DIA Real-World Evidence Conference

Mike D'Ambrosio

SVP, Global Head, Real World Research

Case study spotlight
Friday, Oct. 25 from 10:40 – 11:10a.m.

Title – Transforming evidence generation: Scalable solutions for complex requirements

Case Study Summary

Parexel is conducting a post-authorization safety study (PASS) and registry build to assess the long-term safety of a drug treating a rare neurological disease. The study, mandated by EMA's PRAC, aims to characterize and quantify potential risks and address queries from European regulators. With the development of a novel data ingestion and analysis engine to process over 15 disparate sources, data is transformed into a common model for segmentation and analysis. This creative approach allows our customer to effectively assess product safety in line with regulatory mandates while maintaining access to the novel medicine for the rare and vulnerable patient population.  

Featured Topics

• Innovative frameworks and infrastructure for all stakeholder needs
• Integrated evidence platforming across the product lifecycle
• Best practices for scalable evidence generation
   

Andrew Wilson

Head of Innovative RWD Analytics

Presentation
Friday, October 25th from 9:20 – 10:35AM
Session 7 – Methodological Insights on Aspects of Non-Interventional Studies
Title – Traditions and Frontiers in Causal Methods - from the rise and fall of propensity scores to Causal AI for RWE

Karina D'Angelo

Director, Scientific Data Strategy

Presentation
Thursday, Oct. 24, from 4 – 5:15p.m. 
Session 5 – Health Equity in Drug Development: Leveraging RWD to Inform and Improve Diversity
Title – Discovering patient barriers in real-world data in inform diversity strategies