Adina Pelusio brings more than 15 years of experience in drug development, most recently as the Vice President, Clinical Operations at SillaJen Biotherapeutics (formerly Jennerex, Inc), where she spent a decade advancing oncolytic viruses in clinical trials. In addition to overseeing the Clinical Operations department at SillaJen, she managed and pioneered the medical educator role to expand hospital personnel comfort and knowledge globally with working on these types of agents. Prior to Jennerex, Ms. Pelusio served as a SWAT Senior Clinical Research Associate at PPD, a large, global CRO, where she was tasked with study rescue and served on a technology committee assigned with developing training for CRAs and project teams on new technologies within the field.
As we discussed, a topic for the event is clinical trials are becoming increasingly complex and require an increase in the scope of site education. Strategies for engaging and ensuring protocol compliance amongst multiple stakeholders on site. Cancer therapies are increasing utilizing complex biologics such as live replicating viruses or bacteria and radioactive materials, but clinical sites remain uneasy or ill-suited to with the preparation, administration, or handling of these products and/or the patients receiving them. In these instances, designing and outsourcing education to clinical sites may a strategic plan between the Sponsor and the CRO, as well as specialized educators above and beyond the classic CRA model to increase patient enrollment and site interest in this and future studies
– Identifying stakeholders
– Designing a comprehensive education plan
– When and what activities can be outsourced, but which activities should remain in-house
– Benefits and budget impacts