Pre-BLA (Type B) Meeting Consulting Specialists

Snow Consulting will efficiently navigate your pre-BLA Meeting with the FDA.

Prospective Pharmaceutical Company Meeting with the FDA: A Path to Drug Approval

Introduction to Pre-BLA (Type B) Meetings

As a leading pharmaceutical company, our mission is to bring innovative and effective treatments to market, improving patient outcomes worldwide. To achieve this, we must navigate the regulatory landscape efficiently, ensuring our submissions meet the rigorous standards set by the FDA. A pivotal step in this journey is the Pre-Biologics License Application (Pre-BLA) meeting, a Type B meeting, which offers us the opportunity to engage directly with the FDA and address critical aspects of our marketing application.

Purpose and Objectives of the Pre-BLA Meeting

The primary goal of a Pre-BLA meeting is to discuss the planned content of our marketing application comprehensively. This crucial meeting allows us to:

• Identify and resolve any major outstanding issues from our development program.
• Familiarize the FDA review team with the pivotal studies that will demonstrate our product’s effectiveness.
• Assess the status and requirements of ongoing or planned studies needed to evaluate pediatric safety and effectiveness.
• Acquaint FDA reviewers with the overall information to be included in our marketing application.
• Discuss appropriate statistical methods for data analysis.
• Optimize the presentation and formatting of our data.
• Ensure readiness in Chemistry, Manufacturing, and Controls (CMC) for the BLA, including commercial manufacturing processes and product comparability, if applicable.

Submitting a Pre-BLA Meeting Request to the FDA’s Office of Therapeutic Products (OTP)

Our meeting request should be submitted as an amendment to the existing Investigational New Drug (IND) application. This request must include:

• A list of specific objectives for the meeting.
• A list of questions grouped by discipline, such as CMC, pharmacology/toxicology, clinical, and statistical concerns.

Upon receipt, OTP will respond within the timelines outlined in Table 3. They will either grant or deny the meeting request, providing the meeting date if approved or reasons for denial if not.

Timelines for Pre-BLA (Type B) Meetings

Action	Timeline
OTP Response to Meeting Request	21 days
Meeting Scheduling	60 days
Meeting Package Submission	At least 30 days before the scheduled meeting date
Meeting Length	90 minutes for original BLA submissions, 60 minutes for efficacy supplemental BLA
OTP Preliminary Response to Questions	No later than 2 days before the meeting
Sponsor’s Response to FDA Preliminary Response	No later than 24 hours before the meeting

Timing and Preparation for Pre-BLA Meeting Requests

We should request the Pre-BLA meeting well in advance of our planned submission. Ideally, the meeting should occur no less than two months before our BLA submission. Consequently, we should submit our meeting request at least four months before the anticipated BLA submission. For products eligible for rolling review, such as those with Breakthrough Therapy or Fast Track designations, we should avoid submitting portions of our BLA before the Pre-BLA meeting.

Content and Structure of the Pre-BLA Meeting Package

The meeting package should provide comprehensive information to facilitate a thorough discussion, ensuring the completeness of our BLA application. Key components should include:

• Topline results from clinical studies that form the primary evidence of effectiveness.
• An overview of the safety database, detailing the number of subjects exposed to the proposed dose/regimen, common adverse events, serious adverse events, and adverse events of special interest.

It’s crucial to limit the number of questions in the package to what can be reasonably addressed within the allotted meeting time. For a 60-minute meeting, a maximum of 12 questions is recommended, while a 90-minute meeting can accommodate up to 15 questions.

Best Practices for Managing Pre-BLA Meetings

Prior to the Meeting:

• OTP will send preliminary responses according to the timeline in Table 3.
• We must respond to OTP’s preliminary responses within the specified timeline.
• Identify which original questions we wish to discuss, listing them in order of importance.

During the Meeting:

• Focus on obtaining clarifications on OTP’s preliminary responses.
• Consider forgoing a presentation to maximize time for discussion.
• Reserve time at the end of the meeting to summarize key discussion points and action items.

Post-Meeting:

• OTP will issue official meeting minutes within 30 calendar days.
• We can submit our version of the minutes to summarize our understanding, though OTP may not review this submission.
• For any clarifications, we may submit questions to the Regulatory Project Manager within 20 calendar days of receiving the minutes.

Conclusion

Navigating the FDA approval process is a critical step in bringing our innovative treatments to market. By effectively utilizing the Pre-BLA meeting, we can ensure our application is robust, addressing any potential issues and aligning with the FDA’s expectations. This strategic engagement not only facilitates a smoother review process but also brings us closer to our goal of improving patient care through cutting-edge therapeutics.

So let Snow Consulting “guide you” or help with your pre-BLA Type B Meeting or the part that you need, give us a call, 714-553-3736.

We look forward to discussing your needs with you!