'To fail to prepare is to prepare to fail': how many times has this adage been offered in presentations from agencies, encouraging attendees to make sure their product launches are well planned? Over the last three decades, there has been unprecedented growth in pre-launch activity, accompanied by the proliferation of delivery agencies (in advertising, public relations [PR] and medical communications) keen to service this need.
Plus, over the last decade, there has been the emergence of even earlier activity 'upstream' of the pre-launch period, referred to as Early Phase Strategic Communication Planning (EPSCP). The purpose of EPSCP is to put in place a long-term vision, a comprehensive plan and the tools to equip both the pharmaceutical company and, subsequently, its downstream delivery agencies, for the work ahead.
To bring a product to market, the pharmaceutical industry has traditionally embraced the three imperatives:
The first and third imperatives require the harnessing, and probably supplementing, of internal expertise. The second imperative has, today, largely been superseded by disease awareness, which is educational in nature and is required to be non-promotional. To deliver a quality disease awareness programme requires experience, knowledge and understanding of the specific market dynamics, and a vision of how and where disease area treatment may shift in the future. Vision, imagination and a receptive mind are essential.
Applied to EPSCP, the principle overriding these three imperatives requires having a 'vision of the cathedral while laying the foundations'.
Three major forces are at play that have created the need for EPSCP. The first one is financial costs to the industry. The research and development costs to bring a new drug to market in 2008 exceeded $1.3bn, representing an increase of over 60 per cent since the start of the decade, and a ten-fold growth in three decades.
The growing cost of drug discovery
Pharmaceutical key trends 2011: Pharmaceutical industry infrastructure overview
(Source: Datamonitor, March 2011)
Second, product life cycles are contracting, which means less time is available, post-launch, to recoup return on investment.
Third, these are times of rising healthcare costs, as demands increase through ageing and larger patient populations, coupled with the growing prevalence of chronic disease and expanding healthcare coverage. Healthcare providers increasingly seek justification for the use of new medicine. And the old commercial aim of just 'getting a share of the market' for the company's product no longer works. This is the digital age: either a product is approved by payers or it is not. It is all or nothing. So it is essential to have a proven clinical justification for the product's promise to bring a new benefit or advantage to the treatment of a disease, backed up by a robust scientific rationale to support that position.
All these factors combine to make a compelling argument for communication planning early in clinical development. Alex Dorr is an associate director in global medical communications where this is now standard practice, but he has also worked in environments where it is not done. He is in no doubt as to the value of early phase communication planning: “It is the foundation for all internal and external communications,” he states. He believes it brings internal teams together, which can include partnerships between companies. “Teams then talk to each other, agreeing on scientific terminology and taking a forward-looking approach to outcomes from clinical trials and beyond,” he continues.
So, what is the framework for developing an such a plan? To help examine this in a little more detail, here is some analytical wisdom from Rudyard Kipling:
'I keep six honest serving-men
(They taught me all I knew);
Their names are What and Why and When
And How and Where and Who.'
From a planning perspective, 'why', 'what' and 'how' help with the strategic approach and 'who', 'when' and 'where' give guidance on tactical thinking.
It is worth considering each of these in turn, in a little more detail.
Why undertake EPSCP? It is both legitimate and desirable to characterise a product's intellectual property (IP) so that, at the right time, the world can be told about it. It may sound obvious, but communication begins as soon as someone has something to say about the product. This inevitably starts internally and early. Who decides how the various internal groups (preclinical, clinical, commercial and so on) describe the product? Where does the CEO look for information before briefing the board or would-be investors? And what descriptors are used in the earliest internal presentations? If this process is not managed and guided, it will take place of its own accord, with as many descriptions of what the product is, and how it works, as there are channels of communication (formal and informal)! It is vital that internal stakeholders have agreed the fundamentals of communication strategy and messaging internally, before even considering going external.
What is achieved by doing this? At its simplest level, the plan will be to tell the compelling scientific story of the product and its place in future markets; the scientific rationale and the product value proposition in a clear, consistent and robust way. First, this will need to be done internally. Then, when the company is ready and fully prepared, it will be taken to a receptive outside world. These are the imperatives of preparing the product for the market, preparing the company to market the product and the need for disease awareness within the market.
How is it done? Key components in the plan should be structured scientific statements, the product essence and the core concept. Disease awareness is also a 'must', if the scientific rationale for the product is a new concept to the medical world. The messaging will need to stand up to scientific rigour, including:
The product essence is often delivered in different forms, according to the target audience, e.g. the clinician, a patient or a research scientist, but it should always comprise three key elements: 'functional', 'evaluative' and 'psychological'. The core concept defines and then expands on: what the product is, why the product is being developed, how the product works and the anticipated benefits of the product (leading to the 'product value proposition').
Who should do it? 'Never write your own biography' is the policy here. Dorr is a firm believer that using senior and independent external specialists offers a major plus to early phase communication planning.
The benefits of using external, senior specialists are three-fold, according to Dorr. First, they have a neutral perspective and can moderate and advise internal stakeholders. Second, they can bring senior experience and expertise to bear, together with tried and trusted processes. Third, a broad perspective is required to deliver a balanced plan that will serve internal needs as well as 'downstream' external delivery agencies in medical communications, PR and healthcare advertising.
When should it be done? Ideally, when the product is in phase I or II clinical development, the plan should be taking shape. In phase I a positive decision will have taken place regarding commercialisation, so communication activity is a reality. In phase II, a team should be assembled that includes marketing and communications. Anders Wesslau, a director in global strategic marketing, based in Switzerland, believes the timing should be determined by changes in the environment and the understanding of the disease biology. New research and new thinking in a disease area can be potent forces for change. Wesslau believes it is important to update the strategic communication plan throughout the life cycle of the product.
Where should it be done? The plan should work internally before the IP is revealed to the outside world. It is important that all the components of the plan are put in place and agreed with internal stakeholders first.
In developing what should be said about a product, Dorr believes that, above all, honesty brings integrity. This approach in the internal process gives strength and substance to external communications.
The ultimate benefit of EPSCP should be a successful product, both helping patients and optimally commercialised for the company over its entire life cycle. However, those benefits may not be realised for up to two decades. What are the immediate returns?
First, internal stakeholder ownership should have been achieved. It is quite common to see internal teams taking a much more unified approach, working to a common purpose and with a greater appreciation of the roles of others, as a result of the process. Second, a common language with agreed descriptors will have been developed around the product. Third, making one plan, with components that should last the lifetime of the product, will save time and money.
The three most common pitfalls that are encountered are discussed below. In speaking to a company that undervalues EPSCP for its products, one of these three replies is likely:
“We don't do it at all”: This approach could hand control directly to competitors. Increasingly, companies today do not see this as an option, for all the reasons explained earlier.
“We do it ourselves”: That is better than doing nothing. But do team members really have an impartial perspective on their own work? Remember: 'never write your own biography'.
“We let our communications/PR/advertising agencies do it for themselves”: This could result in duplication or, more likely, different and inconsistent outputs. In the case of one global company (and probably many more) this approach resulted in more product messages than published papers at product launch! Not only is this approach expensive, it is a recipe for confusion.
The emergence of EPSCP and the rise of its importance to pharmaceutical companies is the result of rising development costs, shorter product life cycles for return on investment and increasing constraints in the marketplace. The key learnings are:
Do it once – but update, regularly. Dorr makes the point that it should be a forward-looking, long-term plan.
Do it early – although it is never too late. Wesslau believes it comes down to timing: “It's never too late to create your own blue ocean.”
Do it professionally – it is the foundation for the future.
Rob Kemsley is a Fellow of the Chartered Institute of Marketing and a founder and director of Syntropy Medica
The views of those quoted are the individuals' own and not necessarily representative of the organisation in which they work.
This article first appeared in Communiqué Volume 29 www.communiquelive.com
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