A cross-disciplinary collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.
Working Group |
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Lead: Mary Nilsson:nilsson_mary_e@lilly.com
Research AdvisorSafety Analytics, Global Statistical Sciences, Eli, Lilly and CompanyMary received a MS degree in statistics from Iowa State University in 1989. She has been employed at Lilly since 1989 and is currently a research advisor in the Safety Analytics group within the Statistical Sciences function.She consults with compound teams onsafetysafety analysis planning for Phase 2-3 studies and integrated submission documents.Her primary interests include analyses of adverse event data, analyses of laboratory data, statistical analysis plans, and collectionandof analysis of suicide-related events. | Working Group Lead: Greg Ball:greg.ball@merck.com
After graduating from Northwestern University with abachelor’sbachelor's in economics,GregGregy served in the Navy for 4 years and taught high school math and physics for 5 years,before going back to school to get amaster’smaster's in applied statistics from Purdue University.Eventually, while working as a statistician, he earned his PhDinin biostatistics from the University of Texas Health ScienceCenterCentre.His current research on blinded safety monitoring procedures emerged from his early work at academic medicalcenterscentres (MD Anderson and the Methodist Hospital) andCROsCRO's (WestatWest and Quintiles), developed into his college dissertation and continues to be developed in collaboration with statistical and clinical scientists from several pharmaceutical companies (Astellas, AbbVie and Merck).Greg established, with Bill Wang, the ASA Biopharm Safety Monitoringworking groupWorking Group and is pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientificworking groupWorking Group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement. |
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