At AGTC industry-leading experts and innovative thinkers merge to create a diverse atmosphere of scientific growth and discovery.
Executive Director, Regulatory Affairs
Ellery is the Executive Director, Regulatory Affairs at AGTC and is responsible for leading the company’s regulatory and GxP compliance initiatives. He has over 20 years’ experience managing global regulatory and quality activities for both small and large molecule development programs and has led products through all critical stages of development; from preclinical to first-in-human studies, from early to late phase clinical evaluation and from license application through approval and post-marketing development and label expansion. His areas of therapeutic focus have included CNS, immunological, cardiovascular and infectious diseases. Prior to joining AGTC, Mr. Mangas held regulatory and quality positions of increasing responsibility at UCB, Nabi Biopharmaceuticals and COR Therapeutics. Ellery earned a B.S. degree in Microbiology from the University of Florida and is Regulatory Affairs Certified by the Regulatory Affairs Professionals Society (RAPS).
An experienced entrepreneur with a strong scientific and operational background, Sue brings a decade of experience in pharmaceutical management and research with Abbott Labs and Eli Lilly & Company and more than 16 years of senior management experience with entrepreneurial firms in Florida including three start-ups. At AGTC, Sue has successfully secured investments of more than $91 million from nationally recognized venture capitalists and granting agencies; negotiated and closed on a major collaboration with a top five Biotech company; lead the company to complete critical milestones; and recruited an experienced management team. Her experience as a group leader with Abbott’s Diagnostic Division helped hone her skills in bringing new products and technologies from the lab bench into the market place.
Sue is the chair of Southeast BIO, is a member of the Executive Committee of BioFlorida and sits on the board of the Florida High Tech Corridor Council. She has a degree in biochemistry from Michigan State University and an MBA from the University of Florida where she was one of the first graduates from the Warrington College of Business Entrepreneurship program.
Stephen has more than 15 years of experience as a senior executive in the biotechnology industry. Prior to joining AGTC, he was most recently employed by NeoStem, Inc., a developer of cell-based therapeutics, where Stephen served as Executive Vice President and a member of the Board of Directors. He was Senior Vice President of Operations and Corporate Development for Osiris Therapeutics, Inc., where he was part of the senior leadership team that achieved approval of the first-ever stem cell drug therapy, Prochymal®. Stephen was also responsible for the launch and overall management of the Bio-Surgery business unit as well as operational oversight for multiple functional areas including manufacturing, human resources, IT, legal and business development. Prior to Osiris, Stephen served as Senior Vice President of Corporate and Business Development at Genzyme Corporation and as Vice President of Corporate and Business Development. Over his ten years at Genzyme, Stephen was the senior leader for its global corporate and business development team that provided strategic and transaction support, including support for many of Genyzme’s gene and cell therapy opportunities. He has also held positions at DuPont Pharmaceuticals, E.I. Dupont de Nemours and Company, Inc., and Booz Allen & Hamilton. Stephen earned a B.S. from University of Massachusetts and an MBA from Harvard Business School.
Dr. Shearman is responsible for leading the company’s product candidate selection process, pre-clinical and translational research and long-term research and development planning, while also contributing to the overall strategic direction of the company. Dr. Shearman was employed most recently by EMD Serono, Inc., the U.S. and Canadian subsidiary of Merck KGaA, where he served as Senior Vice-President of Research & Early Development since 2009. Previously, Dr. Shearman was Executive Director of Merck & Co. Research Laboratories, Boston, and Senior Director at the Merck Sharp & Dohme Research Laboratories Neuroscience Research Centre, U.K. Dr. Shearman earned a B.Sc. from the University of Bristol, a Ph.D. from the University of Nottingham and conducted academic research at institutes in Japan and Germany.
Bill has more than 20 years of experience in corporate finance, leading strategic transactions, fundraising, and accounting. Prior to joining AGTC, he worked at Merrimack Pharmaceuticals Inc. for close to 10 years and held a variety of important leadership positions, including Chief Financial Officer, Principal Accounting Officer and Treasurer. While at Merrimack, he led the company’s $100 million initial public offering, helped the company raise more than $400 million in debt and equity capital as a public company, and played a key role in the company’s commercial launch of ONIVYDE® and subsequent asset sale to Ipsen SA for up to $1.025 billion. Prior to his role at Merrimack, Mr. Sullivan held a variety of positions in the areas of financial planning and analysis, operations management, and auditing.
Bill holds a B.A. in Economics from Williams College and a M.B.A and M.S. in Accounting from Northeastern University and obtained his certified public accountant license while working at Arthur Andersen, LLP.
Dr. Feinsod is a board-certified ophthalmologist with extensive corporate and regulatory expertise in the development of novel therapies for ophthalmic diseases. In his previous positions he has played key roles in corporate finance, developing and implementing clinical and regulatory strategy, due diligence, and licensing. He has been a founder in several companies including Imagen Biotech, a venture-backed company dedicated to developing breakthrough ophthalmology treatments for high unmet needs. At Imagen he secured financing of $40MM from a syndicate of three global investor groups and led all company activities. Prior to Imagen, Dr. Feinsod was SVP of Strategy and Product Development at Eyetech Pharmaceuticals where he spent five years in a variety of functions helping to develop and launch Macugen and an anti-PDGF aptamer now in Phase 3 clinical trials with Ophthotech. Prior to joining Eyetech, Dr. Feinsod served as medical officer for the FDA Division of Anti-inflammatory, Analgesic and Ophthalmologic Drug Products, where he was a primary reviewer for both IND and NDA ophthalmology regulatory applications. Concurrently, he held a clinical trials/drug development fellowship position in George Washington University’s Department of Ophthalmology and served on the University hospital’s Institutional Review Board. Previously, Dr. Feinsod conducted post-doctoral molecular biology research with a focus on nucleotide science at Cornell University Medical Center.
He received his undergraduate degree from the Wharton School of Business and his MD from the George Washington University School of Medicine and completed his residency at the Manhattan Eye, Ear and Throat Hospital. Dr. Feinsod holds several patents in the field of ophthalmology and in emitted light-stabilization. Dr. Feinsod serves on the board of directors of World Eye Mission, a non-profit organization. He continues to practice ophthalmology on a part-time basis.
Since AGTC’s inception, Dr. Knop has been responsible for the development of all upstream and downstream unit operations comprising the company’s proprietary rHSV co-infection method for rAAV manufacture.
Dr. Knop joined AGTC in 2002 after completing his doctoral research in Chemical Engineering at Michigan State University which focused on biocatalytic production of value-added pharmaceutical intermediates useful in the synthesis of anti-influenza medicinals. He has defined, and executed technology transfer on, multiple phase 1 and 2 clinical material generation processes for rHSV raw material and rAAV clinical trial material to contract manufacturing organizations, academic and corporate partners. Dr. Knop has authored dozens of manuscripts, presentations, and posters encompassing the production, processing, and purification of rHSV and rAAV vectors for use in gene therapy applications.