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Experiences with Adapting RWD into CDISC Submission Standards 

5 October 14:00–15:00 (BST) 09:00–10:00 (EDT)

insert abstract / summary 

LINK TO REGISTER



Presenter

Bio

Lauren Green, Amgen

Lauren Green is a Biostatistical Programming Senior Manager at Amgen, where she provides leadership to the US-based oncology therapeutic area pipeline programming team. As the programming lead, she supports the execution of oncology-related real-world evidence observational studies and collaborates closely with epidemiologists and product leads in their respective spaces. In her career, Lauren has led additional efforts in the evaluation of real-world data aimed at improving the quality, safety and value of healthcare, publishing papers in emergency medicine, internal medicine and medical education. Her main interests include dissecting the challenges of real-world data (RWD) and the unprecedented opportunity it provides in preventative medicine and population health.


Christine Rossin, Pfizer

Jeff Abolafia, Pinnacle 21

Jeff Abolafia is currently Director of Product Innovation at Pinnacle 21 and supports multiple offices at the FDA. Previously, Jeff held the position of Chief Strategist of Data Standards and was a member of the faculty in the Department of Biostatistics at the University of North Carolina. He has been involved with public health research and data standards for over 30 years. Jeff co-founded the RTP CDISC User’s Group and is a member of the CDISC ADaM and Analysis Results teams and several PHUSE Real World Evidence Working Group Projects. His areas of interest include regulatory submissions, real-world evidence, mobile health, data standards and bioinformatics.


Sandra VanPelt Nguyen, Pfizer