Wilson Sonsini is pleased to present the first of our 2021 Innovator’s Edge Series. Start-ups in the life sciences and biotech sectors, with an urgency to see their products come to market, continue to react to today’s ever-changing business and regulatory landscape. With an abundance of life sciences companies in the spotlight, regulatory strategic planning is more urgent than ever. The stakes are high as companies are faced with the task of navigating regulatory requirements and coordinating regulatory activity with business and patent strategies.
Lori Doyle
ldoyle@wsgr.comMaya focuses on strategic patent counseling for healthcare and other technology-driven companies.
Eva 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.
Dr. Lorelei (Lori) Westin is a partner in the San Diego office of Wilson Sonsini Goodrich & Rosati. Before joining the firm, Lori served as a federal law clerk for the Honorable John A. Houston in the Southern District of California. She also was a patent agent at Howrey Simon Arnold & White. Prior to Howrey, Lori had extensive experience as a research scientist, serving as a senior research scientist in Advanced Technologies at Nanogen, Inc.; a research associate in the Regulatory Biology Laboratory at the Salk Institute; and a postdoctoral fellow in the Laboratory of Molecular Genetics, CMB, at the Karolinska Institute in Sweden. She is the primary author of numerous scientific and legal publications, and is an inventor on seven issued U.S. patents on microchip and DNA amplification technology.
Julia Minitti is a partner in Wilson Sonsini's patent and innovation strategies practice and currently serves as co-chair of the firm's Hiring Committee.
Dr. Rex Watkins is an associate at Wilson Sonsini Goodrich & Rosati, where his practice focuses on patent procurement—both domestic and international—for life sciences, physical science, medical device, and mechanical apparatus clients. In addition to patent drafting and prosecution, Rex has experience with freedom-to-operate analyses, validity and infringement opinions, IP due diligence, patent litigation, and licensing.