January 14, 2009

Do your best to eliminate fads and hype in management styles and be skeptical of all claims by vendors and consultants

If you cut enough corners you eventually go around in circles

Harmonizing regulations at ICH should ideally be done prospectively, before any exist, as it is much easier than harmonizing them retrospectively, when three different sets of regulations have to be harmonized into a single whole

To win the hearts and minds of regulators one must establish the Medical Need for a new product (i.e., the Public Health message) and then establish the Medical Value of your product in terms of how well it addresses the Medical Need.

The Development Process begins the day the company agrees on a specific product (e.g., compound, device, agent) they will take to the clinic for testing.

The army has a motto that there is never enough time to do it right, but there is always enough time to do it over. A company's motto must be "We must do it right the first time."