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Risk mitigation requires transparency

We see three main risk categories for any biologics program

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All programs should be derived from your company’s strategy

How do corporate goals translate into operations programs?

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As the leader of your organization, your charge is to align your team

Prioritize your programs based on the value
to your business

You’ve secured financing for your new program. You’ve outlined timelines to your investors and stakeholders.

Now it’s time to deliver.

Primecore is a life sciences consulting firm focused on operations: Product and pipeline program management, manufacturing, supply chain, capital projects and delivering on strategic initiatives.

At Primecore, we use best practice program management skills to help life science and gene therapy companies deliver on their commitments and realize the full potential of their product portfolio. We partner with you to roll out strategic programs designed to create optimum value for patients and shareholders alike.

Our services are focused on your operations

We help clients by providing program leadership and expertise in the pharmaceutical, biotech, gene and cell therapy space. Our service offerings help optimize performance and better deliver on our clients’ strategic and operational commitments. We also provide subject matter experts to augment organizations or programs as needed. In all cases, our teams go beyond just the consulting phase by seeing every project through to success.

Product Program Management

It all starts with your products, or assets, as they drive the value in your company. We help unlock the potential of your assets by deploying best practices of program management coupled with our experienced, pragmatic approach to developing biologics. Priorities can change quickly so the business processes require both structure and agility to be successful.

Network and Supply Strategy

The commercial and business strategy needs to be translated into an operations strategy for the supply network and each product. We help you define the operations strategy and then determine the optimum network based on requirements and guiding principles. Individual product CMC strategies and product life cycles are developed to align with the overall network.

Capital Program Management

Delivering capital programs is where our best practices were developed. The value of any capital project is typically locked in during the requirements and concept phase; we focus intensely on upfront project definition that is aligned with the business case and ensure the program benefits are realized. From there, we manage execution on site to ensure the strategic benefits are realized.

Operations and Continuous Improvement

Your facilities and business processes are key enablers to your products success and require optimization to deliver on the investment. As processes change or new products are introduced, it is important to reevaluate your operations and ensure the product program requirements are met now and in the future.

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The Primecore Difference

Three things set Primecore apart from other consulting firms. Separately, each can make a profound impact on the client experience and the ultimate success of your product. Combined, they define a unique and powerful resource you can trust to deliver results.

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Experience

We’re industry specialists and all of our team members have worked on the client side.

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Focus

We only focus on the biotech and the ATMP space providing best practice solutions unique to the industry.

Agility

We can work across the full development cycle, taking you from pre-IND all the way through launch and life cycle management.

A case for experience

Over the years, we’ve had the privilege of partnering with some of the most progressive and innovative firms in the industry. Here’s some examples of those accomplishments.

Product Program Management

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Providing Program Management for a Phase 3 CMC Program

The client required the development of an integrated program approach for a schedule driven Phase 3 program. There were several key workstreams such as process development, tech …

Network and Supply Strategy

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Realizing Asset Full Potential through Operations Best Practices

A leading Gene Therapy organization had a significant pipeline of high potential pre-clinical and clinical assets. While the assets were mature from a research perspective, they had …

Capital Program Management

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Leading a Business Critical Capital Project for API Production

Primecore was approached by a biologics company to review the status of a ‘business critical’ capital project which was in the early stages of execution – the …

Operations and Continuous Improvement

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Development and Deployment of Manufacturing Accounting Model

The client is a multinational, biotech company with manufacturing facilities around the world. Each facility had a complex mix of processes at different stages of production and …

Product Program Management

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CMC Package for Phase II Regulatory Submission

The client was a small, cell therapy company developing a novel patient-specific immunotherapy vaccine for cancer. The FDA placed the company on clinical hold pending submission of …

Network and Supply Strategy

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Developing Pharmaceutical Product Strategies for Operations

Following a major acquisition that more than doubled the product portfolio, the client wished to create product operation strategies for their commercial and pipeline products. Primecore was …

Capital Program Management

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Auditing a $2.1B Capital Project for the Board of Directors

A significant capital project had been re-baselined, following a Monte Carlo risk assessment, which resulted in a significant increase in the project budget and timelines. As a …

Product Program Management

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Biopharma Portfolio Management

A client was struggling to retain control of a complex and ‘evolving program’. There was a general lack of clarity in terms of how the program was …

Operations and Continuous Improvement

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Deploying Pharmaceutical Operations Strategy

The client was a mid-size pharmaceutical company based in the EU but had a global manufacturing network. The assignment was to identify the optimum API network of …

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