Constructing a model of the Eiffel Tower with 706,900 matches over eight years may appear to have little relevance to a product launch, but the fact that it was disqualified from world-record status because it used the wrong type of matches serves as a graphic warning.

Labouring with intense focus and unswerving attention to detail is a fundamental of pre-launch planning, but the fallout from not assessing and understanding the market can be catastrophic.

Richard Plaud innovated his intricate design by cutting off the red tops of matches. It helped his modelling but the exquisite shortcut breached regulations, which he only discovered at the unveiling of his 23ft tall labour of love.

Few organisations will get it that wrong, but the pharmaceutical launch pad is scorched with failure and the debris from misfiring projects, with analysis from Trinity Life Sciences revealing that 62% of biopharma products launched between September 2019 and December 2021 ‘underperformed expectations’.1

Sticking to routines and mechanisms that served well over previous generations of launch will not insulate against the fierce failure rate of the current, volatile climate infused with the often competing interests of patients, HCPs and healthcare systems set against the constant drum beat of digital change.

While advancing science has improved treatment potential, it has also created crowded launch arenas with multiple products jostling for attention and commercial success. Sticking to launch templates created in the blockbuster era can create roadblocks along the product journey, and fine-tuning them may not be enough.

“Whether you’re launching for a small, breakthrough biotech or big pharma, the traditional launch playbook is not fit for purpose. It’s outdated and outmoded,” says Vernon Bainton, Chief Medical Officer at leading healthcare communications agency Havas Lynx.

‘To achieve success, biotechs need to grasp the importance of market access and start early’

“We need a new, responsive approach; simply throwing money at a launch is not the solution because it does not deal with the market dynamics and the seismic changes that have happened and are continuing to happen.

“The new playbook is built on a better understanding of your customer needs and the market dynamics. It needs a greater understanding of how our communications are consumed, digested, shared and enjoyed, and that allows us to problem solve and communicate in better ways, and have an ongoing relationship with our customers.”

The headwinds are swirling, with separate gusts from crowded markets, price pressures, access challenges and soaring expectations from HCPs and patients, but the maelstrom does not need to wreck all who sail towards launch excellence.

“It is a tough sector, but there is massive opportunity to modernise, to be more competitive, differentiate ourselves and, critically, be more effective at providing what the markets need from new medicines and launches,” he says. “It starts with a unified data-led business analysis that removes the uncertainties and allows us to start a bit earlier to shape markets earlier and more effectively.

“This data gives us much higher fidelity to understand our customers and deliver effectively and at scale.”

A recent Havas Lynx campaign to immunise against respiratory syncytial virus (RSV) succeeded because of a programme of deep engagement with parents and families that provided empowering intelligence that was coupled with a global launch campaign for clinicians integrated with local access and immunisation programmes. It resulted in unprecedented demand, with more than two million immunisations being administered in three months, which prevented 40,000 hospitalisations of infants.

The positive outcome was forged by an alloy of understanding HCPs and patients, addressing global and local challenges and the applied use of data, says Vernon.

Many organisations will have those aspirations in their launch strategies, but the challenge is to mine for deeper understandings and more personalised data as well as deploying an acute sensitivity to market needs and changes.

“Our customers want authentic, personalised content that’s meaningful for them,” he observes. “There is so much noise out there and how they experience our brands can be atomised, so how we join those things up is fundamentally important.

“Through use of our proprietary Point.1 research platform, we have a richer behavioural and emotional understanding of our customers and how to engage with them meaningfully. It helps us unleash our creativity and be more responsive in real time.”

Havas Lynx believes its work with supporting HCP wellness and illuminating the impacts of climate change on healthcare gives it an empathy that informs its launch initiatives and Vernon adds: “Our thought leadership last year was all about healing the healers. If HCPs are overstretched, burnt out, recovering from the aftershocks of COVID, overworked and underappreciated, are they going to consume our marketing? Are they going to implement change within a stressed, under-resourced system? Our contention is ‘No’ and we must be aware of their challenges and respond to them.

“We can’t just appear from time to time and hope to have a relationship. This is about being part of the health ecosystem ourselves. These are hugely exciting times and we are constantly evolving, learning and embracing challenge, which are all essential elements of creativity.

‘It is a tough sector, but there is massive opportunity to modernise, to be more competitive and differentiate ourselves’

“The speed of change is something we have never experienced before, but if you don’t change, then sooner or later you will become obsolete.”

Market access and launch specialist Sheila Reddy, of Innovate Works, underscores the imperative of cross-functional collaboration and fusing business, evidence and product narrative into a compelling value story.

These components become more critical and complex because of the shifting sands of the sector, embodied by the rise of smaller biotech companies and start-ups that have acquisition and partnership front of mind as they drive innovative science towards commercialisation.

The book Breakthrough to Blockbuster: The Business of Biotechnology showcased the power of small scale entrepreneurial biotetchs, revealing that they currently develop 40% more key treatments for unmet needs than large pharmaceutical companies.2

That short-term mindset can result in market access planning – a launch essential – being marginalised and Sheila emphasises the need for this growing army of biotech companies to devote time and resource to launch excellence to enhance their chances of commercial success.

“It is crucial to integrate market access because you have to consider what the payers want, and you need to start early,” she says. “Science is the dominating force of most smaller biotechs and university spin-offs because that is their background. But if they get too locked into their groundbreaking science without thinking ahead then they might struggle to commercialise it.

“They are focused on selling out to a venture capital company or getting big pharma to partner with them with the view that someone else will take care of the headache of commercialisation. But they have to show they have thought about the route to market to have a chance.

Investors may not have a strong science background; they are good at investing but they need to know how a product will get to market, the competitor landscape, financial forecasts and the priorities of healthcare systems in different countries.

“They want to have the confidence that their investment has been de-risked. If they don’t, investors can go elsewhere, irrespective of the science.”

Innovate Works, which specialises in applying launch and market access strategies to biopharma innovations to secure positive HTA outcomes, optimal formulary placement and accelerate the uptake of new therapies, has deep experience of launches across the entire pharma sector.

Sheila underscores that real-world evidence (RWE) is increasingly pivotal to reimbursement and a product’s success, saying: “The business case is important for investors and pharma companies, but the RWE and value it shows payers is becoming just as important because of the need to show cost-effectiveness. Payers want to know why they should reimburse your drug over the standard of care. For some of these therapies, generics are the standard of care. There have to be clear advantages and you need to show that in your value story.

“Health and social care budgets are becoming more integrated so even if the drug is expensive, how it performs in other metrics, such as reduced hospital costs, fewer clinic visits, patients returning to work and becoming more productive, is important.

“This drives having a good value story that is backed up by evidence. You don’t need a huge team to do this, but if you don’t include market access early on – ideally at proof of concept stage – then you will miss out. To achieve success, biotechs need to grasp the importance of market access and start early.”

Hristo Deyanov, Founder and Managing Director of TWO Communications, a boutique agency specialising in healthcare and pharmaceutical communications, has driven positive internal and external communications for clients, which he views as integral to success in the prevailing climate of regulatory fast-tracking, personalised medicines and the expanding suite of digital tools that accompany many launches.

“RWE is playing an increased role with pharmaceutical companies relying on data from patients outside clinical trials to support drug approvals, inform clinical decisions and demonstrate the value of their products post-launch. It is essential in proving effectiveness in broader populations and securing regulatory approval in cases where randomised controlled trials may be insufficient,” he says.

“A client’s real-world data is something we are increasingly being asked to talk about by the media too and particularly with our rare disease clients. This is especially compelling as it’s much more difficult to build a case for reimbursement in rare disease sector. Pharma companies need to start being more open and proactive with offering this data as it can be a unique selling point, especially, but not exclusively, in the rare disease sector.

“Launch strategies, in rare disease specifically, must deeply consider patient experiences, adherence challenges and patient outcomes. Engaging with patient advocacy groups and incorporating patient feedback early in the development process is becoming standard practice. It takes effort but it is something companies can be proud of.

“Another important factor is leveraging real patients in campaigns aimed at patients. This paints a far more realistic, more authentic picture and encourages others living with a rare disease to see others like them, creating a sense of community. Giving patients tools to self-advocate for better health outcomes is, in my eyes, also a really genuine way of landing the plane when it comes to engaging with your key audiences – patients.”

‘Launch strategies, in rare disease specifically, must consider patient experiences, adherence challenges and patient outcomes’

Hristo, whose agency supported a rare disease client in the development and execution of the NMOSD in Focus campaign providing tools for patients with the severe and rare neurological condition, believes that pharma companies are responding well to emerging challenges by developing relationships with patient advocacy groups to co-create clinical trials, empower patient-reported outcomes and shape drug development strategies.

“These collaborations ensure that therapies are developed with the patient’s real-world needs and experiences in mind,” he comments. “We see this more collaborative approach in pharma partnering with biotech firms, academic institutions and technology companies to bring innovative products to market and these partnerships can be key to navigating complex regulatory landscapes and achieving broader market access.

“We witnessed this during the pandemic when companies were very good at sharing data, learnings and information and as a result, it improved the prospects of getting vaccines and therapies to the public at speed, and hopefully that will continue to improve.”

Uniting staff behind the purpose of a product is also a prime ingredient of commercial success and Hristo observes: “It is critical as it can make or break the success of a launch, and any campaign or activation you execute.

“A sense of community across teams helps foster open communication, leading to smoother coordination and collaboration between these functions. Teams working in unison, rather than in silos, are more likely to problem-solve proactively and anticipate potential bottlenecks or regulatory challenges, leading to quicker solutions. Ownership and accountability and generally feeling part of a collective community encourages team members to take ownership of their roles and responsibilities.

“In pharma specifically, at the bare minimum, the life-saving potential or impact of the drug you are working tends to become a shared goal, inspiring employees to work together.”

He sees the sector continuing to evolve under the influence of data and AI along with accelerated approval programmes that vest even more power in RWE.

“I am excited about many things in the sector, but the rare diseases sector is of particular interest at the moment,” Hristo says. “Rare diseases have historically received limited attention due to the smaller market sizes and high costs of R&D but, over the past three to five years, there have been several emerging trends, technologies and regulatory shifts that are creating new opportunities for innovation and access.

“Tailoring communications to internal and external audiences is a significant part of seizing the potential that is out there. These are also key to navigating the bumps arising from the vastly changing landscape. The sector has indeed changed drastically in recent years resulting from the huge advancements in technology, regulatory shifts and evolving market dynamics. If we successfully adopt the advances to fit our needs and those of our audience, without losing sight of timeless best practice communications, the potential is immense.”

Organisations are clearly adapting and innovating to ensure the waves of transformational science and regulations result in huge patient benefit. Tactical vision and planning form the jigsaw pieces that unlock the full picture.

The Guinness Book of Records eventually relented so that Richard Plaud’s 4,200 hours of matchstick assembly and 23kgs of glue did not go to waste…but he would have endured far less heartache had he assessed the market, liaised with the regulatory body and paid attention to its needs.

The moral is in the matchsticks.

References

1. https://trinitylifesciences.com/media-center/news/trinity-life-sciences-unveils-industry-impact-series/#:~:text=According%20to%20an%20analysis%20conducted,the%20first%20year%20of%20launch
2. https://www.thebusinessofbiotechnology.com

Danny Buckland is a freelance journalist specialising in the healthcare industry