Nancy C. Motola, Ph.D., RAC
Dr. Motola is a consultant to the Pharmaceutical Industry for Regulatory Affairs, Drug Development and Product Compliance. She offers a wealth of Pharmaceutical Industry experience spanning over 30 years in these areas:
- From 2008 to 2010 she served as a member of the Senior Leadership Team, as well as Senior Vice President, Regulatory Affairs for Rib-X Pharmaceuticals, Inc., a phase 3 development-stage anti-infective company (Rib-X is now Melinta Therapeutics).
- From 1998 until 2008 she was Vice President and Senior Vice President, Regulatory Affairs and Quality, at Alexion Pharmaceuticals Inc.
- As a member of the company's Management Team, Dr. Motola built and managed the company's global Regulatory Affairs organization and Quality Unit, while serving in a leadership role in the development, approval (US and EMEA), launch and lifecycle management of Alexion's first product, Soliris® (eculizumab).
- Soliris is a novel monoclonal antibody indicated for paroxysmal nocturnal hemoglobinuria (PNH), a rare hematological disease.
- Prior to Alexion she spent 7 years in Regulatory Affairs positions of increasing responsibility at Bayer Corporation, Pharmaceutical Division, where she led all US registration activities,
(encompassing early development, approval and lifecycle management) of several investigational and marketed products, including Baycol® (cerivastatin sodium),
Sular® (nisoldipine) and Adalat® CC (nifedipine).
- Prior to Bayer, Dr. Motola was a Regulatory Product Manager at Abbott Laboratories, where she managed, among other products, the Depakote® (divalproex sodium) product line, and E.R. Squibb and Sons, Inc., where, in addition to Regulatory Affairs, she began her industry career as a Research Investigator, Chemical Process Technology.
- Dr. Motola received her Ph.D. and MS degrees in medicinal chemistry from the University of Rhode Island, College of Pharmacy, her BA degree at Central Connecticut State University and is Regulatory Affairs Certified (RAC).
"Make the Pharma Regulatory Connection"