Patrick Melvin has spent the last two decades serving as an executive-level leader in the design, launch and management of hematology and oncology clinical trials. All oncology cell and gene therapy trials at Syneos Health are managed under Mr. Melvin’s group. These programs range from phase I first-in-human studies through global phase III programs. This work has included the oversight of clinical trials in all common hematologic malignancies, and also includes CAR-T therapy (autologous and allogeneic, and both liquid and solid tumor), TIL therapy (tumor infiltrating lymphocyte), cell therapies in non-malignant hematology, as well as multiple gene therapy trials. Mr. Melvin works closely with the leadership teams for the owners of investigational products on the design, set up, and logistics management associated with these trials, including drug product manufacturing centers, tech-transfer, and shipment vendors across North America, Europe and Asia-Pacific regions. Mr. Melvin’s portfolio of work currently, and regularly, includes management programs spanning more than 40 countries, and includes multiple novel trial designs including large umbrella (“master”) trial designs. His leadership role has frequently included close consultation with biotech and Pharma companies on Clinical Development Plan design and protocol formation. He is an active member of both the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA), and has close relationships with drug development executives and hematology key opinion leaders worldwide.
The global pandemic radically accelerated changes in our industry, including the rapid uptake of decentralized clinical trials. Now that the dust is settling, it is important to better understand the many options and technologies available in our toolbox and to apply these in a thoughtful way in order to ensure trial success. This panel discussion will address key considerations for applying decentralized solutions for oncology including the long term follow-up aspects to meet the needs of multiple stakeholders, including sites, patients, regulators and payers.