Speaker Profile
JD, CEO & Founder, Goldbug Strategies
Biography
Sheila D. Walcoff is a nationally recognized FDA policy expert who advises precision medicine companies and investors on LDTIVD regulatory strategy, FDA submissions, and application of FDAISO quality systems to CLIA laboratories. She is CEO and founder of Goldbug Strategies, which provides clinical, regulatory, quality systems, and PCCP consulting for LDTs, IVDs, pharmaCDx, and AIdigital health technologies. In addition to many successful FDA submissions, including firstofakind LDTIVDs, Sheilas 25+ years experience includes FDA associate commissioner, U.S. HHS senior science public health official, BigLaw partner, congressional committee counsel, and entrepreneur. She earned her J.D. at Georgetown University Law Center.
Session Abstract – PMWC 2024 Silicon Valley
Track Chair: Laura J. van 't Veer, UCSF
- PMWC 2024 Award Ceremony
Pioneer Honoree: David Sidransky, Johns Hopkins
Pioneer Honoree: Helmy Eltoukhy
Pioneer Honoree: AmirAli Talasaz, Guardant Health - Utilities of Liquid Biopsy in Biomarker Testing
- Laura Vent Veer, UCSF - Status Quo of Clinical Liquid Biopsy (PANEL)
Chair: Helmy Eltoukhy, Guardant Health
- Sadakatsu Ikeda, Tokyo Medical University
- Heather Parsons, Dana-Farber Cancer Institute
- Sanjay Popat, The Royal Marsden - Liquid Biopsy for Health Monitoring and Disease Prevention (PANEL)
Chair: Anne-Renee Hartman, Adela Bio
- AmirAli Talasaz, Guardant Health
- Heather Parsons, Dana-Farber Cancer Institute
- Mary Pat Lancelotta, Adaptive Bio
- Sylvia Katina Plevritis, Stanford - Multi-Cancer Early Detection Through Multi-Biomarker Class Liquid Biopsy Testing (PANEL)
Chair: Tom Beer, Exact Sciences
- Wendy Rubinstein, Cancer Screening Research Network (CSRN)
- Sheila D. Walcoff, Goldbug Strategies LLC - Keynote: Pioneering Liquid Nucleic Acids Tumor Fragments in Health and Diseases
- David Sidransky, Johns Hopkins - New Approaches in Liquid Biopsy (PANEL)
Chair: Victor Velculescu, Johns Hopkins
- David Sidransky, Johns Hopkins
- Dan Laudau, NY Genome Center
- Daniel De Carvalho, University of Toronto - Global Implications: A scalable Liquid Biopsy for HPV-related Cervical Cancer (PANEL)
Chair: Debra Fraser-Howze, D. Fraser Associates
- Belinda Nedjai, Wolfson Institute of Population Health
- Elisabeth Adams, Aquarius Population Health Limited - NCI Showcase
- Xiaohui Ni, Early Dx
- Daniel Kim, UCSC
