Nadia Barozzi
PhD, MAS ETH NH, PharmD, NLP Master Practitioner
RWE & RWD | Pharmacopidemiology | Clinical Research & Operations | Drug Safety | Evidence Generation
Multidisciplinary expert in evidence generation, real-world data (RWD) strategy, pharmacoepidemiology, and clinical operations with over 15 years of experience across pharmaceutical, CRO, and freelance settings. I work at the intersection of science, regulation, and innovation, designing fit-for-purpose Real-World Evidence (RWE) solutions across the product lifecycle, from data feasibility and protocol design to regulatory submission and strategic communication. Known for analytical rigor, intellectual curiosity, and cross-functional thinking, I bridge technical aspects to operation in drug development. Recognized for intellectual rigor, cross-functional fluency, and a distinctive ability to translate methodological complexity into actionable study designs, and stakeholder value.
KEY EXPERTISE and CORE COMPETENCIES
Data Strategy & RWE Operations: Proven ability to design and implement fit-for-purpose RWE studies, including hybrid NIS. Strong focus on feasibility, data source evaluation, and regulatory-aligned execution. Track record across oncology, neurology, cardiometabolic, respiratory, gastrointestinal, and rare diseases.
Pharmacoepidemiology & Drug Safety: Extensive experience in RWE study design, including non-interventional studies (NIS), post-authorization safety studies (PASS), and safety surveillance. Aligning pharmacoepidemiology with study objectives in product safety, regulatory compliance, and lifecycle evidence generation.
RWD Feasibility & Proxy Outcome Definitions: Deep expertise in data quality, governance, and the development of proxy outcomes. Known for scalable approaches to evaluating data fitness and translating feasibility insights into actionable study designs.
Scientific Thinking & Thought Leadership: Solid foundation in epidemiology and research writing. Frequent communicator of complex concepts to regulatory, cross-functional, and scientific audiences. Author of over 50 articles on RWE methods, data strategy, and feasibility.
Regulatory & Compliance Strategy: Skilled in aligning studies with GVP/GCP requirements and managing EMA/FDA interactions for post-marketing commitments and RWE dossiers.
Cross-Sector Navigation & Stakeholder Engagement: Demonstrated success in industry, CRO, consultancy, and public health contexts. Experienced in building collaborations with global teams, regulators, vendors, and academic partners.
GET TO KNOW ME
I have completing a PhD in Pharmacoepidemiology & Health Services Research, and throughout the different experiences in the pharmaceutical industry, I have built a solid scientific background in multiple therapeutic areas and strong clinical operation experience.
As a public health and pharmacoepidemiology professional, I have spearheaded the development, implementation, and monitoring of global epidemiology research projects for new product development and post-marketing surveillance. My contributions include designing epidemiology studies to investigate natural history of disease, treatment patterns, safety signals, and post-authorization safety studies (PASSs).
I have worked with diverse data sources (e.g., THIN, Nordic Registries, MDV, JMDC, HIRA, SNDS, GePaRD, disease registries), and contributed to clinical protocol design and development, review of statistical analysis plans (SAPs), and signal detection in large adverse event reporting system databases.
I have conducted data landscaping, fit-for purpose data source feasibility, literature reviews, and authored the epidemiology sections of Periodic Safety Update Reports (PSURs) for known and potential risks as defined in Risk Management Plans (RMPs). Additionally, I have authored regulatory responses, risk management and safety reports, and expert statements.
As the Scientific Data Strategist Director at a leading CRO, I have overseen a broad range of activities in the pre-award and post-award phases. My role involved planning integrated evidence generation plans and conducting hybrid studies (primary and/or secondary data collection) throughout different product life cycle stages, including early engagement (Phase II/III), pre-launch (Phase III), and post-marketing (Phase IV).
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