Speaker Profile
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 2025 Silicon Valley
Track Chair: Razelle Kurzrock, Medical College of Wisconsin
- PMWC 2025 Award Ceremony:
Luminary Honoree: Hedvig Hricak, Memorial Sloan Kettering
Pioneer Honoree: Michael E. Phelps, UCLA - Keynote: Precision Imaging for Precision Medicine
- Hedvig Hricak, Memorial Sloan Kettering
- Keynote: PET Imaging and Theranostics: Revolutionizing Cancer Detection and Treatment
- Michael E. Phelps, UCLA
- Radiopharmaceuticals for Cancer Therapy (PANEL)
Chair: Wiliam Oh, Yale Caner Center
- Naga Vara Kishore Pillarsetty, Memorial Sloan Kettering
- Jones Nauseef, Convergent Therapeutics
- Thomas Hope, UCSF
- Advancements in Digital Imaging: Enhancing Accuracy in Cancer Diagnostics
Chair: Razelle Kurzrock, Medical College of Wisconsin
- Hedvig Hricak, Memorial Sloan Kettering
- Eliot Siegel, VA Maryland Healthcare System
- Sharmila Majumdar, UCSF
- Wafik El-Deiry, Brown University - Digitalizing Oncology Care: Challenges and Opportunities (PANEL)
Chair: Christian Wolfrum, Siemens Healthineers
- Ashley Smith, Varian
- Marshall Pitz, Manitoba Cancer Care
- Measuring Tumor Aggressiveness: How Nanotechnology is Shaping the Future of Cancer Diagnostics
- Marija Plodinec, ARTIDIS
- Alastair Thompson, Baylor College of Medicine
- Stacey Tinianov, Advocates for Collaborative Education
- Overcoming Health System Barriers and Redefining Oncology Endpoints: The Role of MRD
- Krupa Paranjpe, Sanofi - Unlocking MRD Testing and Beyond: Combining Ultra-High Sensitivity WGS with Low Cost
- Gilad Almogy, Ultima Genomics - Ultra-Rapid NGS Testing: Why Time Matters
- Luca Quagliata, ThermoFisher
- Ibiayi Dagogo-Jack, Massachusetts General Hospital
- PMWC Showcase
- Tuvik Beker, Pangea Biomed
- Navigating Regulatory Hurdles and Reimbursement Pathways for Oncology Innovations
Chair: Sheila Walcoff, Goldbug Strategies
- Wui-Jin Koh, NCCN - Gabriel A. Bien-Willner, Palmetto GBA
- Erin Satterwhite, Optum Specialty Pharmacy
