BioPharm International-11-01-2007

An overall increasing proportion of future product approvals will be engineered in some way, either directly or indirectly.

The biopharmaceutical sector can look forward to a financially flush venture funding environment in 2008

The challenge is not in coming up with a list of activities to discard, but in finding a feasible way to stop doing them.

Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development

Contrary to popular belief, the out-of-specification problem started years before the Barr Decision.

A true visionary leadership is required to drive the progress of operational excellence programs in biopharmaceutical organizations

CMOs must take a proactive approach to ensure the availability of local talent

Biotechnology is definitely a hot topic in China-the country's administrators recently identified it as a "cornerstone of China's national economy by 2020." But most realize that getting there will require a better trained, specialized workforce than currently exists. The Chinese government has been pumping money into life sciences education as part of its plan to achieve a global biotechnological presence over the next 15 years.

The industry needs a clear regulatory pathway for the approval of biosimilars.