|21st March 2019
“If you want guarantees, buy a washing machine.” Ralph Hasenhuttl’s words as he was unveiled as the new manager of relegation-threatened Southampton FC brought some refreshing everyday logic to a world accustomed to sporting hyperbole. His message could just as easily be applied to new drug launches. When introducing innovation there’s no such thing as a dead cert; ground- breaking science and a huge field force are no longer a guarantee of commercial success. The most effective drug launches rely not only on a compelling clinical profile but on organisational proficiency and agility across a range of inter- related disciplines. Launch excellence is a team sport. Achieving it is a tough assignment.
Most drug launches, like Premier League football, fail to live up to the pre-match hype. Research suggests that fewer than a third of new products meet commercial expectations, with 72% falling short of revenue targets. The ‘tyranny of the forecast’ is undoubtedly a contributory factor – and it’s one that puts jobs and patient care at risk as underperforming brands are (often unfairly) labelled a failure. But there’s no escaping the fact that suboptimal launches are a recurring industry problem.
"As the healthcare landscape becomes increasingly complex, the drug industry finds itself stuck in a spin cycle of commercial under-performance"
Studies reveal that two thirds of drug launches between 2003-2009 and half between 2010-2017 underperformed against their pre-launch ambitions. Worse still, a quarter of all launches since 2010 failed to reach even 50% of their external revenue forecasts. Is that poor forecasting or poor performance? It’s impossible to tell. Whatever the reason, the impact is far-reaching: mistakes made at launch are expensive, difficult to correct and can leave stubborn stains that discolour a product’s long-term performance. Crucially, more than 75% of all launches never improve on the trajectory established in the first six months. The pressure to get it right first time is significant.
There are indeed no guarantees with pharmaceutical launches, but Ralph Hasenhuttl’s washing machine metaphor still holds water. As the healthcare landscape becomes increasingly complex, the drug industry finds itself stuck in a spin cycle of commercial under-performance. With the market environment underscored by multiple stakeholders with diverse needs and divergent definitions of value, companies can no longer afford to maintain a rinse and repeat approach to launching new medicines. It’s time to change the programme. But how?
Discussions with a range of experts and thought leaders from across the industry – all of whom have long-standing experience of launching new medicines – confirms that the killer ingredients of launch excellence are impossible to isolate. The launch process is a complex jigsaw and every piece combines to create the bigger picture. What’s more, every picture is unique. There are, however, common elements of best practice. Here are some of the key learnings from expert commentators.
“Companies know they need clear processes in place to maximise success at launch”, says Ed Corbett, Principal and Commercial Practice Lead at Novasecta Consulting. “That begins with a strong partnership between commercial and R&D, frequently at the design of phase II trials, and continues into a launch plan that requires cross-functional collaboration, clear checkpoints and leadership support. However, an over-reliance on process can breed complacency and often leads to a box-ticking mentality. Ultimately, launch excellence is part process, part experience but all mindset.”
In fact, a confluence of factors is forcing companies to adopt a new mindset for launch. “Growing demand for real-world evidence and the drive towards individualised medicines are bringing new considerations to launch planning,” says Ed. “The rise and importance of emerging markets is challenging existing models of customer intelligence as companies strive for deep insights into unfamiliar territories. Furthermore, as downward pressure on pricing intensifies, algorithmic prescribing management is redefining the dynamics of customer engagement. In the malaise, it’s easy to lose sight of the fundamentals. Often, companies and teams can get seduced by ‘shiny toys’ at the expense of understanding the basics.”
The fundamentals of launch, says Ed Corbett, are simple. “To have any chance of success you’ve got to have a great data package, a solid health economic story, deep stakeholder insight and an understanding of customer channel preference. Moreover, you’ve got to have clear patient and physician segmentation and a total commitment to it. It’s important to focus only on your chosen segments – even if this means you’re not targeting other customers that may use your product. Unfortunately, some pharma companies are weak in this area – they lose focus and dilute their approach. This is a mistake; you only have finite resources, so launch excellence is about ensuring you deploy it to the most attractive segment.”
“Isolating the critical components of a successful launch is difficult,” says Peter Smith, SVP, Cello Health Consulting. “There are so many things you need to get right simultaneously. However, although the fundamentals of a good launch are well known, some key elements receive less air time. For example, the importance of the launch team is often understated.” The quality, motivation and culture of the launch team is a success factor in its own right, says Peter. “To be effective, the brand team requires thoughtful set-up, considered and clearly laid out processes, and a defined, agreed culture. In addition – with launches typically frenetic and requiring huge energy – teams need support from leadership and freedom to operate without common organisational distractions. An effective launch team will be cross-functional and diverse; it’s likely to include stakeholders from regulatory, medical, marketing, HEOR and Business Intelligence, as well as sales force, country and, increasingly, regional representation. Ensuring all these components – and associated sub-teams, work streams and project management – successfully come together requires upfront clarity around structure and processes. All these elements will ultimately be dictated and shaped by your product goals, the market environment and the nature of your challenge.”
Everyone knows that a good brand positioning and proposition is pivotal. However, articulating one isn’t easy. “Organisations are swimming in market complexity and research covering the full spectrum of the science and the healthcare ecosystem,” says Peter Smith. “This abundance of data means you can easily lose sight of the fact that what you’re trying to get to is a simple, focused proposition. Fundamentally, you need a brand positioning that you can tweet. It’s got to be differentiating, sustainable, enduring and compelling – but, ultimately, it must be clear and concise. If it’s not, your message will likely get lost in the miasma of launch and the desire to share all your wonderful data. Your proposition is the anchor point for all your brand communications. It’s vital that you get to it early and, when you do, it must be clear and compelling.”
Consider the wider environment – and set realistic expectations “Launching a new product or service is no longer what it used to be,” says Alexander Fink, Managing Director, Europe, Commercial Strategy & Planning, Syneos Health Consulting. “In today’s world, new therapies are launching into much more complex markets than they did in the past. What’s more, physicians’ and patients’ expectations on data and outcomes have never been higher. In order to prepare best for launch, you need to focus on four broad areas.” Primarily, says Alexander, it’s important you know your market inside out.
"Agility must be present throughout – from early stage development and pre-launch planning, right through to and beyond launch. Sustaining commercial success will be contingent on it"
“To ensure the success of your product, you need to be certain that there is room for it. Thus, understanding the patient journey and the unmet needs both from a patient as well as a physician perspective is eminent. Secondly, know your product. As physicians and patients are looking out for outcomes more than they look out for specific brands, developing evidence-based products and solutions that address the unmet needs of target populations is key. Thirdly, make sure you’ve a clear and appropriate definition of success. There is no template for this – every launch has its own set of success factors.”
Finally, says Alexander, understanding and managing the complexity of a launch is essential. “Your launch plan and management needs to ensure all critical steps are considered including preparing the product, the market as well as your organisation. Why? Because you can’t simply assume there’s a need for your product. Just because you think that your product will be a success does not mean that anyone else will. Poor research and data can lead to this problem. Ultimately, if you don’t properly consider the wider environment, you’re likely to end up with a product that fails to live up to expectations. History is littered with products that were pushed into the market overpromising on their benefits. “Fundamentally, an optimal launch will clearly address an unmet need that allows a drug to be positioned for defined patient segments, creating differentiation from existing therapies. To get there, companies must consider innovative ways of generating insights into stakeholder needs and their behaviours.”
“There are many factors that influence the commercial success of a launch – but the first step should always be to understand what those factors are to can ensure you make the right decisions,” says Jeremy Poland, Senior Launch Excellence Consultant, Blue Latitude Health. “Against that important backdrop of deep market understanding, organisational responsiveness is a critical success factor (CSF). Rapid learning and the agile incorporation of new insight into brand strategy is essential. Our own research has found that while companies are good at identifying and developing deep customer insights, there’s room for improvement in how those insights are incorporated into the strategy and the plan. In competitive and fast-moving markets, the ability to respond to fresh insight is becoming increasingly important.
"Organisations must not only have their finger on the pulse, they should also increase the rate at which they do their planning. Annual planning is no longer sufficient. The most progressive companies operate quarterly planning cycles and, in many cases, augment them with monthly reviews that allow light-touch validation of core assumptions. This facilitates an organisational agility that goes beyond traditional strategic planning and helps companies become more attuned with what’s working from a customer standpoint, and to pivot and adjust quickly where necessary. This agility must be present throughout – from early stage development and pre-launch planning, right through to and beyond launch. Sustaining commercial success will be contingent on it.”
Another important pillar of market understanding relates to segmentation within the brand strategy. “In competitive segments, the degree of focus on priority stakeholders and the patient experience is another CSF,” says Jeremy Poland. “We still see companies developing brand strategies that 'target' all patients and all physicians – but that is simply not focused! The most effective launches concentrate on a specific segment or even subsegment of a patient or physician experience. They really understand the core needs of those target stakeholders and work backwards from there to capture non-core secondary and tertiary segments. It’s important to recognise that your target is rarely the whole market. What’s more, focusing on a smaller, core segment doesn’t mean that you won’t get sales from the broader market. However, it does mean you’ll find customers that resonate with your offering and share their positive experiences with others.”
“There’s a plethora of activities, elements, logistics and resources that need to be in place to ensure an optimal launch. However, in the broadest sense, success depends on a willingness to do two things: be brave, and be bold,” says Gerry Crawford, VP, General Manager, Carling Communications. “Launch excellence requires truly differential positioning married with the courage not only to stick to it but also to implement the outstanding creative such positioning dictates. Too often, the desire to not be niched and to appeal to as wide an audience as possible leads to a ‘vanilla’ positioning. The results fulfil an old cliché: “If you try to be everything to everybody, you end up being nothing to no-one.” A single-minded proposition (SMP) is the cornerstone of good positioning – and the shorter and simpler it is, the better. Crucially, it must be based on a customer insight to hold water.” The other ‘secret sauce’ ingredient, says Gerry, is courage.
“Marketers and commercials teams have to be the Standard Bearers; the Troop Ralliers; the Team Motivators. They must have the courage of their convictions and keep their eyes on the prize to steer, direct and align all activities and communications with the SMP. They must also have the courage to ensure that sci-comms and commercial comms – often seen as church and state – are aligned. An agency that spans both disciplines can help with this alignment.”
In addition, launch teams need to ensure that digital is truly integrated into the marketing mix. “The brave recognise that ‘digital strategy’ is dead; and that there’s only marketing (launch) strategy where digital plays an integral but integrated role,” says Gerry. “Teams must also have the courage to involve the key decision-makers and affiliates at the right milestone points through development. Finally, marketers must be brave enough to deny the over-reliance on market research. Research should be used for mining for insights; illumination not support, or covering your own back.
Don’t make the mistake of choosing the middle ground. The best advertising often polarises responses. Nirvana? Of course. Hard work? Most definitely. But if you’re bold and you’re brave, in the words of Arthur Daly: “The world is your lobster, my son.”
|13th June 2019
Laura Holmes Haddad is a breast cancer survivor. She made the incredibly brave decision to participate in a PARP inhibitor precision medicine trial. Here, the author and precision medicine advocate tells her story and explains what industry needs to remember when treating cancer patients with precision medicine.
|7th June 2019
Blue Latitude Health speaks to Professor Gavin Giovannoni, key opinion leader and Chair of Neurology, Barts and The London School of Medicine and Dentistry, about his theories on brain health, the importance of a holistic approach to MS and why digital technology is the future of effective MS care.