Accounting & Auditing Blog

Pre-Clinical Phase of the FDA Approval Process: Communication Strategies

I recently attended an event sponsored by BioEnterprise where speakers from ProEd Communications and Fleishman-Hillard discussed the importance of companies’ communication strategies during the FDA approval process. 

Overall, companies venturing down the FDA approval path want to ensure that the message they’re delivering throughout the process is accurate and consistent.  The product being approved should be solving an unmet need and you should be able to provide clear support for the science involved.  There are four key groups that you’ll be speaking to throughout the process including the regulators, the medical scientific community, the patient community and the investors.

Over the next few weeks, we’ll be overviewing the FDA approval process from the Pre-Clinical phase through the Approval phase. This week, we’ll start our series with the Pre-Clinical phase.  

In the Pre-Clinical phase, start initiating relationships.

Regulators – Introduce your concept and start to build credibility.  You may want to request a pre-Investigational New Drug (IND)/Investigational Device Exemption (IDE) meeting (optional).  According to the FDA’s website, the pre-IND meeting helps to foster communications between sponsors and new drug review divisions in order to provide guidance on the data necessary to warrant submission.  The pre-IDE meeting was designed to allow the sponsor to obtain early input from the agency on selected sections of the IDE application and help facilitate the initiation of clinical trials.  However, these meetings could cause delays in the process.  The cost and benefits should be weighed carefully.

Medical Scientific Community – Start to present your story, but be careful about how much information is disclosed.  Some of the information may be proprietary knowledge.  You should also start trying to assemble a scientific advisory board.

Patient Community – Find out who the key people are leading advocacy groups that relate to your product.  Work to understand where they’re coming from so you can communicate at the same level.  Don’t sell your product.  Be genuine.  Learn about your potential future customers and what they need.

Investors – Starting telling a simplified version of your story.  Your story should include the potential market opportunities, but be realistic about potential competition and how it will be addressed.

Check back next week for part two of five of our FDA approval blog.

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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