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Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU up!”, a good physical trainer listens to your goals and then develops a plan to help you achieve them. Likewise, experienced regulatory and medical writers possess the unique blend of talent—scientific acumen, oral and writing communication skills, project management expertise, and deep knowledge of the regulatory landscape—that can help you develop a strategic roadmap for your drug.

Getting your drug to market is a marathon, not a sprint

Do you ever feel daunted by the many documents required by regulatory agencies during the course of a drug’s development? Let’s walk through some of the major steps in the process to see where sponsors frequently get tripped up by inadequate planning. The need for clinical documentation starts with the Investigational New Drug (IND)/Clinical Trial Application (CTA) package. At this point, the goal of your group preparing the clinical package is to get your compound into the clinic for First In Man trials. When considering later milestones—end of Phase 2, the New Drug Application (NDA), post marketing requirements, it’s easy to adopt the mindset of “we are so busy right NOW, we will deal with all that later.” Big mistake.

The benefits of early planning

Pharma companies, especially small biotechs, often wait to start planning their regulatory writing strategy until their product is already in the clinic. This understandable, but ultimately, short sighted view, can end up costing lots of time and money in the long run for a single, often overlooked reason. The clinical information created in these early documents will follow you through the entire lifecycle of your product. You can re-use this information in different documents and/or media down the road to save yourself valuable time.

Just how many places could the information contained in the IND/CTA package reappear? The clinical study report (CSR) is an obvious one, but there are lots more. Your group may be required to provide annual reports. Likewise, as your drug is being evaluated in Phase 1 studies, you may need to present an annual comprehensive review and evaluation of safety information—the Development Safety Update Report (DSUR). You may want to publish the hard earned findings of your clinical research as publications in peer-reviewed academic journals. In addition, you have to address transparency and disclosure mandates such as Section 801 of the Food and Drug Administration Amendments Act (FDAAA), which requires registering studies and reporting trial results. The European Medicine Agency (EMA) has similar legislation regarding posting clinical trial results summaries to EudraCT—the European Clinical Trials Database. Finally, this information has to go into briefing packages and your final submissions.

Why in the world would you want to recreate all this information from scratch for each and every one of these documents? It seems hard to fathom, yet I have seen sponsors fall into this trap time and time again.

Common reasons sponsors get off track

I’ve noticed that there are a couple reasons why sponsors often miss the opportunity for developing a comprehensive regulatory documentation plan:

  1. Failure to think through a regulatory strategy when creating the first clinical trial protocol
  2. Not having the right people involved in the initial development of clinical documentation—like medical writers
  3. A lack of forethought for how the information you are creating today will set the foundation for future documentation and how regulatory agencies may view your drug

There are many different stakeholders that you need to gain buy in from to support a drug’s approval. Regulatory agencies are an obvious one, but there are many others. Potential collaborators. Health care professionals. Key opinion leaders. Potential investigators. And most importantly, the patients who will benefit from your drug. Will your clinical documentation satisfy all their different concerns and priorities? If you are not creating consistency in your messaging, somebody will be paying attention!

Formulating a game plan

Here are a couple of ideas that I’ve found helpful in developing and executing an efficient and effective plan for managing the flow of clinical information throughout the drug development lifecycle.

  • Create a map that shows where information can be reused or adapted for other required documents
  • Develop templates that can help facilitate reuse of information. This has the added benefit of helping to ensure consistency in messaging, no matter who is creating the actual documents.
  • Make sure that you have the right people working on the project from the very beginning who have the vision of the desired end result. As the adoption of modeling ands simulation (M&S) for drug development expands, so too does the need to integrate it into the documentation submitted to regulatory agencies. M&S—also known as model based drug development—includes physiologically-based pharmacokinetic (PBPK) and pharmacokinetic-pharmacodynamic (PK/PD) modeling. This methodology is emerging as not just an internal decision-making aid to reduce expenses and time, but also as an ethical imperative to optimize the number of subjects exposed to newly tested therapies. Does your writing team have the experience and knowledge base needed to clearly justify an M&S approach to the agency?

Using M&S and strategic medical writing to get your drug across the finish line

Certara’s medical writing consultancy, Synchrogenix, has successfully helped dozens of clients obtain drug approvals using this approach. Having technology-enabled pharmacometricians and strategic medical writers as part of a sponsor’s team will improve their chances of success. To learn more about how to integrate regulatory writing and M&S into the drug development process, read our white paper.

About the author

By: Kelley Hill

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