Dr. Brenda Faiola has over 15 years of experience in the pharmaceutical and medical device industries.  She received her PhD in Immunology from Duke University in 2001 and has been a Diplomate of the American Board of Toxicology since 2004.  As Senior Director, Nonclinical Development at Rho, Inc., Dr. Faiola provides support regarding nonclinical aspects of Integrated Product Development and Integrated Regulatory Submissions for pharmaceutical, biologics, and medical device programs. In previous roles, Dr. Faiola developed biocompatibility and nonclinical testing programs for various medical devices and other products, served as the sponsor representative for GLP-compliant nonclinical studies, authored/reviewed applicable sections of regulatory agency submissions, served as the biocompatibility subject matter expert for project team and regulatory authority interactions, and managed other staff within the department.  She was also responsible for assisting clients with development and implementation of therapeutic product development and life-cycle management strategies for pharmaceuticals, biologics, and medical devices, including writing and reviewing of study protocols and reports, IND applications, and 501(k)/PMA applications.  Dr. Faiola was responsible for the design, conduct, and management of preclinical and nonclinical studies/programs under current FDA, OECD, and EPA guidelines, interpreted study data, and wrote study protocols and reports.