Getting Ahead of the Evolving Landscape in Radiopharmaceuticals

Radiotherapies are dramatically changing the way patients are treated in a wide variety of diseases, particularly for patients with neuroendocrine tumors (NETs) and other oncologic indications like metastatic lung, breast and prostate cancer. There is now a sizeable development effort with many clinical trials ongoing in this area; that includes theranostics with a focus on combining molecular targeting with radiation to detect and modulate the tumor microenvironment and cause radiation-induced cell death. Consequently, the dynamic market for innovative radiopharmaceuticals, whether they are intended for therapeutic or diagnostic purposes, has grown globally.

Academic institutions and biotech companies are increasingly contributing to these developments both in terms of scientific discovery and commercialization efforts. They aim for regulatory approval to image and/or treat specific oncology populations. Well-informed radiopharmaceutical clinical research and development remain crucial for getting diagnostic and therapeutic innovations to patients.

In this webinar devoted to radiopharmaceuticals, the featured speakers will explore the scientific, operational and regulatory considerations for radiopharmaceuticals. With a focus on oncology, they will discuss the current regulatory landscape and how this impacts overall development programs. The speakers will explore the challenges of conducting radiopharmaceutical trials, offering insights into trial start-up, site selection and operational aspects to seamlessly execute these studies as part of clinical development plans.

Join experts from Medpace’s radiation oncology, imaging, regulatory and operational team as they explore:

• Regulatory Considerations: Current requirements of advancing radiopharmaceutical programs; how this impacts a group’s global regulatory strategy and clinical development plans
• Oncology Trial Management: Operational considerations to ensure expedited start-up, efficient and accelerated execution
• Imaging Advancements: The new and exciting aspect of radiotracers in oncology imaging for a variety of indications, with a deeper dive into solid tumors

Speakers

Jess Guarnaschelli, MD, Medical Director, Hematology & Oncology, 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 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. Prior to joining Medpace, Dr. Guarnaschelli was an Assistant 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 (PI) of five clinical trials and received numerous 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 numerous boards and advisory committees, remaining active in several that are focused on oncology initiatives.

Message Presenter

Alexia Daoust, PhD, Imaging Project Manager, Medpace Core Laboratories

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.

Message Presenter

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 the EU and North America, using both imaging and therapeutic compounds. Stephanie has also gone on to lead the development of the Medpace Radiolabelled working group, where she discusses and collates lessons learned across multiple departments in the conduct of radiopharmaceutical studies run at Medpace. Her in-depth understanding of the unique risks, complexities and management tactics utilised for radiopharmaceutical trials will be shared throughout this Webinar.

Message Presenter

Sanje Goonasekera, PhD, PharmD, RPh, RAC (US, Drugs), Sr. Regulatory Affairs Associate, Scientific and Strategic Development, Medpace

Dr. Sanje Goonasekera obtained his PhD in Pharmacology from the University of Rochester in New York and did his post-doctoral training at Cincinnati Children’s Hospital Medical Center, Howard Hughes Medical Institute. Later, he obtained his PharmD from the James L. Winkle College of Pharmacy at the University of Cincinnati. He has over 10 years of combined experience in pre-clinical and clinical research and has been with Medpace since 2017. During his tenure at Medpace, Dr. Goonasekera has led multiple project teams from both Medpace and sponsor companies and currently provides tactical consultancy in scientific and strategic affairs with global regulatory authorities. Dr. Goonasekera is also an adjunct professor at the James L. Winkle College of Pharmacy at the University of Cincinnati and is RAC certified, a credential offered through the Regulatory Affairs Professionals Society.

Message Presenter