University of Washington, Fluke Hall
Seattle, WA
On Thursday, September 19th, at 4:00pm at the UW CoMotion - Fluke Hall, regulatory partner Eva Yin will be participating in Nucleate Seattle’s most recent installment in the Genesis Lecture Series, an engaging panel on Clinical Development Pathways for biotech companies. Come gain insight into how biotech companies prepare for clinical validation and learn more about the FDA/health regulations that are required before bringing innovations to market.
Come hear from Eva, Shannon Eubanks (Proprio Visio), Ajoke Sobanjo-ter Meulen, M.D. (AstraZeneca), and Arna Stoll (Wavely Diagnostics) about how to navigate these regulatory processes and how to incorporate these during the development of your product.
This event will provide practical advice on transitioning from academia to bio-entrepreneurship, and provide critical insight into how biotech companies prepare for clinical validation. Don’t miss this opportunity to learn from and network with industry leaders.
Mikayla Kurland
mkurland@wsgr.comEva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.