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.com
Maya Skubatch was a partner in the Palo Alto office of Wilson Sonsini Goodrich & Rosati and a former member of the firm’s board of directors. Maya focused on strategic patent counseling for both private and public life science companies. She worked closely with licensing, litigation, corporate, and regulatory counsel to provide integrated IP strategies and often assists clients with intellectual property matters pertaining to financings, M&A, and partnership deals. Maya also worked with investors on IP diligence matters.
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. Lori prepares and prosecutes patent applications before the USPTO, covering therapeutic drugs, formulations, treatment methods, and diagnostics, and manages global patent portfolios to protect innovations throughout the product lifecycle. She has extensive experience in patent prosecution and litigation for companies in the animal health industry, representing clients across veterinary pharmaceuticals, medical devices, diagnostics, and animal nutrition.
Julia Minitti is a partner in Wilson Sonsini's patent and innovation strategies practice.
Rex is an experienced patent professional who has assisted life science companies, from start-ups to public companies, for more than a decade.