A Storybook Approach for A Successful End of Phase II (EOP2) CMC Meeting

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A Storybook Approach for A Successful End of Phase II (EOP2) CMC Meeting

Storybook

STORYBOARD DEFINITION

What is a storyboard?

A storyboard is a visual representation of a film sequence and breaks down the action into individual panels. It is a series of ordered drawings, with camera direction, dialogue, or other pertinent details. It sketches out how a video will unfold, shot by shot.

It is similar to a trial-run for your finished film, video, or commercial laid out in a comic book-like form.

How this is analogous to planning for an FDA Meeting

There is quite a bit of preparation involved with planning and carrying out a successful meeting with the FDA. It starts with determining what questions to ask.

The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase ll (EOP2) Meeting, and the third milestone is the Pre-NDA Meeting.

Each meeting has a different agenda. This is because each meeting occurs at a different point in the development continuum.

Nevertheless, all of the meetings share the same ultimate goal, which is to gain clarity in order to be able to proceed successfully to the next step in the development process.

The EOP2 is especially important. It is essential that you are not afraid to ask certain questions just because you don’t want to get negative answers to those questions. Getting a firm “no” after you’ve submitted the NDA or hurts a lot more than getting that “no” earlier in the process.

How to Approach the End of Phase ll Meeting

With a typical program, the End of Phase ll Meeting will take place several years after the Pre-IND Meeting. By now, you will have conducted clinical trials, so in this meeting, you are presenting clinical data to the FDA in pursuit of enrolling into your Phase 3 pivotal trials.

You will present your Phase 3 development program to the FDA during at this meeting, which outlines the data that you plan to generate to include in your submission. Your goal in this part of the meeting is to ask the question: “If we generate this data, will this warrant submission and approval of our NDA/BLA?”.

The three Rules of Engagement

The following three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency. Note the fundamental position of the approach in every case:

  1. Bring the discussion to the data presented on e.g., the process capability and robustness, acceptance criteria, effectiveness of the analytical capabilities etc.
  2. Seek clear understanding of the FDA position
  3. Seek agreement that the data package is adequate to support the approach while understanding that the FDA must review the actual NDA submission to come to a final determination

Putting the puzzle pieces on the table

A reviewer once told me to put yourself in the shoes of a reviewer. We take all the information and we mesh it together and it creates a picture of what it is…

  • Where does the sponsor want me to go?
  • Where does the science tell me to go?
  • What does common sense say?

You have a big FDA Meeting coming up. Like in Hollywood when you have a big shoot coming up, You want to visualize the scenes you plan to shoot with a storyboard, but you are wondering how to make a storyboard that touches on everything a good storyboard should.

Odds are many filmmakers create storyboards “wrong.” Or (*cough*) ignore the crucial step of storyboarding altogether. Drawing and formatting fears, technical limitations, concerns about budget, there are a lot of reasons to avoid storyboarding.

Similarly, when planning for an End of Phase ll meeting. But it does not have to be stressful. You just must know how to create a storyboard in the most efficient way.

All the interesting work had already been done.

Alfred Hitchcock was notorious for his ‘boards', precisely crafting the movie in his head and on the page. He was so detailed, in fact, that shooting the film was boring.

Does this mean that you must be as precise as Hitchcock? Absolutely not. Storyboarding is a tool that filmmakers bring into their process, but everyone is different. Defining “what is a storyboard” is up to the individual and what they make of it.

Again, you are looking for “Yes” or “No” answers. As such, you want to make sure that you plan to do what the FDA wants you to do, making it crucial that you get clarity on all aspects of the planned development studies.

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