HELPING PHARMACEUTICAL COMPANIES
DELIVER THEIR PRODUCT STRATEGY

Support Services

Many of our clients are Top Ten Bio- Pharma , we also deal with start-up organisations ..
This is feedback from our clients over the last 5 years

Leadership Mentoring Program (Regional Leadership Team)

Testimonial

“Primecore provided expertise – the ability to understand our business and to apply the general principles of the Primecore business models to our business.  Its all round quality.”

Snr. Director of PMO Europe.

Background

Company size:  3,000 employees; Valuation $20B to $50B

Industry sector and location: API Pharmaceutical  Europe

Assignment Duration:  Six months

Client Sponsor:  Head of Operations

Assignment Objective 

Following the successful roll out of a new governance program, the client requested that Primecore provide an individual for a period (six months) who had expertise in the management and governance of strategic programs.  While the theory of Program management best practice was well understood by the client, they had the maturity to recognize that new business processes take between six and twelve months to become embedded within an organization.

Approach

While Primecore had a lead on site who had just completed the roll out of the new processes, the decision was taken to change out the lead and to provide an individual with expertise not just in Program Management but with Change management expertise also.

The objective of the program had now changed, the emphasis was no longer on the education and familiarization of the client with Program management best practice but was to provide support and encouragement to the client’s Program Managers as they developed their inner leadership capability.

Outcome

Primecore see this program as particularly successful as true success is  measured when the assignment has been completed and the client has demonstrated the capability to sustain the improvements.

A number of the Program managers spoke at the company town halls describing their experience, their key learnings and how they have developed a more effective leadership style.

Lessons

It is important to recognize that the needs of a program will vary at different points in its life cycle and that the individual with the appropriate skills to launch a program may not be the most appropriate during the mentoring and embedding phases.

Leadership Mentoring Program (Regional Leadership team)

Testimonial

“Primecore has a demonstrated track record in delighting us here with an excellent service for over 4 years. Their responsiveness is excellent, providing a range of capable & knowledgeable solutions & people fulfilling identified business needs in both technical and leadership areas. Primecore provide only the best and most experienced people to us, standards are consistently maintained throughout and flexibility assured without ever compromising the quality of service.”

Snr. Financial Director

Background

Company size:  1,000 employees  (Site impacted); Valuation $100B to $150B (Parent company)

Industry sector and location: BioPharma  US

Assignment Duration:  Twenty four months

Client Sponsor:   Head of Operations 

Assignment Objective 

The client in question was subjected to a consent decree by the FDA for both its Drug substance and Drug product operations. The decision was taken at an exeutive level to upgrade the Bulk drug substance process and to transfer drug product operations to a contract manufacturing organization (CMO) until suitable facilities were built to transfer the drug product back in-house.

Primecore were requested to provide a program leader who could find a suitalble CMO, transfer the process and manage the CMO until a suitable in-house resource had been identified.

Approach

Fortunately Primecore had an individual available who had both worked as a General Manager for a CMO in the past and had also managed a number of CMO contracts on behalf of a previous employer.

The primary focus from a Primecore perspective was to ensure that a robust and achievable plan was put in place. Once this was agreed, this assignment effectively became a secondment from a Primecore perspective as all communications from that point forward were with the appointed CMO and the client organization.

Outcome

This program was very successful and all products have now been transferred into a new European based filling operation within the clients in-house network.

Lessons

The key lesson on this assignment was the importance of building a good working relationship with the CMO’s team.  It is important that the program manager has a good understanding of both perspectives and works towards the achievement of a ‘win win’ scenario.  While much work was done upfront to develop a good and fair contract between the CMO and client, once agreed their was little reference to this contract.  More emphasis was placed on the development of a good an flexible relationship that met the needs of both parties.

Support with FDA Compliance Audits

Testimonial

“The individual Primecore provided to fill our Program Management needs blended seamlessly into the company and quickly established an important presence. He has contributed significantly to the efficient and effective management of a number of important projects. He is definitely an A-list player.”

Chief Regulatory Officer

Background

Company size:  Valuation $20B to $50B

Industry sector and location: BioPharma US

Assignment Duration:  Twelve months

Client Sponsor: Chief Regulatory Office

Assignment Objective 

To provide program leadership to support the client with the addressing of regulatory issues with the FDA.

Approach

From a Primecore perspective, this was a secondment where we provided a high caliber individual to provide needed resources and expertise to the client organization.

Outcome

The client successfully addressed all of their regulatory issues to the satisfaction of the FDA and the international regulatory bodies.

Lessons

In many situations the best support that Primecore can provide to a client is to provide a high caliber resource, to provide them with additional expertise and resources for a critical period in a company’s development.

What Our Clients Say About Us

“The Primecore staff I have worked with take time to understand the business requirements and tailor the solution to ensure the business outcomes are at the heart of the solution. ”