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Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development
Session Chair(s)
Donna Rivera, PharmD, MSc, FISPE
Associate Director for Pharmacoepidemiology, Oncology Center of Excellence
FDA, United States
Regulatory, industry, and academic organizations discuss modern approaches to clinical drug development by describing novel methods and use cases integrating real-world data and AI to generate real-world evidence, with focus on oncology and rare diseases.
Learning Objective : Discuss global regulatory guidance and frameworks supporting innovative designs using real-world data as well as approaches to inclusion of artificial intelligence (AI); Describe innovative approaches and methods through examples of applied AI use in drug development; Discuss areas of research interest and promote community collaboration.
Speaker(s)
Applying Artificial Intelligence in Drug Development
Sid Jain, MBA
Recursion, United States
Senior Vice President, Clinical Development and Data Science
Real World Data and Artificial Intelligence in Oncology: An FDA Perspective
Catherine Lerro, PhD, MPH
FDA, United States
Senior Pharmacoepidemiologist, Oncology Center of Excellence
Use of Artificial Intelligence Approaches for Rare Diseases
Christina Mack, PhD, MPH
IQVIA, United States
Chief Scientific Officer, Real-World Solutions
Panelist
Kelly Robinson, MSc
Health Canada, Canada
Director General, Pharmaceutical Drugs Directorate
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