However beautiful the strategy, you should occasionally look at the results.
Winston Churchill, British stateman and author
However beautiful the mechanism of action, you should occasionally look at the evidence that supports it.
Bert Spilker, author and consultant

Nothing is impossible. Some things are just less likely than others.
Jonathan Winters, comedian and author

Emperor's Advocates are people who tell the Emperor that his last comment has made the bullshit detector go off the scale.

Have you ever noticed that most people's sense of humor improves as they rise on the corporate, government or academic ladder. This is usually a function of those who report to them wanting to please and appreciate their boss's attempts at humor.

Perform all activities as if they are the only things that matter.

Pharmacokinetic, quality of life and pharmacoeconomic studies can be designed as add-on or as free standing clinical studies.

Golden rules help a company decide where they are in terms of standards and where they want to be. Golden rules also provide a path to help guide changes toward the goals.

Consider the degree of extrapolatability of every clinical trial and every pre-clinical experiment designed. For example, it is generally desirable to use strict inclusion criteria in Phase 2 to obtain a fairly homogeneous and narrow patient population, whereas in Phase 3 it is usually the opposite. Thus, large Phase 3 trials include patients with other diseases, other drugs and other types of medical status to enable the sponsor to be able to extrapolate the data to a greater proportion of the entire patient population to be treated.

Zero based inclusion criteria means that each protocol starts with a tabular rosa. Only those criteria that are essential are added. Each criterion is kept as broad and least restrictive as necessary (e.g.,age limits).

Truly great scientists do not generally make good managers. Creative scientists must be encouraged, stimulated and rewarded so that they are happy to remain creative scientists.

Good managers do not generally make good leaders. Good leaders will have charisma, charm and qualities that encourage people to follow them. Good managers have other traits that get things done efficiently and on-time and on-budget.

The regulatory cascade consists of laws that lead to regulations, which lead to guidelines, which lead to points to consider, which lead to formal recommendations, which lead to podium policy, which lead to informal comments, and which finally lead to gossip.

Harmonizing regulations at ICH prospectively before any regulations exist is a lot easier and more efficient than attempting to harmonize them retrospectively, where three different sets of regulations exist and have to be harmonized into a single whole.

When you are asked for a date when you can complete an assignment, always ask: "When is it needed?"

Without pharmaceutical, biotech and genetic research, mankind has little hope of major advances in treating disease, but public support for clinical research is a mile wide and an inch deep.

Exercise great caution in hiring academic or government executives into the industry as you may have to spend years of "on the job training" to have them reach the state that many industrial managers are at today. Many acacdemic and government executives, managers and scientists never adapt adequately in industry, and a company takes a great risk in hiring these professionals, regardless of their experience and intentions.

Always maintain a sense of urgency in your work, and be cautious if you are told that you can "take it easy."

Remember that when a person is doing X they are not doing Y and when a person is doing X and Y they are not doing Z. The same principle holds for a company.

Accept responsibility for your actions and errors and do not make excuses or become defensive. Rather than saying "it's not my fault" seek a solution that helps everyone.