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Solid Foundations

Involving marketers as early as possible in drug development can help to build a stable launch platform for new medicines further down the road

Never before has so much been expected from pharma's marketing people. Not only are they increasingly relied upon to make up for significant patent expiries, but they do so with fewer than ever new drugs coming through the pipelines. On top of all this, they must continue to work effectively and unperturbed when the industry is still reeling from some of the worst publicity it has sustained in its history.

First there was Vioxx, casting doubts among the public about the processes in place to ensure a medicine's safety. Those doubts are now being tested in the courts as Merck takes on the litigants, case by publicised case. Then came the nightmare of Northwick Park, the hospital in north-west London where six healthy volunteers were rushed into intensive care within minutes of being injected with investigational drug, TGN 1412.

That product - and the processes to protect the public - went on to be taken apart by the media with an intensity usually reserved for mid-air collisions.

The effect of such incidents has been well-documented and underlines an already cautionary mood among regulatory and industry bodies. Marketing practices, at least so far as their implementation is concerned, have been reined in on both sides of the Atlantic. The Association of the British Pharmaceutical Industry's (ABPI) voluntary Code of Practice has been tightened, for example, to curb excesses in hospitality and such like offered to prescribers.

Similarly, the US industry body, Pharmaceutical Researchers and Manufacturers of America (PhRMA), has sought to curtail escalating spending on direct-to-consumer (DTC) advertising
and adjust its content to present a better picture of both the risks and the benefits of drugs. In the summer of 2005, company chiefs in the US agreed to introduce guidelines for a voluntary `moratorium' on DTC activity for the first two years of a drug's launch. The idea, explains Wood Mackenzie consultant, Cliff Kalb, was to enable firms to gradually cascade their promotion of a new product to specialists, then GPs and finally, the consumer.

It was also, he admits, a pre-emptive move to prevent the government saying that the whole DTC experiment was over; and there was always the question of cost, especially when belts are being tightened everywhere else in the industry.

There are approximately 600,000 GPs in the US and around 300 million consumers, Kalb says. The cost of reaching that much larger audience is high and the impact is difficult to measure.

Yet, while the broader economic conditions would seem to suggest that steady, more measured, not to mention cheaper, marketing campaigns are on the horizon, more direct commercial considerations suggest otherwise. It could be argued that with fewer new blockbusters on the cards, pharma will look to ensure that existing products are being used as fully as is safe and appropriate. The way forward, therefore, is to start marketing at a much earlier stage than has been the traditional norm.

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Clarify your aims
However, if marketing people are to satisfy conditions that call for firms to be both marketing heavy and marketing discreet at the same time, new definitions of marketing savvy must evolve.

Consultants, such as Wood MacKenzie that advise the largest firms, suggest that for some in the US it already has. Multi-disciplinary teams of scientists and commercial people are routinely working together from phase zero, says Kalb. Commercial people are actively involved in commercial assessment and developing target labelling for an ideal product from very early on.

Having launched a number of drugs over more than 35 years in the business, he says he has always experienced what he describes as a relatively open exchange of ideas between the scientists and the business staff. Although largely US-based, his experience helps to make sense of the reasons why UK folk are thinking about involving marketers as early as possible.

Paul FitzGerald, for example, worked for almost as long as Kalb in pharma marketing before setting up a consultancy, Syntropy medica, with a colleague. Specialising in early marketing services, he is naturally keen to point out the hazards of delaying such thinking until late phase II or phase III, when traditional agencies are more likely to be engaged.

He mentions how the experimental drug TGN 1412 was being picked apart mercilessly while the biotech company that made it, TeGenero, was scrambling to say what it was. It didn't even have a name, he says. Companies are under much greater public scrutiny, and not only when disaster strikes. There are powerful new audiences at every stage of the drug development process and companies have to be better prepared.

These audiences include business analysts, who are entering the picture increasingly early, eliciting notable influence over market sentiment, and, hence, stock value.

But how do outsiders get a look in? Nathan Waller, a senior marketing manager with global CRO, Charles River Laboratories, believes the only thing stopping marketing from adopting a higher profile from the start of the development process is inertia on the part of big pharma.

This is the widely-felt frustration of anyone who would be in the loop earlier and is, as Kalb points out, the distinction between marketing planning and marketing execution. It is the line between what gets done internally and what is communicated externally.

A drug's identity is discerned in those early commercial exercises. The main focus is to set a target product profile based on anticipated unmet medical need in 7 to 10 years' time, Kalb says while describing the basic commercialisation process.

From this profile, you develop differentiation factors around the product - in safety, efficacy and so on. Then, as the molecule moves through phases I and II, you see how data generated from trials is shaping up compared to that ideal in reality.

CROs naturally feel well-placed to help pharma firms find the information they need to support their product in whatever particular niche it is being marketed. As a collective group, CROs are party to information that is extremely valuable, says Waller. When a company comes to us to put a molecule through a trial, they ask about things like patient recruitment, of course, but also about the particular therapeutic area. Our bread and butter is R&D, and knowing the status of the big therapeutic areas helps.

If it is a popular area, the chances are we will have worked in it before, and while we can't be explicit about specific companies, we are implicitly knowledgeable and can pass on the general lessons we have learned.

CROs, for almost as long as they have been in business, have been trying to broaden their image beyond simply conducting clinical trials, which is now a highly competitive business. It hasn't been easy though and the obstacles are usually all too human, in the form of new product managers, for example, who want to make their mark. Or old ones, who simply want to hold onto their jobs. It is up to companies like Charles River and consultants like FitzGerald to convince them of the value they can offer.

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Early-bird benefits
Waller sees clinical research as part and parcel of marketing and his challenge lies in getting people to appreciate that fact more keenly. A trial in itself is a marketing tool. If your definition of marketing is knowing where the product will fit into the wider scheme, then CROs have always been key players.

It is no longer just clinical data that is important. Buying groups in the US and institutes like National Institute for Health and Clinical Excellence in the UK require more economic data now; studies that demonstrate how costs of hospitalisation are reduced, or which highlight the costs of significant numbers of people not working in the economy, are also in demand.

Yet, while CROs and small consultancies have ample expertise in bringing together a comprehensive profile of a product, it remains difficult to get the larger firms to buy their services much before phase III/late phase II. FitzGerald laments this state of affairs because, as he sees it, many firms do not have the internal structures to properly support a product from R&D into commercialisation.

Who decides what is said about products, and on the nature of the therapeutic class? he asks. It is usually the corporate department and is all about promise - because the support structures aren't necessarily there to link in with R&D, products are left to make their own way through the wilderness.

Structures that don't genuinely integrate R&D and marketing create a lot of unnecessary grief among the research scientists, he adds. Everyone wants to attract the best researchers but you have to know how they tick, and that is through public recognition of their work. Yet, increasingly their output is controlled by a publication programme, which means that they usually don't get recognition until phases II or III, when the programme gets underway. This can create bad feeling that can be avoided by thinking through how the science is going to be communicated right from the start.

Clearly, the earliest possible target-message platform can benefit several parties in the equation, and pipeline products groups have evolved in many companies to act as a bridge between R&D and marketing to do precisely that work. The major issue for people like me is finding out who our client is, says FitzGerald. Who is responsible for early-phase marketing?

This can be as much a mystery to those inside the top companies, as it is to those on the outside. Each company has its own culture where decision-making takes place, points out Wood Mackenzie's Kalb. Some are clearly more R&D-driven and others are more market driven. Both can succeed.

With the smaller companies, this isn't an issue and Charles River, for example, has set up a navigation group to mirror the business model of a biotech company from discovery proof-of-concept onwards. The idea, Waller notes, is to do everything we can to help close the gaps in their dossiers so they have something to sell to pharma.

Cart before the horse
Meanwhile, the decision makers driving big pharmacos have reasonable concerns about not hyping something up too early. Kalb points out that regulations in the US (and everywhere else) prevent companies linking a brand name to an indication before approval. This means they can only talk about the disease area, and that can backfire massively if the clinical research can't ultimately substantiate what has been said.

The danger of hyping up drugs too early is not only that significant spends aimed at raising awareness of the disease are wasted, but also that companies face accusations of disease-mongering from a public that is already concerned about the value they get for their increasing drug spend.

First it was sales that was looked at, says FitzGerald. But soon it could be marketing. There are guidelines for good clinical practice and good manufacturing practice. Yet, outside of the provisions made in the ABPI's voluntary Code of Practice, there is nothing expressly for good marketing practice; firms are operating in a new environment, unsure of what is required of them.

Indeed, firms can, and do, push so hard downstream that they create problems for marketing strategies upstream. According to FitzGerald, the lasting lesson of Vioxx could be that it acts as a kind of brake on the forces that always strive for maximum commercialisation. There are no limits to the skills and hard work of lawyers when they are presented with the challenge of fighting for a cut of the awards, he says, noting the quarter of a billion dollars that was awarded to the widow of a Walmart store worker who died of a heart attack after taking Vioxx for three years.

A cut of that kind of money, multiplied by thousands of litigants, prompts the thought that guidance with what is said about a drug from the off might well be a shrewd move.

2nd September 2008

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