Cell therapy, as defined by the American Society of Gene & Cell Therapy, is “the administration of living whole cells for the patient for the treatment of a disease” – a simple definition that belies a great deal of complexity. On the whole, the pharmaceutical industry is shifting to new therapy models, focused on tailored, personalized medicine, such as cell therapy. Driven by the potential and opportunity in these new therapies, pharmaceutical companies are making massive investments to acquire or develop capabilities relative to cell therapy – including multibillion dollar acquisitions, specialized talent, and upending tried-and-true manufacturing processes.

While most drug makers are now focusing on building the necessary infrastructure to operationalize the science behind cell therapy, soon that focus will shift more heavily to the commercial processes necessary to deliver, administer, and optimize the outcomes of the treatment as well.

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This shift to personalized medicine is making headlines and dominating boardroom discussion today but some companies have been pursuing cell therapy treatments for years. Argos Therapeutics, a North Carolina-based biotechnology company began developing individualized immunotherapies to treat cancers and other infectious diseases. Shortly following a successful Phase 2 clinical trial, Argos engaged Clarkston’s cell therapy consulting experts to help define and prepare the business processes and systems for commercial operations, with specific focus to:

• chain of identity management,
• coordination with clinics and apheresis centers,
• billing, reimbursement, and revenue recognition,
• patient enrollment,
• logistics and materials transportation, and
• manufacturing capacity allocation.

Through this project, Clarkston partnered with Argos to develop a system and process roadmap for commercialization, including a proprietary, industry-leading physician/patient collaboration and communication platform. Furthermore, the project provided Argos with a complete and comprehensive chain of identity risk assessment to ensure the full safety and efficacy of the treatment for each patient.

The commercialization roadmap and chain of identity risk assessment were designed to scale with the organization and included a multi-year deployment plan to ensure long-term success for the business. Each step of this project was designed and implemented to the complex nature of the differentiated processes and science of cell therapy. To learn more about Clarkston’s life sciences expertise or experience in personalized medicine, subscribe to our insights below to receive newsletters like this one,  or reach out to me directly.

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