Fast Tracking Your Way to Success

摘要

Recent reviews have suggested that it takes the evaluation of 10,000 compounds to produce one approved medicine containing a new chemical entity (NCE), and the development time is typically between 10 and 14 years with costs in excess of $1billion.1,2 Nevertheless, the continual discovery of new potential target pathways, the re-purposing of drugs, and advantageous regulation focused on orphan drugs is stimulating companies from the largest multinationals to the smallest single drug biotech startups to continue to invest time, effort, and resource in the development of the next commercially successful drug product. The development strategies taken by these companies can be very different, and a fundamental consideration is their attitude to risk. It is typically dependent on their funding structure and the funds they have available, the markets they are aiming for, their corporate culture as it relates to risk tolerance, and regulatory agencies assessment of the medical need for the product.