Alexander R. Giaquinto, Ph.D., Joins Regado Biosciences as Senior Vice President of Regulatory Affairs and Quality Assurance
BASKING RIDGE, N.J. and DURHAM, N.C., Nov. 11 /PRNewswire/ – Regado Biosciences, Inc., today announced the appointment of Alexander R. Giaquinto, Ph.D., to the newly created position of Senior Vice President of Regulatory Affairs and Quality Assurance, effective immediately. Dr. Giaquinto brings to Regado over 35 years of experience in the pharmaceutical industry, including 30 years at Schering-Plough where he held executive management positions in the areas of Worldwide Regulatory Affairs and Compliance.
In his new position, Dr. Giaquinto will report to Dr. David J. Mazzo, Ph.D., Regado's President and Chief Executive Officer, and will be based in the Company's recently established office in Basking Ridge, New Jersey. The Company's locations in both Basking Ridge and Durham, North Carolina will have members of the executive management team and development staff.
Dr. Mazzo stated, "We are tremendously pleased to welcome someone of Dr. Giaquinto's vast experience to Regado's management team. His long-standing regulatory expertise will be essential as the Company further advances its lead therapeutic candidate, the REG1 Anticoagulation System, into late-stage clinical development." Regado recently announced completion of enrollment in the Company's Phase IIa clinical study (REVERSAL-PCI) in patients undergoing elective percutaneous coronary intervention.
Dr. Giaquinto attained the level of Senior Vice President, Worldwide Regulatory Affairs as well as being named to a special post reporting directly to the CEO overseeing Global Compliance at Schering-Plough. These experiences, coupled with that gained as the U.S. Industry Representative of the Steering Committee of the International Conference on Harmonization (ICH), has allowed him to acquire a unique understanding of national and international regulatory processes, including regulatory submissions, reviews and approvals. At Schering-Plough, Dr. Giaquinto was instrumental in establishing the development and regulatory strategies for the approvals of 74 New Drug Applications (NDAs) and Supplements, nine Biologic License Applications (BLAs) and 28 Abbreviated NDAs.
Dr. Giaquinto currently is a Director of SemBioSys Genetics, Biothera, and PQRI. He is also a member of the Advisory Boards of Avaan Therapeutics, Allozyne Inc., Sagamore Capital and EndoCeutics, and served on, as well as chaired, the Regulatory Affairs Coordinating Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA). Dr. Giaquinto participates in a number of charitable activities, including as Director on the Board of Trustees of the Children's Specialized Hospital and Chairman of the Board for Children's Specialized Hospital Foundation, both in Mountainside, NJ, and Chairman of the Board of Caldwell College in New Jersey. Dr. Giaquinto earned a Bachelor of Science in Pharmacy from St. John's University and a Ph.D. in Pharmaceutics from the University of Connecticut.
About Regado Biosciences
Regado Biosciences is pioneering a new therapeutic field with the creation and development of two-component drug systems, comprising an aptamer therapeutic that can be controlled directly by its specific and matched reversal agent. Regado's technology is designed to give physicians the ability to directly control and titrate each system's therapeutic effect. Enhanced control and flexibility allow physicians to meet the individual needs of patients independent of the setting. Regado is focusing its discovery and development efforts on acute care injectable antithrombotics, a multi-billion dollar market in need of therapeutics with improved safety profiles and a greater degree of therapeutic control.
Current investors in Regado include Domain (Princeton, NJ), Quaker BioVentures (Philadelphia, PA), Aurora Funds (Durham, NC) and Caxton Advantage Life Sciences Fund (New York, NY), as well as individual investors, including Robert Kierlin.