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!

It’s not news that market pressures are driving the healthcare industry’s increasing medical orientation. Recognized trends that are leading this shift include:

• Growing prevalence of chronic diseases and novel treatments for them lead to more complex questions
• New types of data that supports comparative effectiveness, Health Economics and Outcomes Research (HEOR) and real-world evidence (RWE)
• Growing credibility gap between pharmaceutical companies and regulators, legislators, media and public
• More stakeholders weighing scientific data: physicians to recommend treatments; payers to make their reimbursement decisions; corporate providers to support design of their care pathways; and of course patients.
• Increased focus in recent regulations on safety and efforts to avoid medical and pharmaceutical risk

These trends have far-reaching and often underestimated implications for pharma and device companies at large and especially for medical functions and their leaders. An increasing medical orientation represents a unique opportunity, one that requires leaders to find new ways of working and operating models that put an organization’s medical and science expertise at the center of what pharmaceutical companies are all about.

In addition, with the recent advent of biologics and complex molecules, drugs themselves have changed. These innovative medicines are too complex for many consumers to understand without expert guidance. Recognizing this, doctors have realized that they themselves increasingly need in-depth, high-level clinical education. And pharmaceutical companies have responded by moving toward a more informational and scientific approach to product introduction to the market and support.

Going beyond the traditional pharma model

The fact is that the level of expertise required to provide this educational, informational support goes well beyond what has traditionally been supplied by pharma marketing and sales teams. These teams are strictly limited to providing the information contained in the approved product label. Also, this type of support isn’t in the scope of most clinical development departments.

Seeking to fill the gap between what physicians need and what pharma had offered in the past, some companies began turning to their medical affairs functions. They realized that medical affairs already had the ability to identify and quantify medical value across the product lifecycle. In these companies, medical affairs also began finding new ways to develop and communicate relevant medical data to regulators, physicians, payers and patients. These departments are able to effectively discuss cost, risk and efficacy in detail, while also providing other important information.

However, these tasks can only be accomplished through a strong medical affairs organization that works in close collaboration with research and development (R&D) and commercial teams.

In fact, in many companies, medical affairs has been serving a limited support function, serving on medical/legal/regulatory committees and facilitating peer-to-peer interactions. In response to the changing environment, these companies now need to ensure that the right talent, capabilities and organization structure/size is in place to take on the strategic medical leadership role for data development and communication to internal and external stakeholders.

The expansion of the role and the scope of medical affairs is driven in part by the demand from the medical community for useful medical/scientific dialogue with the industry, and also by significant changes in the regulatory environment. For example, several large companies are under corporate integrity agreements that require a clear delineation between commercial and medical organizations. Those agreements strictly limit what commercial (both marketing and sales) team members can say. Only approved products can be detailed and only information on the approved product label can be discussed or presented.

On the other hand, medical affairs team members an address unsolicited questions from health professionals, including products in development, recent publications, presentations at medical congresses, etc.

In most organizations, medical affairs representatives are now not only actively engaged in communicating medical information directly to opinion leaders, but also connecting with practicing physicians, payer medical directors and other decision makers. They are asked to provide medical/clinical insights in a way business can use it, in partnership with marketing and clinical development. Pharma companies are making more and more use of medical affairs’ in-depth product knowledge as well as their growing alignment with and understanding of marketing strategy. The more medical affairs have been asked to provide, the more has the value of these departments’ services been on the rise.

Evidence of the shift

How do we know that medical affairs are on the rise and becoming stronger equal partner to marketing and clinical development teams across the industry? Look around and you’ll see an unprecedented number of conferences, webinars and other types of presentations focused on the growing scope and essential value these departments supply. Recent conferences and webinars have had titles such as, “Bringing medical affairs earlier into development,” “The evolution of medical as the mission-critical function,” and “Medical Affairs Strategic Summit.”

It’s important to mention that those conferences have gathered large numbers of professionals; not only medical team members, but also their partners from commercial side, medical science liaisons (MSLs) teams and R&D.

Getting involved, creating value

Most medical affairs teams are embracing the challenge and establishing their leadership in:

• Providing medical expertise to a range of clinical/scientific questions
• Driving development of medical strategy and delivering scientific communications
• Actively engaging with key opinion leaders (KOLs) and championing KOL mapping and engagement planning within organizations
• Offering various medical education functions
• Developing data through Phase IV and RWE
• Publication planning and execution
• Representing the company at professional conferences and congresses
• Extending medical directors’ reach to the field through medical science liaisons
• Performing HEOR studies

In addition, medical affairs is becoming stronger partners and contributors to:

• Strategic launch planning and execution
• Strategic and tactical planning for marketed products
• Education for payers through partnership with managed markets teams
• Many other important initiatives

Beyond this broad scope of responsibilities, more advanced organizations have started involving medical affairs much earlier in the product development process — having them take part in the design of Phase II or even Phase I clinical trials. Those organizations view medical affairs team as an equal business partner with R&D and marketing teams.

Medical affairs brings a lot to the table: medical knowledge, scientific insights, and feedback from the field that helps companies understand clinicians’ ongoing struggles and unmet medical needs. All of this helps effective organizations 1) better define and manage product strategy and 2) design product value propositions that motivate choices by physicians, payers and patients.

While medical affairs is clearly growing in importance and influence, at some pharma companies its effectiveness remains limited by internal cultural barriers and political/territorial considerations. Reports of a lack of resources in terms of both dollars and staffing are not uncommon. Across the industry, medical affairs departments continue moving from providing limited support functions into a broader, more strategic, and more valuable organizational role. The successful ones may be those that are able to agreeably share their new-found influence with other key departments, while clearly demonstrating their value both internally and externally.

In summary, the evolution of medical affairs is driven by a changing healthcare landscape, marked by specialized medicines and new stakeholders who demand more complex scientific information across all channels. With their deep clinical expertise, medical affairs departments are uniquely positioned to meet these needs and create competitive advantage for their companies.

As we have observed with the COVID-19 pandemic, a lack of preparation may cause serious consequences for your organization.

We have created a Risk and Consequences Log to help you identify and mitigate the threats that can severely and negatively impact your project or your organization. This tool will help you examine each risk’s consequences and their relative severity, enabling you to make educated decisions about your risk mitigation strategies.

We encourage you to download our Risk and Consequences Log and begin discussing the development of risk management strategies with your key stakeholders and executive team.

While we self-quarantine, practice social distancing and adjust to the new world order wrought by the COVID-19 virus, we can take away multiple business lessons from this pandemic. Today, the topic is risk management.

The practice of risk management has been a cornerstone of project management for decades. It involves the identification, assessment, mitigation strategy and tracking of risks that can have an adverse impact on an organization.

It is important to note that “organization” in this context can refer to a project team, a company or even an entire country. For the purposes of this article, we’ll discuss the first two, as the COVID-19 pandemic has provided a fascinating (albeit grim) platform for illustrating the strengths—and limitations—of key risk-management strategies related to project teams and a company at large.

The answer is out there… in the matrix

The risks of any given event are commonly quantified by assessing two key characteristics:

• The likelihood of an event actually occurring
• The severity of the consequences of an event if it does occur

Looking at the risk-assessment matrix, we see that risks that are deemed both likely to occur and have severe consequences would justifiably garner the most attention.

Before the current COVID-19 virus hit, many firms—and even industries—would have classified the risk of a pandemic as severe in consequences, but very unlikely. As we’re learning amid our economic shutdown, most enterprises put very few risk-management efforts in place to deal with such a pandemic.

Those that did have risk-management plans in place related to the broader consequences of a disaster like a pandemic were far better prepared to react to and survive our current reality than companies that had no disaster recovery plans in place at all.

Understanding how probability can lead to greater risk management 

To illustrate how this subtle but important shift in risk definition can (and should!) influence how you develop your risk-mitigation plans, I’ll start with a quick review of the theory of probability.

Let’s say you are flipping two coins and recording the outcomes of each. (For the more persnickety reader, assume that the coins are evenly weighted, cannot land on their edge, etc.) You have four potential outcomes (A, B, C or D):

Now, to make it a little more interesting, let’s say that I offered to buy you dinner if Coin 1 AND Coin 2 come up heads, but you had to buy me dinner if they didn’t. That would be a bad bet for you to take, as the probability of both coins coming up heads is only 25%:

But if I said, “OK, I’ll buy you dinner if Coin 1 OR Coin 2 comes up heads. Otherwise, you buy.” How would this influence your decision on taking that bet? Your chances of winning jump from 25% to 75%, just by changing that “AND” to an “OR.”

With this example in mind, let’s circle back to risk management and how the probabilistic theory could apply. Instead of coins, let’s look at three potential risks that could impact an office building:

While the probability of any three of these risks actually occurring may be moderately low, the probability that the staff may need to work from home for one of these three reasons is significantly higher because it is a consequence that is shared by the three risks—and any one of these risks eventuating would trigger this consequence.

Specifically, a pandemic OR a flood OR a fire would force the staff to work from home, making this particular consequence more likely to occur than any of the other consequences identified in the example. To that end, it would be reasonable for the risk-mitigation plan to identify and address any mitigating activities in the event that the staff would be required to work from home.

The lesson? By focusing on the likely consequences of high-level risks, project managers can identify common patterns in these consequences and develop mitigation plans to address them. These plans can then be repurposed when extremely unlikely, but extremely consequential risks to your project suddenly become your reality.

Adapting risk mitigation to disaster preparedness

While it’s a bit late to start planning for the COVID-19 pandemic, it’s always the right time to start identifying the likelihood of other severe risks and start strategizing how to mitigate their effect on your organization.

Starting with what you’ve learned from this current crisis, I suggest you create and maintain a risk log of those factors (should they occur) that could negatively impact your business, your customers and your employees. Then answer the following two questions for each risk identified:

• What is the probability of this happening?
• What is the impact it will have in the worst-case scenario?

Next, chart the consequences (as in the grid above or in a Venn diagram) to identify those consequences that overlap. The most severe overlapping consequences should be at the top of your risk mitigation planning list. Over time, you can work your way down to the less severe, but still mission-critical consequences so that you are well prepared for a host of calamitous events that may occur.

In my next article, I will show you how to develop a simple spreadsheet that takes consequences into account.  As this pandemic has made abundantly clear, risk mitigation is not optional.  You can’t stop the next catastrophe, but if you have a comprehensive mitigation plan in place, you can most assuredly blunt its impacts.  Stay well, everybody!

In a perfect world…

• Every company would have unlimited budgets to fund every project that its managers envision as strategic relative to the company’s success.
• Every project funded would see all of its intended outcomes achieved and promised benefits realized.

In the real world, however, unlimited budgets are not realistic. That is why astute companies use benefits realization to select which projects to undertake and to identify which completed projects were actually successful.

It’s hardly a new concept. Benefits realization refers to the planning, structuring, assessing and tracking of the benefits that a project generates during and after its completion. These benefits can be tangible (e.g., measurable cost savings, increased productivity or software that prevents phishing from penetrating an organization) or intangible (e.g., customer satisfaction, alignment to the corporate mission or risk mitigation).

An old concept, applied only sparingly

Many organizations, even those that consider themselves “mature” project management shops, overlook this critical component in their planning and execution. They spend tremendous sums of money funding scores of projects every year and declare a project successful because it was completed on time and on budget. Yet they fail to track whether the project met its measurable goals at six months, a year or more down the road.

Did Project A save the company $1.5 million by eliminating IT redundancies? Did Project B achieve the 6% reduction in expenses in year two as projected? Did Project C result in fewer product returns and increased repeat purchases?

If you cannot answer questions like these, how can you accurately determine whether your projects achieved its maximum return on investment (ROI)? You cannot—and if you cannot, there is a strong likelihood you have squandered at least some of your limited resources on projects that have not delivered measurable value to your organization.

Now think about the potential missed opportunities for funding projects that could have maximized their ROI.

What process does your organization use to decide which projects get the green light? How much of it is personality-driven? Did last year’s golden child’s or the perpetual squeaky wheel’s project get the rubber stamp over other solid ideas? Did the business case they presented have clearly defined and measurable benefits? Your organization needs a formal process of accountability in place to track and optimize the benefits they can achieve from a project and calculate the value delivered to the business.

“OK, Houston, we’ve had a problem here.”

Launching a benefits realization program in an established organization can be difficult, at best. It requires a conscious decision to create a structure that tracks project outcomes over months and/or years.

It requires a shift in culture. Benefits realization means holding your executive sponsors accountable for the value their projects are supposed to generate. Shocking as this may sound, not every executive is enthusiastic about having their projects interrogated in this manner. . You will most certainly meet with some initial resistance by adding a layer of discipline to the creation of project plans. But this is a crystal-clear case of the ends justifying the means.

There are logistical/staffing considerations. Project teams are typically comprised of individual employees or consultants across functional groups, from multiple geographies, who come together for only a defined period of time. Each member has a specific job to do, and unless you specify which team member is responsible for post-project tracking and analysis, that role—and the process—goes unfilled.

Realistically, many companies are not willing to make the necessary investments.

But if you want it, there is a path to implementation

If you’re unsure whether your company has the bandwidth to implement a benefits realization program, consider the following three-phased approach:

1. Obtain leadership commitment/backing. The decision to integrate a benefits realization program in your organization MUST come from the top. If your leadership team is not entirely on board, consider your program dead in the water.

Be prepared to sell the benefits (no pun intended) and the critical importance of a benefits realization program to your CEO and/or other senior executives. Emphasize how tracking project ROI can reduce the funding of bad projects and increase the value recognition of good ones.

2. Select uniform benefits realization metrics. Your company should agree on a list of both tangible and intangible measurements that will be applied to all projects, so an apples-to-apples analysis of candidate projects can be conducted at specific time points, not just at project completion.

With defined metrics, you can begin vetting and ranking the projects that offer the highest potential value and should be considered first during the next planning cycle. When that sexy $10 million project brought in from the squeaky wheel shows only a promise of $1 million in return, it’s easy to deem it low-value and not worth pursuing.

Metric measurements may be translatable (dollars versus percentage points), and they may change or be adapted over time. But they should continue to be uniformly applied to all projects up for funding consideration.

3. Establish a benefits realization team. The final step is typically more complex in nature and more long-term to formalize. Your organization will identify a specific group with the responsibility for tracking and reporting on the ongoing benefits realization for every project funded.

Once the team begins building a dossier of project benefits realization reports, it establishes its own value to the organization by creating a dashboard that lets senior executives easily identify which projects yielded the greatest ROI. The results can help companies avoid funding the types of projects that show low or limited value.

In a perfect world, every company would follow all three steps in creating a comprehensive benefits realization program. However, if you can implement even just steps one and two, you will have a strong foundation to begin identifying and tracking high-value projects in your organization.

The first step is getting started

No, that’s not a Yogi Berra bon mot. It’s a recognition that nothing is going to change in your organization without agreeing that change is needed. Once you take that first step, there are defined processes you can follow and outside consultants who can help you establish a benefits realization program so your organization can begin achieving greater value on the projects it funds.

If your company is like the many that run an annual project cycle, you’ll begin your project planning for 2021 in late summer/early fall. That makes now the perfect time to take that first step.

The Value of an Open-Door Policy, a Phone Call and a Handshake

Put down the smartphone. Step away from the email. Take a break from the emojis. Give your indoor voice some exercise and say something…out loud.

When it comes to communicating in 2020, it’s so easy to send a text, an email or an instant message (IM). Really, why would anyone pick up the phone or knock on a door to start a conversation when they can tap away on their smart device or laptop? I know I’m guilty of this, as I’m sure most of us are.

While I understand there is a time and a place for digital communications, they also offer a much too easy way out of engaging in live conversations and interactions. We are missing opportunities to learn and bond as a result. As business leaders, we have a responsibility to role model what effective communication looks like with our teams—which, in my mind, includes more live interactions.

I want to share five reasons why I encourage live interactions.

1. They build trusting relationships.
   I have an open-door policy in my office, which has helped foster an environment where my employees know they can come to me in person to discuss things that may be sensitive in nature, inquire about new opportunities or share concerns about a project, client or coworker.

   Some things are just better said in person; doing so helps to build connections that just cannot be formed through the filter of digital technology.

2. Engaging with coworkers creates deeper bonds.
   Workplace communication doesn’t always have to be about work. It’s nice to learn about someone’s weekend, see pictures of the kids or gripe about the morning commute. But those asides don’t occur much over text, email or IM. With digital communications, our brains are wired to get our messages across in as few words as possible and move on to the next task. We’re missing the opportunities to relax, engage and connect with others in deeper, more significant ways.

   Let’s not forget the power and team-building benefits of brainstorming, where everyone sits around a table and no idea is a bad idea. One person feeds off another’s suggestion until we have more opportunities on the board, in less time than it takes the same team to respond to an email chain. Employees leave these meetings empowered by their collaboration, having built stronger working relationships with their colleagues in the process.

3. Your voice conveys inflection and emotion.
   Have you ever read a text or an email from someone and taken offense when none was intended? Or not realize how serious an issue was because the Arial 11-point font didn’t leap off the page? We’ve all been there. That’s the nature of the digital beast: too much gets lost in translation.

   In my experience, it’s hard to form genuine connections and meaningful bonds without voice intonations, facial expressions and even gestures that emphasize our ideas beyond words.

4. Talking helps foster more effective conflict resolution.
   While it’s much easier to send a stern email in response to a challenging situation rather than do it in person, when was the last time you actually looked someone in the eye and shared what’s on your mind? It’s the real-time exchange of dialogue with body language and voice inflection that paves the way to healthy conflict resolution. This is a mandatory practice in my book.

   I truly believe that hiding behind a computer screen is one of the most ineffective ways of getting to the heart of the matter. Next time a situation arises, bring those well-thought-out, typed-up notes you were planning to send with you as you meet your colleague(s) or manager face to face. Keep them on hand for reference, for clarification or even to steel your nerves and give you the confidence to state your case.

   And be sure to give the other person or persons the same attention and heed they give you.  Understanding both sides of a situation and holding constructive conversations in real-time leave little room for ambiguity, which ultimately leads to a more productive resolution.

5. Face-to-face conversations save time.
   Raise your hand if you’ve ever been stuck in a lengthy back-and-forth email dialogue only to pick up the phone to finish the discussion. While I generally try to avoid this scenario, it does happen—and it always serves as a reminder that email is not the most prolific way to communicate. The truth is, when you talk it out, you can accomplish the same objective (or better) in a fraction of the time.

Text, email and IMs are great, and I will always depend on those forms of communication in some aspects of my life. But the more I grow as a leader, the more I value authentic and meaningful connections. A smiley face emoji will never replace the real thing. Exclamation points after a “congratulations” do not feel nearly as good as hearing it said out loud—with feeling.

What are your thoughts on effective communications? Stop by or give me a call and let’s talk about it.

The success of a business depends in large part on the quality of its leaders. A strong leader has the power to motivate, energize and drive results. They know how to get the best out of their team and build trust while making a marked impact on the business. The question is, how do you define a “strong” leader? And what is it that employees look for in a leader?

While there may be no right answer to that question, per se, I’d like to explore one leadership trait in particular that holds great transformative power but is all too often overlooked: transparency.

Why does transparency matter?

Gone are the antiquated leadership styles of the past where leaders ruled with an iron fist, expected employees to do as they were told with no questions asked and communicated with their teams only on a need-to-know basis. (Sound familiar?) The workplace has evolved; employees want more. They want authentic interactions and two-way communication up and down the hierarchy. They want to understand how they fit into the bigger picture of the business. They want a satisfying work experience built on a foundation of trust with their leader. Without transparency, none of that can exist.

The question is, if transparency is such an effective leadership strategy, why isn’t it more widely used? In my experience, it really comes down to perception (and maybe a bit of ego). Many leaders believe that being transparent with employees will strip them of their authority status, and thus, their power. Not so. Transparency, as a matter of fact, offers the potential to make you a more powerful leader, not less.

Does transparency make you slightly more vulnerable? Yes—a bit, but that’s a good thing. It makes you more of a human being in the eyes of your employees—not just “the boss.” While most of us are naturally geared towards self-preservation and an appearance of strength, it’s important to note that transparency is not a sign of weakness. Just the opposite, in fact. It’s about bringing others in the loop on what’s real, authentic and true to create an environment that’s conducive to collaboration, productivity and success.

Here are six ways transparency can benefit your organization:

1. Stronger team relationships: In a transparent environment, each member of the team can learn more not just about you, but about each other as well. When you all get to know one another’s strengths and weaknesses, likes and dislikes, and successes and challenges, you form chemistry and create synergies.
2. Better problem solving: When you’re open with your team about the happenings in the company, they can help you overcome business barriers. Don’t problem-solve in a vacuum; more minds are better than one.
3. Positive, open environment: The honest interaction between you and your team sets the tone for authentic relationships. When employees are in the know, they feel more empowered to share their own insights, ideas, concerns and more. An environment where creative suggestions are valued is one that fosters openness, acceptance and trust.
4. A more engaged team: According to a Harvard Business Review survey¹, 70% of respondents said they are most engaged when senior leadership continually communicates on company strategy, while another 70% cited a clear understanding of how their job contributes to the company’s strategy as a key driver. Need I say more?
5. Employees who want to excel: When you openly communicate employees’ accomplishments to the team, you naturally infuse them with an energy and excitement that compels them to continue to do better. When they know what they’re doing well, where they need to improve and how they’re contributing to the bigger picture, they not only have a clearer path forward, but also gain the respect of their fellow team members in the process.
6. Improved productivity: The culmination of each of the above elements will naturally give way to higher productivity with improved outputs. When you work together with your team in an open and honest way, together you will inevitably drive positive results that impact the business.

Lessons learned: It’s not cut and dry

Adopting any new leadership behavior is rarely a linear process. It takes some trial and error, honest self-reflection and a touch of humility. Throughout my own leadership journey, I’ve learned what works and what doesn’t, and I’ve had to course correct along the way.

Yes, you want to communicate openly and forge genuine relationships. You want to give employees information they need to do their job well (and feel good about it in the process), but there is a shutdown point. Don’t allow your team to confuse transparency with friendship. You are still in a position of authority and you are the leader. Work towards authentic relationship-building—but do so in way that allows you to maintain that level of respect.

In the end, it comes down to what works for each of us individually as leaders. I do believe that transparency is one of the most effective ways to build a culture of trust—and I will continue to employ this leadership tool on a regular basis. But as I do so, I will continue to assess what I’m doing, how I’m doing it and the impact I’m having on employees, myself and the business—and make changes as needed. Along with everything else in life, it’s a work in progress!

1. The Impact of Employee Engagement on Performance. Harvard Business Review

Effective performance metrics depend on a healthy culture and communication

“No one will ever use red” is always the first comment at the start of every product launch kickoff when discussing how the team will report performance status. Followed immediately by laughter, the second response. And both will probably be the most honest and genuine communications in the launch process from then on out until approval.

Whether it is the launch of a pharmaceutical product, an implementation of a new technology platform, or the integration of two companies, organizations have been utilizing the traffic light approach for decades when reporting project status.  Color-coded readiness deliverables at pre-identified points in time organize, prioritize, and reduce the risk of not achieving key strategic objectives. Whether utilizing traffic light signal colors or the words that define them, signals are required and need to be defined, socialized, and, actually used.

What are traffic-light metrics and why do they matter?

Traffic light colors are simple and universally understood.  Drivers know the three standard colors on traffic lights allow vehicles to proceed safely through intersections and cross streets. Green means ‘go’, yellow means ‘slow down’ (unless you are in the state of NJ), and red means ‘stop’.

This color-coding approach is used in many fields, from road intersections, to airport departure boards, terrorist threat levels, factory production lines, hospital occupancy, and even the healthiness of prepackaged food. When launching pharmaceutical products, traffic lights provide a simple and clear way to quickly convey the launch status to stakeholders. Green means ‘on track’, yellow means ‘at risk of going off track’ and red means ‘off track’ and needs attention quickly.

Why is red the loneliest color?

Patients quickly answer physicians’ questions about pain using the intuitive 1-10 pain scale. And everyone understands the purpose of the ‘check engine’ light in their car’s dashboard or the red ‘low gas’ message. Yet using traffic light colors, particularly the color red, to measure launch readiness evokes a different reaction. And, it prompts a counterintuitive behavior, which is rarely using ‘red’ or not using it at all.

One reason for this is ambiguous definitions, leaving their interpretations up to the users with the assumption they know what the colors mean. For example, many teams note milestones or deliverables as green since they are confident they can complete it by the agreed-upon deadline. However, when it is 30 days to launch, and a deliverable generally takes more than that timeframe to complete, coupled with multiple go-to-market priorities, designating a deliverable as ‘green’ is inaccurate. Though this may seem like an obvious example of something that should be considered ‘red’, human nature guides us to apply our own perspectives including how confident we are in our ability to get something back on track within prescribed time frames.

Another reason is that team members may be reluctant to use the color red since they perceive ‘red’ may reflect poorly on their job performance. If their project is off track, does that mean that their launch team members will think they are not doing a good job? And/or that their manager will perceive their performance at professional performance review time is off track as well?

So how do we remove these barriers?

It is not difficult. It requires a disciplined but not complicated approach including the creation of team norms and definition of colors before kicking off the launch. The result is worth it – key stakeholders trust the readiness colors and are confident that there are “no surprises” since they are provided genuine status at specific scheduled time points. The approach I take includes:

• Aligning with stakeholders regarding the definition of each traffic light color prior to kicking off the launch. This includes defining the colors with specific examples and reinforcement so that use of the red color metric is not construed as being punitive. The converse — not raising concerns — is much more concerning.

• Communicating traffic light definitions at the launch kick-off meeting and training new launch team members upon point of entry
• Establishing and fostering healthy team norms during the kick-off meeting. Team norms, including trust and accountability, are created and agreed upon, and may include mantras such as ‘we win together as a team” and “communicate early so there are no surprises and we can pivot and course correct effectively.”

Defining traffic light colors and establishing a culture that supports accurate metrics will help ensure your team is set up for success. Let me know what your best practices are!

The Challenge

A biotechnology company was preparing for a merger and had no formal M&A processes in place for IT specifically. Most of its existing company-wide standard operating procedures and templates were hard to locate, many out of date, and couldn’t be leveraged for this effort. The company was faced with the need to rationalize its commercial IT applications – including onboarding, retiring and/or enhancing existing applications – as part of the merger process. In order to meet the needs of regulators and shareholders, a proper management plan for the full IT portfolio integration needed to be created over a short period of time.

The Solution

CMK Select coordinated a number of different groups and departments to give everyone who had a stake in the acquisition an opportunity to voice their opinion on determining the application rationalization requirements. CMK recognized an opportunity to bring together a team of industry experts alongside key stakeholders in each of the affected departments within the organization – legal, compliance, security, digital marketing, patient services, etc. – to incorporate the assessments of all parties.

Drawing upon the consensus of each group, CMK then constructed a set of requirements for the various applications and brought forward a concrete plan detailing how to rationalize each one, whether retiring or decommissioning, onboarding or enhancing. The plan also required the team to assess data and outlined how to ensure it adhered to data retention requirements.

The Result

Over a period of six months, CMK rationalized approximately 50 applications; and with each rationalization, we provided the pharma corporation with an additional means of cost savings by reducing the number of month-to-month contracts they had to maintain.