All programs should be derived from your company’s strategy
How do corporate goals translate into operations programs?
Risk mitigation requires transparency
We see three main risk categories for any biologics program
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.
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.
Experience
We’re industry specialists and all of our team members have worked on the client side.
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 are some examples of those accomplishments.
Capital Program Management
Capital Program Management Best Practices
The client’s Capital Investment program more than doubled per their latest LRP and it included several strategic growth projects. The client realized that their existing team was …
Product Program Management
Remediation and Qualification of a Cell Therapy Device
A small cell therapy company was developing a combination product intended for the treatment of malignant tumor cells in patients. The product was a combination product consisting …
Product Program Management
CMC Lead for Early Phase Gene Therapy Program
The client had a broad, gene therapy portfolio and was limited on resources to manage the CMC aspect of one of its programs. They requested Primecore to …
Capital Program Management
Asset Lifecycle Management across a Global Biopharmaceutical Network
A global biopharmaceutical company recognized that they did not have a consistent process for re-investing capital in their equipment assets to maintain their network. Historically, each site …
Operations and Continuous Improvement
Operational Evaluation of a Biopharmaceutical Plant
The client was a small, EU-based biopharmaceutical company that was experiencing challenges manufacturing its product. They had a single manufacturing site that continuously missed production slots, produced …
Operations and Continuous Improvement
Manufacturing Capacity Assessment for Biopharmaceutical Company
A small, new EU based biopharmaceutical company combined two manufacturing facilities into a single new network for manufacturing. The new company leadership wanted to understand the current …
Operations and Continuous Improvement
Selecting an IT Strategic Partner for a Gene Therapy Company
A start-up, gene therapy company had seven vendors providing various pieces of IT services to meet the needs of their growing organization. The client wanted to optimize …
Product Program Management
Program Management of Formulation Optimization
A growing biotherapeutic company, advancing a proprietary cytotoxic drug (against various cancers) with a better toxicity profile than the drug of standard treatment, required a much-needed revision …
Product Program Management
CMC Program Management of a New Gene Therapy Product
An innovative start-up, C> company advancing a rAAV gene therapy advancing a ground-breaking gene therapy for a rare debilitating genetic condition affecting both neurological and cardiac functions, …