Speaker Profile

Ph.D., Chief Scientific Officer, IQVIA; Adjunct Professor, University of North Carolina at Chapel Hill

Biography
Her current work is focused on regulatory use of real-world evidence for decision making. She leads IQVIA’s Center for Advanced Evidence Generation, where they develop and implement innovative approaches to minimally interventional and non-interventional studies. She also directs a large community-based registry designed to study COVID-19. A Fellow of both the Drug Information Association (DIA) and the International Society of Pharmacoepidemiology, she is widely known for her thought leadership, particularly in terms of understanding when real-world evidence is fit for purpose. She received DIA’s 2019 Global Inspire Award for Author of the Year for “Advancing a framework for regulatory use of real world evidence: When real is reliable,” and is an elected member of DIA’s Scientific Advisory. She served for many years as a standing consultant to the National Football League Health & Safety Executive Committee, and continues to lead work on injury analytics for NFL and NBA.

Talk
Real-world Evidence Offers a Path to Precision Medicine
Advances in precision medicine will come from capturing and aggregating vast amounts of data about molecular markers, treatments and outcomes that can be used to shape insights about comparative treatment effectiveness and dosing schedules, but how do we know what evidence we can trust and when?


 Session Abstract – PMWC 2022 Silicon Valley


Track Chair:
Keith Yamamoto, UCSF

Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support

Sessions:

  • Realizing the Promise of Precision Medicine Using Real-world Evidence
    Session Chair: Atul Butte, UCSF
    - James Wall, Stanford
    - Nancy A. Dreyer, IQVIA
    - Mark Laabs, RCRF
    - John Concato, FDA
    - Rhonda Cooper-DeHoff, University of Florida
  • Opportunities and Challenges in Using Real World Data (RWD)
    Session Chair: Vivek Rudrapatna, UCSF
    - Kathy Giacomini, UCSF
  • How Are Patient Data Revolutionizing Precision Medicine?
    Session Chair: Clara Lajonchere, UCLA
    - Sharon Terry, Genetic Alliance
    - Farid Vij ,Ciitizen
    - Latha Palaniappan, Stanford
  • Regulatory Requirements and Challenges for Using RWE
    Session Chair: Sheila Walcoff, Goldbug Strategies
  • Government Partnerships: California Initiative to Advance Precision Medicine
    Session Chair: Julianne McCall, California Initiative to Advance Precision Medicine
    - Pablo Tamayo, UCSD
    - George M. Slavich, UCLA
  • Leveraging RWE to Create Value
    Session Chair: Kathryn A. Phillips, UCSF
    - Phil Febbo, Illumina
    - Suzanne Belinson, Tempus
    - Patricia Deverka, UCSF
    - Stacey Dacosta Byfield, OptumLabs
  • The Past, Present, and Future of RWE
    Session Chair: Keith Yamamoto, UCSF
    - Matthew Porteus, Stanford