title: Does process excellence handcuff drug development?
abstract: R&D expenditures in the pharmaceutical industry have been increasing, whereas the number of new drugs has stagnated. The patent cliff and increasing pricing pressure from payers urge for greater effectiveness and efficiency throughout the industry, including R&D. Good processes are at the heart of increased efficiency, while carefully maintaining and expanding freedom for scientific exploration and innovation. Primary targets for process improvement are service platforms, administration and interactions with suppliers, which are already applicable during the early research phase for new products. Further down the value stream, developments such as quality by design (QbD) promise increased flexibility in manufacturing processes on the condition of increased process understanding and control, based on mature process governance and management.
authors.affiliation: Software AG, IDS Scheer Consulting, Altenkesseler Str. 17, D-66115 Saarbruecken, Germany. jochen.koenig@softwareag.com
authors.forename: Jochen
authors.initials: J
authors.lastname: Koenig
mesh_terms: D055808:Drug Discovery / Q000191:economics* / Q000379:methods / Q000592:standards*; D004345:Drug Industry / Q000191:economics* / Q000592:standards*; D012106:Research / Q000191:economics* / Q000592:standards*