Awakening the dragon´s breath: biostatistics, competency and competition in the pharmaceutical industry

Innovations in chemistry and biology have generated multiple products and built significant revenue streams in the pharmaceutical industry. However, the complex and multi-disciplinary process of drug discovery and drug development makes it difficult to identify specific core competencies within a company. There is a need to better identify and manage sources of innovation that lead to new markets as ever-increasing investments in R&D have recently been accompanied by mediocre success in new product introduction. Additionally, outsourcing of clinical research and even early-stage discovery research continues to increase, creating a need to better define core competencies for strategic management decisions in pharmaceutical innovation In this context, we investigated the possible role that biostatistics -a key competence-could play in innovation in the drug development process. A sampling of case interviews from biostatisticians and executives in the pharma industry indicate that biostatisticians do contribute to innovation in the drug development process. Data gathered from contract research companies in the pharma industry suggests that outsourcing practices in the pharmaceutical industry increasingly include the outsourcing of biostatistics capabilities. We conclude that pharmaceutical companies should consider directing their management and outsourcing practices to retain and gain novel innovation through biostatistics.