A visual representation of the End of Phase II Meeting

A storyboard is a visual representation of a film scene and compartmentalizes the action into different panels. It is a sequence of categorized drawings with dialogue, camera direction or other important factors. It illustrates how a video will develop during each shot.

It is like a trial run for the completed video, commercial or film presented in a form similar to comic books.

How is a storyboard analogous to planning for an FDA meeting

There is a high degree of preparation required for organizing and carrying out an effective meeting with the FDA. It begins with establishing which questions to ask.

A drug development continuum has been outlined by the Food and Drug Administration (FDA) that involves three events, or Type B meetings. The first is the Pre-IND Meeting, the second is the End of Phase ll (EOP2) Meeting and the third event is the Pre-NDA Meeting.

Every meeting has a unique schedule. This is because every meeting happens at a distinct time in the development continuum.

All the meetings have the same aim, which is to increase understanding in order to be able to effectively progress to the next stage in the process of development.

The EOP2 is particularly crucial. It is important that attendees are not scared to ask particular questions for fear of receiving negative answers. Receiving a negative response at an early stage in the process is less harmful than being rejected after the NDA has been submitted.

How to approach the End of Phase ll Meeting

The End of Phase ll Meeting within a standard program will be organized a few years after the Pre-IND Meeting. At this stage, clinical trials will have been performed, so in this meeting, clinical data is presented to the FDA with the aim of registering onto the Phase 3 pivotal trials.

During this meeting, the Phase 3 development program is presented to the FDA, which details the information that is required to be produced to include in the submission.

In this part of the meeting, the aim is to ask whether the production of this data will warrant approval and submission of the NDA/BLA.

The three rules of engagement

At an End of Phase II Meeting, the following three rules of engagement are advised to take place either on the telephone or face to face. Every rule assists in developing an effective negotiating strategy established on the real discussions with the agency.

Note the main position of the approach in each case:

  1. Focus the discussion on the information being presented, for example, the acceptance criteria, effectiveness of the analytical capabilities, the robustness and capability of the process.
  2. Seek agreement that the data package is sufficient to support the approach while recognizing that the FDA must evaluate the actual NDA submission to reach a final conclusion.
  3. Seek clarity on the FDA’s position

Putting the puzzle pieces on the table

Considering the meeting from the perspective of the reviewer may be helpful. The reviewer takes all the data and pieces it together to gain a picture of:

  • What does common sense say?
  • What is the aim of the sponsor?
  • Which direction does the science point towards?

If an important FDA meeting is upcoming, similar to Hollywood, when an important shoot is upcoming, it is important to use a storyboard to visually represent the scenes that are scheduled in the shoot.

One may ask how to create a storyboard that covers all the elements that an effective storyboard should.

There is a chance that several filmmakers produce storyboards incorrectly or disregard the important stage of storyboarding completely. Formatting and drawing technical limitations, budget concerns and fears all provide a number of reasons to ignore storyboarding.

This is the same when preparing for an End of Phase ll Meeting. The preparation does not need to be stressful. There simply needs to be knowledge of how to produce a storyboard in the best way.

All the interesting work had already been done

Alfred Hitchcock was well-known for the ‘boards’ he would create, where the movie was precisely detailed on the page and in his head. He was so meticulous, in fact, that he found the film shooting to be tedious.

An equal precision to Hitchcock is not required when creating a storyboard. Storyboarding is a technique that filmmakers include in their strategy, but everyone has unique ways of working. The definition of a storyboard will depend on the individual and what they can bring to it.

Again, ‘yes’ or ‘no’ answers are the aim. As such, it is important to ensure that the plans of the process match what the FDA requires and that all the factors of the planned development studies are understood.

Acknowledgments

Produced from materials originally authored by Edward A. Narke from Design Space InPharmatics.

About DS InPharmatics 

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.

In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.

French-headquartered ProductLife Group (PLG) is well-known in the Life Sciences market. It has a track record of successfully managing global outsourcing programs and insourcing services for its international client base. The company is on a mission to help transform human health outcomes by optimizing regulatory affairs, safety & vigilance, and quality compliance for life sciences organizations worldwide.

The fit between our two organizations could not be more perfect. We will complement PLG's growing biotech services portfolio. US biotech sponsors recognize DSI as a leader in consulting for go-to-market strategies and RA pre-market consulting. At the same time, PLG has a strong reputation for managing end-to-end outsourcing of regulatory affairs and pharmacovigilance activities worldwide.

Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database - as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements.

We see enormous potential in this new chapter for DSI and you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we're incredibly excited to add our momentum to that effort.


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Last updated: Jul 11, 2024 at 2:18 AM

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