Nancy C. Motola, Ph.D., RAC, has over 35 years of experience in the Pharmaceutical Industry, encompassing both small molecules and biologics, in many therapeutic areas; in regulatory affairs and quality assurance, as well as chemical development/manufacturing.  Through her consulting company, Pharma Regulatory Connection, she provides strategic Regulatory and scientific expertise for small/start-ups, as well as large pharma companies.  Nancy was previously Senior Vice President of Regulatory and Quality for Alexion Pharmaceuticals Inc. and VP Regulatory Affairs for New Haven Pharmaceuticals Inc.  In these roles, she was a member of the company’s Management Team, built and managed the product compliance organization, and was responsible for the approvals of both companies’ first products, Soliris, a monoclonal antibody for a rare hematological condition and other rare diseases (Alexion), and Durlaza, a controlled release aspirin product for secondary prevention of acute cardiac events (New Haven). Nancy received her PhD and MS degrees in Medicinal Chemistry from University of Rhode Island College of Pharmacy; her B.A. degree in chemistry from Central CT. State University; and is Regulatory Affairs Certified (RAC).