Course Content

Sara Toyloy

Course Overview

Needs and Markets

Intellectual Property

Regulatory and Reimbursement

Company Formation

Funding

Financials

Director for Regulatory Affairs and Clinical Research Guidant Corporation Santa Clara, CA

Ms. Toyloy is a seasoned Regulatory Affairs professional who has been with Guidant since 1990. Under her direction, Guidant’s Vascular Intervention Regulatory Affairs Group has been recognized in the industry for record approval times and her team has provided industry leadership in shaping future regulatory directions. Ms. Toyloy has made significant contributions in innovative negotiations with the US FDA such as the reduction of clinical trial requirements for established disease etiologies, as well as working with industry groups such as ADVAMED to establish harmonized standards for regulatory review, and ASTM to establish standardized test methods for new medical devices. Ms. Toyloy joined Advanced Cardiovascular Systems in 1990, now a division of Guidant Corporation, as a Research Associate primarily focused on blood-materials interactions and in the development of passive coatings that could potentially reduce intravascular stent thrombosis. Prior to joining Guidant, Ms. Toyloy was the Quality Assurance Unit at Northview Laboratories, a contract testing facility. In 1993, Ms. Toyloy joined the Regulatory Affairs department where one of her first assignments was to obtain US FDA IDE approval to conduct a clinical trial using Guidant’s flagship MULTI-LINK Stent. Ms. Toyloy also participated in FDA’s electronic submission pilot program, which provided interactive reviews and produced guidelines for the submittal of electronic submission to the cardiovascular group at FDA’s Center for Devices and Radiological Health (CDRH). Subsequently, Ms. Toyloy obtained Pre-Market Approval (PMA) for the MULTI-LINK Stent in 113 days. Ms. Toyloy has worked extensively with worldwide regulatory agencies including agencies in the United Kingdom, France, Canada, Australia, Brazil, Israel, Egypt and Japan, and is an expert in navigating the international clinical requirements and obtaining global regulatory approvals.