It started with a miss – PMLiVE

Posted: February 11, 2020 at 8:44 am

One common theme was the importance of companies having their own launch protocols and fine-tuning them to suit individual therapy areas and markets. Although many companies have developed launch excellence codes, their diffusion and adoption across global organisations seem to be variable.

There are two key questions companies should ask themselves when theyre preparing to introduce a new product: do they have a launch framework, and is the company empowered to use it?, said Suzie Denton, Managing Director, Consulting at McCann Health.

The most successful organisations establish their own codes of practice to ensure theres a standardised approach to launching across the company. Then within that framework, theyll define clear launch archetypes; what type of launch is it? What level of investment does it require? What is the size and scale of expectation? Who needs to be involved? And what is the protocol for becoming launch ready from global to local? Secondly, empowering teams to use a framework is as important as establishing one.

"Everybody involved in the launch preparation phase must both understand and be able to implement the launch excellence approach the company believes in. It has to be cohesive, joined up and embedded across regions because, whatever the market nuances are, consistency in global and local delivery is essential.

Customer-focused

A second core component is the need to be customer-focused rather than brand-led. This philosophy underpins all successful launches throughout the brand life cycle. Launch excellence is about prioritising what matters for the launch brand. Every product is different, so you cant launch everything in the same way, said Denton.

The complexities of todays marketplace mean we really need to get beneath the surface of the brand and the opportunity, and take a bespoke approach to every launch. Running through all of this is the need to be customer-centric. Companies can sometimes become so focused on the data and the science that they forget to think about what matters to the doctor, the patient or the payer.

"What are the critical things that drive their behaviour now? What shift in behaviour is required to take them to where you want them to be? And how can you create meaningful engagement to help that transition? You wont change that belief state by focusing solely on the data you need to get closer to customers to help them along that journey. Customer-centricity is arguably the most important aspect of launch excellence. Without it, a brand cannot hope to succeed.

Sustainable healthcare: a key driver

Emma Gorton, Director, Hanover Communications, believes that advances in medicine are rewriting the rules of healthcare and changing the nature of pharmaceutical launches. The essence of what a launch is has changed, said Gorton.

Weve been through an era where we had incremental increases in innovation delivering blockbuster treatments for prevalent long-term conditions and headline diseases. However, were now moving into areas like immunotherapy and are on the edge of amazing innovations that will deliver great outcomes for patients.

"These advances are putting huge pressure on healthcare budgets. The debate has shifted; previously it was all around access to innovation but now theres a greater focus on the need for sustainability in healthcare systems.That has affected how launches work because people are looking for, and are now able to measure, different things from treatments cost- effectiveness, societal value, whole system costs.

There are huge implications for communications. Take gene editing, for example. Were going to get to the point where treatments like gene therapies will be ubiquitous so we need to set ourselves up for them now and embrace the ethical debate so that we bring the public along with us.

"We dont want to be in a situation where the public only understands the complex access challenges we will face for potentially curative medicines when people are being denied them due to cost. We need to get ahead of it. That means thinking about the things that might affect a launch as early as possible and shaping those communications proactively. As things get more complex, we need more time to explain them, to prepare the market.

Timing is everything

When it comes to launching a new medicine, timeliness is key. Essentially, a good launch is about getting breakthrough treatments to the people that need them as quickly as possible, said Gorton.

There are lots of stakeholders involved in that process right across the ecosystem and were all working towards that same goal. Progress is about developing relationships, creating collaborations and building long-term advocacy to ensure medicines get to the right people in the shortest possible time.

"Success requires being agile and responsive to fast-moving environments, and also being much more efficient. The rise of AI, along with better access to deep data, has the potential to reduce R&D time frames making it easier to develop launch plans closer to launch when the environment is much clearer.

Right customer, right time, right message

Stakeholder engagement is critical, but in an era characterised by significant pressure on costs both among customers and companies optimising resources is the name of the game. Companies are striving to be more innovative in how they go to market, said Sabine Dettwiler, Managing Director, Commercial Advisory Group, Syneos Health.

Its a huge ongoing challenge. How do you deploy your resources so you get to the right customer at the right time with the right messages but, at the same time, minimise costs? Theres a real focus on customer-centricity, yet we still see launches where companies go after the wrong stakeholder or dont tell the right story.

"Fundamentally, you need to develop a relevant, resonant story that differentiates your product and clearly conveys the value you bring to the patient and the healthcare system as a whole. Doing this means knowing your market and your stakeholders inside out, and understanding whether you can carve out a niche where youre likely to get more traction.

"The best launch plans define how theyre going to target that niche. Many companies have moved away from one-size-fits-all messaging.Theyre developing tight, customer-specific stories that align with an overarching message and theyre leveraging market insight to create sound strategies for how they target them. The key is to engage early.

Develop launch plans by purpose

One long-standing challenge in pharma launches is the engagement between R&D and commercial. In most pharma companies, the owner of an asset until phase 3 is typically development, said Dettwiler. However, development people rarely have commercial backgrounds or even if they have, they are incentivised by commercial metrics.Too often, companies are late in considering the market potential of a compound.

"Those that leave those commercial considerations until phase 3 are invariably getting there too late. Its improving, but its still an issue. The most progressive companies have shifted their approach; instead of developing launch plans by function, theyre designing them by purpose. Theyre looking at their strategic objectives and working backwards.

If pharma companies want to rewrite the headlines of launch excellence, they need to ensure that their planning, strategy and execution provide unambiguous answers and leave no lingering question marks at all

"What are we trying to achieve? What do we need to get there? Do we need a cross-functional approach that involves input from market access, HEOR, marketing etc and at what point do we get them on board? This approach is helping to tear down silos and develop a structured, cross- functional roadmap that helps get a product to market as efficiently as possible. Ultimately, all these functions have a shared purpose. Launch excellence is about understanding that purpose, as early as possible, and collaborating with the right people at the right time in order to deliver it.

Trial and error: the danger of isolating clinical and commercial

One of the most frequently voiced theories on launch excellence is the importance of starting with the end in mind. In pharmas case, this means configuring clinical development in line with identifiable customer needs. Its a common sense principle but its not yet become a default behaviour across the industry.

The traditional approaches to launching a product still tend to sit in the commercial function, said Chuck Stevens, Vice President and Global Head of Access, Commercialisation & Communications at ICON plc. However, those approaches need to migrate out and begin to align with HEOR, medical affairs and clinical teams. Companies need to look at how they design their clinical trials and what their target regulatory approaches are in different markets around the globe and start to overlay a commercial launch approach onto that regulatory sequencing.

Often, the way clinical and regulatory teams configure clinical trials to meet local regulatory requirements is misaligned with how a drug needs to be introduced commercially in those markets. Similarly, commercial teams need to drill down and understand HTA requirements within the disease category to ensure trials are designed to capture the necessary data for modelling.

"When drugs dont receive HTA regulatory support in major markets, its sometimes because companies havent modelled correctly so when HTA bodies reverse engineer those models, they find that either information is omitted or things are included that skew the way they would normally assess a drug. These costly errors underline why the early alignment of R&D and commercial is essential at launch.

Dont forget the patient

Another area where theres room for improvement is pharmas understanding of the end user the patient consumer. Although every company says and believes that theyre patient-centric, their understanding of what constitutes value to a patient is often suboptimal, said Stevens.

Definitions of value will obviously differ from customer to customer payers, patients, prescribers and providers will all have different views. In todays marketplace, with the level of innovation coming through in areas like rare disease and genetic disorders, its incredibly difficult to model cost-effectiveness to determine value for the patient or caregiver. Theres also lots to do before we can define societal value for expensive curative treatments.

So how does this translate into launch excellence? Very early in development as early as phase 1 and 2 patient insight is critical, said Stevens. Pharma must move beyond traditional market research and engage patients, one-to-one, to uncover their perspectives on everything from their disease experience and diagnostic pathways, to the things that prevent treatment and the real-world implications of taking a medicine.

"Understanding all these things is important it will shape trial design, identify unmet need and help articulate the patient value that will drive adoption at launch. True patient insight and engagement is critical.

The headline

Launching a new medicine is like crafting an article that captures attention: its how you start that matters. If pharma companies want to rewrite the headlines of launch excellence, they need to ensure that their planning, strategy and execution provide unambiguous answers and leave no lingering question marks at all.

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It started with a miss - PMLiVE

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