ABSTRACT

In the pharmaceutical industry, patents protecting the key molecules that are the essential ingredients in the development and manufacture of the drugs are the fundamental currency. In a leading US pharmaceutical company, an identified gap in the future product pipeline between drugs already in clinical trials and those still in discovery prompted the need to acquire additional molecules that were in development external to the firm. A number of recent failures of prospective new products in 296testing had culminated in this break in the pipeline. Only by filling a gap that corresponded to about two or three years of the typical ten-year development cycle would the company be able to maintain the continued and constant release of major new drugs into the marketplace, something that it, its customers, its investors and the markets all expected. The fact that previous successes and failures during the early discovery stages of new drug development had coincided to produce such a lengthy gap could not have been predicted up front. However, once it had occurred and had consequently been identified as a key area for action, some means of solving the problem had to be defined. For this, the analysis of options available, ranging from full-scale merger with a competitor with a complementary pipeline through to the acquisition of a number of smaller players with the sought-after molecules at the right stage of development, had in the end pointed at a combination of in-licensing and partnered cross-selling as the most appropriate solution. This would provide both additional molecules that could progress through the company's own clinical trials and product launch processes, as well as approved drugs that could be strategically co-branded with the respective manufacturers so that a stream of new products would continue to enter the company's product portfolio. However, despite this clear strategic intent and focus, before this approach could be implemented it had first to be designed:

Candidate companies and appropriate molecules had to be clarified

The in-licensing process itself had to be developed

Due diligence activities had to be planned

Regulatory approval procedures had to be verified

The necessary financial resources had to be secured

The required human resources had to be made ready for deployment

Individual projects needed to be scoped and team leaders identified

Overall strategic options and considerations had to be reviewed

Applicable metrics and reviews to monitor progress had to be established.