The seven worst mistakes of pharma launch (and secrets to avoid them)
In todays pharma environment, the product launch period has become critical. To set up a pattern for long-term sales and profits, products must make a big splash upon their introduction. But making this happen is a process that can be filled with uncertainty, confusion and frustration. Mistakes can set back years of effort and millions of dollars in expenses. Understanding the biggest mistakes pharma marketers can make during launch can help savvy leaders prevent catastrophes, and plot a clear path towards profit.
What are the biggest mistakes pharma marketers make during pre-launch planning, and how can they be avoided?
1. Focusing on Product, Forgetting Everything Else
Sure, a big part of launching a drug revolves around the drug itself - developing the chemical composition, submitting the drug for approval, ensuring formulary positioning, and more all focus on the physical product. But often lost in the mix is the customer and market.
Long before a product is complete and ready for sale, you need a deep understanding of your customers and the market youre targeting. That means understanding, in-depth, some key points:
The disease youre treating, including standards of care for that therapeutic area
The people it affects
The needs of patients with the disease
The needs of physicians treating these patients
Key opinion leaders and professional associations in the therapeutic area
Trends in patient access, managed care acceptance and reimbursement in the disease area
Key regulatory milestones and requirements affecting the disease and the product
To further know your market, you must also understand your product in terms of the competition that already exists, and that which is likely to develop before and after launch. Knowing how your product will stack up against other players in the marketplace points toward the true benefits of your drug for customers. Pre-launch planning should include some tough questions:
How is your product better than the pharmaceuticals and intervention that already exist?
How can an average customer, payer, physician or pharmacist differentiate between your product and its competition?
How will the product provide benefit that is different than other pharmas offerings?
How will your competitors respond to your market entry?
How will the competitive landscape change over time? Is this area going to explode with entries? Will generics infiltrate soon?
2. Working with the Wrong Team
A good product is important. But just as, if not more, important is the team guiding that product to market, and pushing it towards success.
Instrumental in developing, marketing and selling the pharma product is a team that boasts knowledge, experience and skills. 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, chosen for their titles, successful product launches need a team with creativity, problem-solving ability and persistence, skills that can transcend titles. Businesses should therefore build launch teams based on experience and talent for the unique process of launch.
3. Working in Silos
For effective pre-launch planning, company departments must work together. Why is cross-functional work necessary for successful pre-launches? 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, incorporating 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, long organized by silos and strict division of tasks. Cross-functional collaboration is the pinnacle of marketing and pharmaceutical hopes, but what often happens in implementation is a crash and burn. Breaking the idea down into tactical steps, however, can ease the process from the very beginning:
1. Establish and gather the pre-launch cross-functional team, including R&D, medical and regulatory affairs, and other divisions of importance. For this team of leaders from these departments, the need to differentiate the ultimate product and create value must be explicitly stressed.
2. Provide clear objectives for the team, as well as clearly assigned responsibilities. Everyone must understand his or her role in developing and capturing the product value.
3. As key activities take place, particularly market research, review all findings with the team.
4. Brainstorm and determine the needs of customers in the target area, including what is meaningful and valuable to physicians, patients and payers.
5. Develop options for creating and demonstrating value to the customer base. Together, the team must brainstorm options, anticipating 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 that between marketing and sales. Most marketing communications people don't have a direct relationship with their sellers, and dont 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 to a big bang, and all the materials and information they need to address target questions.
4. Rushing Launch
Everyone wants the competitive advantages of being first to the market, or first to address a unique need. But rushing product launch can come at the expense of long-term success.
In attempts to speed along launch, many companies give short shrift to critical areas, and dont try to accelerate more appropriate areas. The most-commonly skipped steps in a time crunch include primary research, business case development and cross-functional coordination, all of them crucial in best serving the market and customers. Companies can also neglect to devote enough time to marketing and sales tactics, brand positioning, pricing, operational support, and other key decisions.
Due diligence is essential in these areas, and can be tightly project-managed without losing time. An area that can be sped up rather easily, however, is one that many companies dont think about. By investing more attention and energy into initial regulatory approval, and obtaining that approval as quickly, efficiently and comprehensively as possible, far greater value can be earned over a products life. Several regulatory means exist through which companies can look to accelerate market arrival.
Priority Review: In the US, the FDA offers an abbreviated priority review process for specific products that can demonstrate a key point: they serve a specific and notable unmet medical need.
Orphan Drugs: Orphan drug programs in the US and EU offer market exclusivity for the drugs for rare diseases, but this period is offered only to the drug that receives market approval first. Applications for these orphan drugs are given greater levels of support and feedback from regulators, meaning approvals are accelerated.
European Named Patient Programs: These programs are similar to the US programs of compassionate use, with a key difference. 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. Failure to Track, Assess and Learn
Launching a new product can be a very educational experience for all those involved. But without the means of measuring success, tracking activities, and learning from mistakes, all the lessons of launch can be forgotten, creating a missed opportunity to improve future launches.
Companies should take advantage of credible metrics to measure success during the pre-launch period, and participate in a post-launch review. Companies can strengthen their processes, and set themselves up for future successes.
6. Using a One-Size-Fits-All Approach
Consistency is a critical business practice. But many companies can take this desire overboard, fitting every new product into the same mold, and eliminating the creativity and uniqueness of each product.
One way to resist the cookie-cutter approach, and create a product that can be in it for long haul, is lifecycle management. The key to better, customized product success far into the lifecycle is considering these types of strategies early, even in pre-launch. Product lifecycle management means more than plotting a counter-attack against generics. 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.
Be Proactive. Start early, plan ahead, and prepare for any and all scenarios that will arise during a products life.
Organize. Set up the cross-functional teams that will enable a comprehensive perspective and approach, whether or not these are official Lifecycle Management teams. Establish clear ownership and accountability for key actions, and defined lines of authority. More than anything, the team must include members that have the actual power and skills to drive action forward and make any necessary changes.
Franchise. Make plans for your specific product, but also consider the possibilities for further expanding into the therapeutic area. A therapy franchise dominates this area through complementary products, and can be accomplished through solo efforts or licensing partnerships.
Expand. Plan for current uses of the product, but also never stop thinking about the future uses and areas to expand into.
Reformulate. Choose the best form of delivery that makes sense in todays environment, but set the groundwork for new innovations. Scientists are advancing the art of formulation every day, so keep aware and keep focus on newer, patient-friendly methods of administration. Reformulation down the line is an important way of expanding a drugs usefulness and audience.
Protect. Through the pre-launch period, the focus should be on speeding the product to approval to leverage the amount of patent exclusivity. During a products 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. Think you shouldnt even consider the end of the line when youre in pre-launch? Think again. Exit strategies should be planned and plotted. Far too often a product is allowed to limp along in its latter years, consuming valuable organizational and financial resources. 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. Missing Out on the Secret Weapon of Analytics
No matter how much you plan ahead, new drug development is inherently risky in todays environment. Increasingly, pharma managers and marketers need a way to assess the potential of new products, and the likelihood of success upon launch. Analytics models can provide insight on what drives your target consumers, and help predict actual launch results.
The Eularis Pre-Launch Analytics Systems, for example, have been implemented and worked successfully during both pre-launch and launch of numerous pharmaceutical brands. Due to effective pre-launch analytics and planning that created strong preparation for a successful launch, these products continue to be category leaders. For anyone involved in the pre-launch and lifecycle management of the product, analytics will provide significant assistance through the myriad problems and challenges. A comprehensive list of things you should consider analyzing is available here.
In todays pharma environment, the product launch period has become critical. But to set up a pattern for long-term sales and profits, products must make a big splash upon their introduction. Making this happen is a process that can be filled with uncertainty, confusion and frustration. Pharma marketers that avoid these common pitfalls and problems during launch and strengthen the launch with strong analytics will be poised for profit. Throughout the multiple phases of pre-launch planning, using sophisticated analytics can help you answer key questions, supporting your process and removing the dangerous uncertainty that can doom your product.
Author: Dr. Andree Bates, Eularis