Session Chair Profile

J.D., CEO & Founder, Goldbug Strategies LLC

Biography
Sheila is widely recognized for her skill in integrating her FDA and CLIA regulatory, legislative, and policy expertise in the field of personalized medicine and molecular diagnostics to craft effective FDA strategies and identify novel regulatory pathways for innovators. She leads Goldbug Strategies, a specialized consulting firm focused on helping companies understand evolving FDA requirements for diagnostics, software, and companion therapeutics. Areas of particular expertise are NGS-based molecular tests, artificial intelligence (AI)/machine learning applications, COVID-19 EUAs, Breakthrough Designation for novel diagnostics, DTC requirements, and use of RWE to advance novel Dx and therapeutics.


 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
    - Joseph Wu, Stanford University
  • How Are Patient Data Revolutionizing Precision Medicine?
    Session Chair: Clara Lajonchere, UCLA
    - Sharon Terry, Genetic Alliance
    - Farid Vij, Invitae
    - Latha Palaniappan, Stanford
  • Regulatory Requirements and Challenges for Using RWE
    Session Chair: Sheila Walcoff, Goldbug Strategies
    - Kathy Hibbs, 23andMe
  • 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
    - Stacey Dacosta Byfield, OptumLabs
  • The Past, Present, and Future of RWE
    Session Chair: Keith Yamamoto, UCSF
    - Matthew Porteus, Stanford