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

Industry revolution and implications

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

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

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

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

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

IT evolution and what’s needed

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

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

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

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

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

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

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

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

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

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

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

The Challenge

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

The Solution

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

Results

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

The Challenge

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

The Solution

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

Results

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

The Challenge

When the FDA announced its new Breakthrough Therapy Designation in 2012, it meant that the pharma industry would be able to move new life-saving drugs more efficiently through the approval process, allowing for the right drugs and therapies to reach the right patients at the right time. Any drug that is designated as a breakthrough therapy is fast-tracked through the FDA approval process.

Shortly after the new designation was instituted, a Top 5 pharmaceutical company was seeking to optimize the launch of a new breakthrough therapy oncology drug, and needed a plan in place that would allow for an adequate supply of the drug at launch – both to avoid any negative press and to open the gates for revenue gain early on.

The Solution

CMK Select first reviewed the existing timeline and assessed the risks and opportunities. We interviewed key stakeholders to better understand the brand objectives and ideal project timelines, and discovered that the existing schedule would send the drug to market two months after launch. Because this would result in a highly unfavorable response from the public, we assembled key decision makers from the manufacturing and distribution teams to critically evaluate the existing process and streamline the tasks that could be completed ahead of time to improve efficiency.

Results

We successfully reduced the pharmaceutical company’s drug availability delay by 60 percent, which placed the breakthrough drug on the market less than two weeks after the fast-tracked launch, rather than the initial estimate of two months. With such an efficient turnaround time, there was ample product available just days after launch. This ensured an additional five weeks to generate revenue and eliminated the threat of negative press. In fact, the abbreviated process worked so well that the client continues to use it today.

The Challenge

A major pharmaceutical company hired CMK Select to manage all of its therapeutic compounds in early development – from proof of concept to regulatory submission. The CMK Select team soon identified a need for a new process for transitioning projects from the pharma company’s development team to its brand team. The development team struggled with transferring critical pieces of information to the brand team during the handoff – each time a drug compound was submitted to the FDA for approval – which caused the brand team to often question the development team’s work or the decisions they made along the way. Ultimately, work was being repeated unnecessarily to fill those information gaps.

The Solution

CMK Select evaluated the company’s existing communication channels and pinpointed the areas where information was most often lacking or getting lost in translation. We then developed a centralized and fully shareable project-tracking tool that records all work done by the development team from the start of the project until the transition period. All information is organized and tracked under defined headings and marked by date. Each section serves as a means to track the work being done in all phases of the project, plus the tool acts as a comprehensive summary for the brand team to pull information from later on and even contains links to final reports.

As a critical second step in the new transition process, we advised the development and brand teams to organize a meeting of key stakeholders from both sides to review all information contained in the project tracker and to open up the proper avenues for communication going forward. When combined, the project tracker and meeting facilitate a smooth transition for hand-off from development to branding.

Results

By tracking and walking through the process with the brand team and presenting them with a complete package of information, the development team was able to bring their colleagues up to speed on the status of the project much more efficiently than had been done in the past. It also kept the brand team from having to perform any duplicative tasks and allowed them to take their work to the next level.

The Challenge

A major pharmaceutical company hired CMK Select to manage all of its therapeutic compounds in early development, from proof of concept to regulatory submission. Upon realizing that the pharma company frequently hired multiple outside agencies to help produce major deliverables – oftentimes bringing on several new agencies at various points throughout a single project – the CMK Select team identified an opportunity to streamline the onboarding process.

As part of the existing process, senior members of the medical and marketing teams would conduct an hours-long on-boarding process concurrent with each new hire, to ensure each team member had a complete understanding of the project status. The new process initiated by CMK Select worked to improve efficiency by cutting down on the amount of time spent in redundant on-boarding meetings, as well as the replicated work that was being done by senior staff members as a result.

The Solution

CMK Select conducted a review and analysis of the existing on-boarding process. We observed the senior team members as they led their on-boarding meetings to gain an understanding of the content of these meetings and how they could be more efficiently utilized.

We determined that a single on-boarding meeting for all agencies at the start of each project would drastically cut down on the time spent in these meetings by senior staff, and we put a process in place to help make that happen. We directed our client at the start of each project to map out all of the work that needed to be done from start to finish, as well as to identify all of the agencies that would be needed to attain each deliverable. From there, they could plan one single meeting to onboard all agencies at the same time.

Finally, we set up a more streamlined communications process that provides each of the on-boarding agencies with digital copies of all work that has been completed to date, and then continues tracking all subsequent work, which can then be provided as a resource for additional agencies to reference.

Results

The single, comprehensive onboarding meeting produced multiple benefits, including saving approximately 10 man-hours of work on each project for the most senior team members. Rather than scheduling out multiple hours-long meetings, the client was able to schedule one meeting and bring all agencies up to speed in a single four-hour period. This new approach also allowed for a clearer explanation of each agency’s role in relation to the next, and it gave all of the agencies the opportunity to communicate with each other about what sort of work they would each be doing and what could be done in parallel to keep the project moving as efficiently as possible. This produced a cleaner and higher-quality end product, and because there were such open lines of communication in place from the start, it was accomplished without the need for multiple follow-up meetings later on.

The Challenge

A leading pharmaceutical corporation needed a defined system for selecting the right healthcare physicians (HCPs) for each requested speaking engagement, while also ensuring that those HCPs stayed within the limits established by the brand, as well as on budget and within each program’s financial cap. The existing process took a tremendous amount of time, effort and resources by the brand managers. The overall volume of the existing process was too time-consuming and therefore required an alternative solution to simplify the operational effort for the marketing team.

The Solution

Before crafting a solution, CMK Select evaluated the overall process for the field force submissions, including the existing systems for program entry and the overall brand structure. The CMK Select team worked closely with the brand managers to understand and identify the current pain points and how they could best structure an alternate solution to simplify the process for selecting the best HCPs for each speaking engagement.

After thorough analysis and careful review, CMK Select was able to quickly design and implement a back-end operations system designed to track all of the documentation for speaking engagements from submission to finish.

This new solution included process management recommendations and communication plans, and it also provided a dashboard of reports for the brand managers.

Results

Not only did this newly designed system reduce process management for the brand team by approximately 15-20 hours per week, it also increased speaker approval rates on a month-over-month basis since its inception and enabled corporate compliance requirements to be activated more rapidly. In addition, this new solution helped ensure that the best HCPs are being thoughtfully utilized for the appropriate events, and it enabled the brand managers to easily communicate to company leadership the number of committed speaking events and which HCPs will be attending.

There is only one opportunity to successfully launch a pharmaceutical brand. Brand leaders must navigate pitfalls and obstacles by planning, coordinating, and executing a comprehensive plan that will set a trajectory toward brand success. We call this plan the Integrated Launch Plan.

WHAT IS AN INTEGRATED LAUNCH PLAN?

An integrated launch plan is a cross-functional approach to marketing that all pharmaceuticals – from big to small – ought to follow. Without an integrated approach, the launch will fail before it begins. This meticulous plan ensures an appropriately timed launch and mitigates the risk of missing phase deadlines that can ultimately lead to launch postponement and missed market opportunities.

WHO NEEDS TO BE INVOLVED?

Quite simply, everyone who partakes in the brand launch process needs to be involved in the Integrated Launch Plan. Team members will need to work together and, more importantly, communicate effectively throughout both the pre-launch and launch phases.
In the pharmaceutical space, the marketing strategy needs to be implemented across all departments including marketing, regulatory, legal, market access, sales, accounting, and manufacturing. This ensures that all aspects of a launch work together cohesively toward a successful outcome. And, of course, Senior Management needs to ensure that the launch plans, strategies and tactics are in line with corporate goals and objectives. Because of the number of key stakeholders, many pharmaceuticals are likely to face communication challenges in developing their integrated launch plans.

Smaller companies are likely to have fewer communication challenges due to small team sizes and more control over the process; however, this means that very a small group of people will need to account for everything: sales, marketing, access, supply chain, finance, legal, regulatory, medical, etc. The overwhelming responsibilities and workload required to successfully execute an integrated plan can present potential risks and oversights caused by a lack of man power.

THE CHALLENGES OF INTEGRATED LAUNCH PLANS WITH PARTNERS

Integrated launch plans are challenging enough for a single company to manage; now imagine the complexities that might arise with a cross-company or partner launch. This presents a whole new layer of intricacy that must be considered as brand and strategic imperatives are now multiplied by two.
And, if one company is a private company and the other is public, the private company will need to align with the public company’s reporting obligations to the financial and regulatory markets, something that it’s likely not used to and probably not well-versed in.

SUCCESSFULLY IMPLEMENTING AN INTEGRATED LAUNCH PLAN

Taking a step back and looking at the entire landscape of an integrated launch, it becomes clear that proper planning and management are paramount to its success. An experienced project manager is often the critical missing link to ensuring that an integrated launch plan is successfully designed, planned and implemented. The project manager will oversee the process and make certain that the proper planning, collaboration, and communication is happening across all stakeholders. Additionally, the project manager can ensure that the right people are in the right “seats” on the product launch team thus confirming that the appropriate allocation of “man power” is in place to mitigate risks and increase productivity.
CMK Select has a proven team of brand launch professionals who can help pharmaceuticals develop and implement their integrated launch plans for a successful brand launch.

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.

KPIs, or key performance indicators, are critical to the success of a pharmaceutical product launch. By their very definition, KPIs are measurable values that demonstrate how effectively a company is achieving their business goals – in this case, a successful product launch. Of course, there are many KPIs that can be tracked over the course of a launch, but only a handful are truly vital for measuring the overall success of your product’s introduction into the marketplace.

Ideally, eight to 10 KPIs should be identified for each of the three product phases: pre-launch, at launch and post-launch. These KPIs will provide true success measures of the overall launch and – eventually – of brand performance.

1. 1. PRE-LAUNCH: The pre-launch phase starts about a year prior to the scheduled product launch and ends when your product finally hits the market. During this phase, project leaders will reach out to stakeholders and educate them on the plans of the launch so there are no surprises along the way
   2. AT LAUNCH: Lasting only about six months, the at-launch phase is the shortest but most important. This is the point at which stakeholders really dig in to ensure the product is market ready and properly positioned to succeed in a competitive environment. It is during this phase, that the critical launch curve – the ultimate measure of success for a new product – is defined.
   3. POST-LAUNCH: Starting approximately six months after your product is introduced to the marketplace, and lasting for nine to 12 months thereafter, the post-launch phase is a period of analysis and scrutiny. During this time, the product is continually monitored so that modifications can be made as necessary, with one end goal in mind: brand success.

WHAT TO MEASURE DURING EACH PHASE:

Once the individual pre-launch, at launch, and post-launch KPIs are established, they are then tracked, monitored, measured, and assessed. At the end of each phase, the resulting data is evaluated, which allows the launch team to clearly quantify a product’s success.

We recommend measuring the following KPIs across each of the pharmaceutical launch phases:

WHY MEASURE KPIs?

When examining recent pharmaceutical launches – ones that have hit the marketplace over the past few years – there are several clear examples of unsuccessful product launches, and many of them have the same thing in common: critical KPIs were not set, measured, or tracked.

Example 1: Supply Readiness: GAZYVA (Genentech)

Gazyva received approval from the FDA in November 2013 for a breakthrough therapy designation. Because of the strong safety and efficacy review during clinical trials, the FDA requested that Genentech accelerate the launch of Gazyva by six weeks. This was a struggle for their team because they did not have a supply readiness KPI in place to ensure that supply was available when required. Ultimately, the product launch team worked closely with its internal teams and the FDA to obtain the necessary supply, and they launched earlier than planned, but it was more of a challenge than it needed to be, due to the lack of a supply readiness KPI.

Example 2: Messaging and Targeting: Toujeo (Sanofi)

Toujeo, insulin glargine U300, was approved by the FDA in February 2015 and launched in April 2015 to the same patient segment that currently was prescribed a drug called Lantus. PCPs prescribed Lantus to patients for whom they were not comfortable giving a higher concentration of insulin.

At the time of the product launch, Sanofi decided to stop promoting Lantus in favor of the newer drug. Meanwhile, despite price parity between the two medications, physicians were skeptical of Toujeo’s mechanism of action. As a result, Sanofi lost market share to competition, and a year later, the pharma company ultimately had to re-introduce Lantus due to the unsuccessful launch of Toujeo. Had a launch readiness KPI been in place for this product portfolio, Sanofi could have avoided the negative impact on its business.

If you need any help defining KPIs or understanding what KPIs would be beneficial for your business, CMK Select can help you.