To win the hearts and minds of regulators one must 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.
The Development Process begins the day the company agrees on a specific product (e.g., compound, device, agent) they will take to the clinic for testing.
The army has a motto that there is never enough time to do it right, but there is always enough time to do it over. A company's motto must be "We must do it right the first time."
SPILKERISMS
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Spilkerisms presents weekly postings of pithy comments and pearls from myself and others that will help people remember the principles, tips and lessons of developing, discovering, marketing, regulatorily approving and related topics for new pharmaceutical and medical products, including drugs, medical devices, biotechnology products, diagnostics, vaccines and others. These pearls will help avoid errors and increase one's chances of success. Reader feedback is welcomed. Readers wishing more information may visit my website (www.bertspilker.com) or email me at bspilker@comcast.net. My latest book "Guide to Drug Development: A Comprehensive Review and Assessment" is available from Lippincott, Williams and Wilkins in Philadelphia (pub. 2009).
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