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.

As we’ve already begun to look into in Part I of this two-part blog, Medical Affairs teams play a critical role in bringing new treatment options to market in the current pharma industry environment.

In the first part, we focused mainly on the key deliverables that Medical Affairs could and should provide to optimize value to the patients, including patient access and, ultimately, commercial potential at launch – specifically a clear medical story/key medical messages, a competitive medical strategy and a comprehensive set of tactics summarized in a tactical plan.

In this second part, we will dive more deeply into some of the specific deliverables championed by Medical Affairs during pre-launch and at launch. We will also provide a breakdown of the timeline for the periods leading up to, during and following the launch.

It’s common practice in the pharma industry to begin launch preparation approximately 12 to 24 months before launch. However, based on our experience, that is simply not enough time for the majority of companies to prepare the market and get maximum value out of their launches. The launch strategy has to be laid out by the time of completion of the POC (Proof of Concept) study and before the start of the Phase III program, and the medical affairs teams must play a very active role at this stage to ensure that development and commercial teams understand the unmet medical needs in the specific therapeutic field and have a solid understanding of how those needs are expected to evolve by the time of anticipated approval and launch. This important first step is critical in ensuring that the appropriate clinical endpoints are selected for the Phase III studies. From that point forward, medical affairs teams serve as a bridge between the medical community (external stakeholders, such as physicians/healthcare professionals, hospital administrators, professional associations, and patient groups) and R&D and commercial/marketing teams (internal stakeholders).  

What to Expect from Medical Affairs in Preparation for Product Launch

There are many critical activities that take place well in advance of the actual launch of a new product, and Medical Affairs departments pay a vital role in that process, as the organization prepares for the successful commercialization of the new product. Each of these activities is time bound and should have a very clear objective. From a timeline perspective, these activities are often divided into three categories: pre-launch, at launch and post-launch.

During the pre-launch phase, the Medical Affairs team plays a dual role. Internally, it is responsible for training medical science liaisons (MSLs) and sales representatives; providing medical input to all pre-launch and launch initiatives championed by other departments within the company; and last but not least, reviewing and approving promotional material to be utilized at launch. Externally, it acts as the face of the organization and focuses on educating physicians on clinical and scientific data related to the disease state and unmet medical needs; addressing queries of physicians; and, when and if appropriate, sharing data about the product(s) in development.

During the post-launch phase, the function of the Medical Affairs team is to update physicians on emerging information and answer queries on the drug’s safety and efficacy profile. In addition, Medical Affairs team members play an important role in partnering with physicians on investigator-initiated research and epidemiological studies, which is currently a real need in pharmaceutical and biotech companies.

To maximize the value and effectiveness of Medical Affairs teams, their representatives are typically involved in the strategic product activities beginning with Phase II/early Phase III; and, depending on the length of the anticipated Phase III program, a focused Medical Affairs launch team should be formed about two to three years in advance of the anticipated product launch.

In the earlier stages of this process, Medical Affairs representatives will bring valuable medical expertise and understanding of the current medical practices in the given disease state to the development and commercial teams. Their expertise helps to ensure that the most valuable information is brought forth from the medical community so that key experts in the field may provide input and help the company guide key decision making on the Phase III study design and study execution as needed. During this time, the Medical Affairs team will also become familiar with the product’s mechanism of action and all available data, and it will develop further understanding of the evolving related issues, ultimately becoming true experts within the larger launch team.

Toward the later stages of the pre-launch phase and during the period immediately surrounding the time of launch, medical directors and other professionals are starting to become more and more involved in the educational efforts targeting payer organizations, focusing on unmet medical needs during pre-launch and addressing how the new innovative therapy can help address those needs after the product is approved. Ensuring product access at launch has become one of the most critical elements of product success, and the role of Medical Affairs in those efforts is dramatically increasing.

It’s also important to note that the Medical Affairs department should have current policies and procedures in place to train and support a culture of compliance among its employees. The adoption of these policies is important regardless of what stage any given product is in, but it is especially critical during the pre-launch phase, which addresses the dissemination of off-label literature; responding to unsolicited requests for information regarding off-label usage; grant funding; medical letters; KOLs and related activities; disclosure of payments to healthcare professionals; and any other activity that falls under the purview of the Medical Affairs department. Moreover, as the law changes, policies and procedures should also be updated, and employees affected by such changes should be trained accordingly.

Collaborative Partner

While the role and importance of Medical Affairs departments in product launches are continuously increasing, cross-functional collaboration remains very important. Medical Affairs teams are becoming stronger partners to marketing and clinical development teams across the industry. Within the most successful launch teams, open and effective collaboration is mastered – from broad, company-wide team meetings to detailed, one-on-one conversations. When the team leaders from each department work well together, it sets the tone for the entire launch team to work together, respect each other’s opinions, and seeks expertise and advice – all while ensuring that individual and functional accountabilities are in place.

Medical Affairs professionals have lots of knowledge and expertise to share, and an open line of communication is critical in understanding the therapeutic area trends and challenges, as well as in being able to have a dialog with other physicians and peers.

In summary, the role of Medical Affairs in preparation and execution of successful product launches is driven by a changing healthcare landscape; the development of very complex treatments for devastating conditions; and new internal and external stakeholders who demand more complex scientific information. With their deep clinical expertise, Medical Affairs departments are uniquely positioned to understand and translate complex clinical data into clear and relatively simple pre-launch and launch communications, as they focus on the patients’ needs and create a competitive advantage for their new products and services.

Bringing each new pharmaceutical product to market is a complex and somewhat unique process led and executed by a cross-functional team who undertakes a number of activities to ensure the success of the product launch. In the current pharma industry environment, a company’s Medical Affairs department plays a critical role, especially as it relates to the launch of innovative treatments.

Throughout this two-part blog, we will discuss the role of Medical Affairs and its key functions in execution of successful launches, and we will look at, and highlight, the timelines for pre-launch, at launch and post-launch activities. Although there are already several well-established activities that Medical Affairs teams traditionally manage for each product launch, we will examine some newer, more innovative ways in which companies can leverage their Medical Affairs teams to maximize their product potential and reach the “right” patients at launch.

In this first part, we will focus mainly on the key deliverables that Medical Affairs could and should provide to optimize commercial potential, access and value to the patients.

The first step, however, is understanding the background. Medical Affairs teams originally emerged as a reaction to increasing pressures from regulators to separate the medical and commercial functions within big pharma as companies began experiencing an increase in internal demands to focus on generating and developing new products, rather than on managing products after FDA approval. Over the past 25 years, continued regulatory pressure has shifted a number of marketing activities to people with medical expertise – most often to Medical Affairs groups. These individuals are an integral part of launch success.

Typically, a Medical Affairs team is responsible for three critical deliverables, all of which are focused on clinical data analysis and dissemination, when preparing for a successful launch:

• Development of the key medical messages (story)
• Development of the competitive medical strategy for introduction of the product to market
• Development and flawless execution of the comprehensive tactical plan to support the strategy

Key Medical Messages (Story)

What do we mean by that? The key medical message should clearly and concisely communicate unmet medical needs in the given therapeutic area, as well as which patient population would benefit from this product and why; and it should explain the features of the product that physicians need to understand in order to decide whether this product is right for a specific group of patients.

This may seem like something very simple to do, but it’s really not. Current drug development requirements call for companies to invest in a large number of Phase III studies, and oftentimes the endpoints can be quite different from one study to another. As a result, new products typically come to launch with quite a lot of data, and it is not always consistent or easy to understand.

Given how busy physicians are, they simply don’t have time to read every publication and dive deep into all the data. That’s where the Medical Affairs team comes in. It’s very important that the message, or story, is clearly crystallized early in the pre-launch phase so that the Medical Affairs team can educate all internal stakeholders on what the data means and how to communicate it effectively and consistently through all channels to the external stakeholders upon approval.

Competitive Medical Strategy

Understanding the needs of the market is key to product launch success. With the rare exception of a new product that comes to market as a first-in-class, the majority of new launches face some sort of competition. Having clear communication messages and a defined strategic approach is very important. The goal is to differentiate your product from other available treatment options and upcoming competition to reach the right patients at the right time in their patient journey – when they can benefit from this treatment most.

In the past, launch strategy landed solely in the hands of marketing departments, but we tend to see that in the most successful companies, in today’s environment, there’s a joint effort between the medical and marketing teams. After all, medical accuracy; the understanding of unmet medical needs; and a simple and consistent – but still scientifically sound – story are very important elements of a successful launch strategy.

Comprehensive Tactical Plan

From a tactical point of view, Medical Affairs teams can champion and execute a number of tactics targeting their key customers: physicians, allied healthcare professionals, medical directors at the payer’s organizations, etc. Those tactics shall include disease state education highlighting the unmet medical needs in the relevant areas; ensuring consistency of all communications related to the new medicine in publications and other appropriate venues; providing input on where the product could potentially fit in current armamentarium of the treatment options; and discussing the science related to the medicine. Medical Affairs teams, in partnership with R&D, must also ensure the timely publication of results from Phase III studies, provide a quality presentation of the data at medical congresses, and spearhead several other initiatives focused on educating the medical community about challenges and the latest science in the given disease during the pre-launch phase.

In this part of the article let us highlight one very important element of successful launch lead and executed by Medical Affairs – well-organized series of Advisory Board meetings. The importance of advisory board meetings cannot be underestimated during this time. With the right experts attending those meetings, and with the right expertise and knowledge from both scientific and clinical practice points of view, a company can gain very valuable insights. They can tailor their strategy as needed to ensure maximum success and guarantee that the right patients are able to benefit from the newly introduced therapy. 

In the second part of this blog, we will dive more deeply into the exact work done by Medical Affairs teams to attain these deliverables. Part II will be posted next week and will provide a breakdown of the vital 12- to 24-month period immediately leading up to a successful launch.

In meantime please share your thoughts!

The major trends in the life sciences industry are profoundly affecting the way we all work – from conducting research to distributing products, and everything in between. These major changes have made the need for an IT-enabling business strategy all the more necessary, as IT-enablement is essential to every major change occurring in the industry right now. Creating (or refreshing) and properly articulating your strategy will help your organization stay on track through all of the change, no matter how sweeping those changes turn out to be. 

Industry revolution and implications

A broad view of the industry reveals little about the change underway. The drug discovery, development and commercialization processes remain the same. Companies…

• Identify commercially interesting targets (diseases)
• Research therapies and delivery mechanisms that reach the target
• Test the therapies in animals and humans for safety and efficacy
• Obtain regulatory approval in target markets
• Market and sell the drug
• Work with many third parties along way (KOLs, investigators, CROs, HCPs)

However, advances in science, changes in regulatory priorities and the resulting impact on market economics have had a profound impact on business operating models.

• Greater understanding of the genome and bio-markers is resulting in novel therapies that treat diseases more effectively for ever-smaller cohorts (micro-targeting). Advances, in some cases, have progressed to the point that we are targeting cures rather than recurring treatments, using techniques like gene-editing.
• The scientific breakthroughs have motivated the creation of a new generation of research start-ups that are disintermediating traditional Research and Development departments at traditional Big Pharma and now legacy Bio-Techs. There is a lot of money chasing the next big breakthrough.
• Pricing these new therapies has coincided – and collided – with a changing macro-economic and political environment that has put a spotlight on the cost of treatments. Regulatory agencies are now much more likely to approve only those therapies with evidence of much improved outcomes, especially with regard to quality of life. Payors (e.g. Medicare, CHIP) will only grant market access if the therapy is economic.
• These competing pressures have resulted in an ever growing desire to get the science right, earlier in the process. This requires greater end-to-end integration across departments and ever-closer collaboration with all third parties. Additionally, it demands hyper vigilance about cost control throughout the discovery and development cycles.

Everyone is seeking the Holy Grail: a patent-protected platform targeting multiple indications approved globally at desired pricing. Those that win will require a bit of serendipity and an intuitive understanding that everything about their business has changed, including science, competition, pace of execution and the required operating model. The latter often includes a never-ending cycle of M&A, divestitures, new partners and collaborators. For purposes of an analogy, we are still playing chess, but we are now on the clock and playing multiple games simultaneously.

IT evolution and what’s needed

Similarly, at a macro view, little has changed about IT-enablement. We need:

• Core departmental solutions, including: LIMS, CTMS, CDMS, AERS, eSubmissions, Sales Force Automation
• Analytics (data science) capabilities
• Collaboration capabilities
• Knowledge management to sustain our intellectual property
• Validated and secure IT operating environment

With that said, the changing operating models and increasing urgency to execute is increasing demand for IT-enablement, including:

• Tighter integration of the departmental solutions to improve process automation and information sharing end-to-end
• Significantly greater number of external partners (CROs, KOLs, payors, HCPs, regulators, …) requiring the same heightened integration
• Comprehensive data analytics capabilities enabling integrated analyses incorporating both internal and external data; research science; clinical data; market; patient outcomes; and economics
• Robust and seamless collaboration capabilities with all parties
• Ability to integrate and separate data and functions with ease as the business (operating) model changes

In short, our business strategy likely requires a conscious refresh of our IT strategy to ensure continued competitiveness.  And, we need to approach the refresh with same newly found sense of urgency because the ever-changing business environment will not stop and wait for us to catch up.

Fortunately, the strategy refresh can be done quickly. A good enough strategy can be created without delay because the macro requirements are well known, and the delivery of many components can be phased. We know:

• Core department solutions exist with the requisite APIs that enable process integration and data sharing
• Analytic environments can be architected to support the requisite dimensions (views) of data
• Collaboration and knowledge management tools exist to support tagging & sharing structured and unstructured data
• Validated and secure IT environments can be sustained internally or in the cloud

While the traditional department solutions often take a year or more to implement, the analytic and collaboration environments should be architected one time and delivered in phases. Phasing should be determined by relative value and readiness (data, organization, etc.).

Keys to creating a good enough strategy that can evolve both priorities and pace include:

• Leaders appreciating the relationship between business strategy and an IT strategy. Any business strategy includes the IT-enablers. They are not separate, disconnected activities
• Leaders sponsoring a small but representative cross-functional team to develop and sustain the strategy
• Shared understanding of what a strategy is. In its simplest form, it answers the following questions:
  • Where are we going? What is the relative value of each desired business capability?
  • How are we getting there (roadmap)? Why are we using this sequence of activities (value and critical path)?
  • What resources are required: people, money and time?
• Time-bound each iteration, and then socialize and refine until good enough to execute the initial phases
• Keep in mind that a little architecting upfront will help ensure flexibility down the road

CMK Select can help you create or refine your own IT-enabling business strategy quickly and efficiently. We’re experts when it comes to the life sciences industry, and IT-enablement possibilities. Contact us today for a consultation.

The Challenge

A major pharmaceutical company engaged CMK Select to create a streamlined process for submitting, processing and approving monthly expense reports generated from their sales team’s lunch-and-learn meetings with healthcare professionals. With a field sales force of more than 800 representatives, the existing system was inefficient and ultimately led to major compliance violations and late fees. Each district manager was responsible for reviewing an average of 50 to 80 detailed expense reports each month – checking them for completeness, accuracy and compliance – and it all had to be completed within a strict timeframe to avoid financial penalties.

The Solution

By starting with a detailed audit, CMK Select carefully examined each phase of the existing process and successfully identified the problem areas that led to the timing and costly compliance issues. CMK then developed a more streamlined process that included the assembly of a team of coordinators to act as a liaison between the client’s sales reps and their managers. These coordinators took a granular approach to reviewing each expense report and communicated back and forth with the sales reps to identify any areas that were incomplete, noncompliant or needed revisions. Once a coordinator signed off on a report, it was then sent to the district manager to review and ultimately approve. Because all reports were fully vetted before reaching a manager’s desk, the review and approval process became significantly quicker.

Results

The new process led to drastic time savings for both the sales representatives and the district managers, and that increase in efficiency has led to improvements and growth in multiple areas. First, as the company had hoped, their sales reps are incurring far fewer late fees because their expense reports are being filed on time. Even more importantly, compliance issues have dropped drastically because ample time has been built into the new system to ensure accuracy and completeness. The time and cost savings have allowed each rep to accommodate an additional three lunch-and-learns per week – or 12 per month – which has resulted in an even greater marketing push and increased sales for the client.

The Challenge

Following the December 17, 2014, FDA binding guidance that all pharma studies starting after December 17, 2016, must conform to a set of FDA-sponsored standards, formats and technologies, pharmaceutical companies found themselves in need of a tool or process for ensuring the standards were being met and followed. One major pharmaceutical company had already put a tool in place in an effort to follow the CDISC standards, but they required assistance in fully implementing the tool. Although the tool they had installed was a good starting point, it had not yet been completely tested or qualified, so it was unclear whether the tool would work as intended – leaving open the possibility that drugs that passed through the system would be rejected by the FDA for not meeting the required standards.

The Solution

CMK Select supported the pharmaceutical company’s clinical and statistical business teams in identifying the gaps in the existing tool and processes, in terms of its capabilities and what the FDA binding guidance required. CMK helped the company implement three key components to ensure accuracy and consistency in meeting the new standards: a metadata repository for the storage and maintenance of clinical data standards; a Pinnacle 21 Enterprise software to support compliance validation checks and standards; and a change-request and workflow system to support standards governance. CMK also helped to develop and re-engineer the operational processes to support the standards implementation.

Results

With the updated tools and processes in place, the company is able to ensure that all studies meet the CDISC standards prior to submission, minimizing the possibility for rejection and the subsequent need for correction and resubmission. By guaranteeing conformity from the start, the company is able to avoid any delays in launch that would ultimately lead to major losses of time and revenue.