Communications before launch
pharmafile | October 16, 2003 | Feature | Medical Communications |Â Â communications, pre-launchÂ
Producing and launching a profitable drug is no easy task and requires cohesive planning throughout all stages of the product's lifecycle. Over the years, successful companies have learned to streamline drug development into an almost seamless process. Once that potential top-selling molecule has come through rigorous clinical trials, it then becomes the job of the marketers to make sure the drug hits the market with sufficient impact.
But where and when exactly does this changeover really begin? While many second-tier companies say marketing budget limitations mean they can't start brand awareness campaigns until late-stage clinical trials, big pharma has increasingly sought to maximise use of its marketing departments much earlier in the drug development process. Companies such as GlaxoSmithKline, AstraZeneca, Merck & Co and Eli Lilly have all committed themselves to integrating marketing muscle into the process for certain major products. A recent report by Cutting Edge Information said that 25% of pharmaceutical company brand managers begin building long-term thought leader relationships early in the pre-clinical development stage.
With the inherent uncertainty in the drug development process, it could be argued that investing in a marketing campaign when the product in question is still several years (not to mention difficult regulatory hurdles) away from launch is a major risk.
Effective integration
Rob Wood, Marketing Director at AstraZeneca UK, says that effective integration of marketing into the development programme of brands is essential if the aim is to generate maximum initial market penetration and continued acceleration of growth.
"Early integration of marketing with R&D not only helps to ensure that we launch a brand that is based on true customer insight (physicians, patients and payers) but also helps ensure that we choose the most appropriate study centres with a view to developing key opinion leader exposure to the brand, as well as achieving the fundamental aim of patient recruitment," he says.
Big pharma is also motivated by thinning pipelines and the need to create brand awareness as soon as possible, says Tom Kass, Head of Healthcare & Biotech Investment at EFG Private Bank. He cites AstraZeneca's Iressa (lung cancer) and Eli Lilly's Cialis (erectile dysfunction) as two examples of companies building the momentum early on at phase II.
"Companies want to advertise that they've got a vibrant pipeline," he says. "They want to build pull for their products within the prescribing community, whether the product is supposed to tackle an unmet need or is already entering a well-served market."
By activating the marketing mechanism so early, companies are obviously displaying tremendous faith in their products – perhaps too much faith some would argue.
Barrie James, President at consulting firm Pharma Strategy, argues that phase II is simply too early to start the marketing mechanism.
"A major reason why companies do it is to boost their share price, especially those who have had a lot of failures recently," he says. "They want to tell people that they're back in the business and not hurting anymore. The problem comes when the product you've been announcing fails six months later. Analysts don't have short memories when they've been sold a pup."
Doing the right thing
There are also ethical considerations. The Cutting Edge report tells of an unnamed company that creates a clear division between the clinical/R&D department and sales and marketing during its key opinion leader programme "to preserve ethical boundaries". Barrie James says that creating noise about a product while it is still in early clinical trials may give false readings about the treatment, stirring up a demand among patients that can never be fulfilled.
"I was involved with Biogen when we were working with interferon and used to get a sackful of letters from distraught parents whose children were dying from leukaemia asking to go on a clinical programme," he says. "We weren't even doing it, it was being done by Schering-Plough."
He also believes that early-stage communications work can sometimes prove to be a liability for companies who risk divulging too much information to competitors.
"I don't think this type of work is valuable at phase II, because its not good to tell people too much. At the end of phase II youve got some pretty good ideas about the treatment profile but before that youre still dealing with toxicity and dosage issues."
Tom Kass says that while over the last 30 years R&D departments have put up resistance to marketing involvement in the early clinical process, it has inevitably had to succumb to pressure from above, namely the chief executive.
He is of the opinion that chief executives who commit themselves to premature marketing campaigns are playing a game "dangerous beyond belief", which could ultimately destroy a company's credibility with doctors and clinicians.
"Some big professors involved in clinical trials were presented with a certain product 10 years before it was launched and resented the fact that they were already told at that stage what the label and indication was going to be," he reveals. "The integrated multidisciplinary team consisting of research, regulatory and marketing personnel was really driven by the chief executive saying at phase II stage that the drug was going to be a winner."
Integrating marketing and clinical
Of course, integrating the marketing department into clinical development does have its success stories. The multidisciplinary teams within big pharma that Tom Kass speaks of are often essential requirements. Their huge remit involves, among other things, working on the label, preparing the marketing material and PR and kick-starting the brand awareness campaign.
"If you're good and smart you can figure out what you want the labels to be and then design a tight set of phase II and III trials," he says.
He cites Merck & Co's launch of Zetia (a cholesterol drug co-marketed with Schering-Plough) as a great example of the marketing-R&D interface working well: "It was fast-tracked by the Food and Drug Administration and just sailed through with perfect trials and a perfect launch. Suddenly Merck is back and working like a machine again with a first-in-class product."
While smaller companies may not have the cash to follow big pharma's example, they are becoming increasingly aware of how valuable the marketing effort is to product development. Tim Kneen, Head of Marketing at the UK arm of German company Merck KGaA says that, while his company could never afford to do what GSK does in terms of pre-launch campaigns, it will set about generating opinion leader interest at the phase II stage.
"It's about educating on development in the disease area," he says. "You have to get investigators interested in doing the clinical studies to carry them out and I think some of the marketing effort is necessary to build interest in people to carry out the studies. But in terms of what the organisation spends overall on marketing, at that stage it's just organisational and logistical costs – it's communication and medical contact with clinical experts rather than direct marketing costs."
The drive to succeed
Whatever the company and whether the marketing department is integrated into a multidisciplinary team or not, no one would deny that pharmaceutical marketers working on such young products need immense drive – after all, there is the realisation that the drug they've been heralding for the past few months or even years might never actually make it to launch.
Tom Kass shrugs off the question of whether plugging pharmaceutical brands during the early stages can be de-motivating. "Like any brand manager or marketer, you have to convince yourself that your product is the bee's knees and stimulate yourself. Marketers get deeply into the message they,re portraying and live their products."
Tim Kneen concedes that 95% of pharma marketers don't work on blockbuster products, but take satisfaction from being involved in a project from the start. "Of course marketers want to see their products launched but one of the drivers of all product managers is to be able to bring a full project from start to finish. If your product is five years away from launch and there's a risk it won't get to market, you take on the job knowing that."
With several of the big pharma players feeling investor pressure to come out with successful new chemical entities, it will be interesting to see whether the trend to integrate marketing into the development equation will continue. As Tom Kass says, one key sign to look out for is whether companies already have a brand name for a product in its early stages.
"It's traditionally seen as bad luck to name a baby before its born," he says. "If you see a product named early, you can be sure the company's in brand management."
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