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Strategic Realization Case Studies

Organizational Transformation

Goals and Business Driver:

Our client (a CDMO) initially hired a global management consulting firm to lead an organizational transformation initiative. The intent of this initiative was to return the company to profitable operations for the first time in several years. This strategic consulting firm, which came with a high price tag, failed to accurately define strategic success, resulting in a negative return on investment. Enterey was brought on board as an alternative option and worked directly with the Executive Leadership Team (e.g., CEO and all his direct reports) to define success and develop the roadmap to return the organization to profitability.

Discovery & Design

During the Discover phase, Enterey assumed responsibility for current transformation activities but at a fraction of the cost. Additionally, the Enterey team facilitated executive-level planning to define long-term strategic goals, objectives, and success criteria.  During the Design phase, Enterey led the development of a detailed action plan to enable the client to achieve their clearly defined strategic objectives. Additionally, the Enterey team established the procedures, cadence, and tools to manage all action-plan activities. Finally, Enterey helped our client establish the behaviors that would ensure long-term and sustainable success

Implementation

During the implementation phase, Enterey drove all management processes, maintained the established meeting and coordination cadences, and maintained all management tools to ensure the completion of all critical tasks. Additionally, the team facilitated executive-level decision-making to ensure timely decisions in accordance with plan requirements and established a formal Portfolio Management process cadence.

Results Achieved

Our client was able to meet all strategic objectives (including closing one existing production facility, selling a second production facility, relocating all North American lab operations, capturing all outstanding product invoices, and establishing an entirely new and capable project management team) and returned manufacturing operations to a profitable status by the end of the calendar year in which Enterey was first contracted.

PPM System

Goals and Business Driver:

The company did not have a holistic and transparent view of current activities (both current operations and projects) to support strategic level decision making for their sole biologics manufacturing facility. The client goal was to develop a portfolio management program (processes, tools and templates) that would standardize and increase efficiency of project methodologies, provide transparency and visibility to internal and external workflows and enable executive level decision making that is clearly aligned with strategic objectives.

Discovery & Design

Enterey was brought on-board to create this portfolio management system.

Implementation
  • Defined current state portfolio of projects
  • Developed and formalized a standard methodology for individual project management
  • Developed and formalized a methodology for overall portfolio management 
  • Developed key tools and templates, including intake form, charter template, status update form, request to close form, benefits realization form
  • Developed a fully automated portfolio dashboard
  • Developed supporting processes (e.g. Issues Escalation)
  • Established formal Portfolio Management process cadence
Results Achieved
  • Significantly improved transparency and visibility of all ongoing site activities (estimated increase from ~10% visibility of current activities for the executive leadership team to a >90% visibility)
  • Fully enabled strategic level decision making in support of clearly stated strategic objectives
  • Decreased documents associated with portfolio from ~137 to 1
  • Decreased individual project leads required data input by ~47%
  • Improved status update timeliness by ~300%
  • Provided an annual PPM cost savings of ~$130,000

Clinical Capacity Expansion

Goals and Business Driver:

Our client acquired a clinical plant to meet three key business drivers:

  • Enable the “go fast” methodology for process development and reduce the average timeline from 22 months to under 12 months.
  • Expand clinical capacity so no project waited more than 2 months for a production slot.
  • Allow the expansion of company pipeline for new molecular entities.
Discovery & Design

Enterey was brought on to help meet these three key business drivers.

Implementation

Enterey consultants worked closely with corporate sponsors to define the overall project goals in alignment with the corporate goals, which included reduced project budget, timeline and start up team. Our team drove achievement of project objectives, by managing a multi-dimensional start up team and defined the timing of first production run.

Results Achieved

This effort enabled the client to meet all project milestones, budget and workforce constraints. The acquired plan delivered the first ever 100% successful clinical run for our Client, while attaining on the highest products yields, therefore enabling the expansion of clinical trials.

Resource Optimization

Goals and Business Driver:

Our client wished to identify proposed headcount targets and required efficiencies at specified run-rate targets to enable a 50% reduction in cost per gram by year end. The overall process and implementation of the plan required engagement of the department management.

Discovery & Design

Enterey was brought on-board to identify these headcount requirements in order to assist the client with their wider goal.

Implementation

Enterey consultants determined the optimal organizational structure to achieve the specified run rates and benchmarked data against other sites. Our team then developed a customized matrix model of run rates and headcount by department, leading to a proposal of required efficiency to enable headcount reduction with increased span of control.

Results Achieved

The identification of headcount targets enabled our client to reach improved operational performance goals, with no impact to business operations. As a result of this effort, opportunities for staff to improve and build skill sets were increased, and opportunities for displaced employees were identified. 

Capital Management

Goals and Business Driver:

Our client was reorganizing due to a separation event and required a structure to manage capital projects in the Regulatory function, with specific focus on aligning the IT, Business and Project Management Teams. 

Discovery & Design

The Enterey consultants were brought in to support the client in the definition of portfolio governance structure, roles and responsibilities (R&R), project management methodology, templates and capital budget tracking.

Implementation

Our team facilitated workshops aimed at refining the stage-gate requirements and defining accountability for all project deliverables across functions. Enterey consultants built and delivered customized tools and templates for project management deliverables, covering each phase from business case creating to closeout, including a new capital portfolio tracking tool. To ensure alignment with and commitment to the new model and role definitions, a special focus was given to change management and involvement of stakeholders.

Results Achieved

The increased level of clarity led to a reduction in time devoted to portfolio governance by 75%. The establishment and implementation of defined framework and R&R followed by each project ensured consistent alignment and accountability. New roles were successfully adopted by IT, Business and PM team members, with a feedback loop to enable continuous improvement in adherence to Project Management Office requirements.

Plant Transfer

Goals and Business Driver:

Our client acquired a large biotech manufacturing plant nearing construction completion. Enterey consultants were brought onboard to support the need to integrate the new site and employees into its operations to address significant demand concerns. Aggressive deadlines were set to ensure the new plant was producing marketable product within the targeted time frame.

Discovery & Design

Enterey was brought on-board to ensure product deadlines were met and employees were integrated efficiently. 

Implementation

Enterey consultants determined focus areas, as part of an overall program, and created specific project plans for their integration. Decisions were made about the systems and processes the new site would either adopt, integrate with or keep unchanged. Our team provided project management support to 3 key business areas.

Results Achieved

Our client successfully completed the transition of the new site, according to the schedule. The new site not only integrated with corporate, but also had established plans to complete the integration of all business areas. The success of this transition enabled the site to focus intently on the transfer of new product technology into the facility.

Acquisition Integration

Goals and Business Driver:

Our client initiated a $9B acquisition and brought Enterey consultants on board to support the goal to fully integrate and ensure operation and compliance of both quality systems and regulatory processes within 9 months.

Discovery & Design

Enterey was brought on to ensure operation compliance of quality systems and regulatory processes.

Implementation

Our team assessed the effort, clearly scoped the responsibilities into a new project workstream structure and worked with the client to create an integrated project plan with a detailed work breakdown structure and a timeline adhering to the overall project completion date assigned by upper management.

Results Achieved

Our client successfully kicked off fifteen projects during the first phase of this program. The establishment of the PMO enabled monitoring progress and issues of each project, and regularly reporting on their status to the Steering Committee. Over $2M of efficiencies were identified during the first phase of the program.

Site Integration

Goals and Business Driver:

Our client acquired a large biotech site and marketed product from another global pharmaceutical manufacturer. Enterey consultants were brought onboard to support the need to integrate the new site and employees into its operations while ensuring the company seamlessly continued manufacture of its newly acquired product as well as four contracted products.

Discovery & Design

Enterey was brought on to support the integration of the new facility and ensure a smooth transition.

Implementation

Our team designed detailed project and communication plans, set key milestones and developed project teams to ensure completion of the construction phase of the plant, manufacturing setup and transfer of the antibody. Enterey consultants provided key project management support for both the lead project manager of the receiving plant, who reported into the site leadership team, and for site preparation for regulatory inspections by the state, FDA and EMEA.

Results Achieved

With Enterey consultants’ support and guidance, our client completed on time construction, plant commissioning and commercial product manufacturing activities. These led to successful state, FDA and EMEA approvals within the initial project timeline.

Facility Startup

Goals and Business Driver:

Our Client commissioned two new plants to be built on the West and East Coasts to be strategically located, in order to streamline their supply chain and better service their patients. Mid-way through construction, the newly hired Vice President and General Manager assessed the plant build-outs were each four months behind schedule from the corporate timeline for regulatory approval, and decided to bring Enterey onboard to manage the effort.

Discovery & Design

Enterey was brought on-board to identify ways to ensure the facilities met their buildout timelines.

Implementation

Enterey consultants carefully managed key decisions and activities from construction turnover through regulatory approval. Our team engaged with key stakeholders to ensure alignment of objectives and to create practical solutions that could be implemented rapidly. By fully characterizing the existing gap and setting key milestones with the project core-team, Enterey consultants developed a detailed execution plan, and ensured all critical deadlines were met.

Results Achieved

Our Client was able to close the gap and get both plants fully qualified on-time. With Enterey consultants’ close monitoring and guidance, deadlines were met and regulatory approvals were gained, resulting in an on-time commercial licensure which provided a net gain of over $100MM in captured revenue for our Client. 

Facility Transfer

Goals and Business Driver:

Our client anticipated rapid operations growth and had plans to move to a significantly larger facility. They knew that, to achieve the expanded scale necessary to operate the new facility, they must improve existing business processes and eliminate inefficiencies. Process improvement is the goal of this project.

Discovery & Design

Enterey was brought on-board to identify ways to improve existing business processes in order to acclimate to the expanded scale of their new facility.

Implementation

Enterey consultants facilitated collaborative sessions with client stakeholders, identifying projects and scoping a phase-gate approach to enable the company to achieve the necessary process improvement in alignment with the facility construction timeline. Our team supported the creation of  a Project Management Office (PMO) to establish governance and organization to all the projects.

Results Achieved

Our client successfully kicked off fifteen projects during the first phase of this program. The establishment of the PMO enabled monitoring progress and issues of each project, and regularly reporting on their status to the Steering Committee. Over $2M of efficiencies were identified during the first phase of the program.

Partner Collaborations

Goals and Business Driver:

Our client was collaborating with multiple partner companies to test combination therapies in clinical studies. Due to the lack of a robust business process to integrate partner documents and data into their regulatory, manufacturing and distribution systems, our client experienced delays to supply for trials. They identified a primary goal as minimizing disruptions to mitigate delays in supply.

Discovery & Design

Enterey was brought in to assist with the process of partner collaboration in order to minimize disruptions in supply and allow for smoother operations going into clinical trials.

Implementation

Enterey consultants quickly identified the pain points and focused on Planning, Quality and Regulatory to address these issues. In addition to completing an end-to-end process map linking the required documentation to the systems, our team also built a project management tool that ensured visibility to where all Partner Collaboration project stood with relation to supply.

Results Achieved

Our Client has leveraged this process since then, to prevent any supply disruptions. The Client also benefited from the improvement in their relationships with Partners, due to better communication around documentation requirements.

Manufacturing Streamlining

Goals and Business Driver:

Our client recently commissioned two new plants to streamline supply chain processes. Halfway through construction, it was identified that both plants were 4 months behind schedule from the corporate timeline for regulatory approval. The goal of the project was to ensure both facilities met regulation on time.

Discovery & Design

Enterey was brought on board to carefully manage key decisions and activities, from construction turnover through regulatory approval, and ensure critical deadlines were met. Enterey consultants fully characterized the existing gap, set key milestones with project core-team, and developed a detailed execution plan.

Implementation

Enterey worked with key stakeholders to gain alignment of objectives and to create practical solutions that could be implemented rapidly.

Results Achieved

The team was able to close the gap and get both plants fully qualified on time. With Enterey's close monitoring and guidance, deadlines were met and regulatory approvals were gained, resulting in an on-time commercial licensure, which provided a net gain of over $100M in captured revenue.

Inspection Readiness

Goals and Business Driver:

Following completion of construction and plant commissioning, our client set timelines to license its new facility and to pass all the required inspections, including State, FDA and EMEA Pre-Approval Inspections. The project goal was ensuring the new facility met these inspection criteria.

Discovery & Design

Enterey was brought in to ensure the new facility met inspection criteria by working with the internal Quality Team to identify and amend gaps in the facility's Quality System.

Implementation

Enterey consultants performed a gap analysis and provided action plans to remediate or defend the gaps identified in the plant’s Quality System. Our team provided project management support to the 14 departments throughout the plant and to the Director of Quality Assurance. In addition, our team ensured regular communication by providing updates to the Corporate Compliance and the GMP Core Team.  Enterey consultants also supported the staff during the inspections as related to defense strategies, documentation and final inspection room preparation.

Results Achieved

Our client’s facility was licensed as planned and both the State, FDA and EMEA inspections were successful. Only minor observations were issued by the State and EMEA, while there were no FDA observations. Action plans to correct the minor observations were timely and successfully implemented.

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