NCRAF: Accelerating Clinical Research by Leveraging EHR Data

Description

The pharmaceutical industry is at a tipping point.  Clinical trials in the United States have become increasingly more expensive and complex with 70% of clinical trials missing their timelines and 11% of research sites failing to enroll a single patient.  Data are abundant and the recent FDA guidances around the use of RWD in clinical research has made the investment in vast clinical data sets even more compelling.  By harnessing clinical data, specifically electronic medical record data, and leveraging technological advances, the current clinical trial paradigm can be re-engineered to execute clinical trials that are faster, that utilize fewer resources, and that are more grounded in real world practice.

Kristen K. Buck MD is Senior Vice President, Chief Clinical Development for the Life Sciences business at Optum.  She delivers expert therapeutic advice and strategic support to sponsors for the design and implementation of their clinical trials using the Digital Research Network (DRN). Prior to joining Optum in 2018, Dr. Buck served as Vice President Strategic Drug Development in a Global CRO where she delivered strategic support to pharma and biotech companies worldwide in the development of TPPs, CDPs, trial designs, due diligence, portfolio prioritization, project valuation, and risk-sharing opportunities. Prior, Dr. Buck served as a Chief Medical Officer, SVP of Scientific Affairs and Board Member for a global medical device company and held multiple leaderships roles in Pharma including designing and delivering several global studies for an NME up through registration and FDA Advisory Committee. Dr. Buck also served as a Medical Officer at the United States Food and Drug Administration (FDA) where she was responsible for sponsor guidance on drug development strategies (Phases I-IV) and review of new drug applications and investigational new drug applications. Dr. Buck holds a Bachelors in Biochemistry from the University of Virginia, an MD from Penn State University College of Medicine, and board certification from the American Board of Internal Medicine (2002/2012).