Howe's Law: Every man has a scheme that will not work.

Gordon's First Law: If a research project is not worth doing at all, it is not worth doing well.

First law of evolving system dynamics: Once you open a can of worms, the only way to re-can them is to use a larger can, giving you a bigger can of worms.

Ninety-Ninety Rule of Project Scheduling: The first 90% of the job takes 90% of the time, and the last 10% takes the other 90%.

The six phases of a project are:
1. Enthusiasm
2. Disillusionment
3. Panic
4. Search for the guilty
5. Punishment of the innocent
6. Praise and honors for the non-participants

Some people react to good or bad important news by going Mmmmmmmmmm, as if they already knew this or didn't care. This can be a useful technique to learn, or a ruse that you may want to challenge.

The concept of a product's medical value has to be carefully and creativiely built and developed. Medical value is not a simple concept and various ways of expressing this must be evaluated.

Agreements between a pharmaceutical company and an investigator have morphed over the last 35 years from being a gentlemen's agreement and a single page letter to a rigid contract geared to protecting the institution, preserving academic freedom and rights of the company.

Data from several small trials or even from case studies, can be combined in a meta-analysis to achieve a whole that is greater than the sum of its parts.

A clinical professional assigned to focus on patient retention in a clinical trial should be proactive and try to prevent issues that may lead to patient withdrawal.

One will make better decisions about a drug's development using high quality clinical data from fewer patients than by basing the decision on mediocre data from a large number of patients.

Challenge yourself and others to reduce the number of inclusion criteria, even for Phase 2 trials where you want a homogeneous population of patients.

While a statistical interpretation of clinical data is done by a statistician, the clinical interpretation of clinical data is done by a clinician. Even if a single person is trained and experienced in both fields the two processes are different.

Analyses of clinical data usually refer to statistical analyses. A clinician is important for making suggestions (to a statistician) of which analyses to conduct, both in advance of the trial being completed and after the initial analyses are completed.

Unexpected or strange interpretations should always be carefully assessed, questioned, and reassessed before they are either accepted or challenged.

One can improve the value of a product by focusing attention on how you refer to the product you are developing. The first point is to try and find another term than "drug" to describe the product. A few of the many alternative terms are: enzyme replacement, antidote, chemopreparative regimen, essential nutrient. Note that an enzyme replacement does not have to be an enzyme. The connotations of the chosen term may facilitate interactions with regulatory agencies and eventual marketing.

The closer that community based trials can approach the actual practice of medicine, the more willing practicing phsicians will be to accept the results of the trials and apply them to their own patients.

Active drug surveillance techniques can preempt accusations by a vocal consumer activist group that a company is not acting responsibly to investigate and study an issue or problem with one of its drugs.

If more than three people have to approve routine drug development proposals the company has an important issue to investigate as it is not being efficient.

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?"