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.
Session Abstract – PMWC 2017 Silicon Valley
Session Synopsis: Firms that develop companion diagnostics face numerous challenges. Among them are attracting a pharma partner, FDA procedures and regulations, reimbursement and engaging labs to run their tests. This panel will discuss those challenges as well as the incentives for developing and selling companion diagnostics.