5 keys to position your marketing application for success

For many pharmaceutical and biotech companies, the submission of a marketing application – such as a New Drug Application (NDA), Biologics License Application (BLA) and Marketing Authorization Application (MAA) – is a huge milestone in the regulatory process, eclipsed only by a positive review result – approval to market.

Having supported hundreds of marketing applications in just the past 5 years, we share key success factors that have in our experience had the most significant impact on marketing application success, in terms of completeness, quality, timeliness and maximum probability for a first cycle review result.

Are you a small or mid-sized pharmaceutical or biotech company that will soon be approaching its first NDA, BLA or MAA? Or, have you already guided one or more marketing applications to completion – but are seeking a smoother process the next time around the track? If so, following these imperatives can help accelerate a successful submission – while minimizing frustration, costly rework and delays – so you can speed your therapy to patients, faster.

Getting through this important milestone in drug development requires dedicated leadership from a seasoned expert who possesses hands-on experience – and the bandwidth needed to shepherd the many facets of the submission process to completion. While it may be tempting to assign this important role as ‘an additional’ task for a current member of your team – resist the temptation to make submission leadership and management anyone’s ‘part time job.’ The submission process requires deep collaboration with multiple partners, and the management of seemingly countless interrelated moving parts – and as such, it requires the exclusive focus of a dedicated leader and program manager.

Once the right submission leader is in place, scorecards should be developed – identifying key steps in the submission plan, who’s responsible for each, potential obstacles, and plans to overcome them. These scorecards should be updated by, shared with and discussed across a broad, cross-functional team of stakeholders in the application preparation process, at least monthly – and more frequently as the submission date draws closer. This ensures all team members are informed and engaged, and that they have a factual and visual overview of program status, at all stages in the process. An abbreviated, 2-3 page executive summary of the program scorecard should also be regularly shared with key executives, to ensure they’re also in the loop, every step of the way.

Identify all key stakeholders to the submission process – not just within your organization, but also including contacts at contract research organizations, contract manufacturing organizations, experts engaged in developing chemistry manufacturing and controls (CMC) processes and documents, and specialized firms like biostatistical providers. Then clearly identify the processes you’ll use to establish regular, timely, relevant communication among each of these stakeholders, to keep the program on track. Setting this communications structure and cadence early on will help sustain team alignment and provide the opportunity for rapid, joint problem solving and decision making. It will also enable early discussion of team expectations, work flows, processes and timelines.

Consider all the key components of your marketing application…the product description, the indication statement, the target patient populations, the analysis and explanation of results from clinical and nonclinical studies, and all the labeling claims related to the product. The pathway to successfully completing each of these components of a marketing application is based on a series of important decisions that need to be made collaboratively, with input from medical, scientific, clinical, nonclinical and CMC experts.

This kind of collaboration and decision making doesn’t happen by accident, and it doesn’t happen overnight. It requires methodical planning, clear frameworks for decision making and consensus building, and consistent processes and cadences for communicating each key decision to all stakeholders. It also requires the development of clear processes for soliciting the right input from the right stakeholders at the most opportune times in the application preparation process.

This advance preparation helps set the stage for effective decisions and follow through – and reduces the risk of decision reversals, which can cause costly delays.

When a marketing application is submitted, the sponsor needs to provide a massive set of data and information related to its chemistry, safety, efficacy and benefit-risk assessment. A successful marketing application won’t simply recite these large volumes of data – it will contain robust analyses and strong, consistent summaries and messages that present the data in a way that convincingly supports approval.

Like most important steps in the application process, completing this step effectively requires proactive planning, collaboration and advance preparation. It also requires a series of discussions and meetings to review the draft labeling text and graphics to ensure that the data from final clinical studies provides adequate and appropriate support for the label. The sooner this data review and analyses can occur, the better.

Every marketing application has pre-identified “crunch times,” when the project plan calls for significant decisions to be made, or large amounts of data to be processed, simultaneously. Every application also invariably encounters unforeseeable problems or challenges, which also require an ‘all-hands-on-deck’ approach to problem solving. While not every obstacle can be predicted from the start, you can set your team up for “crunch time” success by agreeing with all stakeholders, up front, regarding how you’ll handle each of these types of high-stakes, “what if” situations.

When a large volume of work needs to be completed quickly – how will the team handle it? Does each key stakeholder have a ‘back up’ who can step in and make decisions and complete large volumes of work, in the event that any one team member is for some reason unavailable during a “crunch time?” If multiple deliverables are due at the same time, how will the pool of resources be leveraged to maximize throughput?

By answering these questions up front, you’ll create an efficient authoring and review process – one that reduces avoidable stressors and ensures there are always enough resources to collaborate and complete each document in the application, without sacrificing quality or consistency.

The old adage “an ounce of prevention is worth a pound of cure” doesn’t just apply to patient care – it also rings true when it comes to planning for and preparing a successful marketing application. By working early on to select an experienced, dedicated submission leader who can create and implement clear processes for communication, decision making, data analyses and resource allocation – you can set your marketing application up for expediency, cost efficiency…and success.