(Part 3) 5 best practices for preparation

By Neelu Agrawal

PharmApprove has a long track record of alerting our clients to the potential for an Applicant Orientation Meeting (AOM) – and ensuring that teams seize the opportunity. 

In our last two posts, we discussed how Applicant Orientation Meetings (AOMs) originated and the basics in terms of agenda, audience and presentation content. They are clearly high stakes meetings – and rigorous preparation is critical. 

Follow these 5 best practices to prepare:

  • Identify the likely review issues.  “Application fatigue” is common after the submission is complete.  Teams have been so immersed in their own perspective of the data, they can no longer think objectively about the vulnerabilities of the submission. However, it is important to start by stepping back to conduct an objective analysis of where the FDA may still have concerns.
  • Develop the key messages. You will have only 1 hour to present and answer questions. Too often teams begin writing the presentation without first deciding what key messages need to be delivered during the presentation and Q&A.  These messages should build a compelling case for approval, while also addressing the critical review issues.
  • Storyboard” the presentation.  The outline from FDA is a starting point, but it does not usually lend itself to a seamless narrative.  Think through your story.  Decide what the key message should be for each section and each individual slide.  Be sure to allow sufficient time for your discussion of Risk/Benefit and the key data that support approval.
  • Develop the slides and script . . . and REHEARSE.  The slides need to be concise and compelling. Data presentation should be visually impactful. Since time is short, develop scripted talking points. Be sure the slides support the script and vice versa.  Rehearse, time the presentation and rehearse again.
  • Prepare for Q&A.  Create an inventory of potential questions, decide who will respond and develop the responses. Align on the response strategy for the most critical questions and practice in role. Responses must be clear and persuasive.

AOM preparation is a core area of expertise for PharmApprove.  We provide objective, strategic counsel on the likely review issues, key messages, presentation and Q&A.  We also offer end-to-end support – including leading and implementing all aspects of preparation. 

Our support can be stand-alone or a synergistic extension of our other services, including our signature advisory committee service.

For more information on how PharmApprove can support your team, please contact info@pharmapprove.com

A copy of FDA’s General Advice for AOMs can be provided upon request. 

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