Accounting & Auditing Blog

Phase II of the FDA Approval Process: Communication Strategies (Part 3 of 5)

Don't forget to check out parts one and two of this five-part FDA approval process blog.

Now that we know about initiating and maintaining relationships, we will continue on to Phase II where we will learn how to take action on these relationships.

Regulators – Early on you should be establishing your target product profile, looking at doses, regiments, end points and patient outcomes.  Consider whether you should take the Fast Track or Orphan Designation.  According to Wikipedia, the Fast Track program speeds up the approval of INDs undergoing clinical trials with the goal review time of 60 days.  The purpose is to get important new drugs to the patient earlier.  Similarly, an Orphan Designation allows for less statistical burdens in order to keep momentum going in the development process.  There could be certain advantages to both options.  It’s also important at this point to have an End of Phase II meeting.  Statistics show that those sponsors who have End of Phase II meetings have a higher success rate in the approval process. 

Medical Scientific Community – Be transparent and consistent with your message.  Start telling more of your story to get your contacts from this group excited about your product and its potential.  Describe the unique aspects and the benefits.  This is also the time when formal publications should start occurring to report the results of the trials performed.   

Patient Community – Start to sponsor events to help generate awareness about the problem that your product will be solving.  Sponsoring events also allows you to show your support for the community.

Investors – Determine how to generate a liquidity event in order to fund Phase III and budget for upcoming costs. 

Check back next week for part four 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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