Bert Spilker's Pharma Principles of The Week
Posted by: Bert Spilker
- Internal benchmarking tracks activities and is extremely important to measure progress toward goals. External benchmarking is generally a case of chasing the other guy’s tail. If the external data can be validated then those data will also have value.
- Good ethics and high scientific and medical standards can and should be used as a means to beat the competition. Regulatory agencies may raise the bar for others developing similar products, if you have raised it yourself.
- Using minimally acceptable criteria for continuing with a product’s development facilitates the best business decisions and helps to avoids games being played on prematurely terminating or prolonging a dying or even a dead project.
Bert Spilker , PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).