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

Sheila D. Walcoff, J.D., provides strategic advisory counsel to companies and investors engaged in diagnostics, digital health technologies, life sciences, and precision medicine.  She is the CEO of Goldbug Strategies LLC, a professional services company providing strategic FDA regulatory and reimbursement consulting and analysis related to LDTs, in vitro diagnostics, companion diagnostics, targeted therapeutics, quality systems, compliance, NGS platforms, CDS software, and other cloud-based digital precision medicine tools. Previously, Ms. Walcoff was Associate Commissioner at the FDA, a senior science and public health official in the immediate office of the Secretary at HHS, partner in a large international law firm, and majority counsel to a congressional committee. 


More Shades of Gray? FDA Compliance After Pathway and Theranos

Sheila D. Walcoff, J.D., CEO of Goldbug Strategies LLC and former FDA Associate Commissioner and HHS senior official, will discuss FDA’s ongoing LDT and IVD policy initiatives in light of its recent compliance interactions with diagnostic companies.  Hear the broader implications of these and other FDA activities for diagnostic test developers, commercial laboratories, digital genomics and information technology companies, and investors.

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