The People of OyaGen
Thomas Fitzgerald, Chief Operations Officer
Tom Fitzgerald was named President & COO of OyaGen in May, 2004, after joining OyaGen as a management consultant in December, 2003. He has provided guidance on commercial issues, regulatory and business development matters.
Mr. Fitzgerald has more than 25 years of experience in the biopharmaceutical industry. As an industry consultant, he has provided strategic advice for a range of early stage companies as well as more established domestic and international businesses. He has also advised the University of Rochester Medical Center on their initiative to generate and nurture spin out businesses in the life sciences.
Mr. Fitzgerald has held seats on the Boards of Directors for a number of public and private entities. During his career, he has been responsible for the development, regulatory and marketing strategies, government relations, and intellectual property matters for biopharmaceutical companies for more than 25 years. He has held senior management positions for a number of both large and small companies, both European and USA.
A lawyer by training, for the past fifteen years his responsibilities have been substantially in the commercial development of products and business opportunities including the acquisition and disposal of products and business units, structuring of strategic alliances, providing intellectual property risk assessment and protection, developing regulatory strategy and overseeing the clinical development of pharmaceuticals and delivery systems for therapeutics, as well as handling day to day business operations for a number of companies.
He was Chairman of the Board, Chief Executive Officer and Chief Operating Officer with Sheffield Pharmaceuticals Inc. (now MAP Pharma) and Senior Vice President, General Counsel & Secretary at Fisons Corp (now Aventis). In addition he has held senior management positions with SmithKlineBeecham (now GlaxoSmithKline).
He is a graduate of Boston College and the St. John’s University School of Law and is admitted to practice law in New York and Connecticut State and Federal Courts. He was awarded the distinguished Alumni Medal from St. John’s University, Jamaica, NY.
Over the course of Mr. Fitzgerald’s career, he has been responsible for the relations with the FDA on a number of strategic issues. He has been a key member or led successful efforts to obtain favorable consideration for NDAs, amendments to NDAs, INDs,505(b)(2) for advantaged generics, ANDAs, Rx-to-OTC switches, drug device combinations, CFC propellant phase out and approval of Dry powdered pulmonary delivery systems, pre-approval inspections as well as certification and re-certification of manufacturing facilities in the US and EU. Specifically product registrations include: Tilade, Tilarin, Tilavist (inhaled ocular and nasal nedocromil), Paxil (Paroxetene) Augmentin (Amoxicillin and Clavulanate), Bactroban (Mupirocin), Intal Nebulizer Solution, Pentamadine and Re-launch and approval of Opticrom in the US and EU. Rx to OTC Switch includes: Delsym and Nasalcrom. In addition Non-CFC Pulmonary Delivery program (Dry Powder) for asthma drugs in US and EU, Re-certification of facilities in Rochester NY; Holmes Chapel UK; LeTrait France and QA/QC functions in US for RX and OTC.