Dear Colleagues,
The International Chinese Statistical Association (ICSA) is pleased to announce our next webinar on May 17th presented by Naitee Ting, who is currently the Director in the Department of Biostatistics and Data Sciences at Boehringer-Ingelheim Pharmaceuticals Inc.
- Speaker: Naitee Ting
- Title: Clinical Development Plan - Understanding the big picture as a statistician in pharmaceutical industry
- Date: Friday, May 17th
- Time: 3:00 PM - 4:00 PM EST / 12:00 PM - 1:00 PM PST
Registration (Zoom, free): ICSA Webinar Registration
Abstract: Most drugs start out as a simple chemical compound. Chemists and biologists study a certain disease process, and synthesize many compounds in the laboratory with the hope that some of these compounds can help patients with this disease. If a compound demonstrates good efficacy and low toxicity, this compound will progress into animal testing (non-clinical studies) and human testing (clinical studies). Clinical trials are broadly divided into 4 Phases – Phases I, II, III, and IV. A clinical development plan starts with a draft drug label, known as the target product profile (TPP). Each phase of clinical development is planned according to this TPP. In this presentation, we will discuss how statistical thinking is applied in supporting the CDP.
About the Speaker: Naitee Ting is a Fellow of American Statistical Association (ASA). He is currently a Director in the Department of Biostatistics and Data Sciences at Boehringer-Ingelheim Pharmaceuticals Inc. (BI). He joined BI in September of 2009, and before joining BI, he was at Pfizer Inc. for 22 years (1987-2009). Naitee received his Ph.D. in 1987 from Colorado State University (major in Statistics). He has an M.S. degree from Mississippi State University (1979, Statistics) and a B.S. degree from College of Chinese Culture (1976, Forestry) at Taipei, Taiwan. Naitee published articles in Technometrics, Statistics in Medicine, Drug Information Journal, Journal of Statistical Planning and Inference, Journal of Biopharmaceutical Statistics, Biometrical Journal, Statistics and Probability Letters, and Journal of Statistical Computation and Simulation. His book "Dose Finding in Drug Development" was published in 2006 by Springer, and is considered as the leading reference in the field of dose response clinical trials. The book "Fundamental Concepts for New Clinical Trialists", co-authored with Scott Evans, was published by CRC in 2015. Another book "Phase II Clinical Development of New Drugs", co-authored with Chen, Ho, and Cappelleri was published in 2017 (Springer). Naitee is an adjunct professor of Columbia University, University of Connecticut, and Colorado State University. Naitee has been an active member of both the ASA and the International Chinese Statistical Association (ICSA)
This webinar is sponsored by the ICSA. Interested in viewing past webinars or learning more about the ICSA webinar series? Please visit the ICSA website for more information: https://www.icsa.org/webinars/upcoming-webinars/
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Qing Yang
Associate Research Professor
Duke University
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