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Cell and gene therapies: Commercialization considerations

Cell and gene therapies represent a major opportunity for patients and pharmaceutical manufacturers alike. With billions of dollars of investment, this emerging field of medicine is on its way to a forecast $50bn market size by 2025.

But working with living cells or genetic material creates new intricacies and dependencies that require changes to the commercialization process. For the first time, the patient is part of the supply chain.

The commercialization model transformed

Traditional small molecule and biologic supply chains and patient programs move linearly from clinical to commercial. Each individual component may be complex but there are only marginal dependencies between them.

The transformed cell and gene therapy commercialization model is interconnected and personalized. Specialized logistics, patient programs and health outcomes evidence must be integrated if the process is to work smoothly and deliver data to drive adoption of the therapy.

The path to the patient looks radically different, causing decisions made during clinical development to have a bigger effect on commercial supply chains than is typical.

Interdependencies Between Components Flow - Image 1
Interdependencies between component (non-exhaustive)

A path moving forward

The challenges related to cell and gene therapy commercialization must be handled via a coordinated, linked approach, not on an isolated case-by-case basis. This is inevitable given the interrelated nature of the challenges.

By recognizing the process interdependency and keeping the end state in mind, therapy owners can make a sequence of complementary choices.

Logistics and Manufacturing Map - Image 2
Logistics and manufacturing scaling up as the study moves through phases

Key considerations

When transitioning from a clinical to commercial state, therapy owners should be asking:

  • Can the supply chain scale up and out to serve an increasing number of patients?
  • Are interdependencies between ordering, patient programs, logistics, manufacturing, payment and other components understood?
  • Can product value evidence be generated to provide therapy owners with what they require to secure and maintain coverage?
  • Can barriers to access and affordability be brought down using a patient-services hub that delivers a consistent experience to prescribers and patients?
  • Can risk-sharing reimbursement models alleviate payer concerns about budget impact?

Word Courier, together with the rest of AmerisourceBergen’s portfolio, establishes interconnectivity at each link from blood draw to billing. This is intended to provide manufacturers with the “needle-to-needle” visibility they need to meet the needs of providers, patients and payers. 

Download the interactive white paper Commercializing Cell and Gene Therapies​ for actionable insights for those ready to shape this new landscape. Authored by AmerisourceBergen’s multi disciplinary and market-leading experts, readers will learn what it takes to design an effective commercialization strategy and execute an integrated solution when the patient is in the supply chain.

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