Radiation Toxicity — Considerations for Implementing Radiation Dose Limits in Radiopharmaceutical Trials

As the radiopharmaceutical research and development landscape continues to advance, so do the complexities and challenges associated with clinical trials. Conducting radiopharmaceutical trials presents a unique set of obstacles, such as the challenge of capturing unique radiation induced toxicities in the context of enrolled patients’ overall radiation exposure. This requires an understanding of enrolled patients’ cumulative radiation exposure from previous radiation treatments and current studies. For clinical radiopharmaceutical studies, the broader team must understand the background of radiation dosimetry, radiation toxicity, normal organ dose constraints and how to capture these metrics within clinical trial data management.

In this webinar, Medpace medical, operational, regulatory and core lab experts will explore considerations for radiation toxicity and analyze previous radiopharmaceutical case studies and draw on their 30+ years of integrated, global experience to examine strategies to successfully operationalize complex radiopharmaceutical trials and increase the probability of clinical and regulatory success.

Register for this webinar to learn how sponsors in the pharma and biotech industry can overcome challenges associated with complex radiopharmaceutical trials through medical, regulatory and operational considerations, including engaging an experienced and full-service clinical research partner with cross-functional expertise.

Click here to learn more about Medpace’s radiation therapy solutions.

Speakers

Jess Guarnaschelli, MD, Senior Medical Director, Medical Department, Medpace

Dr. Jess Guarnaschelli is board-certified by the American Board of Radiology in radiation oncology, radiation biology and radiation physics. She brings more than two decades 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 solid tumor indications including but not limited to breast, neuroendocrine, prostate, gynecologic, lung and brain malignancies. Prior to joining Medpace, Dr. Guarnaschelli served as Professor at the University of Cincinnati College of Medicine. During her academic career, she focused on novel treatments and innovative imaging techniques for patients with solid malignancies. She was the Principal Investigator on numerous clinical trials and received several funding awards. Dr. Guarnaschelli has held nationally recognized leadership positions and is a frequently invited speaker at national and international conferences. She has served on boards and advisory committees, remaining active in several that are focused on radiation initiatives.

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Stephanie Millin, PhD, Clinical Trial Manager, Medpace

Stephanie Millin obtained her PhD in physiology, anatomy and genetics from the University of Oxford before joining Medpace Clinical Operations. Having trained initially in oncology she has now specialized in managing radiopharmaceutical trials, most recently managing several Phase I-II trials throughout Europe and North America, using both imaging and therapeutic compounds. Stephanie has also gone on to lead the development of the Medpace Radiopharmaceutical Expert Forum, where she discusses and collates intelligence across multiple departments in the conduct of radiopharmaceutical studies run at Medpace. She possesses an in-depth understanding of the unique risks, complexities and management tactics utilized for radiopharmaceutical trials.

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Deborah Hirscher, MBA, MS, RN, ARNP, FNP, Senior Director, Clinical Trial Management, Medpace

Ms. Hirscher has more than 17 years’ experience in clinical research, serving as a Clinical Research Associate (CRA) for two years and managing clinical trials for 15 years. She has managed clinical trials in a variety of indications, oncology and general medicine including CTCL, AML/BMT, solid tumors, myelofibrosis, diabetes, infectious diseases, IBS-D and NASH. She is a Clinical Operations Director and founding member of the Medpace based Radiation Leadership Forum. She has managed multiple clinical oncology studies for radiopharmaceutical companies including but not limited to isotopes 131I, 64Cu and 225Ac. Ms. Hirscher provides subject matter support, training and mentoring to CTMs who are new to managing the complexities of radiopharmaceutical studies. She works closely with the sponsors, investigators, vendors, CRAs and Medpace team members to successfully achieve timelines, recruitment and retention goals, quality of data and the overall success of the trial. Ms. Hirscher holds a Bachelor of Science in Nursing, as well as a Master of Science in Family and Community Health Nurse Practitioner and Master of Business Administration degrees. In addition to her extensive clinical research experience, Ms. Hirscher spent 17 years in pediatric nursing, specializing in general medicine, surgery and oncology.

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James Thomas, BSc (Hons), MA, Senior Director, Regulatory Submissions, Medpace

James Thomas has a combined scientific (biomedical sciences, BSc), legal (masters in biotechnological law and ethics) and ethical background to conduct and oversee submissions and approvals in over 65 countries from Phase I to IV over the last 16 years. His additional interactions are with regulatory authorities, government policy stakeholders across the spectrum of therapeutic indications and trial types. He specializes in operationally complex and innovative trials, including those involving both therapeutic and diagnostic radiopharmaceuticals. He is a member of the Medpace Radiopharmaceutical Expert Forum. This diverse experience gives him a unique perspective on regulatory and operational delivery for radiopharmaceutical trials.

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Daphnée Villoing, PhD, Dosimetry Specialist and Senior Project Manager, Medpace Core Labs

Daphnée Villoing is a physicist with 12 years of expertise in the dosimetry of diagnostic and therapeutic nuclear medicine. She obtained a PhD in radiophysics and medical imaging, with postdoctoral training at the National Institutes of Health. Her research program was mainly dedicated to building dosimetry methods for clinical or epidemiological applications, but she also participated in pioneer research on ultra-high dose rates irradiations in proton therapy. Her experience of academic medical research led to 20 publications in peer-reviewed journals and more communications in international conferences. She serves as a member of the European Society for Radiotherapy and Oncology physics workshops and is a member of scientific societies such as the American Association of Physics in Medicine. Daphnée Villoing is currently the Project Manager of several Phase I-III radiopharmaceutical clinical trials involving pharmacokinetics and dosimetry assessments. She regularly provides scientific input for Medpace and Medpace Core Labs studies.

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