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

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.

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.

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

• 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

• 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

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

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.

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.

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

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.

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. 

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.

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.

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.

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

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.

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.

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

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.

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.

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

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.

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.

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

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.