Dean Gittleman
Independent Consultant
The focus of Dean's 30+ years experience in clinical development has been building enterprise-level systems and infrastructure solutions for data acquisition, aggregation and governance in small and large pharma and device companies, as well as Clinical Research Organizations (CROs). His therapeutic development experience includes oncology, CNS, ophthalmology, infectious diseases, and endocrinology.
Dean’s interests and passion are on data-driven, adaptable data flow operations that help move the industry towards rational implementation of risk-based monitoring and paperless (eSource) clinical trials. He is driven to materially contribute to helping to achieve quantum improvements in addressing the longstanding industry challenge, namely, that clinical trials take too long and cost too much. He has published, and presented on the topic of how to combine real-time data collection and near-real time risk-based monitoring at national industry forums, and implemented the paradigm of data-driven fast and quality decision-making across all his corporate roles and customer engagements.
Dean’s focus on creation of organizational structures that optimize speed and quality of pharmaceutical data flows enabled successful achievement of regulatory filing milestones. As the Head of Biometrics at Vertex Pharmaceuticals, Dean led Biostatistics, Statistical Programming, and Clinical Data Management to deliver its first NDA filing for hepatitis C. While at Meadox Medicals, Dean built a Data Management function and infrastructure, and successfully defended two PMAs during advisory panel reviews. At ICOS, Dean established clinical information systems governance that supported global regulatory filings, and introduced the use of electronic data capture (EDC). As a Head of global Data Management at Genentech Roche, Dean was instrumental in establishing a data science approach towards collecting, storing, and interrogating clinical trial data to enable achievement of critical development milestones.
Dean holds a BA in Biology from Rutgers University, and an MS from Fairleigh Dickinson University that combines computer science and MBA, with emphasis on database technologies.