Medicine from Lancaster University in England.
Key Learning Objectives
- How radiopharmaceutical therapy dosimetry differs from external beam and diagnostic imaging dosimetry
- Clinical considerations in radiopharmaceutical dosimetry, integrating dosimetric data into Phase 1 trials and SRC discussions
- How the interactions between the imaging and clin ops CRO teams are crucial for the effective conduct of the trial
- The challenge of site imaging qualification and scanner calibration
- Data entry into EDC and impact on dosimetry data timelines and accuracy
- Directors of Clinical Operations or Outsourcing