The greater the Medical Need for a new product and the greater the Medical Value of a new product in meeting this medical need, the faster the regulatory agencies, physicians and patients will want and lobby to have the product introduced onto the market.

The more hierarchical an organization, the more likely it is to have stronger silos acting as barriers to efficient and open communications.

Never start to answer a research question that requires an experiment, study or research until you are certain that it is the right question to address.

Compassionate plea protocols may serve in some cases as a second trial for an orphan drug to obtain approval. Even if it does not it often allows one to collect valuable data, if designed correctly, and if the optimal type(s) of patients are enrolled.