So much of a drug’s success depends on how well it is launched. To set up a pattern for long-term sales and profits, products must make a big splash upon their introduction. However, the process can be filled with uncertainty, confusion and frustration. Mistakes can set back years of effort and millions of dollars in expenses. Here are seven steps to help you maximize your chances of success.
1. Determine market potential
One of the costliest mistakes you can make is overestimating the market potential. That’s why the data that goes into your forecasts is so important.
Long before your product is complete and ready for sale, you need a deep understanding of your customers and the market you’re targeting, including:
• The needs of patients with the disease you’re treating
• The needs of physicians treating these patients
• Key opinion leaders and professional associations in the therapeutic area
• Trends in patient access and managed care acceptance / reimbursement in the disease area
• Key regulatory milestones and requirements affecting the disease and the product
• Standards of care for that therapeutic area
You must also understand the competition that already exists, and anticipate future competitors. Knowing how your product will stack up against other players in the marketplace points towards the true benefits of your drug for customers.
Ask yourself:
• How is my product better than the drugs and interventions that already exist?
• Are these key drivers for prescribing in the Rx category or just easy USPs that will not influence results?
• How can an average customer, payer, physician or pharmacist differentiate between my product and its competition?
• How will the product provide a driver benefit that is different to other Pharma?
• How will my competitors respond to my market entry?
• What could be the impact of this on my brand launch?
• How will the competitive landscape change over time?
• Is this area going to explode with entries?
• Will generics infiltrate soon?
Until you can answer these tough questions, you’re not ready to proceed with launch.
2. Assemble the right team
The team guiding your product to market and pushing it towards success is just as important as the product itself, perhaps even more so. Choosing this team is a delicate endeavor, and should combine leaders from all pay grades and units. While product managers, marketing directors and managers are often the go-to team members, successful product launches need a team with skills that transcend titles. Creativity, problem-solving ability and persistence are all vital. Businesses should, therefore, build launch teams based on experience and talent for the unique process of launch.
3. Collaborate at all stages
Cross-functional collaboration is the pinnacle of marketing and Pharmaceutical hope. Consider product research and development, which can often take place in a vacuum. With a cross-functional team, R&D can learn the concerns and needs of marketers, and incorporate new research points that can be instrumental in later positioning and sales.
Of course, collaboration on this level can be a daunting prospect for Pharma companies that have been organized by silos and strict division of tasks. Breaking the idea down into tactical steps can ease the process. Firstly, establish the pre-launch cross-functional team and explicitly stress the need to differentiate the ultimate product and create value. The next step would be to provide clear objectives for the team, as well as assigned responsibilities. Everyone must understand his or her role in developing and capturing the product value. As key activities take place, particularly market research, review all findings with the team. Finally, develop options for creating and demonstrating value to the customer base. Together the team must brainstorm options, and anticipate regulatory requirements, clinical development needs and marketing potential. Consider options also in terms of managed care organizations’ perspectives and how the company can alleviate any concerns.
One collaborative partnership that is especially important to launch is marketing and sales. Since most marketing communications people don’t have a direct relationship with their sellers, they don’t understand the realities that the sellers face in everyday sales situations. Cooperative launch planning can ensure that the sales team has the pre-launch education to get new products off with a big bang, as well as all the materials and information they need to address target questions.
4. Secure approval
By investing more attention and energy into initial regulatory approval – and obtaining that approval as quickly, efficiently and comprehensively as possible – one can earn far greater value over a product’s life. Companies can accelerate market arrival through:
• Priority Review. In the U.S., the FDA offers an abbreviated priority review process for specific products that can demonstrate they serve a specific and notable unmet medical need.
• Orphan Drugs. Programs in the U.S. and EU offer market exclusivity for the first drugs approved to treat rare diseases. Applications are given greater levels of support and feedback from regulators, meaning approvals are accelerated.
• European Named Patient Programs. When a patient has a serious illness that does not have an approved drug available, drugs that have shown promise in clinical trials (but are not yet fully FDA approved) can be authorized for use. In Europe, these unlicensed drugs can be reimbursed, granting Pharma companies an opportunity to generate revenue while development is still in progress.
5. Define marketing messaging
Even a product with great intrinsic value will not reach its potential market share without solid communication. Evidence-based marketing messages and themes are increasingly important as market access hurdles make it more difficult to penetrate the market. If your company doesn’t have the resources to launch a deep, multi-layered marketing campaign, then you need to partner with a company that does.
6. Develop a product lifecycle strategy
A true product lifecycle strategy is focused on maximizing the profitability of a product over its life. There are several ways to do this, and they figure prominently in the pre-launch period.
• Franchise. Make plans for your specific product, but also consider the possibilities for further expansion in the therapeutic area.
• Expand. Plan for current uses of the product but never stop thinking about the future uses and areas to expand into.
• Reformulate. Scientists are advancing the art of formulation every day, so keep aware of newer, patient-friendly methods of administration. Reformulation down the line is an important way of expanding a drug’s usefulness and audience.
• Protect. During a product’s lifecycle, the team must study all regulatory trends and methods of maintaining patent protection. Prolonging the time before generic competition is an essential means of protecting the time and energy put into drug production.
• Switch. Think a successful OTC switch will be just the key for protection years down the line? Not without extensive planning that reaches back into the pre-launch period. Some experts contend the switch should be planned while the drug is still in clinical trials, and at a minimum of seven or eight years before action.
• Shut Down. Exit strategies should be planned and plotted early. Consider the long term and the potential scenarios for actively managing the end-of-life phase, and pinpoint the cutoff point for when the product no longer delivers value.
7. Track, assess and learn
Launching a new product can be an educational experience for all involved, but without the means of measuring success, tracking activities and learning from mistakes, all the lessons of launch can be forgotten. Your company should take advantage of credible metrics to measure success during the pre-launch period, and participate in a post-launch review to strengthen your processes and set yourself up for future successes.
Don’t forget your secret weapon: analytics.
No matter how much you plan ahead, new drug development is inherently risky in today’s environment. Increasingly, Pharma managers and marketers need a way to assess the potential for a new product, and the likelihood of success upon launch. Sophisticated analytics models can provide important insight on what drives your target consumers and can help predict actual launch results. However, you have to be careful what data is used: garbage in, garbage out. The only data found to have high levels of accuracy are validated current market data for the brand being studied and its competitors in the market. And even this alone is not enough! The data collection methodology has to be one that works or you still face the garbage in / garbage out scenario.
We have tested many data collection approaches to be used with analytics and found that there are only a few specific approaches for data collection that result in highly accurate predictions.
Conclusion
Pharma marketers that avoid common pitfalls and strengthen their product launch with strong analytics will be poised for profit. Throughout the multiple phases of pre-launch planning and lifecycle management, sophisticated analytics can help you answer key questions that support your process and remove the dangerous uncertainty that can mean disaster for your product.
For more information, please contact the author – Dr Andree Bates – at Eularis.
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To learn more about how Eularis can help you find the best solutions to the challenges faced by healthcare teams, please drop us a note or email the author at abates@eularis.com.