Our previous posts in this series reviewed the history and evolution of Medical Affairs departments in the pharma industry, noting how the growth of these departments led to an increasing need for project management expertise. We then explored the ways that project management can provide value to Medical Affairs, such as:

• Leveraging assets and maximizing budget efficiencies
• Providing creative approaches to project planning and implementation
• Serving as a communications hub and keeping stakeholders informed about project status

These and other project management activities all have the potential to help Medical Affairs deliver positive results for the organization as a whole. However, the above examples also demonstrate something else: that, even when the organization’s and the department’s overall results are positive, it may not be easy to objectively measure the value provided by a function like project management.

For example, how do we know if the manager has fully leveraged departmental assets? Is it possible to accurately judge the manager’s level of creativity in the planning process? How can we ascertain if a manager is communicating with maximum effectiveness?

Finding objective answers to these types of questions can be quite challenging. And, even in cases in which results can be quantified, it can be hard to know how much control a project manager has over specific aspects of individual outcomes.

What’s more, there are many different teams in the Medical Affairs setting, and perspectives can vary from team to team. While one group may see great value in a project manager’s efforts, others may see things differently.

Given that the perceived value of project management can be very subjective, it makes sense for Medical Affairs departments to try to use as many objective measures as possible when evaluating a manager’s performance.

An opportunity for accountability

When seeking ways to gauge the value of project management in Medical Affairs, the business case and related project plans provide benchmarks that are readily available to most teams.

The business case is the argument made at the outset of each and every project that the task is viable; that the core business benefit is worth the investment; and that the opportunity outweighs the potential risk. It is a presentation that outlines the path the organization should take to achieve that specific core benefit.

When leadership agrees that the business case is viable, it signifies the belief that the chosen path is the best of all available options. And, once the business case is accepted, a project plan is then created, offering all of the detail needed to travel down that path.

From that point, Medical Affairs project managers typically become responsible for checking that the path is being adhered to—that the plan is being followed—as rigorously as possible.

These types of plans are filled with schedules, milestones, budget projections, etc. So, if the organization wants an objective means of holding people such as the project manager accountable, project plans can provide a wealth of opportunities.

When measurement is a challenge

Schedules, milestones, budgets and other objective measures are vital when assessing the value provided by project management. But other aspects of project management can be much harder to gauge.

Take quality control. Good manufacturing practices provide objective tools to determine the quality of a product’s manufacture. Unfortunately, that kind of cut and dried quality evaluation isn’t available when considering essential, yet highly subjective, concerns such as the satisfaction levels of a department like Medical Affairs.

Experts say that team satisfaction is among the most important of all success criteria, and project managers are often responsible for managing and maintaining the satisfaction levels of internal Medical Affairs teams—and sometimes external groups as well. For example, project managers can help to ease the traditional tensions between Medical Affairs and the Commercial arm.

But how do we objectively gauge quality in those arenas? Surveys and interviews are often used to rate satisfaction, but given an environment where project managers have so many tasks involving so many teams, these tools may not be fully able to assess the quality of the manager’s performance.

Yet we can’t deny the importance of gauging satisfaction. Simply put, a project manager is unlikely to succeed if he or she is unable to satisfy the department’s teams. In this situation, leadership may have to take more of an “I know it when I see it” approach instead of using any objective measures.

It’s interesting that it’s sometimes possible to determine external levels of satisfaction—also highly important to Medical Affairs—more accurately than that of internal teams. And, in many cases, external customer satisfaction can be generally reflective of a project manager’s effectiveness.

For Medical Affairs, external customers include the product adopters (providers, payers and patients), so we can use product utilization as one measure of their satisfaction. However, even this gauge may not always be reliable. What if the product is well-utilized in markets where organizational communication is highly effective, but is poorly accepted by audiences we have trouble reaching? Is the problem with the product or the promotion? Or is there another intervening issue entirely—a high amount of competition in that market, for example?

Living with uncertainty

The reality is that all clinical projects contain some degree of uncertainty. Despite this fact, sometimes Medical Affairs—and specifically project management—may be faulted when circumstances are actually beyond their control. Consider recruitment-based study delays, or investigator scheduling conflicts. These obstacles can frustrate a project manager’s best attempts to meet pre-established deadlines, yet he or she may still be held accountable.

And, even when every aspect of the clinical process proceeds unimpeded, there can be disagreements within Legal, Regulatory and Compliance teams; or, when they all agree, the Commercial department may opt for a different approach.

As one Medical Affairs project manager has said, “Some things just have to be lived with,” and the planning process needs to accept the reality that uncertainty is an inevitable part of the clinical function.

Many leading organizations recognize that objective standards are hard to come by in many aspects of project management. They know that any assessment of project management’s true value should take all of these factors into account.

Clearing up the picture

Researching the value of project management in Medical Affairs leads us to see that, while objective measures should be employed whenever possible, project managers often provide significant value in less tangible ways. Project management can be more art than science, and some aspects of the project management field seem to defy measurement entirely.

We would like to offer a few of the questions organizations can ask to gain a clearer picture of project management effectiveness:

• Are the priorities set by Medical Affairs leadership being achieved, on time and on budget?
• Does the project’s progress consistently match departmental business requirements?
• Is the project manager’s performance adaptable in changing situations?
• Are shifts in departmental needs and the overall project environment being effectively anticipated and responded to?

Finally, it’s vital to keep in mind that Medical Affairs is ultimately focused on the patients’ interests. This means that, in the end, the organization’s success, the department’s success, and the project manager’s effectiveness, can really only be proven by the way the product is received by providers, payers and, most of all, by patients.

Positive results come from extensive experience

Given the complexity of the project management function in Medical Affairs, experience really counts. Over the years at CMK Select, we have managed countless pharmaceutical projects. We have met the most difficult challenges, and we have implemented tried and tested systems that consistently deliver excellent results. We are happy to share our expertise, or you can engage our highly-trained, expert staff. Either way, you and your Medical Affairs department will benefit. Contacting CMK Select will boost your success, now and in the future.

In our prior article, we discussed the history and evolution of Medical Affairs departments, and reviewed how these departments have grown to perform so many integral functions within pharmaceutical companies. We also observed that, as Medical Affairs’ work streams have multiplied over time, the need for project management expertise has increased substantially.

In general terms, project managers’ duties in Medical Affairs can be described as helping to free other members of the department to do what they do best. These managers can be tasked with everything from streamlining the work, increasing efficiencies, and overcoming or eliminating obstacles, to anticipating and solving problems, and controlling or reducing costs.

While this may sound demanding, it makes sense when we consider the extensive and essential service that Medical Affairs provides within pharma.

Dealing with complex challenges

Project management in Medical Affairs is complex and challenging work. Project managers are asked to handle dozens of competing demands, required to deal with a myriad of priorities, and they must build and maintain relationships with dozens of individuals at varying levels of authority, both internally and outside the company. Also, project managers typically are asked to meet very specific departmental expectations, yet those expectations can differ significantly from those of the company at large.

And, of course, they must manage within Medical Affairs schedules, which tend to be very tight.

In many cases, departmental budgets can be even tighter.

While maneuvering through this stress-inducing landscape, project managers are also counted on to smoothly and capably accomplish such essential tasks as:

• Assisting with a range of product development activities
• Facilitating and supporting ongoing strategic planning
• Managing the development and execution of annual plans including goals, strategies, and tactics
• Helping work streams and product teams plan, execute, track and report on tactics, including clinical trial development and implementation, advisory boards, publications, symposia, and conference presentations, among many others.
• Administrating and tracking departmental budgets
• Assisting with program and portfolio strategies aligned with product lifecycles
• Implementing tools that connect Medical Affairs with commercial programs while maintaining regulatory discipline
• Coordinating and maintaining relationships with and between Procurement, Finance, Contracting, and external vendors

Organizing for increased effectiveness

Even with their daily focus on implementing departmental tactics, strategies, projects and tasks, project managers recognize the need to carefully organize their own work situations in order to achieve maximum effectiveness. For one example, many project managers serve as the communications hub for the entire department. They keep various work streams continuously informed about the status of individual projects, in detail, while also alerting teams about how their individual projects may impact—and be impacted by—the activities of other areas within the department and other departments within the company.

This kind of multi-level communication responsibility is often a stand-alone function in other organizations. However, in the Medical Affairs project management portfolio, it can be one task among many. Project managers therefore have to prioritize their own time even as they address various departmental and company assignments. This self-organizational imperative must be strategically layered in among the general activities listed above, and also seamlessly interwoven with the execution of many specific tasks, which can include:

• Providing detailed status reports of each major initiative
• Developing and managing the contracting process with external vendor partners, including working with Legal and Contracts teams
• Reviewing vendor proposals and supporting contract negotiations
• Assisting in the planning and development of content for medical congresses
• Working with medical directors to find ways to leverage assets for multiple purposes that meet the needs of the medical community while maximize budget efficiencies while
• Interacting with opinion leaders and other healthcare professionals to: arrange speaking engagements and preceptorships, connect them with internal teams, facilitate introductions to company leadership, and process consulting agreements
• Retaining and maintaining institutional knowledge in the face of departmental turnover

In addition, many project managers are asked to find workarounds for departmental budget challenges, which can mean working across the department to minimizing expenses and maximize resources.

Functioning effectively amidst these varying forces and pressures requires not only a talent for organizing but a deep understanding of subtle aspects of each of the department’s functions and activities.

Anticipating departmental needs

If there is a single characteristic that is likely to make Medical Affairs teams value their project manager, it may be the ability to think ahead. There are always numerous ongoing and often competing demands, and new priorities seem to continually emerge. Since project managers often are asked to help the department unravel problems when they arise, they need to be able to look as far down the path as possible. That way, the manager will have the flexibility to take things in stride.

In short, it helps to stay at least one step ahead of the team, even as the manager remains fully aware of both the big picture and the small details.

To do this, they must get to know each Medical Affairs stakeholder. Project managers must also understand the drug development process, regulatory and compliance requirements, and legal implications. Ideally, they would also become familiar with the product, its clinical data, launch schedule, likely marketing trajectory, and projected lifecycle. When this information is readily available and thoroughly understood, a talented project manager will have an excellent chance to provide value on a daily basis.

You can maximize your project management function

Considering the challenges faced by project management in Medical Affairs, it makes sense to connect with people who know it inside and out. At CMK Select, we have the experience and training you need. In fact we have developed innovative processes designed to keep every aspect of your project management function humming. We are happy to share our expertise, or you can engage our highly-trained, expert staff, but, either way, you and your Medical Affairs department will benefit. Contacting CMK Select will boost your success, now and in the future.

In prior articles, we have discussed the critical role played by pharmaceutical companies’ Medical Affairs departments, particularly related to product launch preparations and execution. Now we’ll examine the growing importance of project management within Medical Affairs departments.

The great separation

As prior articles have noted, the pharma industry became increasingly focused on innovating new products about 25 years ago. This created the risk that commercial interests would start driving pharma’s clinical innovations. In response, regulators advised companies to sequester their medical and commercial aspects. The establishment of Medical Affairs departments was a notable result of these events.

From the start, Medical Affairs played a key role, generating and managing clinical data and safety data, while ensuring that the information was not improperly used from a regulatory perspective. And, while commercial departments do what they can within the limits of the medication’s label to market their products, Medical Affairs was designed to focus on using clinical data to help patients receive the maximum benefit from product use.

The evolution of Medical Affairs

Given their strong understanding of regulatory requirements, Medical Affairs departments were tasked early on with helping manage collaborative relationships between themselves and Commercial teams. In some companies, Medical Affairs was also responsible for aligning science and clinical data with brand team strategic imperatives and assisting with medical message development, exposing Medical Affairs staffs directly to products’ marketing interests. While doing their best to work behind a “marketing proof” firewall, many Medical Affairs departments began acknowledging and even aligning their perspectives with those of Commercial departments.

Over time, tensions emerged between maintaining strict regulatory requirements and honoring commercial interests. Guidance from regulators is not always clear, and the interpretation of regulations varies from company to company. Some companies have nudged medical affairs departments toward activities that benefit commercial outcomes. While Medical Affairs typically doesn’t directly engage in product marketing, it has evolved in ways that may be blurring regulators’ original intent.

Primary roles of Medical Affairs

Today, while most Medical Affairs departments remain highly conscious of their regulatory obligations, the roles played by these departments have become inextricably linked to the success of many brands. For example, they are often deeply involved in helping craft the medical “story” for a brand. This work often begins when a product’s initial data starts to surface, well in advance of launch.

Medical Affairs also is key to researching and detailing the product’s patient journey. In this role, these departments often act as patient advocates, helping to ensure that physicians use the product to maximum effect and patients receive optimal outcomes.

Modern Medical Affairs departments carry a heavy load, with those efforts only representing a portion of the typical portfolio. Medical Affairs also:

• Synthesizes and summarizes the data to help create the product’s communications action plan, which is then executed at specific intervals prior to and following approval
• Trains the Commercial team on various aspects of clinical and safety data
• Trains medical science liaisons (MSLs), enabling pro-active discussions with key opinion leaders (KOLs) and other clinicians
• Helps recognize advocates and detractors within the medical community, particularly among KOLs.
• Conducts advisory boards to detect additional product-related information that might be useful and identify opportunities for publications, including clinical papers, posters, abstracts, presentations at conferences, etc.

Medical Affairs is also responsible for health economics and outcomes research (HEOR) functions that provide the real world evidence payers demand for formulary decision-making. Medical Affairs supplies data that helps payers position the product, for example, helping them decide if the product can be adopted as first line therapy.

Medical Affairs work streams include: medical operations, budget management, field medical (MSLs and training leads), medical account (payer) management, HEOR, clinical development, medical communications, publications, medical education (including congress activities, convention booths, and industry therapeutic updates, such as symposia).  They also generate medical information to respond to inquiries from healthcare professionals.

As if this weren’t enough, as noted in our previous article, over the years Medical Affairs has actually been charged with directly supporting some marketing activities. These include:

• Aligning medical objectives, strategies, and tactics to the organization’s commercial goals
• Providing selected medical insights to Commercial to support post-launch activities
• In collaboration with Commercial, partnering with KOLs at leading medical and academic institutions on ways to improve patient outcomes and control healthcare costs

Project management: Responding to a growing need

With this large and still-evolving set of responsibilities, Medical Affairs teams’ overall scope and size has increased dramatically since the function was first conceived. That has led directly to the need for program and project management expertise within these departments.

How crucial is project management to the effectiveness of Medical Affairs? Here is a partial list of tasks Medical Affairs project managers typically address:

• Detailed planning of the various phases of product development
• Planning the implementation of tactical activities to support product strategies
• Executing tactics including data generation, advisory boards, publications, symposia, conference presentations and information booths and other medical meeting-related activities
• Managing the development of annual plans including strategy, goals, tactics, and budgets aligned with the organization’s yearly business planning process
• Facilitating ongoing 3-5 year strategic planning with Medical Operations, Finance, and other key teams
• Tracking and reporting tactical implementation and measures across each work stream/product to ensure alignment with company strategies and goals
• Helping develop new program and portfolio strategies to align with the product management lifecycles
• Providing tools that connect Medical Affairs with each program within the department’s portfolio(s), while maintaining regulatory discipline
• Applying business knowledge to develop solutions for Medical Affairs teams
• Providing insight and guidance to navigate the regulatory landscape and help provide effective and efficient tools to manage expectations across internal and external stakeholders
• Provide vendor management and oversight, potentially including management of contracting, as well as partnering with Legal and Contracts teams

Medical Affairs project managers also must effectively manage a range of documentation, assess risks, ensure team-based efficiencies, interact with a variety of stakeholders, and monitor timelines and budgets.

And the list goes on … and on.

Why project management is vital

While it may have started with a predominantly clinical focus, Medical Affairs has evolved and is now a strategic partner in the overall success of many brands. However, while the strategic imperatives should be the same for Medical Affairs as they are for the Commercial team, Medical Affairs does not generate revenue directly. Its focus should be, and typically is, on the patients, with a goal of differentiating the product clinically for providers and payers to improve patients’ lives.

This responsibility is far from easy and Medical Affairs project managers are pivotal to effectively making it happen on a daily basis.

In our next post, we will see why, when Medical Affairs is managing projects well, the benefits are visible. And we will explore why project management, done poorly, can directly affect product success.

Gain the benefits of top quality project management

It’s fairly simple—effectiveness leads to success. That’s true throughout the business world and it is certainly true in pharma. That’s why so many leading organizations come to CMK Select to support their project management functions. We know how to keep things on track, keep things moving, keep teams focused. Whether you use our expertise or bring in our staff, contacting CMK Select can provide a big boost to your success.

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.

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.