Goldbug Strategies is the leading boutique FDA/CLIA professional services company retained by the most innovative clinical laboratories, CDx drug developers, software & digital health companies, and biotech investors. As an FDA regulatory strategist and LDT/IVD policy expert with over 25 years of experience, Ms. Walcoff is widely recognized for her skill in integrating her regulatory, legislative, and policy expertise in the field of personalized medicine and molecular diagnostics to identify novel regulatory pathways for innovators. Ms. Walcoff is a former Associate Commissioner at the FDA and served as the Senior Counselor for Science and Public Health Policy to former HHS Secretary Michael O. Leavitt. Ms. Walcoff was a partner in the law firm of McDermott Will & Emery LLP and served as majority counsel to a US House of Representatives Committee. She earned her law degree from Georgetown University Law Center.
New federal rules are driving significant shifts in development and marketing of “follow-on” CDx and “Co-CDx”/novel therapeutics and immuno-therapies. The panel will discuss the rapidly evolving regulatory and reimbursement landscape and the impact of new FDA and CMS policies on investor/company approaches to managing companion diagnostic development risk.