Adaptive Designs in nQuery - Case Study

Effective and Efficient Drug Development

Challenge

Increased Cost, Risk, and Competition in the Drug Development Processes
Dr. Luis Rojas, the Executive Director Head of Biostatistics at Target Health, is a subject matter expert in study design and sample size calculations with more than 30 years of industry experience.

He has worked in the leading CROs in the industry and has assisted pharmaceutical companies with the drug development process with clinical trials, programs, and portfolio designs. His experience extends from preclinical, phases I through IV, biosimilar, and bioequivalent using fixed, adaptive designs, stand-alone, and master protocols in multiple therapeutic areas.

Today this work presents new challenges. Drug pipelines are larger than ever before, while the cost of bringing new drugs to market has nearly doubled in the past decade. This trend has compressed drug development ROIs and increased competition.