Best Practices for Successful Execution of Radiopharmaceutical Clinical Trials

Prior to joining PPD in 2015, Dr. Nguyen was VP, Clinical Development at Endocyte, Chief Medical Officer at Tigris Pharmaceutical and Executive Medical Director at Eli Lilly and Co. He started the early clinical development of Pluvicto for prostate cancer while at Endocyte. He also was a Medical Fellow at the Investigational Drug Branch, Cancer Treatment Evaluation Program, NCI, NIH, and Medical Reviewer for INDs and NDAs at the US Food and Drug Administration prior to joining the industry.

Dr. Nguyen holds an MD from the University of Maryland School of Medicine and a PhD in Organic Chemistry from Georgetown University in Washington, DC. He completed an oncology fellowship at the NCI, NIH.

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Over the last two years, he has developed an interest and become involved in trials involving radioligand therapies. Justin holds a bachelor’s degree in Cellular and Molecular Biology from the University of Michigan and is Project Management Professional (PMP) certified by the Project Management Institute.

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In her role, Erin specializes in the clinical study supply chain, logistics including chain of custody and oversight of the study drug case management teams. She is skilled in supply chain development, mapping and implementation in accordance with industry and regulatory standards and guidance. With a background in clinical apheresis and cell processing, she brings a critical understanding of site practices to the supply chain.

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With >30 years of experience in clinical research and the pharmaceutical industry, she has spearheaded multiple cross-functional study teams from early Phase I through to Phase IV post-marketing. Her expertise primarily lies in GI, GU, GYN cancers and rare diseases, with a special focus on early phase I/II studies, bucket studies and specific tumor types. Her experience encompasses a range of studies involving chemotherapy, immunotherapy, CarT and radiolabeled pharmaceuticals for both diagnostic and treatment purposes and ADCs.

Her most significant achievements include securing a breakthrough designation for a compound in RCC based on Phase II data.

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This includes more than two decades on the sponsor side and over five years in a Contract Research Organization (CRO), managing projects from First-In-Human Phase I through to global Phase III and post-marketing Phase IV studies.

Their expertise is particularly pronounced in hematology/oncology, where they have worked with radiolabeled compounds, immunotherapy, antibody-drug conjugates (ADCs) and medical imaging studies. Additionally, they have experience in autoimmune disorders and imaging studies. Notably, they played a pivotal role in the development and approval of the first ADC for triple-negative breast cancer, demonstrating their capacity to lead critical projects from initial human trials to full regulatory approval.

As a leader, she is hands-on and driven, known for her excellent communication skills and high integrity. She excels in taking full ownership of studies, effectively motivating and mentoring teams to deliver projects on time and within budget. This background makes them an invaluable leader in the field of clinical research, particularly within drug development for oncology and complex therapeutic areas.

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In his role, he specializes in regulatory project management, offering consultation and preparing and reviewing documents for regulatory agencies. He is skilled in expedited development, pediatric product development, FDA meeting preparation and attendance and post-approval maintenance. His specific expertise extends to oncology and biosimilars products.

As a member of PPD’s Pediatric Working Group, he has successfully collaborated with the FDA under the expedited drug development guidance for oncology. He holds a PharmD from the University of Illinois at Chicago and a BS from Northern Illinois University.

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