Describe the basis for the initiation of the project and the blueprint for the targeted molecule, and outline the salient features of the disease and current therapy available. What was the initial concept, why was the compound needed? Areas such as medical need, business strategy, intellectual property issues, market issues, etc., may be discussed. A timeline of the key events in the drug’s discovery and development should be provided to aid the reader in following the subsequent discussion.
Discovery strategy and preclinical development:
A detailed analysis of the identification and validation of the compound under discussion. Depending on the nature of the strategies used, this may cover target identification and validation, library screening, assay development, PK/PD, ADME-Tox, in vitro work, animal studies, modelling, translational medicine and so on. An overview should be provided of the methods used, the rationale for their use and the results obtained. Points of diversion from classical development pathways, new technologies, registration strategies and other novel aspects should be highlighted. Detail of the studies need not be as extensive as that required for an original paper but must contain sufficient description of the protocols and outcomes, so that the reader can make appropriate comparison with his/her own experience. For a detailed description of the methods and data, readers should be referred to the original work. Details of any patents filed should be provided here. The section can end with a discussion of the preclinical to clinical transition, which leads logically into the next section. This section should form the main focus of the article.
This section should highlight key trials and data leading to the launch of the drug. Again, this should be presented as an overview in which readers can be referred to original papers for detail.
A discussion of key events following the launch of the drug; for example, postmarketing data, studies on market, safety and pharmacovigilance, success of the drug, what are its main competitors, is the drug due to come off patent, controversial issues arising since the drug’s launch.