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).
