Reimagining a Safety Submission – Aggregate Safety Assessment Planning

This Community Forum took place 16 February 2023. Catch up by viewing the recording. 
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Resources Informing Content for Safety-related Analysis Plans 

PHUSE AE Groupings in Safety (AEGiS) project team

Robert (Mac) Gordon, Janssen Research & Development 

Discussion 

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.

Mac Gordon, Janssen Research & Development 

Mac Gordon has a master’s in statistics and graduate certificates in public health, pharmacovigilance and pharmacoepidemiology and has been with Janssen for 15 years, and in industry for 20 years. He has been involved with lupus research since joining the organisation, with focus areas in late-development immunology and clinical trial safety. Mac has been heavily involved in pharmacovigilance, signal detection and safety data visualisation for most of his career, including membership in several multi-disciplinary industry/regulatory working groups. Prior to joining Janssen, Mac developed a safety surveillance and signal detection team at Cephalon. He is currently the Clinical Team Statistical Lead across 11 indications and several therapeutic areas. Outside of clinical research, Mac is involved in many internal teams focused on safety statistics and process development initiatives and continues to represent the organisation in external safety Working Groups.

Barbara Hendrickson, University of Chicago

Dr Barbara Hendrickson is a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is currently on faculty at the University of Chicago. Dr Hendrickson is a physician with subspecialty training in paediatrics and infectious diseases and has 19 years of pharmaceutical industry experience. She has been involved in multiple new product and additional indication submissions and has participated in several clinical trial safety initiatives and the implementation of internal data monitoring committees. In addition, Dr Hendrickson co-leads the DIA-ASA Aggregate Safety Assessment Planning Working Group.