Supporting Regulatory Obligations with Real World Data
This panel holds an open discussion, with speakers from industry leading pharmaceutical companies, on how they have been leveraging the value of RWD and addressed challenges such data velocity, diversity and volume with the focus on early regulatory authority engagement.
Senior Director, Real-world Data Strategy, Bristol Myers Squibb
Head, Global Evidence & Outcomes, Oncology, Takeda Pharmaceutical
MD, Head of Human Genetics and Medical Director, Biogen
COO, Customer Success & Data Science, BC Platforms
Real World Data (RWD) captures the realities in patient care: comorbidities, complexity and patient path with outcomes in a real-world setting. Long thought of as applicable for post marketing studies only, RWD is now recognized by the drug development industry as a critical capability that can benefit the entire drug development lifecycle. The broader adoption of RWD has been driven by pressure to move towards more personalized patient care as well as higher return on pharma R&D investments with fewer failed drugs in clinical trials. Though this pressure has existed for some time, recent technological developments and the efforts of regulatory bodies on guidelines for how to use RWD have enabled this rapid shift. Though RWD incentives for use are clear, its full utilization remains cumbersome. The lack of fast enough access is a significant hurdle to unlocking RWD’s full value. Data is scattered, siloed, and often structured in various formats that make it more difficult to use in combination. Additionally, divergent access governance and complex legal and ethical frameworks create even more substantial hurdles.