SELECT * FROM sessions where years='2017' and sequence=119
December 4-8, 2017 at Atlantic City, New Jersey
The 73rd Deming Conference on Applied Statistics
Sponsored by Metropolitan Section, ASQ and Biopharmaceutical Section, ASA

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Likelihood-Based Methods for Continuous Safety Monitoring of Pharmaceutical Products

Speaker(s): Dr. William Wang (Merck),
Dr. Krishan P. Singh (GSK)
Dr. Ram Tiwari (FDA))
On Behalf of the ASA Safety Monitoring Working Group
Moderator: Kalyan Ghosh

Dr. William (Bill) Wang is an executive director, clinical safety 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 inspire award award in 2012. He is currently chairing an ASA safety monitoring working group, and a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials.

Krishan Singh has been working in the pharmaceutical industry for 29 years, starting at Smith Kline & French which subsequently became GlaxoSmithKline following mergers/acquisitions. In his 29 years in the industry as a statistician, he has supported the clinical development of drugs across a number of therapeutic areas leading to successful regulatory submissions and market authorization of six new drugs in cardiovascular, inflammation and tissue repair, anti-infectives, respiratory and rare diseases. He is currently a member of the ASA Safety Monitoring Working group. Krishan brings extensive experience in the application of statistical methodologies for the evaluation of safety and efficacy of investigational drugs.

Dr Ram C. Tiwari is the Director for Division of Biostatistics, CDRH, effective June 27, 2016. He joined FDA in April 2008 as Associate Director for Statistical Science and Policy in the Immediate Office, Office of Biostatistics, Office of Translational Sciences, CDER. Prior to joining FDA, he served as Program Director at National Cancer Institute, NIH, and as Professor and Chair, Department of Mathematics, University of North Carolina at Charlotte. Dr. Tiwari received his MS and PhD degrees from Florida State University in Mathematical Statistics; he is a Fellow of the American Statistical Association, and an Elected Member of the International Statistical Institute. He is a past President of the International Indian Statistical Association. He has published 200+ research papers on a wide range of statistical topics. His current research interests include developing frequentist and Bayesian methods in clinical trials and pre-and-post market drug/device safety evaluation.

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