Strategic Realization: Facility Start-up (Regional Scope)
A global biotech company based in Seattle, Washington 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. Midway through construction, the newly hired VP and GM assessed the plant build-outs were each 4 months behind schedule from the corporate timeline for regulatory approval.
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 the 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 anon-time commercial licensurewhich provided anet gain of over $100M in captured revenue.
Strategic Realization: Integration / Separation (Regional Scope)
A global biotechnology client initiated a $9B acquisition, with a goal to fully integrate and ensure operation and compliance of quality systems and regulatory processes within 9 months.
Enterey’s cohesive team of experts 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.
The integration team successfully delivered on every major milestone, meeting timeline commitments to complete the integration work within 9 months. Enterey not only directed project workstreams, but contributed an increasing amount of deliverables to drive resolution of actions. Timely and thorough communication was provided to ensure all team members were aligned and aware of upcoming milestones. The timely and successful integration enabled the acquiring company to drive >500% sales growth of newly acquired product within the year.
Strategic Realization: OCM Major Initiatives (Global Scope)
A large pharmaceutical company 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. This required definition of portfolio governance structure, roles & responsibilities (R&R), project management methodology, templates, and capital budget tracking.
Enterey facilitated workshops to refine the stage-gate requirements and define accountability for all project deliverables across functions. We delivered customized tools and templates for project management deliverables ranging from business case creation to closeout, including a new capital portfolio tracking tool. A special focus was given to change management and involvement of stakeholders to ensure commitment to the new model and role definitions.
Time devoted to portfolio governance was reduced by 75%due to the increased level of clarity. Allprojects now follow defined framework and R&R, ensuring alignment and accountability.New roles were successfully adoptedby IT, Business, and PM team members, with a feedback loop to enable continuous improvement in adherence to PMO requirements.
Strategic Realization: Organization Optimization (Regional Scope)
A pharmaceutical manufacturing site was seeking to identify ideal headcount targets and required efficiencies at specified run-rate targets to support a 50% reduction in cost per gram by year end. Department management was to be engaged in the overall process and implementation of the plan.
Enterey’s team determined the optimal organizational structure at specified run rates and benchmarked data against other sites. Consultants then developed a customized matrix model of run rates and headcount by department, leading to a proposal of required efficiencies to enable headcount reduction with increased span of control.
Headcount targets were identified to reach improved operational performance goals with no impact to business operations. Opportunities for staff to improve and build skill sets were increased, and opportunities for displaced employees were identified.
Strategic Realization: Program Management (Regional Scope)
A leading biotech manufacturer requested Enterey's strategic program leadership 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 the company pipeline for new molecular entities.
Working closely with corporate sponsors, Enterey Consultants developed a comprehensive program strategy that aligned with corporate goals and detailed an appropriate project budget, timeline and start up team. Enterey’s experts managed a multi-dimensional start up team by driving completion of project objectives and defining the timing of first production run.
Project met all milestones, budget and workforce constraints. Plant delivered the company’sfirst ever 100% successful clinical runwhile attaining one of the highest product yields enabling theexpansion of clinical trials.
Operations: Supply Chain, Quality & Regulatory Process Improvement (Global Scope)
A Fortune 500 pharmaceutical company wanted to leverage Annex 16 (EU) Compliance by developing and implementing a business process to map the end-to-end supply chain for all commercial products and those used to support clinical trials.
Enterey’s team of consultants developed detailed solution recommendations and a workable implementation plan. The team collaborated with Manufacturing, Management, Supply Chain, Quality, Regulatory, and Project Management functions to identify data requirements and map future-state business process solutions. Nearly 60 product supply chains were successfully created. The team also worked with IT departments to determine a technology strategy that enables long-term sustainability of new processes.
Throughout the project, the team ensured there would be no interruption to commercial or clinical supply into the EU. The team also identified efficiency opportunities in the client's Supplier Quality Management program resulting in 15% fewer audits. Finally, the client realized a streamlined regulatory filing approach through standardization of packaging, labeling and comparator procurement sites.
Operations: Manufacturing (Regional Scope)
A prominent biopharmaceutical manufacturer requested assistance in transferring its clinical manufacturing capabilities to a newly commercialized facility. This process included coordinating all aspects of the move, consulting on change control, assessing impact, and creating an implementation plan. The goal was to ensure that manufacturing requirements were met and that business processes were allowed to continue during the technology transfer.
The Enterey Consultant developed a comprehensive project plan to schedule and track all aspects of the tech transfer. This included a change control plan detailing changes to the technology system. Due to downsizing, the site became slated for closure. The Consultant proposed an alternative solution to increase productivity per man-hour and financial efficiency at the site, using detailed employee utilization and spend analyses they created.
The teamcompleted the technology transfer on schedulewhile allowing for business processes to continue undisturbed. The Consultant proposed several changes based on inefficiencies revealed in the utilization and spend analyses, including a shift change from five 8-hour to three 12-hour workdays per week. Implementation of the Consultant’s recommendations resulted in the client’s decision to continue operations at the site.Utilization skyrocketed from 50% to approximately 90%, and output increased as a result. Based on the spend analysis, the potential was created at the site formillions of dollars in savings as well as millions more in increased revenue.
Operations: Manufacturing (Regional Scope)
A large, global biologic drug manufacturer determined that human error was a major contributing factor to a considerable number of manufacturing deviations. In mid-2014, the client set a goal to reduce the deviation rate for personnel error by 5% in order to avert regulatory agency scrutiny and potential penalties.
As part of the execution, our team developed a detailed implementation plan that included: a change management and communication strategy, development of training materials specifically for internal specialists to learn how to properly perform deep root-cause analyses, creation of a root-cause analysis tool to guide the newly trained specialists through the new assessment process, a system for monitoring the implemented solution with appropriate metrics, documentation of the pilot program results and subsequent enhancements for the full-scale implementation, and a transition plan for the new human-error prevention program to process owners.
Our client doubled their goal by achieving a >10% improvement on the personnel discrepancy rate. In addition, prior to the project rollout, 100% of personnel discrepancies resulted in counseling or retraining as the only corrective action. As a result of more impactful corrective actions, by the end of 2014 over 50% of these were addressed by a systemic change instead of, or in addition to, counseling and retraining. Our client realized a cost avoidance of approximately $100,000 within drug substance manufacturing in 2014 based on the number of human-related deviations that were closed as something other than personnel issues.
Operations: OE / Tech Enablement (Regional Scope)
A leading biotech manufacturer expanded their existing business improvement program to attain Class A certification, representing demonstration of standards in business excellence. The program included three key projects; Class A certification, SAP implementation and a Lean initiative. Completion of the program would allow our client to ensure planned and predictable performance.
In collaboration with corporate sponsors, Enterey’s consulting team developed a detailed plan including project goals, associated tasks, and a timeline of activities/milestones. The team held project stakeholders accountable to assess readiness and meet project objectives. Enterey organized the formation of project teams with defined goals, standard methodologies, and reporting requirements.
The project is currently ongoing and to date has successfullymet all project milestones, including Class B attainment by Oliver Wight. Process improvements to date have yieldedsignificant labor and raw materials savings. Key savings areas included material prep and site-wide metric reporting.
Operations: Facility Operations (Regional Scope)
A global pharmaceutical manufacturer required leadership and strategic planning for their semiannual maintenance shutdowns. Until this time, their shutdowns involved several different groups but lacked a central project leader to oversee the shutdown and bring stakeholders together to ensure a safe, on-time completion of routine maintenance tasks and supporting projects. This exposed the organization to possible future FDA compliance issues (I.e. Observations, Warning Letters, 483’s or potentially worse consent decree).
Enterey created project plans involving different stakeholders from Manufacturing, Facilities, Safety, and Quality divisions. Enterey, with client input, developed a shutdown project schedule and implemented a process to collect and track maintenance activity during the shutdown. Each day, meetings were held and documented to promote clear communications among the stakeholders and to ensure smooth-flowing project logistics.
The result was atimely and safe performance of all maintenancetasks and animproved collaboration and communication process between the stakeholders for future shutdowns. As a result, a fully-optimized, standard operating procedure (SOP) was developed for the facility to utilize for future maintenance shutdowns.
Operations: Supply Chain (Regional Scope)
A global biopharmaceutical company was collaborating with multiple partner companies to test combination therapies in clinical studies. They lacked a robust business process to integrate partner documents and data into their regulatory, manufacturing and distribution systems resulting in delays to supply for trials.
A team of Enterey consultants quickly established where the pain points existed and focused on Planning, Quality and Regulatory to address the issues. In addition to completing an end-to-end process map linking required documentation to systems, the Enterey team also built a project management tool that provided visibility to where all Partner Collaboration projects stood with relation to supply.
The client has leveraged the process toavoid any supply disruptions. Partnerrelationships have also improveddue to better communications around documentation requirements.
Operations: Training (Regional Scope)
Newly hired Drug Substance technicians required 6-9 months of training before contributing to manufacturing operations, adversely affecting the plant's ability to be responsive to changes in demand. A significant reduction in time-to-proficiency was required to meet increased demand.
Enterey managed the solution design through implementation, partnering with manufacturing SMEs to design a curriculum roadmap from hire to advanced mastery. Solution entailed sustainable training support structure with metrics, documents, qualified trainers, and clear roles and responsibilities.
The resulting process outperformed the goal of a 90-day timeline from hire to proficiency, enabling the plant to meet nearly double the production demand from the previous year. The cost reduction on trainee time to proficiency was estimated to be $4M in the first year.
Quality & Regulatory: Quality Systems (Regional Scope)
With construction and plant commissioning complete, a leading biotech manufacturer set timelines to license its new facility and to pass all required inspections – State, FDA, and EMEA Pre Approval Inspections.
Enterey provided a gap analysis and action plans to remediate or defend the identified gaps in the plant’s Quality System. Enterey provided project management support to the 14 departments throughout the plant and to the Director of Quality Assurance. In addition, Enterey provided the communication updates to Corporate Compliance and the GMP Core Team. Enterey also supported the staff during the inspections with defense strategies, documentation and final inspection room prep.
The facility was licensedas planned. The State, FDA and EMEA inspections were successful. There were no FDA observations. Observations issued by the State and EMEA were minor, and action plans to correct were implemented.
Quality & Regulatory: Regulatory Operations (Global Scope)
A global pharmaceutical company’s benchmarking study showed that their volume of regulatory submissions was ~50% greater than industry average, leading them to develop a strategy to plan and manage regulatory technical changes and reduce overall change volume.
An Enterey team of consultants was brought onboard to refine and implement the program strategy. They worked with the key stakeholders to develop an integrated project plan to set milestones and identify interdependencies while actively coordinating day-to-day activities for a multitude of related workstreams.
The team initiated and collaborated on designing a future state process and associated requirements for supporting IT solutions to reduce the time it takes to assess technical changes by over 50%. The new process standardized documentation, evaluation and prioritization of these changes in order to enable a reduction in the number of regulatory-impacting technical changes that get initiated by 20%.
Quality & Regulatory: Risk Management (Global Scope)
A small drug-development company based in Southern California set out with the goal of acquiring a commercial product license for its oligonucleotide manufacturing facility. They instituted a pre-approval inspection (PAI) readiness program and achieved EU product approval after a successful EMA audit. The company looked to ensure the same success for their upcoming FDA inspection. The goal was to conduct a PAI to ensure a FDA inspection with no critical observations.
Enterey supported this PAI and inspection process through internal audits and mock inspections performed by former FDA inspectors. The Consultant team managed a gap assessment, composed a risk analysis, and partnered with the client to prioritize and address the logistics of tackling each item. The team ensured risks were successfully remediated while maintaining adherence to the applicable regulations and guidelines. Consultants designed and ran an inspection “war room” complete with a custom software program and communication process that provided necessary support and documentation to alleviate auditor requests/concerns during the inspection.
All FDA auditor concerns were quickly and satisfactorily resolved, resulting in a successful inspection with no critical findings. Furthermore, the client achieved their goal of receiving approval for commercial manufacture from both the EMA and FDA.