ABSTRACT
The challenges facing the biopharmaceutical industry today are many. These include pricing pressures, vanishing of the innovator's premium due to simultaneous competitive product introductions, loss of exclusivity from the blockbuster era, low-cost entrants, supply chain security challenges, decreased research productivity, and more. This chapter explores the role of managing the free flow of knowledge in this complex environment to overcome these challenges in a manner that ultimately benefits the patients and stakeholders of the company including employees and shareholders. Knowledge about products and processes is generated at each stage of a product's lifecycle, from development through supply. Manufacturing in the biopharmaceutical industry exists to ensure that safe and efficacious product reaches patients in a robust and reliable manner. Regulatory agencies have recognized the link between how an organization leverages knowledge and a product's quality. Workforce benefits extend well beyond the stewards.
