Shaping the market

Until recently, pharmaceutical companies paid little attention to the process of maximising their data through publications.

Today, several pharma firm and even consumer companies are beginning to recognise publications planning as an integral part of the marketing matrix.

It now forms part of the overall communications strategy, adopted not only to raise awareness of a product and its key messages, but also to provide an evidence base for all other communication activities for the product.

Strategic publication plans are developed in two sections: the publications strategy and the publications plan. The publication plan utilises clinical trial data to recommend publications (including journals/abstracts), timings and maximisation of publication opportunity.

The key factors driving any publications plan is product data, whether it be from clinical trials or surveys and strategic reviews of how to best maximise data. A strategic publications plan can help in the promotion of the product through the dissemination of key messages and key data at various stages of its life cycle, from pre- to post-launch.

There are three main advantages to publications planning, namely increased product awareness, market shaping and the provision of an evidence-base for other communication materials.

Publications provide a medium for communication about a product and a means to increase awareness of that product, its key messages and key data. This is especially important in the UK, where sales representatives cannot discuss pre-launch products with customers. Publications are thus the only available source of product information for companies.

Market-shaping is another distinct advantage of a publications plan. This means simply preparing the market for a product or a study. For example, if a new product is being launched for the treatment of rheumatoid arthritis, which also has a novel mode of action, a publications plan can be constructed to build evidence for the importance of the new mode of action and how this novel method of targeting rheumatoid arthritis would theoretically provide a better treatment option for patients.

Of course the plan has to eventually be validated by clinical data for the product, so it is always a good idea to plan your publications once most of the phase III trials are completed. Market-shaping can also be performed for launched or old products with new data before the data are published.

Finally, publications can be utilised to provide evidence-based materials for marketing and media activities, eg, for over-the-counter or consumer products.

To decide what you want out of your publications plan you must first consider what type of a publications plan you require, who your target audience is and, most importantly, what your brand is.

Are you selling a prescription medicine or are you after reviving an old over-the-counter product? Perhaps you are trying to provide a beauty brand, for example, a hypothetical fair moisturiser with a clinical claim.

Publications can be created around all of these. Development of a strategic plan based on product data is the key.

For ethical brands, it is essential that the key primary data generated from clinical trials are communicated to target audiences globally and locally at appropriate stages, and that information in local publications is obtained and routinely updated. This can be achieved through global and local publications planning.

Here, the publication plan offers another distinct advantage of being able to raise awareness of product data that are not yet launched or within its summary of product characteristics. This is especially important with regulations such as Association of the British Pharmaceutical Industry that prevent discussion of any data not present in the summary of product characteristics (SmPC).

The reality is that science moves fast and new data are produced every year for almost all products (eg, oncology treatments). However, these data do not necessarily get integrated within product SmPCs as quickly, though it is presented at international congresses.

Publications are written by healthcare professionals for healthcare professionals (both at international and local levels) and, as such, do not have to conform to these regulations, providing a hub for sharing product data and creating product awareness.

What happens after a clinical trial in terms of publications? The data are presented at congresses and published in a high tier journal eg, New England Journal of Medicine. This, though useful, limits the reach of the data. Ideally, once a trial has been planned the product must create expectations in the minds of customers.

We will assume a hypothetical product yrr as a new treatment for schizophrenia. We are expecting good efficacy and tolerability results, but not very different from what is out there in the market. However, our product is slightly different in that it is an orally-taken, long-acting antipsychotic that doesn't cause any weight gain.

Publishing the data would generate a lot of interest for a short while, but eventually this will become just another antipsychotic on the market. So how can we achieve maximum impact for longer duration? Key questions to ask are:

• What is the significance of a long-acting treatment that would not cause weight gain in schizophrenia?
• How much awareness is there of the importance of long-acting antipsychotics?
• How much awareness is there of the importance of anti-psychotics and weight gain?

Understanding the science behind the product and the therapy area is key to an effective publications plan. The market can be educated or shaped to understand the benefits and need for a particular product before the data are even announced so that when the phase III data are available it can create maximum impact on a market that has already been prepared and is waiting for the arrival of the new clinical data.

There is no need to end the publications here; further articles can be generated to maximise phase III data. In the case of yrr, combining our market shaping or creating need articles with yrr data would make yrr the new treatment for schizophrenia for which, evidence has shown, there is an extensive need. Thus, we have managed to strengthen the product image by providing a strategic, evidence-based plan for communicating key messages.

A strategic publications plan can even be applied to maximise an already launched brand that is suffering from a lack of new data or perhaps has too much data and no focus. Here, the first step would be to identify where the communication gap is. For example, what are the competitors saying that your product cannot or has not said?

Once identified, a successful publications plan can be developed if there is something new to be said about your product (eg, new trial data). The publication targets the right audience at the right time and international authorities on the subject. Market-shaping or need-creating articles in anticipation of trial data can fill the communications gap until the trial data are published.

Targeting the right audience at the right time, though useful, is not always possible. It is fortunate to own a product that addresses treatment needs of conditions or illnesses recurring in the news eg, Bird flu. Accordingly, therapy area awareness further raises the profile of the relevant drug. However, as this is not always the case, we have to find opportunities or even create opportunities for launching new products or re-creating profiles of old products.

Advocates, particularly international opinion leaders, play an important role in this. Once these advocates are on board, they are able to disseminate the evidence-base behind the product and the key messages for the product in articles, provided that they are convinced by the data and believe in the product.

To have good advocates for a brand, pharmaceutical companies must have good relationships with them. In order to achieve this, it is vital that both sides have a good understanding of the data, the science behind the data and the potential impact of the data on the market. Most importantly, it is vital to have a good grasp of your key messages.

In summary, when developing a publications plan there are a few basic steps to follow:

1. Extract key claims from clinical data

2. Develop a strategic plan for disseminating the data (ie, a therapy area story with your brand at its centre)

3. Develop key messages for your brand based on key claims and therapy area story

4. Find advocates who will validate your story and be happy to author the evidence-base, ie, publications for it

5. Implement the publications plan.

A strategic publications plan doesn't have to apply to only ethical brands, it can also be used by consumer brands to raise their profile and get endorsements from healthcare professionals.

However, the objective here is not necessarily new data dissemination, but creation of an evidence-base for the comsumer brand among healthcare professionals. This might lead to brand endorsement by healthcare professionals or to it being used in product marketing campaigns (eg television advertising) since the claims will be based on published evidence. Also, unlike ethical publications plans that are data-driven, a consumer publications plan is largely key messages-driven.

As with any publication plan, we have to go back to the science behind the product to be able to define brand strategy and the brand plan. In fact, this is more important for consumer brands since they will probably not have any new data to present to their audiences.

I am sure we have all seen the pH 5.5 advertisements where a skin product with pH 5.5 is linked to the fact that skin's normal pH is 5.5 hence the product must be good for the skin, or advertisements for omega-3-acids as essential nutrients in food products based on clinical studies. A publications plan assists in making these claims possible simply because they are quoting a material that can be easily referenced.

New trials can also provide new claims for consumer brands, however, so it is always worth asking whether there are any new trials in the pipeline. If so, a strategic publications plan based on an ethical brand plan can also be developed for consumer brands.

Consumer brands wouldn't need a large amount of publications to be able to use the claim in other materials and the publications need not target high tier journals. The main objective for consumer brand claims is to be published so they can be used in other marketing materials. Where they are published is less important.

If the brand has no new data, we can look at old data for new information. How well known is the brand really? It could be an old brand with very little understanding of the mechanism of action of its generic product, eg, paracetamol.

A new image for this brand could be created via new key messages obtained from looking at old data, eg, mechanism of action data for its effect on a particular system, eg, gastrointestinal system. Molecular data, even of old brands, tends to interest key opinion leaders and you might find advocates more easily than you think for a consumer publications plan.

The publications generated can be utilised as an evidence base for re-launching the brand identity, creating awareness of a consumer brand among healthcare professionals (medicalising the brand) and maximising other communication materials through an evidence-based source that can be referenced.

There are many factors that must be taken into account when planning publications and the rules for these vary with different plans. A few important factors are briefly described here.

Firstly, which journal should be targeted? The number of choices within every therapy area is staggering. Should you target a high impact/high circulation journal that publishes quickly but only has a 10 per cent acceptance rate? Or should you go for a medium tier, high circulation journal with an 80 per cent acceptance rate, but which has a six-month submission to acceptance time?

The answer depends on the objectives of each individual article, whether the article is primary or secondary eg clinical trial or review article, whether the author has a pre-existing relationship with certain journals and whether we are looking for maximum impact or just a published reference.

My advice is that, unless you really have to, avoid any paid-for articles as these devalue the article and compromise its credibility and are tantamount to paying for an advertisement in a journal. Secondly, assess competitive literature and identify key target audiences for publications and education regarding the product and therapy area.

Finally, let's look at the all-important issue of ghost-writing. Unfortunately, ghost-writing has been demonised by most journals, but the truth is that medical writers are the biggest assets of the communications industry. They write articles in close collaboration with authors to ensure impartiality.

Ghost-writing is convenient for authors and companies because it saves time and the final editorial control belongs to the journal and the author, not to the company sponsoring the article or the ghost writer and most companies are well aware of this fact. In addition, most communication companies do adhere to Good Publication Practice (GPP) guidelines so it is always wise to make sure an agency works according to GPP before hiring them.

Product and marketplace issues evolve over time, and publication plans need to keep up with changing objectives, new competitive products and scientific developments.