(Part 2) What you need to know to strategize and prepare
By Neelu Agrawal
In our last post, Applicant Orientation Meetings: Seize the Opportunity (Part 1), we discussed what Applicant Orientation Meetings (AOMs) are and how they originated. In this post, we will cover the basics.
What is the purpose of an AOM?
AOMs have two primary purposes:
- Orient the review team to the content and format of the application
- Exchange early perspectives on the review
When does an AOM occur?
AOMs occur during the filing period, 30-45 days after receipt of the application. Applicants are typically told the division would like to hold an AOM during the Pre-NDA / Pre-BLA meeting and scheduling occurs after the application has been submitted. AOMs can be conducted via an online meeting / teleconference or in person.
Who attends an AOM?
AOMs are attended by key members of the FDA review team, including the division Director, cross-functional Team Leaders and individual reviewers. Other senior FDA officials may attend at their discretion – some of our clients have had over one hundred members of FDA participate! Due to space constraints, in-person attendance by the Applicant can be limited, but team members may participate by phone.
What is the agenda for an AOM?
AOMs generally last 1-2 hrs. The standard agenda is:
- Presentation by the Applicant (35-40 minutes)
- Q&A and discussion (20-25 minutes)
What should the Applicant present?
The FDA currently has the following general advice for what should be covered in the presentation[1]:
Administrative
- Applicant attendees
- Presentation outline
Background and Application Specifics
- Proposed Indication and Dosing
- Risk/Benefit Profile
- Drug/Biologic Characteristics and MOA
- Listing of Efficacy, Dose-Finding, and Activity-Estimating Trials
- Request for Approval Type (e.g. accelerated approval or regular approval); if accelerated approval, review of confirmatory trial design
- Regulatory History
Summary Content of NDA
- Clinical/Statistics (description of trial design, key findings)
- Chemistry, Manufacturing & Controls (CMC)*
- Nonclinical*
- Clinical Pharmacology*
- REMS*
- Summary
- Q&A
*These sections should be limited to 2 slides or less in the absence of unique circumstances
What questions will FDA ask in the meeting?
Questions range from administrative (e.g. where is xyz dataset located?) to substantive (e.g. what is the effect of xyz confounding factor on efficacy?). The questions provide valuable insight into the issues that are likely to be prominent in the review and the types of Information Requests that can be expected.
AOMs are clearly high stakes meetings. As with any high stakes meetings, it is critical to prepare. In our next post, we will discuss best practices – based on our years of experience.
[1] FDA’s General Advice for Applicant Orientation Meetings
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.
