Speaker Profile

M.D., Assistant Professor of Medicine, UCSF

Biography
Dr. Dhruva uses health services research methods to understand and strengthen the evidence base for the safe and effective use of drugs and medical devices, with the goal of improving the quality of care and clinical outcomes for patients. His research has been funded by the NIH, Department of Veterans Affairs, FDA, and multiple non-profit foundations. Dr. Dhruva has more than 140 peer-reviewed publications, including in leading academic journals such as the New England Journal of Medicine, Journal of the American Medical Association (JAMA), JAMA Internal Medicine, BMJ, and Circulation. As a cardiologist, Dr. Dhruva cares for patients at the San Francisco Veterans Affairs Medical Center. Dr. Dhruva earned his MD degree and completed internal medicine residency at UCSF. He completed cardiology fellowship at UC Davis and earned an MHS at Yale University School of Medicine in the Robert Wood Johnson Foundation Clinical Scholars Program.

Talk
RWD generation for medical devices


 Session Abstract – PMWC 2023 Silicon Valley

Track 2 - January 26 9.00 A.M.-4.30 P.M.


Track Chair: - Courtney McFall, UCSF
- Ben Rubin, 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:

  • Clinical Studies Using RWD (PANEL)
    Chair: Aaron Kamauu, Navidence
    - Liora Schultz, Stanford
    - Sanket Dhurva, UCSF
    - Eze Abosi, Optum Life Sciences
    - Motiur Rahman, FDA
    - Atul Butte, UCSF
  • Beyond the EHR: Acquisition of RWD Types to Enable Precision Medicine (PANEL)
    Chair: Riley Bove, UCSF
    - Anna Berry, Sypase
    - Ashley Brenton, Optum
    - Vasu Chandrasekaran, Ontada
  • Data Linkage, Harmonization, and Quality (PANEL)
    Chair: Vivek Rudrapatna, UCSF
    - Rohit Vashisht, UCSF
    - Adam Asare, QLHC
    - Dan Riskin, Verantos
    - Wanmei Ou, Ontada
    - Mindy DeRouen, UCSF
    - Saurabh Gombar, Atropos Health
  • Using RWE to Uncover and Address Health Disparities (PANEL)
    Chair: Chris Boone, AbbVie
    - Robert Hiatt, UCSF
    - Abasi Ene-Obong, 54gene
    - Nuray Yurt, Novartis Oncology
    - Alice Popejoy, UC Davis Health
    - Vic Spain, Genentech
  • FDA RWD/RWE Draft and Final Guidances
    - Motiur Rahman, FDA
  • Fireside Chat:
    - Vivek Rudrapatna, UCSF
    - Keith Yamamoto, UCSF
    - Hilary Marston, FDA
  • From Real-World Data to Regulatory-Grade Real-World Evidence
    Chair: Sheila Walcoff, Goldbug Strategies
    - Elaine Katrivanos, Tempus
    - Kathy Hibbs, 23andMe