Senior Consultants

Brian Masters has significant experience in medical and regulatory writing, including authoring and reviewing documents for medical communications and regulatory submissions for investigational new drugs, new drug applications, biologics license applications, and marketing authorization applications. Prior to joining RPI, Dr. Masters was a principal medical writer for several large pharma/biopharma sponsors, including Onyx, Astellas, Merrimack, Merck, and Otsuka Pharmaceuticals, where he specialized in a broad range of therapeutic areas, including oncology, immunology/rheumatology, neurological disorders, infectious diseases, cardiovascular diseases, diabetes and metabolism, blood disorders, respiratory disorders, transplantation and cell therapy, and rare diseases. Before entering the pharma/biopharma industry, he spent 10 years as a professor and independent research scientist at the University of Miami School of Medicine, where he conducted research on stem cells and neurodevelopment. He has a Ph.D. in cellular and integrative neurosciences from the University of Florida in Gainesville and has completed fellowships in molecular genetics and genomics at the Howard Hughes Medical Institute.

Irene Figari brings 40 years of biotech experience to the RPI regulatory affairs team. She spent the first 16 years of her career in basic research and development, focusing on immunology, cell biology, tumor model systems, and molecular biology. She then moved to the regulatory side in roles of increasing responsibility and leadership. She led a team of regulatory professionals in providing strategic and tactical guidance across therapeutic areas and disciplines in the clinical; nonclinical; and chemistry, manufacturing, and controls arenas. That team delivered both regional and international regulatory strategy for pharmaceutical and biotech drug development teams. She has also provided regulatory leadership and development of strategy for products from the pre-investigational new drug (IND) stage through post-marketing in multiple therapeutic areas, with a focus on oncology. A decisive and results-oriented leader recognized for both project and people management, Irene easily adapts to sudden requests and unforeseen detours. Her accomplishments include leading teams to successful global health authority interactions, INDs, orphan drug applications, fast track applications, pediatric strategies, and marketing applications.

Aurora Sosa brings significant experience in regulatory strategy, regulatory management, and planning to the RPI regulatory affairs team. Prior to entering the industry, she worked in academic research for about 10 years. Ms. Sosa’s experience includes contributing to international teams developing small and large molecules as well as biologics in a broad range of therapeutic areas, including immunologic, neurological, gastrointestinal, respiratory, and blood disorders, as well as dermatology, infectious diseases, and cardiovascular disease. Prior to joining RPI, she was a regulatory leader and contributor at Bayer Biologics, Corus/Gilead Sciences, ARCA Biopharma, Dow Pharmaceuticals/Valeant Pharmaceuticals, Cerexa/Forest Laboratories, and Ardelyx. Ms. Sosa holds a B.S. in biology from Trinity University and has an M.A. in counseling psychology from John F. Kennedy University’s School of Consciousness.

Naomi Kautz brings 20 years of multidisciplinary experience in the biotechnology and pharmaceutical industries to the RPI regulatory affairs team. She has focused on regulatory affairs, research and development, and policy since completing her academic training in biochemistry. Her 15-year tenure in regulatory affairs has spanned development from early through late stage, including new drug application filings. She has also served as U.S. regulatory lead and global regulatory lead on late-stage programs. Since 2009, she has focused on regulatory affairs related to the development of cell and gene therapy. Ms. Kautz has worked on several programs with immuno-oncology agents, including chimeric antigen receptor T-cell therapies, as well as cell and gene therapies for neurodegenerative conditions. She has a B.S. from the University of Guelph and an M.S. from Queen’s University.

Maurice Bancsi focuses on regulatory strategy for Europe and the European Union in conjunction with clients across all stages of development. He brings significant experience in regulatory affairs in the pharmaceutical and biotech industry to his role. Prior to joining RPI, Dr. Bancsi served as an EU regulatory liaison in oncology at Janssen Biologics for 16 years, providing regulatory leadership for products across development stages, from pre first-in-human through marketing authorization. He was also involved in regulatory procedures, including pediatric investigation plan waivers; orphan applications; marketing authorization applications; Committee for Medicinal Products for Human Use scientific advice; national scientific advice for the UK, Sweden, Netherlands, Germany, France, and Spain; and Type I and II variations. Recently, Dr. Bancsi has focused on real-world evidence implications for global regulatory strategies and the use of digital technologies in clinical trials. He holds an M.S. in medical biology from the University of Utrecht and a Ph.D. in bacterial endocarditis from the University of Leiden, both in the Netherlands.