Alexander Cole
Company: Alexion Pharmaceuticals
Job title: Executive Director, Head of Epidemiology & Real World Science
Seminars:
Harnessing RWE to Drive Diversity, Equity, & Inclusion in Clinical Trials to Meet Regulatory Guidance 2:00 pm
• Using RWD to understand your patient population and their geographies to demonstrate the reality • Informing clinical trial exclusion and inclusion criteria to ensure representation of the patient population and prevent mismatch to disease population • Applying these insights to meet the FDA’ diversity action plansRead more
day: Conference Day Two
Chair’s Closing Remarks 4:30 pm
day: Conference Day One
Panel Discussion: Benchmarking the Progress of RWE & Its Applications to Clinical Development in The Pharmaceutical Industry 9:30 am
• How are we challenging the mindset in our organizations to incorporate RWE into clinical development for future benefit? • How are we aligning across evidence generating functions to work intentionally and reduce the duplication of effort? • What does the gold standard for look like for utilizing RWE as components of regulatory submissions?Read more
day: Conference Day One
Chair’s Opening Remarks 8:15 am
day: Conference Day One
Approaches & Opportunities to Bring Real World Data Threads Together to Meet Use Cases in Clinical Development 9:05 am
The sheer volume of existing RWD presents a large but overwhelming opportunity to leverage different sources to inform and innovate drug development programs. Alongside using data sources individually, the opportunity to bring multiple RWD threads together is a new and emerging strategy to take a holistic approach to utilizing RWE for developing a more efficient…Read more
day: Pre-Conference Workshop Day