Achieving launch excellence has been and will always be an important challenge for any pharmaceutical company, both in terms of defining the launch and executing it with excellence.
Historically, performance has been driven by a three-pronged preparation of the company, the asset and the market. Companies have found success when they prepare the company with, among other things, appropriate training and resources; prepare the asset with a competitive TPP; and prepare the market with an understanding of how the asset answers an unmet need for patients, HCPs and payers. In today’s world, many companies are launching multiple assets, with multiple indications in sequence. The investment window for an asset is increasingly short and marketing teams have very little time to prepare and drive revenue before resource is re-allocated to the next indication or asset coming down the pipeline.
Now, more so than ever, launch preparation and commercial involvement should begin as early as possible in the asset’s development. Launch excellence can no longer focus on a single lead indication or the quickest market, it is essential to consider multiple indications and the full life cycle of the asset. In fact, launch is a continuum, not an event that happens at a fixed point in time.
When we consider the haematology space, if there is an unmet need, an asset with an incredibly small data set that shows potential can be approved for launch. For example, Janssen’s Darzalex (daratumumab) was granted accelerated approval based on response rates for patients with multiple myeloma who have received at least three prior lines of therapy. It wasn’t until a full year later, in November 2016, that the FDA approved the asset again as a combination therapy based on the outcome of its two phase III trials Pollux and Castor. This example highlights how strategies need to be flexible and development plans can continue to grow throughout the launch continuum.
Commercial and medical teams need to make decisions earlier with the R&D, regulatory and access teams around whether an asset should launch in a niche market first or, alternatively, go broad and build a wide data set before drilling down into such markets. It is crucial that these teams connect as early as possible, because whether it is intentional or not, the perception of the asset forms as early as phase II. As companies move the asset through the continuum of launch, prescribers and patients build an opinion of it, based on the data they are presented or the news that is shared long before the licensed asset is used.
With less than 2% of launch teams achieving above average uptake curves and rapid market share gain relative to their investment, getting the strategy right is essential. The combination of continuous launching, limited resources, multiple indications and complex or rare disease areas puts strategy, readiness and execution support at the top of the priority list for launch teams, who are being asked to do more with less resources and do it profitably.
In the development phase, launch teams must ask themselves: do we have clear and robust financial expectations? Have we defined our competitive position in the market? Is our core global strategy aligned with local launch goals? Do our launch goals take full account of the access challenge with its new business models, technology platforms and cross-geography diversity? Once the strategy is defined, leadership must ready both the organisation and brand by asking themselves: is our governance flexible and responsive and does the organisation have the right culture of agility and collaboration? Do we have an understanding of the real-time launch activities and how they relate across functions and geography? Launch excellence requires flawless execution with strong strategic counsel and experienced guidance, dependable project management and continuous post-launch diagnostic monitoring, tracking and tactical adjustment. In the cut and thrust of a launch, it is essential to maintain a focus on simple messaging and to have a team with clarity of roles, collaboration and tenacity, as well as a strong focus on implementation. All of which needs to be done in a non-linear timeframe.
