Sheila Walcoff, JD
CEO & Founder
Goldbug Strategies LLC
Gaithersburg, MD
Sheila D. Walcoff is a nationally recognized FDA policy expert who advises precision medicine companies and investors on LDT/IVD regulatory strategy, FDA submissions, and application of FDA/ISO 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, pharma/CDx, and AI/digital health technologies. In addition to many successful FDA submissions, including first-of-a-kind LDT/IVDs, Sheila’s 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.
The 29th Annual Executive War College will be held April 30 – May 1, 2024, at the Hyatt Regency Hotel New Orleans.
Join our carefully selected line-up of clinical laboratory and pathology leaders, along with your peers, at Executive War College — the premier conference focusing on the best ideas, newest lab technologies, and most innovative management strategies now reshaping the clinical laboratory industry!
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