How ready are you for launch?

In 2018, the U.S. Food and Drug Association (FDA) approved a record number of generic drugs as part of its Drug Competition Action Plan. The federal agency has made this market a top priority, reporting a 94% increase in generic approvals since 2014.

Specifically, it has focused its efforts on increasing competition in biosimilars and complex generics, which are difficult to copy, in a bid to increase competition and drive down prices. For consumers it is hoped this will lead to reduced prices and more innovative therapeutic solutions. However, for pharmaceutical companies this means increased competition in an already crowded market place, making the launch landscape far more complex

This hyper-competition is furthered by surging research and development (R&D) spending, which enables new discoveries to enter the market. These elements result in a wealth of new products, driving pharmaceutical companies to compete to meet customers’ needs and resulting in difficulty in identifying new pain points and barriers for therapies to address. These challenges are compounded as teams grapple with drastically large data sets and evolving stakeholder needs, all while navigating a shorter time to market.

The right time to develop your commercial strategy

Pharmaceutical companies can no longer rely on creating the best possible product and basing their launch strategy on the product benefits alone. An agile, market-orientated model for the pharmaceutical launch is needed instead of the traditional, sales-orientated approach. This involves thoroughly assessing customer needs and using this rich insight to create the ideal customer experience. Often this means taking a holistic approach to solving customer needs by developing appropriate services as well as products.

However, to achieve a market-oriented launch, the commercial team will need to collaborate with the clinical team earlier in the drug development process. By applying a commercial lens as early as Phase II, R&D incentives can be aligned to commercial objectives. Here, it is important to take a long-term view. Traditionally, clinical trial design has focused on efficiency in order to help reduce time to market and optimise the bottom line. However, replicating trial protocols without a view of the future market can result in missed opportunities and detract from profitability. By working cross-functionally, the team can shape clinical development and ensure it is in line with market needs. This includes pivoting to keep up with market fluctuations and anticipating the competition.

While the R&D team needs to think more commercially, the commercial team will need to be empowered, enabled and willing to make critical decisions earlier on while taking an objective view of the asset to assess its future market potential.

To facilitate this, functional, regional and commercial leaders should be brought together regularly and given the opportunity to shape the strategic direction of the brand. This will help ensure buy-in from global and local teams.

A launch excellence diagnostic tool

Although this approach may look challenging on the surface, it can be achieved by ensuring launch planning starts earlier. This saves time and energy later down the line – you will be able to rapidly adapt to changing market conditions and you will have the organisational structures in place to ensure decisions can be made quickly. Importantly, you will know that your solution is still relevant at the time of launch.

We have developed a new tool (below) to help you get started. It is designed to help you map the state of affairs in your organisation. The tool is divided into People and Process categories, with subcategories reflecting important success areas we have uncovered in our research. Key success factors are identified within each area and ‘selfcoaching’ questions can help you start thinking about how your organisation is set up to perform product launches, along with what organisational adjustments it might benefit from.

Whether you’re designing and developing new processes, structures or platforms or you are adapting old ways of working for new purposes, Blue Latitude Health is here to help. To find out how we can adapt the tool or help you make overall improvements to your strategy get in touch with daphne.chung@bluelatitude.com

DOWNLOAD THE FULL LAUNCH READINESS CHECKLIST HERE