The Challenge

The Solution

The Results

The Challenge

The Solution

The Results

BENEFITS OF CENTRALIZING THE LABEL UPDATE PROCESS ACROSS AN ORGANIZATION

Pharmaceutical marketing departments that centralize and standardize their approach to required label/Important Safety Information (ISI) updates, including the advance planning of upcoming labeling changes and continued optimization of their internal processes, will provide greater value to the overall organization. In addition, the benefits of cost savings, along with the consistency and transparency of a repeated process, ensures adherence to compliance policies and guidelines.

CMK Project Management Consultants organize and drive the internal label/ISI update review process to ensure completion by the set Regulatory deadline. Brand team members and brand reviewers will remain involved, kept aware of progress, and alerted to any marketing assets or programs “at risk” of not meeting the Regulatory deadline for implementing the required updates.

WHAT WE DO – Centralized Approach

We collaborate with your organization to develop a 2-year rolling plan of label updates that will need to be executed for all products across the enterprise.  Our project management team will drive, manage, and make recommendations to optimize the Important Safety Information updates required for marketing materials (print, digital, web) for any impacted brands across the organization. This allows brand leads to remain focused on their products, field force, physicians, and patient needs. CMK Select can provide:

• Initial Assessment
• Development of a Master Calendar
• Management of Brand Workplan(s)
• Pre-Audit of Brand Assets
• Prioritization of Materials
• Agency and Workstream Management
• Brand and Management Status Updates
• Post-Label Update Analysis

EFFICENTLY MANAGING REVISIONS TO MARKETING MATERIALS

At any time during the active marketing of a pharmaceutical product, there is a high probability of having to implement a safety label update, impacting the Important Safety Information (ISI) that is highlighted in a brand’s marketing material. Whether the label change was requested by a company to expand the data or number of indications within the current product label, or a required change that is mandated by the FDA, safety label updates are time-consuming, time-sensitive and need to be carefully managed to ensure a brand’s marketing materials are not at risk of being pulled from market use.

At CMK Select, we have extensive experience with this process and efficiently project manage label updates for our marketing clients. We have a proven 4-phase process to ensure that the brand’s priority materials remain in use and compliant with FDA guidelines.

Phase 1 – (3 months prior to label approval)

• Identify brand assets that will require updating due to the label change
• Determine priority marketing assets
• Confirm assets that will need to be removed from market

Phase 2 – (1 week prior to label approval)

• Confirm timing/completion date for label updates (as per internal Regulatory guidance)
• Conduct kick-off meeting with brand, internal/external Agencies, and Legal/Medical review (LMR) teams
• Schedule when tactics will be submitted by agencies and track in LMR review

Phase 3 – (at label approval)

• Begin execution of plan
• Facilitate ongoing meetings with brand, agencies and LMR teams
• Continually prioritize and track tactics through the update process
• Notify brand and/or management of any priority items at risk

Phase 4 – (post-label approval)

• Ensure destruction notification is accurate and distributed timely
• Obtain documentation from publishers and internal/external agencies confirming outdated material removal from third-party platforms
• Report Key Learnings to management

The Challenge

When the U.S. Oncology team of a global pharmaceutical company were ready to execute on the vision of industry-leading engagement, they looked to CMK to help them translate it with structured change management. Healthcare providers were receiving massive amounts of information and needing to see more patients in less time. Coupled with lingering protocols from the COVID pandemic, Field teams needed to adopt a new way of working that offered a more personalized customer engagement experience. The client turned to CMK to map out and launch the massive change effort that would connect the integration of the latest analytics and technology with meaningful communications and training, in coordination with the data and digital tools to fully realize the strategy.

The Solution

CMK assigned a seasoned change manager to support program leaders with strategic guidance and support to guide key stakeholders through the change continuum. Several change management measures were mapped to the business goals that included: stakeholder analyses, impact and risk assessments, communications and training deliverables, and field engagement. CMK worked with the client’s key stakeholders to work through iterative plans that were configured for each activated brand’s needs. Change management enabled the program team to communicate effectively with the field and address risks and concerns with the digital workstreams. The Field adopted the new platforms and systems by partnering with the program team to troubleshoot issues, provide feedback and endorse changes.

The Results

By implementing effective change management tactics, the program team successfully launched next generation engagement on schedule and with full commitment from the Field Sales teams. U.S. Oncology field reps who were activated with the new tools experienced over 30% more prescription activity and an increase in customer engagement. The launch was so well-received that the client is expanding the program to additional brands and incorporating the change management and communications processes as a best practice.

The Challenge

A Client’s Life Sciences data analytics team was seeking to gain foundational knowledge of project management.  The team’s existing work environment centered around rapid response to their internal clients. The result was frequent scope creep, dissatisfied clients, and team burnout. This team was looking to move towards a more proactive approach, i.e., taking a more macro view, understanding the strategy for disease areas as it relates to the work, and moving towards a more matrixed environment.

The Solution

CMK interviewed key members of the team to gain a deeper understanding of their current project management practices and knowledge gaps across the team. Feedback from these interviews provided the foundation for the training, which started with a segment of project management theory to establish baseline understanding, scenario-based discussions related to the kind of work the team undertook, and role-playing exercises to demonstrate some of the softer skills related to negotiation and stakeholder management

The Results

100% of the training participants had a favorable impression of the overall quality of the session, and 85% indicated that they would be able to perform their job more effectively as a result of the training.

The Challenge

A privately owned, rapidly growing pharmaceutical company was charged with rolling out 22 releases for a multi-product launch in one year’s time. In the early stages of the program, the client struggled with a series of issues that, if not corrected, would ripple through the subsequent launches. While each release had a project manager, they lacked a dedicated resource who could manage the program at a strategic level to ensure alignment with business use cases, communicate with IT and ensure the overall success of the interconnected projects. The client turned to CMK to correct the inefficiencies observed and offer a more methodical approach to the overall program.

The Solution

The CMK team began by assigning a program manager to oversee the portfolio of projects and provide strategic direction in support of business goals. They built a formal Agile team with clearly defined roles and responsibilities, established a new meeting cadence that made better use of the team’s time, streamlined communication with the project teams and stakeholders and created templates that support a more prescriptive approach. With trust established, the client later turned over the financial management and reporting responsibilities to CMK.

The Results

Since bringing CMK on board to manage the program, the client seamlessly launched three releases over the course of three months—on time and on budget. With repeatable processes and protocols now in place, they are currently on pace to complete the remaining 16 launches by year-end.

The Challenge

The U.S. cardiovascular team of a global pharmaceutical company needed help responding to a new Corporate Integrity Agreement for two launch products. Resource-constrained at the time, they were looking for a streamlined and efficient way to satisfy the strict government-imposed deadlines without blowing their budget or delaying the products’ launch dates. The client turned to their trusted partners at CMK for strategic guidance and support in addressing this immediate need.

The Solution

The CMK team began by exploring creative ways to use the client’s existing procedures and compliance and regulatory documentation to meet the new requirements while delivering long-term efficiencies. They made process improvement recommendations, built templates, created guidance documents and defined a more streamlined approach for meeting deliverables more efficiently. In collaboration with the client’s key stakeholders, the CMK team then developed planning documents and configured them to perform automated tracking and reporting around tactics, budgets, priority, business case, changes, timing, dependencies and more.

The Results

With newly streamlined procedures and enhanced documentation in place, the additional checkpoints were implemented on time and did not impact the client’s budget or launch timelines. The tracking and reporting functionality allows the project teams to have more meaningful, data-backed discussions with stakeholders, while the automation capabilities make it easy to uncover areas of opportunity and track progress for continuous improvement. Today, the client is equipped with repeatable processes that help them ensure ongoing compliance with all policies and procedures and transparency with internal and external constituents—and also serve as a best-practice that can be shared across other therapeutic areas.

The Challenge

Within hematology, Higher Risk-Myelodysplastic Syndrome (HR-MDS) and Acute Myeloid Leukemia (AML) are diseases with a highly unmet treatment need. In response, an NJ-based pharmaceutical leader created an innovative new immune-modulating treatment that shows tremendous promise in the fight against myeloid disease.

While the new regimen offered an effective immunotherapeutic approach that addresses the lack of durable response in myeloid disease, aided and unaided awareness of the treatment among practitioners was very low—around 10%. The pharma giant turned to CMK to create a program designed to drive awareness and generate excitement about the new drug in advance of its launch.

The Solution

CMK implemented a multi-pronged Disease Awareness Campaign aimed at delivering key messages to practitioners through multiple channels. They created a highly engaging website to house all pertinent information about the disease itself, treatment limitations and the drug’s mechanism in the body, followed by a robust media campaign that included banner ads, emails, paid search, videos and social media marketing.

The Results

Within six months, awareness soared to 60%, with total hits to the site approaching 20K. Today, the client is on pace to reach its goal of 80 – 100% aided awareness by the end of the year for what is expected to become the cornerstone of treatment for MDS/AML.

The Challenge

When two large pharmaceutical companies merged, the study teams struggled with a lack of clarity over which operating models to follow for their respective studies. With heritage procedures and IT systems in place across both entities, and pros and cons to each depending on the lifecycle management processes at play, the client needed a way to define, streamline and integrate each disparate component for more efficient, audit-ready processes and protocols.

The Solution

CMK worked with the client to coordinate, compile and evaluate every operating model currently in use. They identified best practices and devised a mixed-models approach that assigned a specific operating model to each of the multiple processes. Recognizing the need for a central repository to house all pertinent information, CMK also partnered with key stakeholders to collect procedural documents and resources for every process, with source links to each respective system.

The Results

With the operating models and related IT systems defined and a single policy portal system that offers one version of the truth, the study team is well equipped to execute trials efficiently and without confusion. And with inspection-ready standard operating procedures in place, the team can quickly and easily respond to compliance inquiries.