Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found that the most exciting projects to work on are with those teams who are facing their very first submission.
These clients may be a small biotech company bringing their first drug or biologic to market or a team within large pharma that’s working together for the first time. Regardless of the team’s make-up, the challenges they face on their first submission can be similar.
Given our experience with teams who are gearing up for their first submission, here are the most common pieces of advice we provide to our clients.
1 – Establish your key messages
Whether you call it a key messages document, a submission strategy document, or something else, the goal of this exercise is the same: to summarize the key messages the team plans to present in the drug’s label. As discussed in our last blog post (Writing for a Regulatory Audience), each endpoint of the pivotal studies should be mapped back to what is ultimately going to be presented in the prescribing information (i.e., the label).
These key messages will form a solid foundation on which your submission rests and will guide both the authors and reviewers of each document. Each key message should percolate up through the various submission documents – from the granular clinical study reports (CSRs), up through the integrated summaries of safety and efficacy, and finally to your Clinical Overview and benefit/risk ratio statements.
2 – Create your team structure
Deciding on the roles and responsibilities of team members is crucial. Who will review each draft and be the ultimate decision-maker on items needing consensus? We often recommend assigning two leads for all the clinical portions of the submission: one devoted to safety and one devoted to efficacy.
The safety team needs to have knowledge of all safety-related issues within the submission and be prepared to speak to those key messages. The efficacy teams need to focus on the effectiveness claims made in the key messages and have a knowledge of any statistical nuances (e.g., statistical hierarchies or non-superiority). And at the top of this team sits the project manager, who often guides the development of the key messages and reviews all documents to ensure those messages are consistently conveyed.
That project manager can also coordinate the critical kickoff meeting. A successful project manager will build a cohesive team by presenting the team roles and responsibilities, start the planning process by getting buy-in on timelines from reviewers and writers, and engage the team early and often for check-ins and strategic problem-solving.
3 – Successful submissions need strategic resources
There are many critical components to consider when building submission timelines, but one of the most important aspects of planning is strategic resourcing. While the quickest way to the finish line might appear to be writing documents in parallel, that may result in your key messages not being presented in a clear, concise, and consistent manner.
We mentioned above how having teams devoted to safety and efficacy can help with the presentation of your key messages – assigning these teams early can also increase efficiency. Starting with your pivotal studies, your safety and efficacy lead writers will author those sections of your pivotal study CSRs – these form the foundation of your submission, and this is where your key messages will form the framework that ultimately supports your label. The safety and efficacy teams gain a fundamental understanding of your data and progress that knowledge into the Integrated Summaries of Safety and Efficacy, which can then quickly transition to your Module 2 summaries.
Yet another aspect of strategic planning is reviewer burden. As the subject-matter experts, it’s the reviewers who need time to focus and ensure that the clinical data are being presented in a consistent and accurate manner. That focus can’t happen if 3 document reviews fall within the same week. A good submission timeline takes reviewer burden into account, yet still strives to get to the finish line as soon as possible.
4 – Tools for high-quality submission documents
If we consider that the pivotal study CSRs build the foundation of a submission and the presentation of your data builds the framework that supports your label, let’s consider what tools we advise using to build a high-quality submission.
First and foremost are document templates and a writing style guide – both of these critical components ensure consistency in presentation. The use of document templates for your CSRs, high-level summary documents, and the clinical overview ensures consistency across all documents and ultimately reduces the load on the reviewers (both internal reviewers, as well as those who are reviewing your submission at the regulatory agency). A good template will include styles for the various section (heading) levels, for table and figure captions, for regular text, for table cells, for internal cross referencing, and for bullets and numbering, to name a few.
A writing style guide built at the onset of the process requires some effort: this is where the team must reach consensus about writing conventions specific to the drug/compound. However, once that consensus is reached and agreed upon, those decisions don’t need to be revisited during the authoring and QC process. Everyone is on the same page regarding how to present the data, how to refer to the drug and/or dosages, and the style for reference lists (among many other topics) which ultimately creates a uniform appearance across all the submission documents.
It can be overwhelming to face your first submission, but we hope our advice provides insight on how to build a strong team that can get a high-quality submission complete on schedule. If you have any questions or would like help with your submission, don’t hesitate to contact us.
Nancy Gasper Smith, PhD, RAC, SVP
Medical Writing Services
Nancy Gasper Smith, PhD, RAC, is the Senior Vice President of Medical Writing Services and has over 14 years of regulatory medical writing experience. Nancy is a member of the Syner-G Executive Leadership Team, and her group of experienced medical writers and quality control (QC) specialists provide support for a variety of regulatory documents across a wide range of therapeutic areas and all phases of development (including clinical study reports, protocols, investigational brochures, safety narratives, and high-level documents such as integrated summaries of safety and efficacy, Module 2 clinical summaries and overviews, and FDA and Advisory Committee briefing documents).
Nancy’s experience includes project management and medical writing for multiple marketing applications (NDAs/BLAs/MAAs). She and her team provide a unique approach to regulatory medical writing and project management, as each document, project, or submission comes with its own challenges. In particular, the Medical Writing Services group at Syner-G has a wealth of expertise collaborating with clients to emphasize the importance of consistent and accurate messaging across submission documents.
Prior to joining Syner-G, Nancy served as the Vice President of Medical Writing Services at Impact Pharmaceutical Services for over 12 years (at which time Impact was acquired by Syner-G in late 2021). Nancy received her PhD in Biomedical Science and Biotechnology from The University of North Carolina at Charlotte and was a Postdoctoral Research Associate at the Duke Human Vaccine Institute within the Duke University Medical Center.