The early bird...

‘To fail to prepare is to prepare to fail’: how many times have we seen this adage in presentations from agencies, encouraging us to make sure our 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, PR and medical communications) keen to service this need. 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 Circles Model (Figure 1), which captures the three imperatives:

• To prepare the product for the market
• To prepare the market for the product
• To prepare the company to market the product.

The first and third imperatives require harnessing, and probably supplementing, 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 The second imperative has, today, largely been superseded by disease awareness, which is educational in nature and is required to be non-promotional.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 us to have 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 1.3 billion dollars, which represents an increase of over 60 per cent since the start of the decade, and a 10-fold growth in three decades (Figure 2).

Secondly, product life cycles are contracting, which means less time is available post launch to recoup ROI.

Thirdly, we live in 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 your company’s product, no longer works. This is the digital age: either your product is approved by payers or it is not. It’s all or nothing. So it’s essential to have a proven clinical justification for your 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”, says Alex. 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 believes.

Guiding principles
So, what is the framework for developing an EPSCP? To examine this in a little more detail, let’s turn to 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 our planning perspective, ‘why’, ‘what’ and ‘how’ help us with our strategic approach, and ‘who’, ‘when’ and ‘where’ will give guidance to our tactical thinking. Let’s consider each of these in turn, in a little more detail.

Why undertake EPSCP? It is both legitimate and desirable to characterize your intellectual property (IP) so that, when you are ready, you can tell the world 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 etc) describe the product? Where does the CEO look for his information before heading-off to brief 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 your 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 do you achieve by doing it? At its simplest you will want to tell the compelling scientific story of your product and its place in future markets; the scientific rationale and the product value proposition. You will want to do this clearly, consistently and robustly. Firstly, this will need to be done internally. Then, when the company is ready and fully prepared, you will want to take it 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 do you do it? Key components in your plan should be structured scientific statements, your product essence and the core concept. Disease awareness is also a ‘must’, if the scientific rationale for your product is a new concept to the medical world. Your messaging will need to stand up to scientific rigor, including:

• Disease area – burden, limitations of current therapy, opportunities for intervention
• Disease biology – mechanisms that cause the disease, relevant to your product
• Product preclinical – mechanism of action? The preclinical evidence that led to clinical development
• Product clinical – studies already undertaken and their results, other studies underway or planned, further studies desirable for commercial objectives.

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,’ or so the saying goes. Alex Dorr is a firm believer that using senior and independent external specialists offers a major upside to early phase communication planning. The benefits of using external, senior specialists are three-fold, according to Alex. Firstly, they have a neutral perspective and can moderate and advise the internal stakeholders. Secondly, they can bring senior experience and expertise to bear together with tried and trusted processes. Thirdly, 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 your 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, you should have put a team together that includes marketing and communications. Anders Wesslau, an associate 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. Anders believes it is important to update your strategic communication plan throughout the life cycle of your product.

Where should it be done? Get it right internally before revealing your IP externally. It is important that all the components of the plan are in place, and agreed with your internal stakeholders, first. In developing what you want to say about your product Alex Dorr believes, above all, you have to be honest with yourself. This approach in the internal process gives strength and substance to external communications.

Benefits
The ultimate benefit of EPSCP should be a successful product, widely used and optimally commercialized for your company over its entire life cycle. However, those benefits could be over a decade in the future. What are the immediate returns?

Firstly, you should have achieved internal stakeholder ownership. 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. Secondly, you will have developed a common language with agreed descriptors around your product. Thirdly, by doing one plan, with components that should last the lifetime of the product, you’ll be saving time and money.

Pitfalls
The three most common pitfalls that are encountered are discussed below. If you were to speak with a company that does not engage external experts in EPSCP for its products, you would likely get one of these three replies.

We don’t do it at all: This approach could hand control directly to your competitors. Increasingly, companies today don’t see this as an option, for all the reasons explained earlier.
We do it ourselves: OK, that’s better than doing nothing. But do you really have an impartial perspective on your own work? Remember the saying: ‘never write your own biography’.
We let our communications/PR/advertising agencies do it for themselves: You could find yourself with duplication or, more likely, different and inconsistent outputs. In the case of one global company (and I suspect there are 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.

Conclusions
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 ROI and increasing constraints in the marketplace. The key learnings from this article on EPSCP are:
Do it once – but update, regularly. Alex Dorr makes the point that it should be a forward-looking, long-term plan.
Do it early – although it is never too late. Anders 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.

The author
Rob Kemsley is a Fellow of the Chartered Institute of Marketing and an expert in strategic marketing and communications planning, within global pharma. He is a founder and director of Syntropy Medica Ltd