After developing, maintaining and taking action on our relationships we continue this process with Phase III, where we will utilize and expand these relationships.
Regulators – Gain agreement on New Drug Application (NDA) filing intentions. Be transparent with the FDA on your Phase III data and risk management plans. Prepare for your FDA advisory committee meeting that will occur after approval (public forum). According to the FDA’s website, the FDA uses 50 committees and panels to obtain independent expert advice on scientific, technical and policy matters. Be prepared to discuss safety risks, risk management, and a SWOT analysis. Restrictive use of your product may result during this time period and you should be ready to update your labeling if necessary.
Medical Scientific Community – Planning is key. Start to get information out to the public, but in an appropriate manner. Make sure the information that is communicated is accurate. Do not make promises to the public that have not been approved yet by the FDA. These could cause regulatory “trip wires”. Evaluate datasets for subset analysis opportunities. Work to understand the mindset of any opponents to your product and be prepared with your support to refute their arguments.
Patient Community – Start to drive conversations related to the unmet need that your product meets. When the data is approved and finalized you’ll be able to present your product as THE solution. In the short term this approach may help your competitors, but in the long term your product will be proved as the best option. During this phase, any discussions should be done in an unbranded manner because your product has not been finalized. Continue to build relationships with KOLs and use connections to introduce KOLs to reporters who will benefit from someone who can provide knowledgeable information for articles.
Investors – Demonstrate clearly the path that will be taken from approval to commercialization and provide third party assessments of the market potential of the product. This is also the time to communicate with investors other products that are in the pipeline. You should be able to prove that you’re not a one-trick pony.
Check back next week for part five 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.