Most recently, Dr. Giaquinto was Senior Vice President for Global Compliance at Schering-Plough Corporation, until his retirement in 1994. In more than 30 years at Schering Plough, Dr. Giaquinto held numerous positions, including Director of Regulatory Affairs and Senior Vice President of Worldwide Regulatory Affairs. During his tenure, Dr. Giaquinto was instrumental in establishing the Development and Regulatory strategies for the approvals of 74 New Drug Applications (NDA), which included such major products as Proventil, Vanceril, Vancenase, Rebetrol, Claritin, Claritin-D, Clarinex, Elocon, Integrilin, Temodar, Asmanex and Zetia; 9 Biologic Licensing Applications (BLA), including Intron, Peg-Intron and Rebetron; and 28 Abbreviated New Drug Applications (ANDA). In addition, he was instrumental in establishing the Rx to OTC strategies for Chlortrimeton, Drixoral, Lotrimin, Gyne-Lotrimin and Claritin. Dr. Giaquinto’s also has participated in numerous professional organization and events. He served as a member and chairman of the Regulatory Affairs Coordinating Committee of the Pharmaceutical Research and Manufacturers Association and was one of the original members to the Steering Committee of the International Conference of Harmonization (ICH) and served as one of the two U.S. Pharmaceutical Industry representatives from 1990 to 2003. While serving on the ICH Steering Committee, he introduced the concept of the Common Technical Document (CTD) and served as Co-chair of both the Common Technical Document Implementation Coordination Group and the Global Cooperation Group. Dr. Giaquinto also is a member of the American Pharmaceutical Association, the American Association of Pharmaceutical Sciences, the American Society of Clinical Pharmacology and Therapeutics, the New York Academy of Sciences and the Drug Information Association. Dr. Giaquinto has been a lecturer on Food and Drug Law at Temple University Graduate Program in Quality Assurance/Regulatory Affairs and serves on their Advisory Committee. He also serves on the Planning Committee at the University of Texas (Austin) for their Program on the International Conference for Drug Development (ICDD). Dr. Giaquinto serves on the Board of Directors for SemBioSys Genetics and the Advisory Board for Avaan Therapeutics. Dr. Giaquinto is Vice Chairman of the Board of Trustees for Caldwell College, where he currently serves on both the Development and Audit Committees. Dr. Giaquinto also serves on both the Foundation and the Hospital Boards of Children’s Specialized Hospital Foundation, and has served as the Chairman of Children’s Specialized Hospital Foundation Board since 2000. Dr. Giaquinto received his B.Sc. in Pharmacy from St. John’s University and his Ph.D. in Pharmaceutics from the University of Connecticut. |