As the Biopharma industry continues to go through significant transformation there are many core capabilities that Biopharma companies must have. But perhaps none is more important than the ability to effectively discover and launch new products. There are many key milestones that a successful biopharmaceutical company achieves during its journey from a start-up to a vertically integrated company. Some are externally visible, such as discovering a breakthrough new molecular entity (NME), shepherding the NME through late-stage development, receiving approval from the Regulatory Authorities, and launching a new drug. Other milestones are more subtle internal indicators of a biopharma’s capabilities and progress down its maturity curve as an organization.
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In The Headlines
Lorraine Moore | Accelerate Success Group
Articles, conversations, and debates abound over the cohort of adults born between 1980 and 2000. Coined the Millennials and Generation Y, the eldest have reached their mid-30s and occupy technical and management positions. They are the successors to Generation X and Baby Boomer executives and corporate leaders. What are the implications for Life Sciences and the Pharmaceutical industries and what shifts have already taken place?
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Topic of Discussion
Ken Bechard | Novitex
In today’s highly regulated and complex medical device world, document control and management are critical to an organization’s success. Creating, producing and archiving all of the materials related to a product, such as a design history file or spec sheet, can be a daunting task especially considering aggressive development cycles, disparate teams and stringent regulatory requirements.
These factors have placed tremendous pressure on the traditional document processes organizations use today and created several challenges companies need to address in order to reduce risk and increase compliance. Before beginning to tackle the issues at hand, it is critical that manufacturers understand the requirements they must comply with first.
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