Reimagining a Safety Submission – Vision of Interactive Safety Reviews

Greg Ball, ASAPprocess

Greg Ball served in the Navy and taught High School maths and physics before earning his master’s in statistics from Purdue and his PhD in Biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). With Mary Nilsson, Greg co-leads the PHUSE Safety Analytics Working Group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement. 

Mary Nilsson, Eli Lilly 

Mary Nilsson is Executive Director-Statistics, Safety Analytics at Eli Lilly. Mary received her master’s degree in statistics from Iowa State University in 1989 and has been employed at Eli Lilly since then. She is currently a researcher in the Safety Analytics group. Mary consults with molecule teams on safety analysis planning for Phase II to III studies and integrated submission documents. Her primary interests include analyses of adverse event data, analyses of laboratory data, statistical analysis plans, and collection and analysis of suicide-related events. Additionally, she co-leads the PHUSE Safety Analytics Working Group, creating cross-functional education and cross-industry recommendations for standard safety analyses and displays.

Wei Wang, Eli Lilly

Wei Wang is an active member of the PHUSE Safety Analytics Working Group. She was the lead author of the recent white paper on Analyses and Displays Associated with Laboratory Analyte Measurements. She was also a co-author of several other white papers from the Safety Analytics Working Group. Wei has been working in the pharmaceutical industry for 23 years and has led various initiatives in the safety analytics area at Eli Lilly. She has a special interest in visual analytics and has developed numerous interactive review tools for safety review and display purposes. She is the lead author for the paper on Clinical Trial Drug Safety Assessment with Interactive Visual Analytics. Statistics in Biopharmaceutical Research, 1–12 (2020) and the paper on Interactive Visualisation for Clinical Safety Data Review. Biopharmaceutical Report, 27(Fall 2019/Winter 2020). 

Xiangyun Wang, Genentech

Raj Kiran, Takeda 

Raj Boddu honed his skills at IQVIA, BMS and Vertex before joining Takeda in 2017 as a statistical programmer in SQS. There, he applied his SAS programming skills and experience in clinical/oncology/CF study-related SDTM and ADaM mapping, programming, testing and documentation. He later pivoted into a different role within SQS, where he worked with leadership to create key operational metrics and optimise processes. Raj then transferred to Alta Petens, where he is a product manager for clinical common data model and statistical computing environment workstreams in systems and architecture.

In his current position, Raj is dedicated to driving clinical data forward with strategic solutions and innovative products. He brings a unique combination of expertise in both product management and clinical data, which enables him to tackle complex challenges and deliver impactful outcomes in the life sciences industry. Raj’s primary focus is on shaping the future of clinical trials through data-driven decision-making and the development of cutting-edge products. He is passionate about innovation and committed to driving progress, to make a difference in the field of clinical data.

Melvin Munsaka, AbbVie

Melvin Munsaka is Senior Director and Head of Safety Statistics at AbbVie. He received his PhD from Queen’s University in Canada and his MSc and MEd from McGill University in Canada. Melvin has more than 25 years of industry experience working in various capacities including strategic leadership roles. He has participated in multiple global regulatory submissions covering a wide range of therapeutic areas. Melvin is an active member of the ASA Biopharm Safety Scientific Working Group, the DIA Bayesian Scientific Working Group’s Safety and Reporting and Tools subteams, and the PHUSE Safety Analytics, Data Visualization, and Open-Source Technology Working Groups.

Neetu Sangari, Pfizer 

Neetu Sangari is passionate about contributing to drug development using advanced innovative methods for patients that will have a meaningful impact on their lives. She currently leads Statistics Data Science and Analytics (Director) at Pfizer and works with cross-functional partners – programming, statisticians, clinicians and digital teams. Neetu established a strategy for using multiple programming software in the clinical area and assisted in the decision-making for the Best Fit analytical tool. She has led multiple projects and accomplished identifying innovative solutions to ambiguous/complex problems using agile data analytics. She has delivered multiple presentations at industry conferences and academic symposiums.

Neetu gained her PhD in Computer Science, with a concentration in big data analytics. Externally, she co-leads the PHUSE Interactive Plots Working Group project, in collaboration with FDA and ASA members. Neetu also contributes to the mentoring circle and Regional Liaison of the Tri-State NY/NJ/CT region in Tomorrow’s Executives Affinity Group within the Healthcare Businesswomen’s Association. At Pfizer, she leads the Summer Growth Experience Internship Programme for university students. Neetu’s interests include the use of AI/ML in healthcare and continuing to transform pharma using big data analytics-based innovation.

Jeremy Wildfire, Gilead

Bill Gibson, Accumulus 

With a tremendous amount of experience in the healthtech/drug development life cycle space, Bill Gibson serves as VP of Product for Accumulus Synergy, where he brings more than three decades of product management and software development leadership experience and expertise. He is also the co-founder of multiple software start-ups.

Prior to joining Accumulus Synergy, Bill held various roles within the product and strategy space at IQVIA, where he focused on decentralised clinical trials and the broader digitalisation of clinical trial operation. Bill is also the former lead for life science product management at SAS.