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STUART, FL. August 26, 2020 -
Linical Americas, a market-leading, midsized, global contract research organization (CRO), announced Steven A. Castillo, a seasoned regulatory expert, has joined their team as Director of Regulatory Affairs. As Director of Regulatory Affairs, Mr. Castillo will support clients' regulatory submissions and strategy, as well as FDA correspondence.
“Steven is a superb addition to our team, and he has over 27 years of experience in Clinical Development and Regulatory Affairs that extends across academia, small biotech, large pharma, global CROs, and niche consulting,” said Dr. Tracy Goeken, Chief Medical Officer of Linical Americas. “He has been a part of numerous product approvals, regulatory submissions, and FDA meetings. Steven is skilled at navigating the clinical development regulatory process in many regions across the globe. His knowledge and experience will be instrumental to our clients as they move through the drug development lifecycle.”
Before joining Linical, Mr. Castillo served as Vice President, Product and Clinical Development at Camargo Pharmaceutical Services, LLC. Prior to that he was the Global Project Head III, Retina Drugs and Biologics, at Alcon, a Novartis, Co. Additionally, Mr. Castillo has served as Director of Clinical Development at Argos Therapeutics as well as the Director of Global Product Development in the Regulatory Affairs Dept at global CRO PPD. Earlier in his career, Mr. Castillo also held various positions of increasing responsibility at Glaxo Wellcome and GlaxoSmithKline in the Infectious Disease group leading clinical development teams.
Mr. Castillo’s career accomplishments have been noted by the global approvals of many products including once-daily lamivudine, once-daily abacavir, once-daily abacavir/lamivudine combination, and ocriplasmin. In addition, Mr. Castillo has led and/or participated in numerous FDA Pre-IND, Type B, EOP2, and Pre-NDA meetings across many divisions of the FDA. Mr. Castillo received his Master of Science degree from University of Washington – Seattle, in Molecular and Cellular Biology under a Pre-Doctoral NIH fellowship grant and a baccalaureate degree from the University of Colorado – Boulder, in Biology.
Linical is a public, midsized CRO headquartered in Japan with a significant presence across North America, Europe, and Asia-Pacific. Linical provides the full spectrum of drug development services from early stage to large-scale, multinational studies. The company’s areas of expertise include Phase I-IV oncology, vaccine, infectious disease, CNS and general medicine.