Senior Consultants

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 industries 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 U.K., 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 a master’s degree in medical biology from the University of Utrecht and a Ph.D. in bacterial endocarditis from the University of Leiden, both in the Netherlands.

Irene Figari brings 40 years of biotech experience to the RPI regulatory affairs team. She spent 16 years in basic research and development, focusing on immunology, cell biology, tumor model systems, and molecular biology, 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 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, Ms. Figari 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.

Chris Hendry is a veteran in the development and manufacture of protein biologics with an emphasis on selection and oversight of drug substance and drug product contract manufacturing organizations, development of commercial manufacturing processes, and quality risk management. He is also experienced in the transfer and validation of drug substance and drug product manufacturing processes; preparation of CMC sections of INDs, BLAs, and CTDs; project management of cross-functional development teams; and GMP facility and equipment design, validation, and development master planning. Mr. Hendry has a bachelor’s degree in biochemistry from the University of Maine.

Willette Jones is a certified clinical research professional with more than 20 years of diverse biotech industry experience in various phases of global clinical trial management and quality assurance for regulated medical devices, pharmaceuticals, and biologics. She has more than 12 years of experience with CROs focusing on compliance with global health authority regulations and ICH GCP guidelines, inspection readiness, quality oversight, and training development and deployment. Ms. Jones is also a GxP subject matter expert in leading root-cause analysis and CAPA strategies; QMS design, delivery, and integration; and driving quality into training and clinical research processes, operations, and systems. A transformational and innovative leader, she has proven success in developing global quality and clinical/operational teams, strategies, and other specialized services within QA, including authorship of various controlled documents, user manuals, course platforms, and training curricula. Ms. Jones holds a bachelor’s degree in biology and medical science from Southern Illinois University Edwardsville.

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, and since 2009 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 bachelor’s degree from the University of Guelph and a master’s from Queen’s University.

Laura Kilgore leads regulatory affairs for chemistry, manufacturing, and controls. Additionally, she specializes in providing strategic input, project management, and technical writing support for the development of agency meeting requests, original investigational new drug applications and new drug applications, and briefing documents. Ms. Kilgore has extensive experience in providing regulatory chemistry, manufacturing, and controls and quality leadership for development products supporting marketing approvals, as well as in lifecycle management for a broad range of marketed products across pharmaceutical, biologic, and medical device products, including solid oral dosage forms, topicals, transdermals, combination products, biosimilars, and devices. Prior to joining RPI, she spent six years at Actavis Laboratories and more than 10 years at Nektar Therapeutics in regulatory affairs and quality assurance. Ms. Kilgore holds a bachelor’s degree in chemistry, magna cum laude, from Auburn University and has Regulatory Affairs Certification for the United States.

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.

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 10 years. Ms. Sosa’s experience includes contributing to international teams developing small and large molecules and 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 bachelor’s degree in biology from Trinity University and has a master’s in counseling psychology from John F. Kennedy University’s School of Consciousness.