Using "common sense" to address or solve a problem may lead you off-track, because what is considered common sense in one country, and by one group of people, is not always considered as common sense in, or by, another.

The perception of a new product's medical value goes through a series of stages: from unrealistic optimism, to unrealistic pessimism, and eventually to a balanced view.

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, and no excuses are accepted.

The drug development pipeline is not rigid, and is better viewed as a long flexible snake, which sometimes swallows a bowling ball, and at other times a ping pong ball. The efforts of the company and staff to pass a bowling ball through the snake will slow most of the other projects the snake has going through it.

Safety and efficacy standards can be viewed as a pair of high jumps for the product to exceed. As safer and more effective drugs reach the market, these bars become progressively raised.

Multinational clinical trials require many more resources and effort than a group of multisite uni-national trials. Is the juice worth the squeeze?

Accept your mistakes without being defensive.

The rule of meetings: From listening comes wisdom and from speaking repentence

When you know one division of FDA you know one division---and often not even that one

It's not sufficient to have SOPs in place. The company must ensure that their busy staff are following them, and that there is a system to keep SOPs up-to-date.

Never describe anecdotal information as data

Success is based less on brilliant ideas than on excellent execution of those ideas.

Avoid procedure bloat in a protocol. This occurs when a clinical trial protocol is prepared by taking the previous one for that product and adding some additional tests. This is fairly commonly done for drugs or biotech agents passing down the development path.

The impact of a statement equals its intrinsic value times the author or speaker's position in the organization to the 3rd power.

Some managers spend most of their time managing UP to their bosses, whereas others spend most of their time managing DOWN to their staff. Others spend their time with peers and ignore both up and down management. How do you balance your time as a manager? Just managing down with subordinates is not very good if you are beating down while you are sucking up.