Registration Deadline: Tuesday, September 25, at 12:00 p.m. Eastern time
Please see below for information regarding the Biopharmaceutical Section Webinar given by
Drs. Naitee Ting and Qiqi Deng scheduled for
September 27, 2018. Details and registration at
www.amstat.org/ASA/Education/Web-Based-Lectures.aspxIf you any question about the registration, please contact Rick Peterson (
<maskemail>rick@amstat.org</maskemail>)
Title: An Innovative Design to Combine Proof-of-Concept and Dose Ranging
Presenter: Naitee Ting and Qiqi Deng
Date and Time: Thursday, September 27, 2018, 12:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section
Registration Deadline: Tuesday, September 25, at 12:00 p.m. Eastern time
Description:
In Phase II clinical development of a new drug, the two most important deliverables are proof of concept (PoC), and dose ranging. Traditionally a PoC study is designed as the first Phase II clinical trial. In this PoC, there are two treatment groups – a high dose of the study medication, against the placebo control. After the concept is proven, the next Phase II study is a dose ranging design with many test doses. This presentation proposes a two-stage design with the first stage attempting to generate an early signal of efficacy. If successful, the second stage will adopt a "Go Fast" plan to expand the current study and add lower study doses of the test drug to explore the efficacy dose range. Otherwise, a "Go Slow" strategy is triggered, and the study will stop at a reduced sample size with high dose and placebo only.
Speaker Bios:
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 and University of Connecticut. Naitee has been an active member of both the ASA and the International Chinese Statistical Association (ICSA).
Dr. Qiqi Deng is a Senior principle Biostatistician at BI. She is currently a member of the Methodology Expert team within global statistics, which focuses on statistical methodology innovation. Her research area includes hypothesis and modeling in dose finding, pragmatic considerations in designing dose finding trials, including adaptive design aspects. Before she joined the methodology group, she has served as leading statistician for multiple projects, across different clinical development phases and therapeutic areas. Dr. Deng received her B.S. degree in Mathematics from Peking University in China, and obtained her Ph. D. in Statistics from University of Minnesota.
Registration Fees:
Biopharmaceutical Section Members: $0
ASA Members: $59
Nonmembers: $74
Each registration is allowed one web connection. Sound is received via audio streaming from your computer's speakers. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).
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Wei Zhang
Mathematical Statistician
FDA
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