Come Meet Zoran | Tuesday, August 11th, 10:15 AM (between sessions) | Booth #431
Optimization of Pharmaceutical R&D Programs and Portfolios: Design and Investment Strategy (Springer, 2014)
Zoran Antonijevic and fellow experts address the impact of study design on maximizing output at the level of pharmaceutical portfolios. This is the only book on the market which examines the critical issues of portfolio optimization by integrating input from multiple development stakeholders. The result is an integrated approach that considers value propositions earlier by incorporating marketing, commercial and medical perspectives.
Come Meet Cyrus | Tuesday, August 11th, 3:45 PM (between sessions) | Booth #431
Designs for Clinical Trials - Perspectives on Current Issues (Springer, 2012)
This book examines current issues and controversies in clinical trial design, including topics in adaptive and group sequential designs and the design of studies in which missing data is anticipated. In the his chapter, Cyrus examines the process of identifying the optimal application of adaptive sample size re-estimation methodology. The result serves as a guidebook for today's statistician engaged in trial design.
Come Meet Nitin and Jim Bolognese | Tuesday, August 11th, 12:30 PM | Booth #431
Practical Considerations for Adaptive Trial Design and Implementation (Springer, 2014)
This volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. Nitin Patel and Jim Bolognese of Cytel each contribute key chapters, joining fellow authorities including FDA/CDER's Sue-Jane Wang. Covering the full spectrum of topics involved in the adaptive designs arena, this volume serves as a valuable reference for researchers working in industry, government and academia.
Following a 33 year stint with Merck Research, Jim joined Cytel in 2008 to work on adaptive clinical trial designs and software development. Jim has worked and published on dose-adaptive designs in clinical pharmacology in the 1980’s, and as part of his experimental medicine statistics role, studied and assisted in design and implementation of dose-adaptive designs to accomplish proof-of-concept and dose-ranging objectives in a single study. Additionally, Jim has designed and served as blinded statistician on the steering committees of two large outcomes trials. He is coauthor of over 60 papers in the biostatistics and medical research literature.
