The state-of-the-art is often too advanced for the appropriate development level and approach to use. This is often seen in the ability to measure blood levels at a far more precise level than can be used clinically to make decisions.When words like “compliance” or “risk” are being used does everyone know which definition you are using? These and many others have innumerable different definitions for people who approach discovery, development and marketing from many perspectives.
Using higher medical and scientific standards than required often trumps the competition, as they will be trying to take some shortcuts, and the FDA and others will be likely to raise the bar for approval when they see the standards you are using.
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).
