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.

The Challenge

A pharmaceutical technology company originally created a tool to validate the safety of medications, and while the tool effectively met the initial goal, after two years of use, many end-users wanted more automation, less paperwork and greater efficiencies. The process intended to help manufacturers determine whether their business processes met the standards defined by the FDA’s Risk Evaluation and Mitigations Strategies (REMS)—a drug safety program that helps ensure that the benefits of certain medications outweigh their risks.

The Solution

The pharma tech company approached CMK Select to help streamline the REMS process for their drug manufacturing customer base. CMK worked with the client’s internal teams to implement an automated REMS tool that could be customized to each end-user while offering a standardized, paperless process across the entire user-base. The tool was also integrated into a common software program used by the drug manufacturers to significantly cut down on the steps required to complete the process.

Additionally, CMK worked with the client’s technology and business teams to help familiarize them with the in-house resources available to them and clarify each department’s role in implementing the new tool so that they could effectively maintain the new validation process and onboard new clients.

Results

Not only did CMK Select create a more efficient process for the end-user, but the team also created a better internal process for the client to onboard those users. What’s more, following the launch of the new tool, the client onboarded three new major clients—with three more expected by 2020. By delivering greater efficiencies, the new process has resulted in an increase in order volume to approximately 1,200 per day.

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.

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 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 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.

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.