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12/6/2016 (Tuesday) 1:30 PM - 4:30 PM
Session G: Quantitative sciences for safety monitoring in clinical development
(On Behalf of the ASA Safety Monitoring Working Group)
Mr. Rober 'Mac' Gordon, JNJ
Dr. Judy X. Li, FDA
Dr. William Wang, Merck
Moderator: Ivan Chan
In an effort to better promote public health and protect patient safety, there is growing interest in developing a systematic approach for safety evaluation of pharmaceutical products, not only for post-marketing safety surveillance, but also for pre-marketing safety monitoring. Recent regulatory guidance, such as CIOMS VI, ICH E2C and FDA IND safety reporting guidance (2012, 2015), have highlighted the importance and given recommendations on aggregate safety monitoring. Biostatisticians and other quantitative scientists can closely engage with clinical and regulatory scientists and play a vital role in these efforts. In 2015, to better enable this, the ASA Biopharmaceutical Section established a working group on clinical safety monitoring.
This tutorial session will present the work that has been done by this ASA safety monitoring working group, in two parts: 1. Summary of relevant regulatory guidance and results of an industry-wide survey on current process and technology enablement. 2. Discussion of various statistical methods for safety monitoring , these include blinded vs unblinded analyses, Frequentist vs Bayesian approaches, premarketing vs post marketing strategies, static vs dynamic assessments, trial-level vs program-level data aggregations, as well as visual analytical methods for safety data monitoring.
We will conclude with a panel discussion. Dr Qi Jiang (Executive Director, Global Biostatistical Science, Amgen) and Dr Olga Marchenko (Vice President, Head of Quintiles Advisory Services Analytics), who established and co-lead the ASA safety working group, will join the 3 speakers in the panel discussion. We will expand our discussion from safety monitoring to regulatory submission and safety confirmation trials (either as pre-marketing or post-marketing commitments). Audience participation will be highly encouraged.
Mr Robert ‘Mac’ Gordon received a Master in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career. In his tenure, he has had the fortune to design and implement end to end surveillance systems Mac served on the FDA/Industry/Academia Safety Graphics working group leading the sub team tasked with developing safety data visualizations for labs and liver toxicity. For the past 10 years, he is been clinical trial and clinical safety statistician at J&J with a focus on immunology and process. Mac is also an active member of the ASA safety monitoring working group, focusing on the industry survey and regulatory guidance.
Dr. Judy X Li is a Mathematical Statistician at the US Food and Drug Administration, Center of Biologics Evaluation and Research. Her research interests include design of experiments, generalized linear mixed model/linear mixed model, longitudinal data analysis, Bayesian statistics, likelihood-based inference and simulation studies, and safety assessment of clinical trials. She is the recipient of FDA Chief Scientist Intramural Grant award for two consecutive years. She is an active member of the ASA biopharmaceutical section executive committee, as the contributed poster award committee chair. Currently, she is serving as a member of the Biopharm Regulatory Statistics Workshop 2016 organizing committee and the co-lead of the ASA Safety Monitoring working group, focusing on the statistical methodology on safety monitoring.
Dr. William (Bill) Wang is an executive director, clinical safety and risk management statistics, in the department of Biostatistics and Research Decision Sciences (BARDS), Merck Research Laboratories. He has over 20 years of experience in the pharmaceutical industry, with expertise and research publications in statistical design, analysis, clinical data management and their technology enablement. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and established the BARDS Asia Pacific operation. Since 2010, he has served on the DIA China Regional Advisory Board and the DIA’s Global Community Leadership Council (CLC), including the chairmanship of the DIA China Statistics Community. He was a recipient of the DIA global outstanding service award in 2012. He is currently chairing an ASA safety monitoring working group, a topics-leader in the ICH E17 working group on multi-regional clinical trials, and a member of the Merck benefit-risk strategy team.
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