Outlook in 2006

The open-source software movement has successfully pioneered several strategies that might also be applicable in drug discovery and development. Munos considers the challenges involved, and proposes a model to harness the potential of open-source drug R&D.

The reasons for the shortage of new drugs coming through the pipeline are the subject of much debate, and the pipeline for diagnostics is one factor that will become increasing relevant to this problem as the co-development of drugs and diagnostics becomes more common. Phillips and colleagues examine the characteristics of the pipeline for diagnostics and biomarkers, and consider what steps could be taken to solve the problems identified.

Companies can decide to pursue switches from prescription (Rx) to over-the-counter (OTC) status for their drugs for various reasons, such as life-cycle management. Mahecha examines the rationale behind switches, the switch process and case studies of switches in the United States to understand the factors for success and anticipate future trends.

Prior studies have suggested that late market entrants within a drug class frequently outperform first entrants. This idea and the general relationship between entry order and quality attributes are explored by Cohen, with a focus on the implications for innovation strategies.

Most monoclonal antibodies so far have been developed for treating cancer or immune disorders, but opportunities for the development of monoclonal antibodies to target infectious diseases seem to be increasing. Reichert and Dewitz analyse trends in the development of anti-infective monoclonal antibodies and discuss factors that influence their success.

Sánchez-Serrano discusses the story of the innovative anticancer drug bortezomib to dissect the key public-sector-private sector interactions that made the development of this drug successful despite many barriers, and considers the implications for improving translational research in general.