Dr. Schindler is VP, Biostatistics & Research Decision Sci. & leads the Late Development Biostat. groups in Merck Research Labs. He is involved in optimizing the development process of new drugs & biologics including use of innovative adaptive CTs & efficient integrated clinical info systems.
Dr. Rotelli is Director of PK/PD at Eli Lilly and Company. Formerly he headed the Statistics Divisions for Cardiovascular, Oncology, and MSK Global Product Development, Global Patient Safety, Data Mining, and Global Health Outcomes. Matt is a member of DIA and ASA. He chairs the DIA CER SWG.
Dr. Wilson has worked as a Statistical Reviewer and Supervisory Mathematical Statistician in FDA/CDER for 24 years and is currently the Director of the Division of Biometrics III and a Captain in the USPHS. He received his doctorate in Biostatistics from UNC/Chapel Hill in 1984.
Description
The statistical methods used in drug development are changing rapidly. This showcase will highlight the tip of the iceberg of the most important and controversial methods just beginning to be deployed. We will also discuss FDA reaction. Developed by the Statistics (ST) SIAC.
Learning Objectives: Identify recent trends in the use of statistical methods in clinical development Discuss competitive intelligence of what other companies are doing.