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COUNT DOWN TO LAUNCH

By Perlotto, Mark
Publication: Medical Marketing and Media
Date: Saturday, October 1 2005
HEADNOTE

Hitting the market with a new pharmaceutical product demands the right blend of good people, astute planning, skilled execution and perseverance. Mark Perlotto suggests five key considerations every brand manager should take on board during the countdown to launch.

Everything

is in place. The clinical trials are going smoothly and the data is looking good. After years of caution, the research scientists are beginning to sound confident. FDA approval - and the subsequent launch - are within sight.

But the marketing team, aware of the high expectations of management, is feeling overwhelmed by the thought of what lies ahead. For the launch to succeed, it is essential to replace that sense of unease with one of enthusiasm. The secret, as with any high-risk situation, is to develop a detailed plan of action and then apply discipline to its execution. For brand management, that means focusing on five key factors that can influence the outcome of the campaign. Together they form the countdown to launch.

5 People

Who is responsible for a successful launch? The answer, of course, is everyone involved. However, in the words of advertising pioneer Leo Burnett, "Collective solutions... start with individual human beings."

In the case of a launch, the most important individual is the brand manager. He or she is captain of the ship, responsible for coordinating the roles of all the others, regardless of whether they are employees of the company or representatives of outside firms (see Getting the Right People on the Team, page 49). These two groups are equally important. The in-house group may include staff from many divisions of the organization, ranging from medical research and manufacturing to distribution, reimbursement and regulatory affairs. In fact, the successful launch of a new product is dependent upon virtually every part of the organization.

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Crucial to the successful launch of Biovail's Zovirax Cream was questioning the conventional marketing approach to cold sore treatments - namely a focus on concealment and misery. Determined to stand out in a crowded category, the team produced an energetic campaign with a theme of empowerment, using enticing headlines and imagery.

Outside groups - such as advertising agencies, public relations and medical education firms, consultants and external advisors - are brought on board to provide specialized services and perspectives that don't exist within the company. To be effective, these individuals must be regarded as partners, not vendors. They are, in fact, members of the extended marketing team.

Having many viewpoints is critical to the success of the launch. Noted French philosopher Emile Auguste Chattier explained why in an essay published in 1920. "Nothing is more dangerous than an idea," he wrote, "when it is the only one you have."

Avoiding the "one idea" syndrome requires frequent meetings - perhaps once a month at the beginning, more often as the launch approaches - attended in person or through teleconferencing. Written reports are essential; without notes, deadlines and discussions may be overlooked.

Most important, however, is the brand manager's role in dealing with corporate, cultural and personality differences. It's the manager's job to keep the team on target, so that members of the group, regardless of their professional status or orientation, can work together and create an effective plan.

4 Planning

A good launch plan has two elements. The first is a realistic evaluation of every aspect of the marketing effort. The second is a step-by-step outline of actionable direction. The plan must be absolutely clear and concrete. A plan that is fuzzy or vague will end up on a shelf, or worse yet, lead inevitably to failure.

In order to create a realistic evaluation, the team must assemble as much information as possible about both the product and the market. Honest assessment is essential. SWOT, the familiar rallying cry of marketing, means understanding the strengths and weaknesses of the product, as well as the opportunities and threats of the marketplace. If the team can recognize the threats, then it can take steps to overcome them.

A good starting point is to read industry publications and medical journals. Then check out existing market research, syndicated data sources, clinical databases, industry contacts, vendors and the Internet. Remember: a product launch is like a military campaign. Knowledge - of both the enemy and the terrain - is essential.

While evaluation depends on curiosity, direction demands discipline. That means sticking to the old rules of marketing by objectives. Since many people tend to blur the steps, it's worth repeating them here:

Objectives are the measurable goals to be achieved, in dollars, volume and market share. Strategies are the concepts that spell out how to achieve those goals. Tactics are the concrete activities that are used to carry out the strategy.

The biggest problem facing most launches is the tendency - on the part of the team - to confuse strategy and tactics. That's because tactics, being concrete, are sexy. They are easy to visualize and fun to implement. Strategies are more difficult.

In order to develop effective strategies, the group must ask questions. For example, Who is the target audience? What is the message? And, most important, why should anyone prefer this product above all others? Good strategists will use the "why" question to make sure their marketing plans are unassailable. Asking questions - such as why are we doing this and why do physicians and patients behave in a certain way - should become the marketer's daily mantra.

A good example of this process is the launch of BiovaiPs Zovirax Cream (acyclovir), a prescription drug for recurrent cold sores. While the cold sore virus is not a life threatening infection, the sores themselves can be as uncomfortable and embarrassing as anything in the medical lexicon. For years, marketers focused on the problem, creating campaigns that highlighted the patient's misery and concentrated on concealment. Noting that the cold sore medication category was teeming with competition - from OTC products to single-dose oral anti-virals - the launch team was determined to find a way to make Zovirax Cream stand out.

So instead of focusing on the misery, the team turned the medication into a tool of empowerment. Using the headline, "Hate cold sores? Be a Sore Loser," the campaign conveyed an image of a vibrant, energetic young person - reflecting the target demographic - and conveyed the unlikely concept of a happy "sore loser." The juxtaposition of opposites enticed the viewer to read on to understand a headline which seemed at odds with the visual.

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After the withdrawal of COX-2 painkillers Vioxx and Bextra, millions of arthritis patients were forced to revert back to NSAID treatments, which are known to pose a higher risk of inducing stomach ulcers. AstraZeneca's brand team saw this as an opportunity to reposition its proton pump inhibitor blockbuster Nexium as an effective way to manage the problem.

The result was an attention-grabbing campaign. And to combat the availability of OTC medications, in-office materials were designed to facilitate conversation between the patient and the physician, even if the patient was not experiencing an outbreak.

All well and good, but what exactly is strategy? Al Ries and Jack Trout, authors of the landmark guide to strategy Positioning:The Battle for Your Mind, pointed out that the French have a phrase for it: Cherchez le creneau, they wrote, meaning "look for the hole or gap." In other words, find a need that exists in the marketplace, then position the product to fill it.

One of the best examples of this approach is the new marketing campaign for AstraZeneca's proton pump inhibitor, Nexium (esomeprazole magnesium). While technically are-launch - it was originally introduced in March 2001 - it illustrates the point well.

The withdrawal of Vioxx and other COX-2 Inhibitors from the market in the past year created an opening, and the Nexium marketers moved to fill it. Suddenly, arthritis patients who had switched from non-steroidal anti-inflammatory drugs (NSAIDs) to the COX-2 class of painkillers - because of their gentler impact on the stomach lining - were forced to go back to NSAIDS. The return to these earlier drugs, which caused more irritation to the stomach lining, meant a resurgence of NSAID-induced ulcers.

Realizing that millions of arthritis sufferers would be facing this prospect, the team repositioned Nexium as a way to manage the problem. The campaign, launched in May of this year, asks "Could your NSAID use a good partner?" By using the "positioning" strategy, the company was able to open a new market for the brand.

3 Playbook

Just as a football team needs a playbook, so does a marketing group, especially when it's launch time. The playbook is the team's plan for success. It's also a way to make sure that everyone is on board, and that everyone understands what is being done, why it is being done, when, how and by whom. Every member of the team must understand how his or her responsibilities impact on everybody else.

The best way to make sure that everyone understands the plan is to make development of the playbook a collaborative exercise. Every member of the team should be involved. The playbook should identify everything that has to be done and specify who is responsible for what. Overall, the purpose of the playbook is to spell out the fact that success is dependent on people working together.

While diversity is an asset and helps marketers to avoid the "one idea" syndrome, it can also be a challenge. A skilled marketer must know how to get everyone - regardless of his or her perspective pulling in the same direction.

The Regulatory Affairs staff - which is sometimes referred to by frustrated marketers as the "sales prevention department" can be a particular challenge. This was the problem facing Janssen Pharmaceutica, a division of Johnson & Johnson, in 1993. The marketing team charged with launching Propulsid (cisapride) adopted a unique approach to bringing the regulatory team members to the same side of the table.

In a move that was unusual at the time, the marketers arranged for their regulatory counterparts to attend market research sessions. By sitting behind the one-way mirror and observing the reactions of the participating doctors, the regulatory people gained a first-hand appreciation of the challenges facing a new product in a competitive marketplace. As a result, they went from telling the team what it could not say to working collaboratively, focusing on ways to achieve communication goals while remaining in compliance with the regulations.

2 Perseverance

To persevere, according to Webster's, is to remain constant to a purpose or an idea... even in the face of discouragement or opposition. To persevere is to persist, to endure, to remain steadfast.

In a product launch, perseverance is vital. It's a simple fact that things often go wrong. The important thing is to think through all the contingencies, and then address them. There will always be people who challenge, discourage or oppose the team's decisions. Sometimes issues emerge that appear to be beyond the marketer's control. Typically, these issues and events are unexpected. But to avoid getting shot down, marketers need to "bullet-proof" their plans, playing devil's advocate and making sure that they are prepared for a worst-case scenario.

However, flexibility is also an important part of the game. Change is inevitable, and brand managers who overlook the possibility of change are playing with dynamite. It is important to know where and how the product is vulnerable.

Knowing that problems may arise - regardless of whether they are changes in medical practice or the regulatory environment allows the marketing team to maintain control by addressing potential changes in advance.

1 Playtime

Everyone needs to take a break, especially during the all-out intensity of a launch. The pressure of wanting to succeed can be a killer. A launch can easily upset the sense of balance that most people maintain. Relaxation - whether spending time with family and friends, working out or reading - is essential for keeping a clear head, so that everyone can function in top form.

Playtime can also be a team-building exercise. Many launch teams have learned the value of cooperative enterprise through community projects, such as cleaning up parks or building houses for the homeless. Working together on a project with a visible goal can help marketers to stay focused while developing loyalty and trust. It could even, be integrated into the overall marketing effort.

Another team-building approach is to get involved with a charity, particularly one that is dedicated to helping sufferers of the disease treated by the new product. Participating in a walkathon or similar fundraiser can galvanize the team and remind them of the value of the work they are doing. It can also create a positive impression of the company with doctors and patients prior to the actual launch.

SIDEBAR

Getting the right people on the team

In-house or out, corporate or agency, everyone has an important role.

DEPARTMENT REPRESENTATIVES:

Marketing: The product or brand manager is captain of the team.

Market Research: While the researchers can provide the keys to understanding the physician or the purchaser, the marketer must determine what to look for.

Clinical: In addition to clarifying data from completed studies, scientific researchers can, if included early enough, pursue additional data, broadening possible indications or claims.

Manufacturing: Accurate forecasting is critical to the campaign. If production is late, then the timing of the launch will have to be changed.

Trade Distribution: The people who control when the product will reach the wholesalers and be on the pharmacy shelves.

Reimbursement: Specializes in filing applications, so that payment is covered by Medicaid, health insurers, benefit plans and HMOs.

Medical Affairs: In-house experts, usually physicians or Pharm.D.s

Regulatory Experts: Will oversee the process of gaining FDA approval for both the product and the promotional materials.

Sales Management: Must understand - and be excited by - the marketing strategy. They can also provide valuable insight into utilizing the sales force most effectively.

Sales Training: For the sales force to sell effectively, they must be trained in the features and benefits of the drug as well as the conditions it treats.

Sales Force Advisory Board: Members of this group serve as a conduit of information between marketing and the sales force, helping the latter to understand the reasoning behind the marketing team's approach.

AGENCIES:

Advertising Agency: Should be the marketer's primary source of help on planning the launch. Marketers have the right to demand an account team that is capable of serving as part brainstorming partner, part sounding board and part product manager.

PR Agency: Using the editorial voice of the media, the PR agency can create an educational campaign, designed to focus awareness - prior to the launch - on a specific aspect of a condition or disease.

Medical Education Agency: Can play a vital role in the clinical differentiation of a product-the agency will understand the strategy and design customized programs for the physicians. Marketers should be wary of cookie-cutter solutions.

PHYSICIAN ADVISORY BOARDS:

In addition to giving advice, these physicians - who should be respected by their peers - can serve as advocates for the new treatment. Instead of being used as sounding-boards, these doctors should be given specific assignments for communicating with their colleagues.

SIDEBAR

Learning about the launch environment

A complete understanding of the market, the competitors and the product itself is critical. Specific areas to explore include:

* Market size, segments and trends

* Market shares of current competitors

* Current practices or buying patterns (particularly those that might undercut this product)

* Clinical data

* Regulations - particularly those that put constraints on promotion Current competitors (products and companies)

* Future competitors (products and companies)

* A complete understanding of the clinical data on the launch product

* Strengths, weaknesses, opportunities and threats (SWOT)

* Key issues and challenges

AUTHOR_AFFILIATION

Mark Perlotto is executive vice president and chief marketing officer of Adair-Greene Healthcare Communications.

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CONTRIBUTORS

AUTHOR_AFFILIATION

MARK PERLOTTO

Mark Perlotto is executive vice president and chief marketing officer of Adair-Greene Healthcare Communications. His article about the five ways a brand manager can increase the chances of a successful product launch begins on page 47. Perlotto can be contacted by e-mail at mperlotto@adair-greene.com.