Working Group Scope

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.

Resources 

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.

If you have any comments or new ideas you want to see on the Education Page, submit them to us at workinggroups@phuse.global.

Estimands in Oncology Safety Task Force

The Pharmaceutical Industry Working Group on Estimands in Oncology in collaboration with PHUSE has started a Safety Task Force on estimands in safety, focusing on oncology. The Task Force will formulate recommendations regarding formulation and use of safety estimands in oncology clinical trials as well as identifying applications of estimands principles to help improve general safety reporting. Recommendations will include trial design, data collection, and analysis issues and ways to integrate clinical, statistical, operations, and data management aspects of study design and execution cooperatively. Key task force activities will include a dive into literature on the subject, formulation of recommendations, development of white papers, and preparation of journal manuscripts and conference presentations. Click here for Biography. 

For more information, please contact Jonathan Siegel at Jonathan.siegel@bayer.comFor information on the Pharmaceutical Industry Working Group on Estimands in Oncology, please visit www.oncoestimand.com or contact Working Group co-chairs, Degtyarev Evgeny at evgeny.degtyarev@novartis.com or Kaspar Rufibach at kaspar.rufibach@roche.com


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

  


nilsson_mary_e@lilly.com

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@asapprocess.co

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@fda.hhs.gov

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.


RGordon2@its.jnj.com

Mac Gordon has a master’s in statistics and graduate certificates in public health, pharmacovigilance and pharmacoepidemiology and has been with Johnson and Johnson 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 Johnson and Johnson, 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.



EUnger@hpm.com

Ellis F. Unger, MD, is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara, a leading consulting FDA law firm. Dr Unger is a board-certified cardiologist, who retired from the US Food and Drug Administration following a 24-year career, where he served in senior leadership roles in the Office of New Drugs, Center for Drug Evaluation and Research (CDER) – initially as the Director of the Office of Drug Evaluation-I, and subsequently as the Director of the Office of Cardiology, Hematology, Endocrinology and Nephrology. The divisions under his direction oversaw the regulation of drugs for cardiovascular, renal, psychiatric, neurologic, endocrine, metabolic and hematologic disorders. Dr Unger obtained his medical degree from the University of Cincinnati, and he received post-doctoral training at what was formerly known as the Medical College of Virginia (internal medicine) and The Johns Hopkins Hospital (clinical cardiology). Throughout his FDA career, Dr Unger was well known for his insights into the analysis, interpretation and display of various forms of data. He was also recognised as a leader in the safety assessment of drugs and biologics, as well as the consideration of complex benefit-risk scenarios. Dr Unger was involved in drafting dozens of FDA Guidance documents and participated in numerous working groups (including the FDA’s Benefit-Risk framework). He served as a key FDA representative on many International Council for Harmonization (ICH) Expert Working Groups, making important contributions to several safety-related guidelines: E2F (Development Safety Update Report, DSUR), E2C(R2) (Periodic Benefit-Risk Evaluation Report, PBRER) and E19 (Safety Data Collection), as well as M4E(R2), the benefit-risk section of the Common Technical Document.


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