There is a wide spectrum for discovering new drugs and new uses for marketed drugs that ranges from purely rational to that of pure chance or serendipity.

There are three key levels to think about various issues and topics: the overall industry, the specific company and a specific drug or product.

In the past, time was generally viewed in drug development (particularly in large companies) as the single most precious resource you had to spend, but in recent years the importance of financial resources has become steadily more important, and often has become the most critical factor.

Excessive travel for workers and also managers is counterproductive and wasteful of a company's resources, not to mention the wear and tear on the person and their family. They are unavailable for various activities from signoffs to internal meetings. The true need for all travel must be carefully examined before being approved.

A leader who gets too far in front of his team will be marching by himself.

Many people on the frontiers of knowledge disappear from view.

Do not issue reports as final if they may need a longer gestation period and more thought or possibly more data. Documents that may be altered after review by Regulatory Agencies (e.g., some medical reports) may also be kept in draft form until approved.

Seek a balance between having too many projects where they slow each other's progress, and too few where a company risks its ability to survive with only a few projects that may or may not succeed and achieve the company's goals. A balance does not mean equal numbers.

Seek a balance between initiating too many high risk projects where you make assumptions of how a drug will behave, and being too conservative and avoiding most risks, by not wanting to make assumptions of how a drug will act.

The state-of-the-art is becoming so advanced in several technical areas that it is not the most appropriate standard to use for medical product development. For example, minute amounts of a drug may be measured in blood, but those levels are not needed or used to make clinical decisions and do not provide relevant safety data.

New drugs and other medical products are like one's children. One has to be very careful with their development until they are old enough to be independent and on their own. This usually occurs some time after the product reaches the market and firms up its safety and efficacy profiles.

Consider the pros and cons of a multinational clinical trial before it is agreed to. Three adequately powered uni-national trials are usually preferable to one large multinational trial.

The primary reason why clinical trials fail is because of problems with patient recruitment.

Ask yourself whose responsibility it is to create a strategy that will recruit patients for a sponsored clinical trial. If you said "the investigator" you are wrong. It is the sponsor's responsibility to create a strategy that will be successful, and if there are problems, it is the sponsor's role to learn the cause of the problem and to adjust the strategy to ensure it succeeds.