Know-how and Knowledge Management in pharmaceutical R&D

Corporate research and development (R&D) centers play a crucial role in the development of innovations. They ensure a financial return for the industry following the marketing of new products or services. These clusters require heavy investment before they are profitable, particularly in the pharmaceutical industry, where the development of innovative medicines takes several decades.

To recoup the costs incurred in the various stages of R&D at an earlier stage, it is possible to capitalize on a value other than the finished product: knowledge. Indeed, during the many stages in the development of an innovation, and in particular during the research stages, a great deal of know-how (SF) is generated.

The production of this knowledge is well known to the players involved in these processes. However, they are frequently unaware that it is possible to generate profits via these SFs by framing and formalizing them, to integrate them into a circumscribed legal framework: that of business secrecy. Indeed, the law on business secrecy, adopted on July 30, 2018, aims to ensure, for the benefit of companies, the protection of information with commercial value. Thus, the creation of a tool that lists these SFs in the form of a catalog enables, not only the dissemination of knowledge within the relevant teams in the company, but also the increase of credibility with other partners. By formalizing FH, it is possible to attribute a commercial value to it, enabling FH transfers to be carried out, in order to generate new profits. This knowledge thus becomes a real economic asset for pharmaceutical companies.

In addition, Knowledge Management (KM) methods can provide access to an exhaustive inventory of FS, and to a complete knowledge catalog. KM is therefore an ideal solution. Its use within companies has a dual objective: to provide a framework for know-how, and to reinforce the legal security of sensitive data.

This article highlights the various intellectual property issues associated with FS. An exhaustive range of possible KM methods is presented. It also describes the difficulties involved in collecting SF. Issues relating to cultural differences, particularly between France and the United States, are also discussed. In order to optimally protect a company's information and intangible assets, teams need to be systematically trained and encouraged to trace their FS in order to achieve quality KM.

A glossary of terms is provided at the end of the article.