You’re approved!

The months of preparation are in the past. It’s time to launch.

By now, you’ve accomplished so much:

• You’ve built a rock-solid strategic foundation
• Your team is fully aligned with your launch objectives
• You have a strong value story, a solid brand strategy and a thoroughly vetted launch plan
• Each cross-functional workstream is committed to the overall plan and its own 12-week execution plan
• You’re prepared with verifiable accountability measures
• Launch readiness meetings are scheduled, reporting mechanisms are set and every pre-launch box is checked

You have the green light—and now the excitement really begins!

Ensuring a laser focus

Studies have shown that, for 85% of pharma products, the launch trajectory is set within the first three to six months. That means there’s literally no time to waste. None at all.

This is the moment that each aspect of the launch, from supply and demand chains to the most specific tactics, get underway all at once.

This is the moment for team-wide laser focus on every detail, on ensuring that everything you’ve planned is implemented with optimal effect.

To ensure optimal implementation, we recommend creating and using an action plan that breaks the overall launch plan into its component parts. The action plan is a day-by-day—even hour-by-hour—agenda that specifies exactly what must happen during the first weeks after approval. The plan document identifies all of the cross-functional teams and specifies the individual duties and responsibilities for each team member within each task.

The action plan needs to be prepped and ready immediately upon approval. This is a challenge because the plan must be produced in advance of the launch date; yet it can’t be finalized until just before approval is granted, so that there is as little room as possible for unforeseen factors to arise and circumstances to change.

When creating the action plan, managers must make it as bulletproof as possible. Long-standing assumptions should be challenged. Accepted processes should be questioned. The launch team should ask itself why tasks can’t be implemented sooner and/or more effectively. Press the sales team—why can’t they start selling on day one? Press the manufacturing team—why can’t supply of the product be available immediately after approval?

Using this planning process to forge the most creative yet compliant solution, your launch might exceed expectations right from the get go.

Extending the plan’s power

This kind of detailed action plan can be extraordinarily valuable. And, when the plan includes mandatory daily check-in meetings, your launch can reach something that is truly rare—a maximal level of accountability. A detailed plan, plus formal meetings, can keep individuals on task and the workstreams consistently and continuously aligned throughout the launch period.

Of course, the culture in some organizations may call for less rigorous, less formal meetings. Either way, as long as regular check-ins are held, you’ll be able to routinely see what teams have accomplished, what issues have come up, and what needs to be done next.

Using “fail fast” methodology

And yet, even when your planning and readiness and accountability have been outstandingly managed; even when you’re convinced you have the right strategy and tactics; even when market testing shows the mindset and the messages are right on target …

Even then, launches rarely proceed exactly as planned.

Because of that reality, we recommend the fail fast/succeed faster methodology. Fail fast is designed to cut losses when a tactic or approach isn’t working. Organizations use this method when jettisoning fast failures seems more likely to achieve the desired result versus taking the time to perfect the solution.

With fail fast, key performance indicators (KPIs) are used to identify poor performing tactics as quickly as possible. Then, the team has to be willing to acknowledge the failure and move on. Simply put, teams have to see the problem, course correct, and implement a revised solution.

That’s why effective measurement is so vital.

Tracking launch performance

Measuring your success is essential from the start of your launch, and this is especially true when using the fail fast methodology. Here are some KPIs your team should track in a highly verifiable way from the moment launch implementation begins:

• Brand awareness
• Payer perceptions
• Barriers to prescribing
• Message effectiveness
• Sales team training effectiveness
• Share of voice in relevant publications
• Number of contacts with opinion leader and/or prescribers
• Social media engagement

The above metrics are called “leading” indicators—that is, these indicators help predict future performance. Obviously, tracking the trends shown by these indicators is not only vital as early in the launch as possible, they should be monitored throughout the launch period.

However, we also recommend measuring “lag” indicators—those that show actual results of past actions. You can start checking these retrospective measures within weeks after your initial launch date. Lag indicators can include items such as market share; the extent of penetration into opinion leader and/or prescriber populations; number of prescriptions written in a given time period; refill rates; and many other measures.

You can achieve consistent excellence

Consistency is the key to overall organizational excellence. That’s why so many leading organizations rely on CMK Select when they plan and implement their product launches. We use a tried, tested and proven methodology designed to optimize each product’s trajectory. Contact CMK Select today to learn more.

Create the plan. Execute the plan.

Sounds easy, doesn’t it? Yet, if you’ve launched a product in healthcare, you know the reality. Even with a well-conceived plan and full organizational buy-in, effective execution can be a daunting challenge.

Launch excellence means overcoming countless obstacles, everything from predictable amounts of procrastination to a wide range of entirely unpredictable events.

Of course, successful launches do happen—statistics say about 50% of launches achieve peak sales. The question is, “How?” CMK Select has developed a tried and true process that can dramatically increase your odds for launch excellence.

Preparing for excellence: Accountability and readiness

A truly optimized launch must operate on a solid foundation. That means achieving complete alignment across the entire launch team, including all of the cross-functional teams (also known as “work streams”). An optimal launch also requires continuous communication, ongoing consensus-building and organizational transparency in every aspect of the launch.

But that’s simply not enough. Reaching true launch excellence also requires verifiable accountability. That means establishing milestones for each individual workstream that are both directly measurable and highly visible.

And then we take accountability even further. Peer-to-peer accountability has repeatedly proven vital to achieving high levels of success. So we find that the best way to keep teams accountable is by holding recurring launch readiness meetings. We use readiness meetings to:

• Determine the critical path
• Drive the project schedule
• Monitor issues, risks, and key decisions
• Prepare for senior management updates
• Ensure operational readiness at product approval

A typical meeting brings together 10-20 cross-functional teams to discuss what’s been accomplished and what’s upcoming. The meetings also serve as a forum to discuss risks, anticipate problems, and develop mitigation strategies when something arises that could negatively impact a successful launch.

This approach increases the likelihood that tasks will actually get done, strongly supporting accountability.

Executing for excellence: Atypical timing

In addition to accountability and readiness, we also find that launch success is enhanced by an important wrinkle—an atypical approach to timing.

When organizations plan, they plan annually—annual budget cycles, annual performance reviews, annual sales meetings, etc.  And annual goals are, of course, important. However, many high performers can lose focus when there’s too much distance between setting and accomplishing goals. They need to keep short term targets unerringly in their sights.

That’s why we recommend chunking your year into smaller pieces, a concept called “periodization.” Breaking the year into chunks, specifically 12-week blocks, provides enough time to accomplish key tasks—and yet each chunk is short enough to give team members a sense of urgency.

Importantly, a 12-week block shouldn’t include too many tasks. It’s actually far more effective to focus on a limited number. We recommend leveraging the focus created through short term chunking by producing a specific plan of action for each task. We find that this approach can drive massive results.

Applying the 12-week planning concept, each cross-functional team or work stream should select the two or three initiatives it will achieve during the next 12 weeks. These initiatives will have already been aligned to the objectives of the launch; and those, in turn, are based on the product’s vision and market position.

Once each workstream’s initiatives are selected, the 12-week chunks should be further subdivided into smaller periods—dividing activities into monthly, weekly and daily assignments. Even the most complex tasks can be managed using this approach.

Progressing toward excellence: Readiness reports

As we’ve noted, readiness is one of the central factors needed for any successful launch. At CMK Select, we find that by tracking and reporting on the following six readiness factors, you can quickly and easily supply a 30,000-foot view of your launch progress to all key stakeholders and senior management.

Marketplace Readiness: Are you ready to establish your brand in the marketplace?

Report on the status of preparations for arrival of your product in the commercial marketplace and the status of specific launch preparations.

HCP & Patient Readiness: Is your medical/patient community ready?

Report on the status of preparations affecting the medical and patient communities.

Supply Chain Readiness: Is your supply chain ready?

Report on the status of supply chain preparations, specifically progress toward stocking that will match the uptake based on forecasted demand.

Access Readiness: Will your product be ready for reimbursement?

Report on the status of connections to a broad base of payers, and efforts to promote the benefits of the product that will lead to reimbursing the product at launch.

Organization Readiness: Is your organization ready?

Report on the status of operational adjustments to add this product to your portfolio.

Approval Readiness: Is your brand ready for approval?

Report on the status of regulatory submissions approvals needed for launch.

Become accountable for excellence

Over the years, dozens of leading organizations have relied on CMK Select to achieve launch excellence. To see how our proven methodology can optimize your product’s trajectory, contact CMK Select today.

It’s time. Your product launch is coming. Are you prepared to go face-to-face with the marketplace?

Our webinar, Achieving Launch Excellence: Creating a Foundation for Success, provides brand and marketing managers and other key launch stakeholders the tools and resources necessary for laying the proper groundwork to ensure a favorable launch.

You’ll learn how to create a foundation for success based on:

• Strategy & Alignment – Establishing clear, achievable and meaningful goals, and developing an impactful action plan.
• Execution – Implementing your action plan and creating real results.
• Measurement – Assessing the full breadth of your plan to confirm what’s working and fix what’s not.

Our experience with more than 65 successful launches allows us to guide you, through this information-packed webinar, on how best to maximize your product’s potential with the end goal of executing a powerful, pervasive launch strategy. Although there is no one-size-fits-all approach to product launch excellence, every launch must start with the proper foundation to avoid failure.

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When you’re launching a product into a competitive market, you plan on nothing less than great success. You know that making a major impact at introduction is obviously critical—and that you’ll also need exceptional performance throughout the product lifecycle.

Yet the odds are daunting:

• 50% of launches never achieve peak sales
• 25% widely miss the mark

How can you improve your chances? The answer is simple—but the devil is in the details.

The answer: Give your launch a rock-solid foundation.

The details: Your entire launch team must be completely and unreservedly aligned—totally invested in your organization’s powerful product strategy while also committed to cross-functional alignment on every aspect of the strategic and operational plan.

If you want to achieve maximum success, this approach is non-negotiable.

Steps to optimize your strategy and ensure alignment

For many organizations, identifying a winning strategy and aligning your team around it can be a challenging assignment. So how does one get that done?

It requires three key steps:

1. Creating a bulletproof value story by evaluating all aspects of the market
2. Leveraging your value story to build your brand strategy and devise your launch plan
3. Aligning all cross-functional teams to the strategy and launch plan

Step #1

Your entire launch team must share in some fundamental market research tasks and then use the data to create the most impactful value story possible. The research tasks include:

Exploring the patient journey. The team must fully comprehend and then define the patient’s experience from the onset of illness until he or she is (at least) stabilized—and, ideally, healed. To understand the journey at a deep level, it’s vital to witness all affected viewpoints—not only the patient’s, but other central stakeholders including caregivers, providers, payers, etc.

Analyzing the market dynamics. All relevant aspects of the product’s environment, including the competitive landscape, must be assessed.

The strongest possible value story must then be produced—one that is solidly based on the research and thoroughly incorporates all of its implications.

Step #2

Once the launch team has developed the value story (sometimes called the value proposition), the team needs to individually and collectively decide how to leverage that story to maximize your launch strategy. It’s important to keep in mind that the strategy should not be overly broad, ambiguous or complex.

The principal strategic tasks in step #2 include:

Developing the product vision. The product’s vision is built on the foundation of your strong value story. The vision must focus on the launch goal while also being able to endure throughout the product’s lifecycle.

Stating the market position. The market position is directly derived from the vision and the value proposition. It’s a compelling statement that crystallizes how you want the market to perceive the product’s positive and differentiating value.

Setting the launch objectives. Once you have a clear vision and a differentiating market position, you are ready to establish the “pillars of launch,” also called the launch objectives. These are three to five very specific imperatives that support the positioning statement and are essential to launch success. Examples of objectives include identifying target patients, raising the awareness/importance of the disease state, and elevating the urgency to treat among providers and payers, among others.

Alignment around your launch objectives can best be achieved by holding a collaborative workshop where representatives of every key functional area provides input and a forward-looking consensus is created.

Step #3

With the launch objectives in place, finalize your detailed launch plan. Effective alignment requires robust, ongoing communication within and among cross-functional teams throughout the organization. These teams (or “work streams”) must operate with true transparency, authentic collegiality, and continuous consensus building. The work streams can have individual strategies for success—but these must be aligned with the overall vision, position and launch objectives.

Each work stream should identify the initiatives in its scope, and which launch objective each initiative supports. Teams also need to specify the business objective; the budget required; the timing; any cross-functional dependencies; and success measures for each initiative.

Each member of each work stream should endorse and promote every component of the launch plan. To best accomplish this level of alignment, hold a workshop-style session that clearly delineates each team’s scope and responsibilities, and how it fits into the overall launch. Capture this information in a detailed yet accessible launch plan document that includes measurable milestones. With this plan in hand, you will increase the odds for launch success.

Get aligned for excellence

Over the years, CMK Select has helped dozens of leading organizations align for launch excellence. To see how our proven methodology can optimize your product’s trajectory, contact CMK Select today.

The Challenge

A reputable pharmaceutical company was experiencing a period of high employee turnover in one of its central departments and did not have a tangible on-boarding system in place to help transition its new hires into their respective roles. Because the department is heavily dependent upon its internal processes, and because these processes are frequently changing, the new hires had a hard time keeping up with the latest rules and requirements. Although there was a buddy system in place, both the new hires and their managers had many questions surrounding the on-boarding process, and too much time was being spent looking for answers.

The Solution

CMK Select created an operations reference guide for the department that includes all relevant information needed to properly on-board a new employee. The guide contains a detailed overview of the company’s global processes, plus operational details specific to the department, as well as a set of key definitions, frequently-used acronyms and links to documents and web pages for easy access. Each time a new employee begins working within the department, he or she is provided with the guide as part of the department on-boarding process. The guide is carefully maintained and regularly updated as new documents and processes become available, and there is a control in place to ensure that older versions are properly archived.

The Results

The reference guide has become a one-stop-shop for the department’s on-boarding needs. Because each new employee is familiarized with the guide from the start, there have been far fewer questions surrounding the on-boarding process, and it has saved lots of time. In addition, it has reduced the amount of frustration experienced by both the new hires and their managers.

The ever-evolving relationship between the pharmaceutical industry and its key opinion leaders (KOLs) has been a hot topic for a while, and there are several reasons for that:

• Recent innovative medicines are so complex that many consumers can’t understand them without expert guidance. Recognizing this, pharmaceutical companies have begun to engage with external experts more than ever before.
• With the federal and PhRMA guidelines, relationships with these physicians are heavily regulated. As a result, there is a need and a requirement to manage the KOL relationships and ensure appropriate reporting systems are in place.
• Pharma companies need to make sure that coordination efforts between functions and external experts is well coordinated and doesn’t create unnecessary challenges.

Driven by a changing healthcare landscape, and marked by specialized medicines and new stakeholders who demand more complex scientific information across all channels, Medical Affairs teams have found themselves in search of the most effective, efficient ways of managing collaborations with the physicians and other external stakeholders who conduct research, write articles, or speak on their behalf. Managing the relationships and interactions with these stakeholders has ultimately emerged as an individual business discipline within Medical Affairs teams.

What does the term “KOL” mean? Is there a better name for them?

According to Pharma Marketing Network, key opinion leaders, or KOLs, are defined as “physicians who influence their peers’ medical practice, including but not limited to prescribing behavior.” Thought leader (TL), opinion and thought leader (OTL), key influential physician (KIP) and key advocacy influencer (KAI) are all alternate labels for these professionals.

But whatever we call them, that definition doesn’t quite reflect the true nature of the engagement that we, as an industry, have with these stakeholders. For one, not all KOLs are physicians. At various stages of the product lifecycle, we need input and support not only from physicians but also from other allied healthcare professionals (nurses and educators, for example), scientists, caregivers, payers, etc. Thus, addressing these stakeholders as External Experts (EEs), rather than physicians, seems much more appropriate.

How do we best engage with these EEs?

1. Identify the External Experts you need.

Determining the right EE for your project is critical. An EE with a poor match in expertise or skills may not be able to provide the expected support for a drug development process or affect a drug’s success or effectiveness before it hits the market. On the other hand, the right EE can help you open up opportunities that you were not considering and exceed expectations. And keep in mind, you may need to set different criteria for each group of EEs involved in different projects.

2. Define and execute a proper engagement strategy.

Most pharma companies are willing to invest resources into EE-related activities; but first, they must figure out how best to collaborate with the proper experts. The more clearly you’re able to define what you need from specific EEs – whether that is attending Advisory Board meetings, facilitating one-on-one consultations, engaging in research collaborations, analyzing data or spearheading educational activities – the more effectively engaged and involved the EEs will be. Having a plan in place that clearly defines your expectations helps to ensure that the experts are available when you need them, and it allows them to prioritize your activities over others, increasing the likelihood that you’ll get their input and participation when it’s most critically needed.

3. Follow through.

Quite often we get asked by EEs, “How did you use the feedback I provided?” And, often, they do not receive a good answer. While not all of their ideas or recommendations will always be relevant, it is still helpful to follow up with your EEs and summarize what was done or implemented based upon their advice. You may also mention what you decided not to pursue.

4. Be compliant.

In recent years, companies have been facing a high level of internal and external scrutiny regarding how they engage with EEs as often the programs are intangible and difficult to measure despite a need to maintain compliance with state and federal guidelines. As a result, companies have adopted strategic EE engagement solutions that include both the timely reporting of key metrics and alignment with necessary PhRMA and AdvaMed industry compliance codes and regulations.

What does the future hold for EE engagement?

As pharmaceutical and life-sciences companies continue to realize the tremendous positive impact that EEs have on their businesses, EE engagement will continue to evolve and develop as a critical industry discipline.

By sustaining a process that creates and maintains meaningful and collaborative relationships between EEs and business functions, life-sciences companies can expect to see increased drug development success and accelerated adoptions at the global, national and regional levels.

The numbers are dramatic: 50% of pharma launches fail to meet forecasts, with 25% widely missing the mark. If you’re in a pre-launch phase, with the odds stacked against launch excellence, what can you do?

To achieve excellence, or even approach it, we first have to define it. Experts on the topic have a range of perspectives, with some saying internal/external communication is key to launch success, and others insisting rigorous strategic alignment or aggressive department-by-department functional planning will get you there. Still others say you need a laser-like focus on the financial bottom line.

Each viewpoint has merit, but do any of them get to the crux of the issue?

At CMK Select, we’ve seen launch excellence first hand—because we’ve helped make it happen. In our experience, while strategy, planning, communication and financial focus are all vital, true excellence at launch comes down to one thing: getting the right drug to the right patient at the right time.

Get that done, and you’ll find a lot of other things falling in line.

The right drug?

Is your drug the right drug? It may be—if it fills a clear and genuine need. That means:

• Physicians will prescribe it consistently
• Patients will take it, compliantly
• Payers will pay for it, dependably

While the clinical/R&D team is charged with creating a molecule that meets the identified need, it’s up to the commercial group to assess if the final, developed product will fully capitalize on the molecule’s attributes. They must determine whether a differentiated space in the marketplace can be effectively owned.

Ideally, these two arms of the enterprise will be working closely together from the outset, meeting regularly, sharing information and planning strategy. We’ve seen early, consistent and cooperative coordination pay big dividends at launch.

The right patient?

Supplying the right drug to the right patient is a foundational mission for every pharma company. Making sure your product fulfills that goal means asking key questions early in the planning process, such as:

• Which patient population will benefit the most from the product’s medical value?
• What are the specific characteristics of those target patients?
• How will we position the product vis-à-vis those patients while differentiating from competitors in a meaningful way?
• How will we communicate so physicians, patients and payers respond?

It’s not easy to verifiably answer those questions, but doing so is well worth the effort. Today, marketers at companies large and small strive to pinpoint patient targets, identify key physicians and access points, and position products strategically. Instead of an older, broad brush approach, pharma is micro-targeting patients, micro-segmenting prescribers and payers, and micro-messaging them all.

This approach puts the idea of the “right patient” in a new light. It opens possibilities like accessing searchable patient databases for patients fitting very specific profiles; or dispatching trained professionals to personally connect with patients and caregivers where they live.

The right time?

Brand teams evaluate countless internal and external factors throughout each pre-launch phase, appraising the marketplace and adjusting timing of their plans in response. They consider everything from clinical trial schedules, length of regulatory reviews, managed care access and marketing implementation timelines to competitors’ moves and countermoves.

The team also has to assess the duration of manufacturing processes and supply chain requirements to ensure product readiness at FDA approval—or before approval, in cases where early access is granted.

Here are some launch timing-related facts to consider:

• Many innovator drugs now have four years before competitors launch—down from a previous eight years
• Breakthrough therapy approval from the FDA can occur in less than six months
• The average time from FDA approval to U.S. reimbursement is six weeks

Given these factors, new product planning teams might ask, “How will our market change between now and launch?” and, “Will we have supply to meet the demand at the time of approval?” If the product is a follow-on medication in a crowded category, they might ask, “Will our product still meet the patient need at that time?” or, “Shouldn’t we launch before the category leader’s patent expires and we face generic competition?”

A myriad of such questions can make launch management more art than science. But, in the end, launch excellence may really boil down to this question:

“Are we delivering the right drug for the right patient, when they need it?”

Optimizing your next launch

Experience shows that brand teams focused on delivering the right drug to the right patient at the right time can be on a path to great success. CMK Select has been walking the path to excellence with leading organizations for more than a decade, working on more than 65 pharma launches. We offer a proven methodology to optimize your product’s trajectory.

When a successful product is about to lose its exclusivity, and is facing incursions by generics or biosimilars, a pharmaceutical manufacturer sometimes decides to walk away. Rather than stand and fight the intruders, resources are demobilized, sales forces are reassigned and management turns its attention to whichever new campaign appears on the horizon.

In many cases, this seems to be the smart choice, even the obvious one. After all, ahead of the “patent cliff,” the original brand team has likely moved on to other endeavors. The manufacturer’s other products are seeking any residual resources that may be available, even as generic competition begins forcing price erosion. Why continue fighting a battle that may end in an extended stalemate?

The implications of brand-building

Some experts believe walking away because of loss of exclusivity (LOE) can be the wrong choice in today’s environment. They say that abandoning an established, successful brand can mean squandering hard-won equity and undermining carefully nurtured relationships with physicians and patients.

Today, most pharmaceutical manufacturers have learned the complex art of brand-building. In fact, many pharmaceutical products are achieving the status of fully developed brands that are comparable to consumer goods like the iPhone, Coca-Cola or Legos. For example, consumers seeking an erectile dysfunction medication are likely to think of the Viagra brand because of years of ads and other brand-building activities. When patients use the drug and find it safe and effective, they can develop the same sense of loyalty that people form with popular consumer products and services.

The combination of extensive brand-building and personal experience can make consumers reluctant to use a different medication, even one the FDA has approved as equivalent. They may balk at a generic replacement as a result.

Similarly, doctors can form on-going connections with manufacturers and their representatives. Physicians develop a sense of trust with certain drugs because they are proven over time and because manufacturers’ sales representatives become a familiar, reliable source of information that generic manufacturers do not typically supply.

Doctors are also aware of the bonds between patients and drug brands. Realizing that patients rely on the predictability that many brands can offer, physicians can be hesitant to interfere.

Strategic and tactical questions

When a manufacturer has worked hard throughout the product lifecycle to create a strong, lasting brand and the brand begins nearing the patent cliff, it makes sense to take stock. Significant investments have been made to nurture what is now a substantial amount of equity. It is, therefore, logical to ask a few strategic questions about LOE, including:

· Does it make sense to simply surrender the brand’s accumulated value?
· Is there a way to maintain the brand’s equity and loyalty when the patent expires?
· How can we stop the product from becoming a commodity after LOE?

By this point, many manufacturers have already asked tactical questions, such as:

· Can an existing name and branding be used with a new or modified formulation?
· Can brands within the portfolio somehow benefit from each other?
· What can be done to maintain and strengthen a brand family?

In pharmaceutical planning, marketers often play a key role in answering these questions and developing a patent expiration strategy. However, considering the potential value that many brands represent, marketers should not be expected to manage LOE alone. The best results occur when the organization’s entire set of strategic resources, including top management, is focused on the situation.

In fact, some successful organizations assign cross-functional teams to plan for patent expiration years in advance. Planning may even start during the earliest stages of product development.

A variety of options

Facing a patent cliff isn’t easy for any manufacturer, large or small. In the past decade or more, a number of viable strategies have been developed.

Patient loyalty programs. Many manufacturers start patient programs to maintain (or even increase) patient loyalty in advance of LOE—and then keep the programs going for varying periods of time. These efforts include:

· Customer relationship management programs
· Refill notification compliance/persistency programs
· Co-pay cards and digital coupons

All of these programs are designed to provide value to the patient. At the same time, it is important to underscore the point by adjusting the product’s messaging toward an intense patient focus. The refined messaging is frequently delivered through carefully synchronized, multichannel promotional campaigns that include digital media, direct mail, email and events. This often means a significant uptick in direct-to-patient communication.

Implicit in these patient-based tactics is the expectation that physician loyalists will continue writing the brand, so non-personal promotion to physicians is also required. Some manufacturers support the physician relationship with tele-sampling, call center programs and “dispense as written” campaigns.

Strategic patenting. Planning well in advance for the patent cliff, the clinical team can identify ways to file multiple patents that offer extended protection. These secondary patents address features that lead to additional indications, extending product life.

Manufacturers can also employ an oblique, judo-like approach. Instead of directly fighting generics or biosimilars, they may yield at LOE—but have a follow-on product waiting in the wings. This “new and improved” innovator product is like a product-line extension in the consumer marketing world. The new product might offer a valuable benefit such as simplified dosing, fewer side effects, or a new route of administration (e.g., oral vs. parenteral). Some manufacturers also produce data enabling a pediatric patent extension with six added months of exclusivity.

Generic strategies. Following the adage, “If you can’t beat them, join them,” manufacturers also sometimes launch their own generic versions of the original drug.

Originator manufacturers follow three basic types of generic strategies. One is to create a branded generic, which allows the manufacturer to directly leverage existing brand equity. If the manufacturer has a viable relationship management program, it can continue connecting directly with patients on its mailing list and maintain a bond as they migrate toward the generic option.

Another option, called an “authorized generic,” provides the manufacturer’s own generic version to a private-label manufacturer. The third involves licensing the product to a generic competitor so that the competitor can enter the market earlier than is otherwise allowed.

Over-the-counter products. Some manufacturers move the product from prescription-only to over-the-counter status. This requires new regulatory approvals, and may mean reformulation and additional clinical trials. It assumes that the brand identity (and accompanying patient loyalty) is strong enough to make up for the loss of the physician’s role as prescriber.

Timing is of the essence

Timing of all of these efforts is an essential factor in their effectiveness; however, the timing varies dramatically from one to another. For instance:

Patient-oriented programs and campaigns. Market research, messaging development and promotional planning for these efforts should begin one to three years before loss of exclusivity. Then, three to six months before LOE, manufacturers can reduce their reliance on reimbursement from health plans as they transition to co-pay cards or other types of patient support.

Strategic patenting. This typically begins during the earliest days of product innovation but can be done later in the lifecycle as well. Development of the new forms, new indications, new delivery systems or follow-on products usually starts some years before patent expiration. Pediatric extensions exhibit a similar timeline.

Generic strategies. Planning for this opportunity starts well before the patent cliff. The timing is often based on a number of market factors, including expected actions of the generic competitor and its products.

Over-the-counter products. Given that this approach involves new regulatory approvals, it typically begins some years before LOE. It is essential to have the product ready to launch concurrent with patent expiry.

Creating a masterbrand

Manufacturers with a robust pipeline and sufficient resources can take a different approach that negates many LOE concerns. This is a category domination approach that is sometimes called “masterbranding.” It means building a commanding presence in a specific drug class. It can take years or even decades to implement and requires an exceptional level of scientific expertise. An example is Novo Nordisk’s high profile in the diabetes class.

Masterbranding has implicit power, because it means that the brand’s equity does not disappear with the patent. Instead, the equity is broadened like an umbrella to cover a range of related products over time. In addition, when the add-on products develop their own value in the market, the masterbrand’s equity actually increases.

It’s time to get started

In most of these situations, the key is to get started as early as possible. Some options, such as strategic patenting, require upfront planning during product development. Others start much later but, in almost all cases, the groundwork should be prepared years before the patent expires.

Whatever the timeframe for your product’s lifecycle planning, CMK Select has the experts and the expertise to make a difference. We have been walking the path to excellence with leading organizations for more than a decade. We are prepared to:

· Build a team of experts to help maximize brand success
· Work with you to implement and manage our proven methodologies
· Assist with cost control and risk anticipation/mitigation

CMK Select is ready to consult with you about these crucial tasks. We can help you create efficiency gains, cost savings, and a remarkable return on investment. If you’d like to talk with our experts about your brand, contact CMK Select today.

The Challenge

A major pharmaceutical company was in need of a review and approval process to help streamline the planning and execution of its external medical events. While the company had certain policies and procedures already in place – including a strict governance board approval process that required coordination among several teams throughout the company ­– those guidelines were not well documented and therefore were not easily available for reference. Because the external events are meant to support the company’s brand, consistency was key, making it imperative that a repeatable process be developed and implemented.

The Solution

CMK Select partnered with the medical directors to observe the various stages of the existing event planning process. Through careful examination, the CMK Select team was able to develop a greater understanding of what needed to be done by each unit when planning, documenting and delivering an event. From there, CMK Select created a comprehensive reference guide that documented each step of the process, noting what could be done in parallel versus what had to be done sequentially, and underscoring the protocol set forth by the company’s existing branding guidelines and governance board approval process.

The Results

With the comprehensive reference guide in place, the medical teams now have a streamlined, consistent and repeatable process to follow for all external events. As a result of the increase in efficiency, events are being documented and delivered on time, on budget and within company guidelines.

The Challenge

A notable pharmaceutical company had agreed to co-promote a drug and, in turn, was obligated to provide a list of contractual deliverables to the partner company. Because both teams were fairly new to co-promotion, there were many questions about how to work together most efficiently. The companies needed direction on how best to collaborate while working toward their common goal, despite their differences in operating cultures.

The Solution

CMK Select created and documented a cohesive operating strategy for the alliance by identifying the key stakeholders from both companies and then clearly defining the roles and expectations for each member of the project. This served as a way to ensure that all deliverables were being met, while also promoting an environment of collaboration between the teams. We also recognized a need to boost the profile of the medical teams, who had previously worked mostly behind the scenes and were rarely recognized for their work, to ensure that both sides understood and appreciated the significance of what they brought to the project.

The Results

Because each member of the team understood exactly what was expected of them, they could more efficiently and proactively prepare for all phases of the major launch, including providing status reports and budget updates to team leaders along the way. Having a defined strategy in place also helped with onboarding new team members quickly and seamlessly. Most importantly, however, the new strategy successfully removed barriers that otherwise could have compromised the co-promotional launch process, and it established the proper balance among previously competing priorities to help ensure that all required deliverables were met on time and aligned with budget expectations.