Accounting & Auditing Blog

Phase I of the FDA Approval Process: Communication Strategies (Part 2 of 5)

Don't forget to check out part one (Pre-Clinical Phase: Communication Strategies) of this five-part FDA approval process blog.

Now that we know about initiating relationships in the Pre-Clinical phase, we must continue this process by maintaining and growing these relationships In Phase I.

Regulators – Maintain a dialog and ensure there is sufficient information on your product’s safety and tolerability.  Avoid program delays by making sure all clinical trials are full.

Medical Scientific Community – Identify key opinion leaders (KOLs) and media and develop them as advocates.  Consider whether you want to publish results from your Phase I trials to help build your story. 

Patient Community – Be involved in discussions in advocacy groups and look for potential opportunities for recruitment for trials.  Be aware of new developments that relate to your product.

Investors – Support milestone completions by demonstrating the progress that’s been made and show them that you know how to run a business.  Ultimately, they aren’t investing in the product, but in how well they think you’ll be able to move the product through the process and to commercialization.  They’re investing in you.

Check back next week for part three of our FDA approval blog series.

To learn more about Skoda Minotti's Life Sciences & Innovation Accounting services leave a message below, or contact Marilea Campomizzi at 440-449-6800.

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