PRECISION MEDICINE LEADERS’ SUMMIT 2019 – EAST
Precision Medicine Clinical Trials and Novel Designs: Levering Data, ‘Omics’, AI and Policy
Moderator: Arturo Loaiza Bonilla, MD, MSEd, FACP, Vice Chair, Department of Medical Oncology, CTCA
Panelists: Selin Kurnaz, PhD, CEO – Massive Bio, Richard Schilsky, MD, FACP, FASCO, FSCT, Senior Vice President and Chief Medical Officer, ASCO, Gary Palmer, MD, Chief Medical Officer, Tempus
The paradigm changes from the ‘phenotype-to-genotype’ to the ‘genotype-to-phenotype’ approach has revolutionized R&D and Clinical trials in oncology and other diseases. This panel will discuss the impact of novel approaches to clinical trial design, including the use of technology, biomarker data and the current regulatory landscape which is moving the needle forward in earlier access and approval of promising compounds. The audience will be able to learn further about ‘basket’, ‘umbrella’, ‘seamless’, ‘adaptive’ design trials, synthetic control arms, ‘Just-In-Time (JIT) trials, as will have the opportunity to how different stakeholders are adapting to recent FDA policies and regulations for their R&D and clinical trial matching enrollment.