The Pathfinder #18 - Bring Clarity to Your Regulatory Strategy using Storyboarding? Just ask Alfred Hitchcock!

How Storyboarding Can Bring Clarity to Regulatory CMC Strategy and Execution

Originally Published on November 4, 2021 (Update May 16, 2023) - Request an editable storyboard template?(Word format) for your Regulatory CMC Strategy here and put it to use in your organization.

A storyboard is a visual representation of how a story will play out, scene by scene. It comprises a chronological series of images with accompanying notes. I heard about storyboards 25 years ago as a crime and suspense movie buff. A storyboard communicates a filmmaker's vision. It sets out how you want the final piece to flow, whether it is a feature film, a novel, a presentation, a short film, or, dare I say, a Regulatory Filing. It simplifies the entire creative process!

Storyboarding does more than summarize your plot's most relevant details. It is a process that gives you and your team members a project's tangible, visual flow when it is time to collaborate and make vital creative decisions in the pre-production process (in movie terms). Although it takes time to make a storyboard, it will save you time and money in the long run.

Just look at Hitchcock’s Storyboards from HIS 13 Classic Films!

Lord Alfred Hitchcock was known for his extensive storyboarding of the finest production detail. He was reported to have never even bothered looking through the viewfinder since he did not need to. Looking at his storyboards versus the final film, it is safe to say that is a vast overstatement.

Think of it as a graphic organizer that plans a narrative, a powerful way to visually present information; the linear direction of the cells is perfect for storytelling, explaining a process, and showing the passage of time. At their core, storyboards are a set of sequential drawings to tell a story. By breaking a story into linear, bite-sized chunks, it allows the author to focus on each cell separately, without distraction.

Storyboards provide a framework for creating clear messaging that can be consistently communicated. This is particularly needed when opportunities for mitigating existing gaps and other unique compliance scenarios are self-identified. They ultimately remove confusion and contradiction when addressing review questions about the most difficult, convoluted aspects of your product’s drug development story.?

The last thing you want during a marketing application review is for a confused reviewer to come to his or her negative conclusion because the story did not relay the facts in a consistent and understandable message that provides confidence that the company took the actions necessary to ensure data integrity and patient safety. Storyboards are the solution if developed and used as intended!

Start early and document thoroughly

That is the lesson for getting through the new drug or biologics license application (NDA/BLA) process. Long before marketing approval, companies developing new products must apply to conduct clinical trials by submitting an investigational new drug (IND).

Your IND amounts to a blueprint for the rest of your program, so gathering all the information you will require is essential. That includes information on the safety and efficacy of your active ingredient, batch specifications to ensure uniformity, storage units, test methods, and product stability. If you keep a record of all this information, what you expect in each area when you wish to get data, and how much, it, in essence, becomes your regulatory strategy document, which, eventually, along with updates, becomes your marketing application.

WHAT'S THE STORY?

Another consideration in the lead-up to preparing a marketing application is building a storyboard that brings together messaging from the different functions – regulatory, analytical, quality assurance, business development, clinical, and even marketing, to create alignment and ensure transparency with everything that goes into the application.

Take an inventory of what you have and will ultimately need because some information may interrupt how you write things or the order in which you prepare your story (content). That is the art behind writing a submission.

Developing storyboards for regulatory strategy and, ultimately, the marketing application is a growing trend, yet the tool is shrouded in mystery (no pun intended here) for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios.

“I can't read fiction without visualizing every scene. The result is it becomes a series of pictures rather than a book.”

―?Alfred Hitchcock

Applying Storyboarding to Regulatory CMC

Developing a comprehensive regulatory CMC strategy and effectively executing it can be a complex and challenging task. However, storyboarding is one often overlooked tool that can bring much-needed clarity to this process. Storyboarding, a technique commonly used in the film and animation industry, can be adapted and applied to the regulatory CMC landscape to enhance strategy development and execution. In this article, we will explore how storyboarding can streamline regulatory CMC processes and help teams navigate the complexities of drug development.

1. Visualizing the Regulatory Landscape: Storyboarding can visually represent the regulatory CMC landscape. By creating a storyboard that outlines the regulatory requirements and milestones, teams can understand the sequence and interdependencies of various regulatory processes. This visual map helps identify potential challenges and allows for proactive planning.
2. Streamlining Communication: Complex regulatory information can be difficult to convey effectively. Storyboarding simplifies the communication process by transforming technical concepts into visual representations. With a well-constructed storyboard, stakeholders from diverse backgrounds can easily grasp the overarching regulatory strategy and its execution plan. This promotes better collaboration and alignment among team members, resulting in a more streamlined regulatory CMC process.
3. Identifying Gaps and Risks: Storyboarding forces teams to think systematically about the entire drug development process, from formulation to manufacturing and regulatory approval. Potential gaps, bottlenecks, and risks can be identified early on by visualizing the sequence of activities and their interdependencies. This allows teams to proactively address these issues, reducing the likelihood of delays or regulatory roadblocks.
4. Enhancing Decision-making: Storyboarding empowers teams to make informed decisions by visually presenting different scenarios and their potential outcomes. By creating alternative storylines or branching narratives, teams can explore various regulatory strategies and evaluate their implications. This enables them to select the most effective and compliant approach for regulatory CMC execution.
5. Driving Accountability and Progress Tracking: A storyboard serves as a visual roadmap for the regulatory CMC journey. Teams can track progress and milestones more effectively by dividing the process into discrete steps or frames. Each frame represents a specific deliverable or action, allowing for clearer accountability and facilitating proactive management of timelines and resources.

Regulatory CMC Topics Best Suited For A Storyboard

While storyboarding can be applied to various aspects of regulatory CMC, specific topics lend themselves particularly well to this visual technique. Here are some regulatory CMC topics that are best suited for storyboarding:

1. Manufacturing Process Flow: Storyboarding can effectively depict the step-by-step manufacturing process of a drug. It allows you to visualize the stages involved, from raw material procurement to formulation, filling, packaging, and labeling. Storyboarding can highlight critical control points, equipment usage, and quality checks, providing regulators, stakeholders, and team members a clear understanding of the manufacturing process.
2. Process Validation: Storyboarding can aid in illustrating the process validation strategy for a drug manufacturing process. It can showcase the different stages of validation, including design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Storyboarding helps identify critical process parameters and demonstrate how process validation ensures consistent product quality and regulatory compliance.
3. Analytical Method Development and Validation: Storyboarding can be utilized to present the analytical method development and validation process. It can showcase the selection and optimization of analytical techniques, method development experiments, validation protocol development, and the execution of validation studies. Storyboarding helps convey how analytical methods are developed, verified, and validated to ensure accurate and reliable product characterization and quality control.
4. Stability Studies: Storyboarding can visually represent the design and execution of stability studies. It can demonstrate the selection of appropriate storage conditions, sample collection, analytical testing at different time points, data analysis, and interpretation of stability results. Storyboarding helps stakeholders understand how stability studies demonstrate the drug's shelf-life and ensure product quality and safety throughout its intended usage period.
5. Regulatory Submission Process: Storyboarding can simplify the complexity of the regulatory submission process. It can illustrate the compilation of necessary documentation, such as the Common Technical Document (CTD), Module 3 sections, and supportive data. Storyboarding can present the sequence of activities, timelines, and the interaction with regulatory authorities for submission, review, and approval. It aids in showcasing the comprehensive and compliant submission package that aligns with regulatory requirements.
6. Change Control and Post-Approval Lifecycle Management: Storyboarding can depict change control and post-approval lifecycle management activities. It can demonstrate the identification of changes, impact assessment, risk analysis, and implementation plans. Storyboarding helps communicate how changes in manufacturing processes, analytical methods, or labeling are managed and controlled to ensure continued product quality and regulatory compliance post-approval.

Conclusion

In the complex and highly regulated world of pharmaceutical development, regulatory CMC strategy and execution are crucial for successful drug approvals. Incorporating storyboarding techniques into the process can bring significant benefits by providing clarity, enhancing communication, identifying gaps and risks, improving decision-making, and enabling progress tracking. By visualizing the regulatory CMC journey, teams can navigate the intricacies of drug development more effectively and achieve regulatory compliance promptly and efficiently. As the pharmaceutical industry continues to evolve, adopting innovative approaches like storyboarding can make a real difference in ensuring the safety, efficacy, and availability of life-changing medications for patients worldwide.

Remember, storyboarding is a versatile tool; these topics are just a starting point. You can adapt the technique to other regulatory CMC aspects based on your specific needs and objectives. The goal is to create a visual narrative that effectively communicates complex information and facilitates understanding, collaboration, and decision-making in the regulatory CMC realm.