Cynthia de Luise

Senior Director, Epidemiology @Pfizer

Provide scientific leadership for a portfolio of sponsor-initiated and regulatory-mandated peri-and post approval drug safety and effectiveness studies, and risk evaluation and mitigation strategies across multiple therapeutic areas and safety issues. Give external speaking engagements and training on the use of real world date in pharmacoepidemiologic research. Conceive and oversee pharmacoepidemiologic studies using innovative designs including predictive modeling and machine learning to assess the validity of real world data for use in in drug safety and effectiveness research and develop new methods for proactive safety surveillance. Lead innovative strategic initiative to develop pharmacoepidemiology capabilities in Japan, spearheading first hospital-based validation study of real world Japanese claims data in rheumatoid arthritis, selected cancer and infectious diseases, and launching first pilot study with the Pharmaceuticals and Medical Devices Agency (PMDA) using MID-NET Japanese real-world hospital database for the safety surveillance of first-in-class CDK4/6 inhibitor. Demonstrated success in negotiating with regulatory agencies concerning peri-post approval safety commitments and risk evaluation/minimization measures. Serve as subject matter expert to internal and external stakeholders on the effective use of real world data for non-interventional safety and effectiveness studies to evaluate the benefit-risk of therapeutics.