Helping Pharmaceutical Companies
Deliver Their Product Strategy
Company Wide Support
Our clients are Top Ten BioPharma and start-up organisations.
This is feedback from our clients over the last 5 years
Global Roll out of Operations Strategy;
Development Deployment and Delivery
“Over the last number of years, I have engaged Primecore to support a number of strategically important initiatives for our enterprise. These engagements have varied across a spectrum of efforts including; portfolio and product reviews, specific project support and strategic review of manufacturing operations. The feedback from my team on Primecore is consistent; they deliver high value for money due to their practical and engaged process towards problem definition and solution development. Their team is composed of mature practitioners who have real world experience of managing operations globally, these attributes resonate with our team and creates a true partnership between the client and Primecore. I have no hesitation in recommending the Primecore team.”
Snr. Director Portfolio Management Office.
Company size: 14,000 employees; Valuation $30B
Industry sector and location: Biologics US, Europe & Asia
Assignment Duration: Two years (ongoing relationship)
Client Sponsor: Global Head of Technical Operations; Operations Leadership Team (Strategy, Manufacturing, Development, Capital Management, Finance)
This company came into being as the result of a split from its parent company. Prior to the split the company operated as a decentralized organization with facilities located within the US, Europe and Asia; each with its own objectives and associated business processes. The desire of the new Head of Technical Operations was to have the various site organizations amalgamated into a single organization operating to one business strategy with centralized leadership and one set of business processes. The company had ambitious plans in terms of product launch and commercialization and operational cost reduction.
1. Feasibility study to establish the viability of a European based manufacturing operation supporting the launch of a new vaccine based product into the US market. – Contact: Vaccine Division Franchise Head.
2. Development of a global operations strategy to underpin all future investment decisions in support of the product portfolio – Contact: Head of Global Manufacturing.
3. Deployment of the above strategy to its network of manufacturing sites; both in-house and contracted manufacturing – Contact: Head of Global Manufacturing.
4. Piloting of a governance business process; to be utilized for new product launch – Contact: Head of Product Development.
5. Development and roll out of standardized business processes to manage the capital portfolio (Strategic and Non-Strategic) and individual capital projects – Contact: Head of Capital Projects.
6. Design and roll out of a standardized cost accounting process across the network of sites.
1. This assignment was a particularly successful assignment for Primecore and its client. Three years on the client has achieved many of its goals and objectives which have been recognized through corporate awards. While there has been some adjustment to the portfolio over the years, this approach has led to very significant improvements to the performance of this region.
2. The plants involved have both endured rationalization and benefited from investment but have at all times been focused on the realization of clear business objectives.
1. To develop a stable and effective portfolio management process, the leadership team must first be fully bought in to a common set of prioritized goals and objectives.
Development and Delivery of a Comprehensive Operations Strategy
“Their structured approach, the Quality of Primecore’s work and focus on risk mitigation helped to bring order to a demanding situation. Taking away emotion and tackling unrealistic expectations resulted in sound decision making.
The Seniority of Primecore’s staff gives our team comfort. The experience of your people, their longevity in the industry, lessons from their past mistakes and scars has delivered benefit. Although some of the larger well-known consultancy houses have impressively qualified people they have not necessarily been ‘in the trenches’
Primecore people are personally invested in the projects they are working on and through partnership moved our people up the learning curve with their excellent knowledge base.”
Company size: 400 employees; Current Market Valuation $3B
Industry sector and location: Gene Therapy, US
Assignment Duration: Two years (ongoing assignment)
Client Sponsor: Chief Operations Officer (COO)
The Client Sponsor (Chief Operations Officer) had worked with Primecore in his previous role as COO with another client company. Soon after joining this company (less than a month) the COO onboarded Primecore to support him with the development of an Operations Strategy to deliver an impressive pipeline of products at various stages of development (pre-clinical, early/late stage clinical and launch).
While some initiatives were in play, no comprehensive operations strategy had been developed to ensure appropriate and timely alignment with the business need.
The Approach was sequenced in four steps based on business importance and urgency:
- Near term needs of the product pipeline
- Medium term needs of the product pipeline
- Near term needs of the supporting functions
- Medium term needs of the supporting functions
1. Measures to address near term needs of the product pipeline.
Each product was looked at and a product specific operations strategy was developed, taking into account: lifecycle status, business need date and business criticality.
i. One product was at an advanced stage of execution towards BLA submission. In this case the Primecore support was limited to document reviews. (This product has since been licensed)
ii. For a second product, the commercial rights had been licensed to a third party. In this situation Primecore was requested to support the client’s Business Development and Legal team with the drafting of a contract whereby the client would continue to manufacture the product for a defined period under contract.
iii. A third product, which was deemed to be ‘business critical’ was transitioning from phase I/II clinical trials to phase III within the coming twelve months.
Primecore looked at the option of building a manufacturing facility to produce this product, however, with this was not feasible with the business need timelines involved.
The focus changed from in-house manufacture to identifying an appropriate Contract Development and Manufacturing Operation (CDMO) as a strategic partner to scale up and manufacture Phase III material on a contract basis. Primecore identified three potential companies which were visited and evaluated by the client and Primecore before selecting one.
Once the partner company was identified, Primecore provided the Program Leadership and governance to Tech. Transfer the process and coordinate the scale up and supporting requirements (Analytical methods etc.) in line with the required timeline. It was critical that Phase I/II bridging studies be completed using the new high-volume suspension process. This would allow the manufacturing process to be used for the higher volume Phase III trials and commercial launch.
This work was completed successfully in time for the bridging study.
2. Measures to address the medium term needs of the product pipeline.
The medium term measures were broken into two categories:
i. Upgrade of the existing cGMP roller bottle manufacturing facility.
The existing manufacturing space was constrained and didn’t provide space for an MS&T laboratory, or for required headcount expansion. Some space was coming available, due to the moving of the Research and Process Development laboratories to a new building, but this would not be sufficient to provide an optimum solution.
Key to success with this assignment was the development of a good Basic End User Requirements Brief to gain a strong understanding of the End User needs and the prioritization of those needs.
Understanding the Basic End User Requirements confirmed that the existing space was too constrained, particularly when constructability issues were taken into consideration.
This required ‘blue sky’ thinking, with the ultimate solution involving the leasing of additional space to house functions which did not have a hard adjacency with the manufacturing suite and the leasing of a short-term office to house some staff during construction.
ii. Identification of the optimum location for a ‘green field’ manufacturing facility.
The client identified the need for an in-house commercial launch facility should one or more of its higher volume products be successful in Phase III clinical trials.
To minimize the timeline to bringing on this facility, the decision was made to conduct the site selection process at risk, allowing the project to go into immediate planning once the need was confirmed.
Primecore followed a standardize process to identify the optimum site locations:
- All site options were identified
- Those options deemed to be non-feasible were eliminated from the list, with an accompanying explanation
- Agreement was reached on the criteria by which one site might be preferred over another; and weightings were applied to these criteria
- Each of the options were scored against the criteria, providing clear prioritization
- The recommendation was presented and signed off by Senior Leadership
3. Measures to address near term functional support issues.
The rapid expansion of our client company had created three near term functional support requirements:
- Expanded Research Laboratory
- Technical Development Laboratory
- Process Development Laboratory
- Additional office capacity requirements for non-laboratory Research staff
These were combined into a single project and followed the standard Primecore approach for strategic Programs:
- Establish the Basic End User Requirements
- Evaluate, prioritize and select the preferred strategic option
- Develop, evaluate and select a conceptual option for the preferred strategic option
- Develop a Detailed End User Requirements Brief for the selected option
- Establish the various workstreams (Capital Project, IT & AV, Branding and Culture, Laboratory Operational readiness, Corporate Facilities Operational readiness, LIMs etc.)
- Develop a Level III Schedule, risk register and budget for the program
- Complete the detailed planning to achieve full scope lock
- Execute the work in line with the approved scope, Schedule and budget, while actively managing risk
This assignment lead to a $40M capital program which was executed on time and on budget with a very high level of End User satisfaction.
4. Measures to address medium term functional support issues.
Up to this point in time, most of the assignments were reactive, in that they were addressing issues that had already arisen (the exception being the future need for a ‘green field’ multi-product launch manufacturing facility).
The building leased for the Research, Tech. Development and Process Development Laboratories had the option available of leasing two additional floors.
A strategic study was commissioned, whereby Primecore established the different uses for these floors, including the transitioning of Corporate and Global support staff from another building to this building, to try as far as possible to have staff under one roof; thereby increasing collaboration and with that creativity and productivity.
Because of the exponential growth of this company; developing a strategy, planning and implementing it in line with the business need remains a challenge. Based on current growth projections, the defined operations strategy; program planning and execution will have fully realized all business needs within the next twelve months. Beyond this point the company should be in a position to be proactive, rather than reactive, in relation to Operations strategy.
1. Primecore is delighted to say that all assignments have been successful and the learnings have been positive lessons. Despite the extreme business urgency of many of the programs, the client and Primecore did not attempt to short circuit the strategic investment and planning process.
i. The investment decisions were sound; if faced with the same decisions today Primecore believes that their client would make exactly the same choices.
ii. All of the programs were well planned; significant time was invested in the development of End User Requirement Briefs to ensure optimum ‘fit for purpose solutions’ were provided.
iii. Much effort was put into scope development to find optimum solutions and to fully define them prior to execution. The outcome of this effort meant that projects were executed to very aggressive timelines with no late End User changes and minimal rework.
2. For Primecore, we learned once again the importance of a strong partnership between the client and Primecore team.
3. The client provided clear and decisive business leadership which was vital to being able to make high quality strategic decisions against very tight timelines.