Bert Spilker's Pharma Principles of The Week
Posted by: Bert Spilker
- To win the hearts and minds of regulators one must first establish the medical need for a new product, i.e., the public health message, and then establish the medical value of your product in terms of how well it addresses the medical need.
- It is legitimate to ask how much it costs to develop a drug when all failures and other costs are included. It is also legitimate to ask how much it costs to develop a single drug excluding other costs.
- Seek a balance between having too many projects where they slow each other and too few where a company risks its ability to survive on a few projects that may or may not succeed and achieve the company’s goals.
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).