Develop and implement patent-extension strategies as soon as an NDA/BLA is approved, if not before.

Working hard to build and maintain a strong and positive relationship with each regulatory group and division you work with will pay important dividends.

Pharmacodynamics is what the drug does to the body after reaching the receptors, and pharmacokinetics is what the body does to the drug.

Good ethics may be defined by answering two questions: Would I do this for my children and how would I feel if this is put on the front page of the nation's top newspapers?

Good ethical standards motivates staff, builds morale and promotes sleep.

"If everybody is thinking alike, then somebody isn't thinking." George S. Patton,Jr. US WWII general

"Wisdom consists not so much in knowing what to do in the ultimate as knowing what to do next." Herbert Hoover, 33rd US President

Using visual models of drug development enables one to conceptualize the strategy for development and to determine if new proposals fit the model or are tangents.

Steps to shorten the time for drug development are usually under the company's control moreso than that of the regulatory agencies, particularly in terms of further gains to shorten this period

Asking the reight question is the single most important aspect of conducting successful research. It is the starting point of the experimental process. Never start to answer the question until you are certain that it is the best one and is phrased as well as possible.

Golden rules of drug development (and of each of the components of drug development) are not only principles and standards to use, but include the best practices, and also represent goals to achieve.

The primary goal of regulatory agencies is not to approve new products but to ensure that existing products and any new ones will help the public while minimizing any harm to patients.

Utilizing operations manuals in clinical trials facilitates the ability of the staff to answer their own questions and to perform a trial more efficiently.

Internal benchmarking tracks activities and is extremely important to measure and assess progress toward one's goals. External benchmarking is generally a case of chasing the other guy's tail. If external benchmark data can be validated then those data will also have great value and may influence decisions.

Success is based on achieving many small goals, and castles are built one stone at a time. Of course having 1000 competent workmen on a project does not hurt, especially if they are working with a sense of urgency under competent supervisors and with a well planned blueprint.

At the start of a project, planning is 100% of the work, but when one is implementing the plan and doing the work it rapidly consumes less time, as long as the plan is reviewed to ensure it remains viable, and the work being done is appropriately monitored.

Some staff never seem to wait for required information and data before making decisions and initiating actions. It is essential to identfiy these people and to speak with them about jumping too soon. Of course the opposite extreme is also a major issue or problem.