Bert Spilker's Pharma Principles of The Week
Posted by: Bert Spilker
- Sunset clauses for all discovery projects are a useful means to insure the company reviews progress on the project to confirm it should be continued. These may occur every two years or at other pre-assigned times.
- The army has a motto that there is never enough time to do it right, but there’s always enough time to do it over. A company’s motto must be: We must do it right the first time.
- 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.
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).