Opinion in 2007

To fully realize the potential of molecularly targeted therapies for cancer and other human diseases, a new level of knowledge about the complex cellular control circuitry is required. Here, the authors explore mathematical paradigms that facilitate the design of network-targeted anticancer drugs.

The digital information revolution has led to the rapid development of many countries, causing the pharmaceutical industry to face a new array of Asia-specific challenges. Epstein discusses how understanding Asia's diverse cultures, talents and markets will bring about success for the industry.

Few truly innovative drugs for central nervous system (CNS) disorders have been approved in recent years, suggesting that there is a need for strategies to improve the productivity of research and development in this field. The authors describe approaches that are being taken to discover CNS drugs, discuss their relative merits and consider how risk can be balanced and attrition reduced.

The scientific and regulatory issues associated with the possible introduction of 'follow-on' versions of protein drug products are currently attracting much attention. Past examples are discussed of the FDA's actions involving the evaluation of various types of follow-on and second-generation protein products and within-product manufacturing changes with a view to illustrating the FDA's scientific reasoning in this area.

Pathological angiogenesis plays a role in a wide range of diseases. Folkman argues that viewing angiogenesis as an 'organizing principle' in biology can lead to novel insights into the molecular mechanisms of seemingly unrelated phenomena, and facilitate the development of new therapeutic approaches.

The therapeutic success of monoclonal antibodies has led to a steep rise in the use of non-human primates for preclinical safety testing. Chapman and colleagues report from a recent workshop on this topic, and discuss the economic, scientific and ethical questions raised by this development.