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Most Common Advice We Give First Time NDA/BLA Submission Teams

June 14, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing & Corporate Communications | Medical Writing Services

Throughout the years, our staff at IMPACT has worked with many clients on marketing applications (large and small) across a variety of therapeutic areas. Each one comes with its own unique challenges, but the most interesting (and often the most exciting) are those where the client is working on a submission for the first time.

Such client teams can represent a small company bringing their first drug to market, or a first-time team within large pharma. Though their corporate atmospheres may differ, the challenges they face on their first submission can be similar.

Without further ado, here are the most common 5 pieces of advice we give to first time submission teams. [Reader’s Note: In this post I use the term “submission” to mean a marketing application (eg, NDA, BLA, MAA).]

(1) Establish your key messages. Pronto!

Whether you call this a key messages document, a submission strategy document, or something else, the intent is the same – to write, and get senior management buy-in on, the key messages for your label. Each message must be supported by data in the submission. We encourage generating the draft label in conjunction with the key messages document.

It’s at this stage that some first time submission teams may realize they don’t have data for every claim they want to support. Better to realize too early than too late, so that you can course correct where possible.

Consistent and accurate messaging across submission documents is key for successful regulatory agency review. See our previous post for tips on writing for a regulatory reviewer.

(2) Build and connect your team.

This one is critical – especially for first time submission teams.

Ensure that all disciplines are represented on your team (eg, medical writing, stats, clinical, nonclinical, clinical pharmacology, CMC, regulatory affairs, publishing, and more) and that lines of communication are open across all necessary parties. If vendors are being used, make sure all team members (at the Sponsor and the vendor[s]) know who to turn to in order to get answers to their questions.

A face-to-face kick-off meeting with all parties present is an excellent start to building a cohesive team. In fact, we encourage that whenever possible, it’s best to have the important meetings face to face.

Key decision makers must be present and engaged to keep the team and the documents focused on the end goal – a cohesive submission that supports the key messages in your proposed label.

In addition, an effective project manager is critical for the success of any submission, but especially so for first time submission teams. (For keys to effective NDA project management, stay tuned for a future post!)

Likewise, determining who the ultimate “decision maker” is in times of conflicting opinions is also critical for a successful submission team.

(3) Don’t (!) underestimate the resources you will need.

As a first time submission team, it’s easy to get excited and plan for the best-case scenario. You have a great drug, great data, and a great team! Of course everything will go to plan! … Right?!?!?

While this is ideal, it rarely (if ever) plays out this way. So it is key for first time teams to plan for the resources they will need, realistically rather than optimistically.

For example, the extent to which writing activities will occur in parallel (as opposed to sequentially) will dictate whether you need more or fewer writers, QCers, programmers, publishers, etc.

With enough writers and effective communication across writers, some level of parallel document authoring may be possible.

Before deciding on parallel vs sequential writing, however, have you considered reviewer “burden”?

Many times it’s a small group of people who review all of the documents, so delivering documents to review teams in a staggered fashion is most effective since, in most cases, there are not “more” reviewers who can be added to the team.

It’s also vitally important to protect, as much as possible, your team’s time from other competing priorities – since submissions typically become all consuming. As a result, non-submission related company activities may need to be managed by other individuals if at all possible.

See our previous post on strategic NDA planning for further tips on resourcing.

(4) Include “wiggle room” in your timelines.

As alluded to above, there are rarely submissions (first time or otherwise) that go exactly to plan, so plan for the unexpected. Challenges will arise and your team will have to adapt.

The easiest way to ensure that these challenges don’t jeopardize your submission deadline is to build in some “wiggle room” when planning your initial timelines. It’s tempting to build aggressive times from the outset, but when the inevitable bump in the road occurs, if your timelines are too tightly developed, your options for how to navigate through it are limited.

It might seem counterintuitive, but trust us, you will be glad you built in this time.

Similarly, when developing timelines with clients, we stress the importance of establishing reasonable timelines and then identifying the target submission date, rather than selecting a submission date and then working backwards to “make” the document timelines fit that date.

Remember to keep your eyes on the goal – it’s the approval date and not the submission date – that’s most important. A too-aggressive submission date that requires low quality work could put your approval date in jeopardy and is not worth it.

So make sure your timelines are reasonable and allow for high quality documents to be produced, which leads to our last tip…

(5) Establish procedures for producing high-quality submission documents.

At the very least, we advise that clients have submission-ready templates, a writing style guide (that ideally includes product-level writing conventions), and an established procedure for writing, review, and QC of submission documents.

The publishing team should be included in this effort. Understanding what the publishing requirements are prior to writing your documents will prevent rework by the authors or extra work (ie, unplanned time) for the publishers.

These procedures will help ensure consistency across study-level CSRs and high-level summary documents, as well as across disciplines (eg, clinical, nonclinical, and CMC), which makes it easier for a reviewer to navigate and digest the submission as a whole.

In addition, high-quality documents require high-quality reviews, so make sure document reviewers have the time they need to critically review the document.

More importantly, ALWAYS encourage reviewers to review first drafts of all documents since it is imperative to get the messages and conclusions right from the outset. This includes any high-level senior management who may need to review. While it may seem acceptable to have them review a near-final version, that logic unravels if they have some big ticket changes that result in timeline delays.

So, what do you think? As a first time submission team member, does this give you some insight into where you may need help? If you have any questions or would like help with your submission, don’t hesitate to contact us. We look forward to hearing from you!

Images courtesy of Stuart Miles of FreeDigitalPhotos.net.

Category: Medical Writing Services
Keywords: NDA submission, marketing application, BLA, MAA

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