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Working Group Scope

A cross-disciplinary collaboration working to improve the content and implantation of clinical trial safety analysis for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.


Safety Analytics Education 

Patient safety is an important responsibility of sponsors and regulatory authorities throughout the drug development process. To better aid the statisticians, statistical programmers, and data scientists who are engaged with these efforts, the PHUSE Safety Analytics working group has developed an educational subcluster to provide these quantitative scientists with a deeper understanding of the key concepts in this growing discipline.

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Visit the PHUSE website to search for all Safety Analytics deliverables. 

Mary Nilsson: Working Group Lead

Research Advisor Safety Analytics, Global Statistical Sciences, Eli Lilly. Mary received a MS degree in statistics from Iowa State University in 1989. She has been employed at Eli Lilly since 1989 and is currently a research advisor in the Safety Analytics group within the Statistical Sciences function.

Mary consults with compound teams on safety 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 collection of analysis of suicide-related events.

Greg Ball: Working Group Lead

After graduating from Northwestern University with a bachelor's in economics, Greg served in the Navy for 4 years and taught high school math and physics for 5 years before going back to school to get a master's in applied statistics from Purdue University. Eventually, while working as a statistician, he earned his PhD in biostatistics from the University of Texas Health Science Centre. Gregs current research on blinded safety monitoring procedures emerged from his early work at academic medical centres (MD Anderson and the Methodist Hospital) and CRO's (West 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 Monitoring Working Group and is pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific Working Group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.

Scott Proestel, MD: Working Group Lead

Scott Proestel, MD, is Acting Associate Director of the Biomedical Informatics and Regulatory Review Science Team at the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). He completed his internal medicine training at The Johns Hopkins Hospital and obtained his medical degree from Columbia University Vagelos College of Physicians and Surgeons. He has previously worked as an FDA medical officer and team leader conducting and supervising pre-market reviews of new drug applications, overseen HIV clinical trial conduct as an Office Director at the US National Institutes of Health, and worked as an FDA Division Director responsible for post-market safety surveillance in CDER as well as the FDA’s Center for Biologics Evaluation and Research.

Scott’s most recent informatics research assessed the use of artificial intelligence to evaluate spontaneous safety reports submitted to the FDA Adverse Event Reporting System and Vaccine Adverse Event Reporting System.