White Papers

MARK-WP-03

Solving Complexities In the Era Of Personalized Medicine

Cell and gene therapies are fundamentally different than traditional medicines, from the patient and product journeys to the systems and supply chain that support it. These
personalized medicines move through development at a faster pace than traditional drugs, with some reaching approval within four to five years from first-in-human trials. Bringing personalized medicine to market successfully, such
as cell and gene therapies, requires industry expertise and a rigorous control process, coupled with advanced technology. Here, in this paper, we outline current challenges, their solutions, and a framework for how to choose a strategic partner in cell and gene therapy supply chain solutions.

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    MARK-WP-03

    Solving Complexities In the Era Of Personalized Medicine

    Request a Copy

    Cell and gene therapies are fundamentally different than traditional medicines, from the patient and product journeys to the systems and supply chain that support it. These
    personalized medicines move through development at a faster pace than traditional drugs, with some reaching approval within four to five years from first-in-human trials. Bringing personalized medicine to market successfully, such
    as cell and gene therapies, requires industry expertise and a rigorous control process, coupled with advanced technology. Here, in this paper, we outline current challenges, their solutions, and a framework for how to choose a strategic partner in cell and gene therapy supply chain solutions.

    MARK-WP-02

    Utilization of Customs Warehouses in the Clinical Trial Supply Chain

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    The global clinical trial supply chain industry has been seeking new opportunities to improve efficiency for many years. As pressures to decrease cost and reduce time to market continue to rise, the design of the clinical trial supply chain must evolve and change to meet those demands. A European Union (EU) based customs-bonded warehouse may provide solutions for reducing costs while optimizing distribution throughout the clinical trial supply chain.

    MARK-WP-01

    Supply Chain Solutions for the Growing Orphan Drug Market

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    Orphan drug development has seen significant growth in recent years, with many large pharmaceutical companies shifting focus from traditional, mass market drugs to treatments for rare diseases. Orphan drugs are defined by the U.S. Orphan Drug Act of 1983 (ODA) as a drug intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.