With one approved biosimilar under its belt, and dozens more under review and in development, FDA’s biosimilar development program is moving “beyond the finish line”. But agency officials still have much to do to address critical issues related to product analysis and testing.
The Alliance for Clinical Research Excellence and Safety (ACRES) is advocating a “systems thinking” approach in efforts to meet increasing demands to standardize and integrate support for trial sites. Casey McDonald reports.
There is much talk today about "open innovation" in business and research forums—but what exactly does it mean? How does open innovation as a concept apply to the pharmaceutical sector? Does it signal a change in the way pharmaceutical companies approach research and innovation?
As brands are required to produce more and more data to convince not only regulators, but payers, physicians, and patients, Jeffrey Jonas is pushing Shire's "search and develop" R&D model into new and sometimes uncomfortable territory.